Friday, September 27, 2013

Antizole 200mg | Albendazole 200 mg/tab.


Antizole 200mg
Albendazole 200 mg/tab.

Company Name
Alexandria

Therapeutic Group
ANTHELMINTICS

Pharmaceutical form
Tablet

Package
2, 10, 20 or 100 tablets

Indications
Antizole (albendazole) is indicated for the treatment of the following infections: Neurocysticercosis. Antizole is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . Lesions considered responsive to albendazole therapy appear as nonenhancing cysts with no surrounding edema on contrast-enhanced computerized tomography Hydatid disease. Antizole is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus This indication is based on combined clinical studies which demonstrated non-infectious cyst contents in approximately 80-90% of patients given albendazole for 3 cycles of therapy of 28 days each

Warning & Precautions
General: Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of anticysticeral therapy Pregnancy: Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus Nursing Mothers: It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when albendazole is administered to a nursing woman. Pediatric Use: Experience in children under the age of 6 years is limited. In hydatid disease, infection in infants and young children is uncommon, but no problems have been encountered in those who have been treated. In neurocysticercosis, infection is more frequently encountered


Product Type
Human

Dosage

As directed by the physician or as follows:
Dosing of Antizole will vary, depending upon which of the following parasitic infections is being treated.
Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required.
Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment.
Indication :
Hydatid Disease : Patient Weight (60 kg or greater) : Dose (400 mg b.i.d., with meals) : Duration (28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles).
Hydatid Disease : Patient Weight (less than 60 kg) : Dose (15 mg/kg/day given in divided doses b.i.d. with meals (maximum total daily dose 800 mg)) : Duration (28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles).
NOTE: When administering Antizole in the pre- or post-surgical setting, optimal killing of cyst contents is achieved when three courses of therapy have been given.
Neurocysticercosis : Patient Weight (60 kg or greater) : Dose (400 mg b.i.d., with meals) : Duration (8-30 days) .
Neurocysticercosis : Patient Weight (less than 60 kg) : Dose (15 mg/kg/day given in divided doses b.i.d. with meals (maximum total daily dose 800 mg)) : Duration (8-30 days).
Children up to 2 years of age:
10 mg /kg body weight as a single dose

Adverse Reactions
Abdominal pain, nausea/vomiting, headache, dizziness/vertigo Dermatologic: Rash, urticaria Hypersensitivity: Allergic reactions Acute renal failure has been observed Abnormal renal function test Leukopenia

Contra Indications
Antizole (albendazole) is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds

Drug Interactions
Dexamethasone: Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when 8 mg dexamethasone was coadministered with each dose of albendazole (15 mg/kg/day) in eight neurocysticercosis patients. Cimetidine: Albendazole sulfoxide concentrations in bile and cystic fluid were increased (about 2-fold) in hydatid cyst patients treated with cimetidine (10 mg/kg/day) compared with albendazole (20 mg/kg/day) alone. Albendazole sulfoxide plasma concentrations were unchanged 4 hours after dosing.

5 EgyDrug Index: September 2013 Antizole 200mg Albendazole 200 mg/tab. Company Name Alexandria Therapeutic Group ANTHELMINTICS Pharmaceutical form Tablet ...

Antiver Suspension | Mebendazole 100 mg/5ml.


Antiver Suspension
Mebendazole 100 mg/5ml.


Company Name
Alexandria

Therapeutic Group
ANTHELMINTICS

Pharmaceutical form
Suspension

Package
30 ml

Indications
Antiver is the anthelmintic of choice for the treatment of infections with: Enterobius vermicularis (Oxyuris, Pinworm) Ascaris lumbricoides (Roundworm) Ancylostoma duodenale (Hookworm) Trichuris trichiura (Whipworm) Strongyloides stercoralis (Threadworm) Taenia spp. (Tapeworm) Mixed helminth infections.

Warning & Precautions
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Product Type
Human

Dosage
As directed by the physician or as follow: The same dosage regimen applies to adults and children over two years. Enterobiasis: One teaspoonful (5 ml ) as a single dose, repeated after two or three weeks. Ascariasis, Ancylostomiasis, Trichuriasis and Mixed infections: One teaspoonful ( 5 ml ) morning and evening for three consecutive days. Strongyloidiasis and Taeniasis: Two teaspoonful ( 10 ml ) morning and evening for three consecutive days. N.B: No special dietary measures, fasting or purging are required before or after the treatment with Antiver suspension.

Adverse Reactions
No side effects have been reported.

Contra Indications
As with other preparations containing mebendazole, the drug is contra-indicated during pregnancy.

Drug Interactions
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5 EgyDrug Index: September 2013 Antiver Suspension Mebendazole 100 mg/5ml. Company Name Alexandria Therapeutic Group ANTHELMINTICS Pharmaceutical form Suspensi...

Antiver 100 mg tablets | Mebendazole

Antiver 100 mg Mebendazole 100 mg/tab.

Antiver 100 mg
Mebendazole 100 mg/tab.

Company Name
Alexandria

Therapeutic Group
ANTHELMINTICS

Pharmaceutical form
Tablet

Package
120 Tablets

Indications
Antiver tablets are used for the treatment of parasitic intestinal infections caused by: - Nematodes (Oxyures, Ascaris, Trichuris or Trichocephalus trichiurus, Strongyloides, Ankylostomes) - Certain cestodes (Tinea saginata and Taenia solium)

Warning & Precautions
It is known that this product is not studied sufficiently on children less than 1 year of age where convulsions have been observed in some isolated cases. - Antiver tablets must not be given to children of such class of age if their nutrition and growth are notably distributed. - This product should be used with caution in patients showing hypersensitivity to acetylsalicylic acid or other prostaglandin inhibitors.





















Product Type
Human

Dosage
As directed by the physician or as follow: Adults & children starting from one year of age, independent on patient's weight: Oxyures: 1 tablet to be taken once daily, it is recommended to repeat the treatment 15 days later. Ascaris, Trichuris, Strongyloides, Ankylostome and Mixed infections: 1 tablet to be taken in the morning and evening for 3 consecutive days. Tineas: 1 - 2 tablets to be taken twice daily for 3 consecutive days. For the administration in children, it is possible to crush tablets into fine powder. It is not necessary to support this treatment with diebetic measures or laxatives.

Adverse Reactions
Patients suffering from parasitic infections may develop diarrhea & abdominal pain when treated with antiver tablets. Central nervous system side effects: headache, vertigo. Gastrointestinal tract: abdominal pain, diarrhea, nausea, vomiting (these symptoms may be due to the infection itself)

Contra Indications
Hypersensitivity to any of the drug components.

Drug Interactions
- Simultaneous administration of cimetidine with mebendazole may interfere with hepatic metabolism of mebendazole thus increasing its plasma concentrations. - Concomitant administration of carbamazepine and phenytoin accelerates mebendazole metabolism thus lowering its plasma & tissue concentrations. - simultaneous administration of mebendazole & metronidazole must be avoided.






5 EgyDrug Index: September 2013 Antiver 100 mg Mebendazole 100 mg/tab. Company Name Alexandria Therapeutic Group ANTHELMINTICS Pharmaceutical form Tablet ...

Antiscab 33% Cream | Benzyl benzoate

Antiscab 33% Cream Benzyl benzoate 33 mg / 100 ml

Antiscab 33% Cream
Benzyl benzoate 33 mg / 100 ml

Company Name
El Nasr

Pharmaceutical form
Cream

Package
Lotion : 100 ml glass bottles

Indications
Benzyl benzoate is an acaricide used in the treatment of scabies. (It has also been used as a pediculicide.)

Warning & Precautions
- Dilution decrease efficacy - Avoid contact with eyes and mucous membranes; do not use on broken or secondary infected skin

Product Type
Human

Dosage
Children above 10 years: Dilution to reduce irritant effect also reduces efficacy Adult dose: it is customary to apply benzyl benzoate as a 33 % application i.e.

Adverse Reactions
Benzyl benzoate is irritant to the eyes and mucous membranes and may be irritant to the skin. Hypersensitivity reactions have been reported. Burning sensation especially on genitalia and excoriations; occasionally rashes.

Contra Indications
- Infants and children below 10 years. - Pregnancy - Lactation

Drug Interactions


5 EgyDrug Index: September 2013 Antiscab 33% Cream Benzyl benzoate 33 mg / 100 ml Company Name El Nasr Pharmaceutical form Cream Package Lotion : 100 ml glas...

Antiscab 33% Lotion | Benzyl benzoate



Antiscab 33% Lotion
Benzyl benzoate 33 mg / 100 gm


Company Name
El Nasr

Pharmaceutical form
Lotion

Package
Cream : 80 mg. Tube

Indications
Benzyl benzoate is an acaricide used in the treatment of scabies. (It has also been used as a pediculicide.)

Warning & Precautions
- Dilution decrease efficacy - Avoid contact with eyes and mucous membranes; do not use on broken or secondary infected skin

Product Type
Human

Dosage
To be applied on the infected area

Adverse Reactions
Benzyl benzoate is irritant to the eyes and mucous membranes and may be irritant to the skin. Hypersensitivity reactions have been reported. Burning sensation especially on genitalia and excoriations; occasionally rashes.

Contra Indications
- Infants and children below 10 years. - Pregnancy - Lactation

Drug Interactions








5 EgyDrug Index: September 2013 Antiscab 33% Lotion Benzyl benzoate 33 mg / 100 gm Company Name El Nasr Pharmaceutical form Lotion Package Cream : 80 mg. Tub...

ANTISEPTOL 20% | CHLORHEXIDINE GLUCONATE.


ANTISEPTOL 20%

ANTISEPTOL 20% | CHLORHEXIDINE GLUCONATE.CHLORHEXIDINE GLUCONATE.

Company Name
El Kahira

Therapeutic Group
STOMATOLOGICALS

Pharmaceutical form
Solution

Package
Bottles of 120 ml.

Indications
Inflammatory conditions of the mouth and throat. As pre and post operative prophylaxis against infection in dental procedures,oro-pharyngeal surgery,intubations etc…., For routine oral hygiene.

Warning & Precautions
Do not swallow it





















Product Type
HUMAN

Dosage
One tablespoonful to be used without dilution 1-3 times daily.

Adverse Reactions
Very rarely tissues irritation or hypersenitivity reactions may occur.

Contra Indications
Hypersensitivity to Chlorhexidine gluconate.

Drug Interactions
Quaternary ammonium compounds loose their antibacterial activity in presence of anionic detergents [e.g - soap. And toothpaste].






5 EgyDrug Index: September 2013 ANTISEPTOL 20% CHLORHEXIDINE GLUCONATE. Company Name El Kahira Therapeutic Group STOMATOLOGICALS Pharmaceutical form Solution...

Analgex Oblong | Analgin

Analgex Oblong
Analgin 500 mg/tab.

Company Name
Alexandria

Therapeutic Group
NON-NARCOTIC ANALGESICS

Pharmaceutical form
Tablet

Package
10 Tablets

Indications
Pain in rheumatic disorders, headaches and toothache. Pain after injuries and operations. Spasmodic pain in the gastrointestinal tract, the biliary tract, kidneys and lower urinary tract. For lowering high tem¬perature in febrile diseases.

Warning & Precautions
Hypersensitivity and disturbance of white blood cells count rarely occurs during treatment with this preparation as with all pyrazolone derivatives. If during prolonged treatment, the well being of the patient is impaired, the leukocytic count should be checked, and in case of granulocytopenia the drug must be discontinued.

Product Type
Human

Dosage

Unless otherwise prescribed by the doctor, the following doses are recommended:
Adults and adolescents aged 15 years or over:
Smallest single dose : 1 tablet.
Maximum daily dose : 4x2 tablets.
Unless otherwise prescribed, the individual doses of analgex may be given for up to 4 times Over a 24 hours period, if required.
Infants less than 3 months old or weighing less than 5 kg should not be treated with analgex unless absolutely necessary, single doses of 22 mg and daily doses of 3 times (66 mg) must not be exceeded.

Adverse Reactions
The most important but rare side effects of pyrazolone preparations , such as analgex , arise from hypersensitivity reactions . the most serious reaction is a reduction in the number of white blood cells ( granulocytopenia )or theire complete disappearance ( agranulocytosis ) . therefore , if there is an unexpected deterioration in the patient’s general condition , if the fever fails to subside or recurs , if painful mucous membrane changes occur , especially in the mouth and throat , it is essential to discontinue analgex immediately and consult a doctor . Shock is the other serious hypersensitivity reaction. Its first signs are pruritus, cold sweat, dizziness, stupor, nausea, flushing or pallor of the skin, dyspnoea. If they occur, medical help must be called in without delay. Until the doctor arrives, ensure that the patient is kept flat with legs raised and airways clear. Occasionally, hypersensitivity reactions of the skin or the mucous membranes of eyes, nose and throat may occur.

Contra Indications
Analgex must not be used in patients with pyrazolone allergy, hepatic porphyria or congenital glucose – 6 – phosphate dehydrogenase deficiency.

Drug Interactions
The patients must be warned against the simultaneous consumption of alcohol because analgin may increase the alcohol effect.
5 EgyDrug Index: September 2013 Analgex Oblong Analgin 500 mg/tab. Company Name Alexandria Therapeutic Group NON-NARCOTIC ANALGESICS Pharmaceutical form Tablet ...

Amypride Tablets | glimepiride


Amypride
"Each tablet Amypride 1 mg contains, as active ingredient, 1 mg glimepiride
Each tablet Amypride 2 mg contains, as active ingredient, 2 mg glimepiride
Each tablet Amypride 3 mg contains, as active ingredient, 3 mg glimepiride"

Company Name
ADCO

Therapeutic Group
SULPHONYLUREA A-DIABS

Pharmaceutical form
Tablets


Package
Boxes of 10 tablets each of each concentration 1 mg, 2 mg, 3 mg

Indications
adjunct to diet and exercise to lower the blood glucose in patients with non insulin dependent (Type 2) diabetes mellitus (NIDDM) also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent. Combined use of glimepiride and insulin may increase the potential for hypoglycemia.


Warning & Precautions
In exceptional stress situations (e.g. trauma, surgery, febrile infections) blood glucose regulation may deteriorate, and a temporary change to insulin may be necessary to maintain good metabolic control. Hypoglycemia may occur

Product Type
human

Dosage
"1 mg Amypride once daily.
If necessary, the daily dose can be raised. and that the- dose be increased gradually, at intervals of one to two weeks and according to the followin dose steps 1mg-2mg-3mg-4mg-6mg-8mg."


Adverse Reactions
Hypoglycemia Eyes :temporary visual impairment Digestive tract :gastrointestinal symptoms such as nausea Blood :Changes in the blood picture may occur allergic or pseudoallergic creations


Contra Indications

in patients hypersensitive to glimepiride, other sulfonylureas, other sulfonamides
In pregnant women, breast feeding women , severe impairment of liver function and in dialysis patients. Severe impairment of hepatic function


Drug Interactions
"Glimepiride is metabolized by cytochrom P450 2C9 (CYP2C9). This should be taken into account when glimepiride is co-administered with inducers (e.g. rifampicin) or inhibitors (e.g. fluconazole) of CYP 2C9.
ACE inhibitors; anabolic
steroids and male sex hormones; chloramphenicol; couramin derivatives; ; cyclophosphamide; disopyramide; fenfluramine; fibrates; fluoxetine; guanthidine; isofosfamide; MAO inhibitors; miconazole; fluconazole; para¬iaminosalycilic acid; pentoxifyllin; (high dose parentral): phenylbutazone; azapropazone: oxyphenbutazone; probenecid; quinolones; salicylates; sulfin¬pvrazone; sulfonamides, antibiotics; tetracycline; tritoqualine; trofosfamide. estrogens and progestrogens; phenothiazine; phenytoin; rifampicin; thyroid hormones. H2 receptor antagonists, beta-blockers,"









5 EgyDrug Index: September 2013 Amypride "Each tablet Amypride 1 mg contains, as active ingredient, 1 mg glimepiride Each tablet Amypride 2 mg contains, as active ingr...

Ampictam 1500 mg vial

Ampictam 1500 mgAmpictam 1500 mg

Ampicillin1000 mg
Sulbactam 500 mg

Company Name
El Nile

Therapeutic Group
BROAD SPECT PENICILL INJ

Pharmaceutical form
Vial

Package
Carton box of 1 vial+solvent

Indications
- Upper & lower respiratory tract infections,- Urinary tract infections , -Intra-abdominal infections .

Warning & Precautions
-It is advisable to check periodically for organ system dysfunction during long term therapy includes( hepatic & hematopoetic systems).

Product Type
Human

Dosage
- For adults:1.5 g. every 6-8 hrs.- For children: 150-300 mg/kg body wt/day in divided doses.

Adverse Reactions
- Nausea, Vomoiting, Diarrhea, Skin rash, itching.

Contra Indications
- History of an allergic reaction to any of the penicillins.

Drug Interactions
It shouldn't be mixed with blood products or protien hydrolysates.

5 EgyDrug Index: September 2013 Ampictam 1500 mg Ampicillin1000 mg Sulbactam 500 mg Company Name El Nile Therapeutic Group BROAD SPECT PENICILL INJ Pharmaceuti...

Ampicillin 125mg Susp.

Ampicillin 125mg Susp.
Ampicillin anhydrous 125mg/5ml

Company Name
Misr

Therapeutic Group
BROAD SPECT PENICILL ORAL

Pharmaceutical form
Suspension

Package
A cartoon box contains a glass bottle of 125mg/5ml .

Indications
urinary-tract infections, otitis media, sinusitis, oral infections, bronchitis, uncomplicated community-acquired pneumonia ,Haemophilus influenzae infections, invasive salmonellosis; listerial meningitis

Warning & Precautions
Patients known to be hypersensitive to penicillins should be given an antibacterial of another class Maculopapular rashes commonly occur with ampicillin but are not usually related to true penicillin allergy. erythematous rashes common in glandular fever, cytomegalovirus infection, and acute or chronic lymphocytic leukaemia. broad-spectrum penicillins should not therefore be used for ‘blind’ treatment of a sore throat. Care is necessary if very high doses of penicillins are given, especially if renal function is poor, because o the risk of neurotoxicity Renal, hepatic, and haematological status should be monitored during prolonged and high-dose therapy. Skin contact with penicillins should be avoided since sensitisation may occur Penicillin therapy changes the normal bacterial flora and can lead to supra-infection with penicillin-resistant organisms including Clostridium difficile or Candida, particularly with prolonged use.
Product Type
Human

Dosage
By mouth, 0.25–1 g every 6 hours, at least 30 minutes before food; child under 10 years, half adult dose *Urinary-tract infections, 500 mg every 8 hours; child under 10 years, half adult dose

Adverse Reactions
hypersensitivity reactions including urticaria, fever, nausea, vomiting, joint pains, rashes, angioedema, anaphylaxis, serum sickness-like reaction; rarely CNS toxicity including convulsions (especially with high doses or in severe renal impairment), interstitial nephritis, haemolytic anaemia, leucopenia, thrombocytopenia, and coagulation disorders; also reported diarrhea (including antibiotic-associated colitis

Contra Indications
penicillin hypersensitivity or to any other ingrediants.

Drug Interactions
. Used with caution hepatic disease , electrolyte imbalance & dehydration


5 EgyDrug Index: September 2013 Ampicillin 125mg Susp. Ampicillin anhydrous 125mg/5ml Company Name Misr Therapeutic Group BROAD SPECT PENICILL ORAL Pharmaceutical...

Ampicillin 1 gm vial


Ampicillin 1 gm .

Ampicillin 1 g.


Company Name
El Nile

Therapeutic Group
BROAD SPECT PENICILL INJ

Pharmaceutical form
Vial

Package
Carton box of 1 vial Carton box of 10 vials

Indications
- Respiratory Tract Infections ,-Gastrointestinal Tract Infections , - Urinary Tract Infections , - Meningitis, -Female Genital Diseases.

Warning & Precautions
- Serious and occasionally fatal hypersensitivity reactions (anaphylactoid) - Prolonged use of antibiotic may promote the overgrowth of non-susceptible organisms, including fungi.

Product Type
Human

Dosage
-Adults and children weighing over 20 Kg:-For Genitourinary or Gastrointestinal tract infections : 500 mg.every 6 hours . - For the respiratory tract infections :.250 mg. every 6 hours.- Children -For respiratory tract infections : 50 mg / kg / day.

Adverse Reactions
GIT : glossitis, Stomatitis, nausea, vomitingHypersensitivity an erythema , mild pruritusLiver : a moderate elevation in serum (SGOT) has been noted. Haemic & lymphatic system : anemia, thrombocytopenia

Contra Indications
- Contraindicated in individuals with a history of hypersensitivity reactions to any of the penicillins and also in cases of infections caused by penicllinase- producing organisms.

Drug Interactions
Allopurionol : may lead to an increased risk of rash (monitor patients). Aminoglycosides : Ampicillin may cause in vitro inactivation of aminoglycosides if mixed in the same infusion container.- Anticoagulants , - Oral contraceptives .

5 EgyDrug Index: September 2013 Ampicillin 1 gm . Ampicillin 1 g. Company Name El Nile Therapeutic Group BROAD SPECT PENICILL INJ Pharmaceutical form Vial ...

Ampicillin 500mg Vials

Ampicillin 500mg Vials

Ampicillin 500mg Vials

Ampicillin sodium for injection B.P 2003 : Each vial contains Ampicillin (as sodium ) 500 mg.

Company Name
CID

Pharmaceutical form
Vials

Package
Box contains 50 vials, each of 500 mg .

Indications
Ampicillin is indicated in the treatment of all infections caused by susceptible microorganisms mainly : • Respiratory tract infections : bronchitis , pharyngitis , uncomplicated commonly-acquired pneumonia , otitis media , and H-influenza infection . • Gastrointestinal tract infections : Enteritis , bacillary dysentery ,abdominal typhoid and paratyphoid • Genitourinary tract infections: Cystitis, pyelonephritis, prostatitis, urethritis and gonorrhea. • Listerial meningitis (in combination with other antibiotics).

Warning & Precautions
Caution is required when using Ampicillin in the following cases: • Known history of allergy. • Patients with cytomegalovirus infection since they are susceptible to ampicillin-induced skin rashes. • Patients with impaired renal function (dose should be reduced). • Patients with acute or chronic lymphocytic leukemia. • SGOT and SGPT should be measured during therapy to monitor for liver function abnormalities. N.B. Ampicillin is not known to be harmful during pregnancy or lactation.

Product Type
human

Dosage
By IM , IV injection or infusion: 500 mg every 4-6 hours. N.B. Children under 10 years should take half adult dose.

Adverse Reactions
- Hypersensitivity reactions like skin rashes and urticaria may occur. - Antibiotic-associated colitis may rarely occur.

Contra Indications
History of hypersensitivity to penicillins or cephalosporins .

Drug Interactions
• Allopurinol : increase risk of developing skin rashes. • Bacteriostatic antibiotics (I.e.: tetracycline, Erythromycin): diminish the bactericidal effect of Ampicillin. • Estrogen-containing oral contraceptives: Ampicillin may decrease the contraceptive effect. • Probenecid: blocks the renal tubular excretion of Ampicillin and prolong its blood level.
5 EgyDrug Index: September 2013 Ampicillin 500mg Vials Ampicillin sodium for injection B.P 2003 : Each vial contains Ampicillin (as sodium ) 500 mg. Company Name CID ...

Ampicillin 500 Capsules

Ampicillin 500 Capsule

Each capsule contains: Ampicillin (as trihydrate ) 500 mg .

Company Name
CID
 
Therapeutic Group
BROAD SPECT PENICILL ORAL
 
Pharmaceutical form
Capsule
 
Package
Box of 12 capsules of 500 mg (2 strips of 6 capsules each) .
 
Ampicillin 500 Capsule Indications
Ampicillin is indicated in the treatment of all infections caused by susceptible microorganisms mainly : • Respiratory tract infections : bronchitis , pharyngitis , uncomplicated commonly-acquired pneumonia , otitis media , and H-influenza infection . • Gastrointestinal tract infections : Enteritis , bacillary dysentery ,abdominal typhoid and paratyphoid • Genitourinary tract infections: Cystitis, pyelonephritis, prostatitis, urethritis and gonorrhea. • Listerial meningitis (in combination with other antibiotics).
 
Ampicillin 500 Warning & Precautions
Caution is required when using Ampicillin in the following cases: • Known history of allergy. • Patients with cytomegalovirus infection since they are susceptible to ampicillin-induced skin rashes. • Patients with impaired renal function (dose should be reduced). • Patients with acute or chronic lymphocytic leukemia. • SGOT and SGPT should be measured during therapy to monitor for liver function abnormalities. N.B. Ampicillin is not known to be harmful during pregnancy or lactation.
 
Product Type
human
 
Ampicillin 500 Dosage
By mouth: 0.5 – 1 gm every 6 hours at least 30 minutes before food Urinary tract infections: 500 mg every 8 hours .
 
Ampicillin 500 Adverse Reactions
- Hypersensitivity reactions like skin rashes and urticaria may occur. - Antibiotic-associated colitis may rarely occur.
 
Ampicillin 500 Contra Indications
History of hypersensitivity to penicillins or cephalosporins .
 
Ampicillin 500 Drug Interactions
• Allopurinol : increase risk of developing skin rashes. • Bacteriostatic antibiotics (I.e.: tetracycline, Erythromycin): diminish the bactericidal effect of Ampicillin. • Estrogen-containing oral contraceptives: Ampicillin may decrease the contraceptive effect. • Probenecid: blocks the renal tubular excretion of Ampicillin and prolong its blood level.
5 EgyDrug Index: September 2013 Ampicillin 500 Capsule Each capsule contains: Ampicillin (as trihydrate ) 500 mg . Company Name CID   Therapeutic Group BROAD SPE...

Friday, September 13, 2013

Tramadol 100 mg Ampoules

Tramadol 100 mg Ampoule

Tramadol 100 mg Ampoule

Tramadol HCl 100 mg/amp. (2 ml)
Company Name
Alexandria

Pharmaceutical form
Ampoule

Package
3 Ampoules x 2 ml

Indications

Tramadol is indicated for the management of moderate to moderately severe pain.

Warning & Precautions

The pediatric use of tramadol is not recommended in patient under 16 years. Seizure Risk: Seizures have been reported in patients receiving Tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of Tramadol above the recommended range. Concomitant use of Tramadol increases the seizure risk in patients taking: • Selective serotonin reuptake inhibitors ( SSRI antidepressants or anoretics ) • Tricyclic antidepressants (TCAs), and other tricyclic compounds(e.g., cyclobenzaprine, promethazine, etc.), or Opioids Administration of Tramadol may enhance the seizure risk in patients taking: • MAO inhibitors (use with MAO inhibitors ) • Neuroleptics , or other drugs that reduce the seizure threshold Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk of seizures ( such as head trauma, metabolic disorders, alcohol and drug withdrawal , CNS infections). In tramadol overdose, naloxone administration may increase the risk of seizures. Anaphylactoid Reaction Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with tramadol. These reactions often occur following the first dose. Other reported reactions include pruritis , hives , bronchospasm and angioedema. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Tramadol. Use in Opioid dependent patients Tramadol should not be used in opioid-dependent patients . Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Consequently, in patients with a tendency to opioid abuse or opioid dependence, treatment with Tramadol is not recommended . Use with CNS depressants Tramadol should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics. Use with MAO inhibitors Use Tramadol with great caution in patients taking monoamine oxidase inhibitors, because animal studies have shown increased deaths with combined administration .

Product Type
Human

Dosage
As directed by the physician or as follows : For the treatment of painful conditions, Tramadol 50 mg to 100 mg (½ -1ampoule) can be administered as needed for relief every 4-6 hours not to exceed 400 mg per day. For moderate pain: Tramadol 50 mg (½ ampoule) may be adequate as the initial dose. For more severe pain: Tramadol 100 mg (1 ampoule) is usually more effective as the initial dose. In a clinical trial, fewer discontinuations due to adverse events, especially dizziness and vertigo, were observed when titrating the dose in increments of 50 mg/day every 3 days until an effective dose ( not exceeding 400 mg/day ) was reached. Individualization of Dose : Available data do not suggest that a dosage adjustment is necessary in elderly patients 65 to 75 years of age unless they also have renal or hepatic impairment. For elderly patients over 75 years old, not more than 300 mg/day in divided doses as above is recommended. In all patients with creatinine clearance less than 30 ml/min., it is recommended that the dosing interval of Tramadol be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7 % of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis. The recommended dose for patients with cirrhosis is 50 mg every 12 hours. Patients receiving chronic carbamazepine doses up to 800 mg daily may require up to twice the recommended dose of Tramadol.

Adverse Reactions
Cardiovascular: Vasodilation Central nervous system : Anxiety, confusion, coordination disturbance, euphoria, nervousness, sleep disorder. Gastrointestinal : Abdominal pain , anorexia , flatulence. Musculoskeletal : Hypertonia. Skin : Rash. Special Senses : Visual disturbance. Urogenital : Menopausal symptoms, urinary frequency , urinary retention. Incidence less than 1% possibly causally related; the following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials and/or reported in post marketing experience. Body as a whole : Accidental injury, allergic reaction, anaphylaxis, suicidal tendency, weight loss. Cardiovascular : Orthostatic hypotension, syncope, tachycardia. Central Nervous System : Abnormal gait , amnesia, cognitive dysfunction, depression, difficulty in concentration, hallucinations, paresthesia, seizure, tremor. Respiratory : Dyspnea. Skin : Stevens-Johnson syndrome/Toxic epidermal necrolysis, urticaria, vesicles. Specials Senses : dysgeusia. Urogenital : Dysuria , menstrual disorder.

Contra Indications
Tramadol should not be administered to patients who have previously demonstrated hypersensitivity to Tramadol , any other component of this product or opioids. It is also contraindicated in cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

Drug Interactions
Carbamazepine : Concomitant administration of Tramadol with carbamazepine causes a significant increase in Tramadol metabolism, presumably through metabolic induction by carbamazepine. Patients receiving chronic carbamazepine doses of up to 800 mg daily may require up to twice the recommended dose of Tramadol. Quinidine: Tramadol is metabolized to M1 by the CYP2D6 P-450 isoenzyme. Quinidine is a selective inhibitor of that isoenzyme; so that concomitant administration of quinidine and Tramadol results in increased concentrations of Tramadol and reduced concentrations of M1. The clinical consequences of these findings are unknown. In vitro drug interaction studies in human liver microsomes indicate that Tramadol has no effect on quinidine metabolism. Inhibitors of CYP2D6: In vitro drug interaction studies in human liver microsomes indicate that concomitant administration with inhibitors of CYP2D6 such as fluoxetine, paroxetine, and amitriptyline could result in some inhibition of the metabolism of Tramadol.



5 EgyDrug Index: September 2013 Tramadol 100 mg Ampoule Tramadol HCl 100 mg/amp. (2 ml) Company Name Alexandria Pharmaceutical form Ampoule Package 3 Ampoules ...

Tramadol capsules

Tramadol capsules


Tramadol

Tramadol HCl 50 mg
Company Name
Memphis

Therapeutic Group
NON-NARCOTIC ANALGESICS

Pharmaceutical form
Capsule

Package
Box containing 20 capsules in 2 strips.

Tramadol capsules Indications

Tramadol capsules are indicated for the management of moderate to moderately severe pain in adults, e.g. in wound pain, fractures,severe nerve pain, tumour pain, heart attack. It should not be used for minor pain.The effect sets in quickly and lasts for some hours.


Tramadol capsules Warning & Precautions

"Seizure Risk Seizures have been reported in patients receiving tramadol hydrochloride within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol hydrochloride above the recommended range. Concomitant use of tramadol hydrochloride increases the seizure risk in patients taking: • Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics), • Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or Other opioids. Administration of tramadol hydrochloride may enhance the seizure risk in patients taking: • MAO inhibitors (see also WARNINGS-Use with MAO Inhibitors), • Neuroleptics, or ther drugs that reduce the seizure threshold. Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In tramadol hydrochloride overdose, naloxone administration may increase the risk of seizure. Anaphylactoid Reactions Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with tramadol hydrochloride. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive tramadol hydrochloride (see CONTRAINDICATIONS). Respiratory Depression Administer tramadol hydrochloride cautiously in patients at risk for respiratory depression. In these patients alternative non-opioid analgesics should be considered. When large doses of tramadol hydrochloride are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures (see WARNINGS, Seizure Risk). Interaction with Central Nervous System (CNS) Depressants Tramadol hydrochloride should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Tramadol hydrochloride increases the risk of CNS and respiratory depression in these patients. Increased Intracranial Pressure or Head Trauma Tramadol hydrochloride should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving tramadol hydrochloride tablets. (See Respiratory Depression.) Use in Ambulatory Patients Tramadol hydrochloride may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly. Use with MAO Inhibitors and Serotonin Re-uptake Inhibitors Use tramadol hydrochloride with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration. Concomitant use of tramadol hydrochloride with MAO inhibitors or SSRI’s increases the risk of adverse events, including seizure and serotonin syndrome. Withdrawal Withdrawal symptoms may occur if tramadol hydrochloride is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been seen less frequently with tramadol hydrochloride discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering tramadol hydrochloride at the time of discontinuation. Physical Dependence and Abuse Tramadol hydrochloride may induce psychic and physical dependence of the morphine-type (μ-opioid). Tramadol hydrochloride should not be used in opioid-dependent patients. Tramadol hydrochloride has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug, are not limited to those patients with prior history of opioid dependence. Risk of Overdosage Serious potential consequences of overdosage with tramadol hydrochloride are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. PRECAUTIONS: Acute Abdominal Conditions The administration of tramadol hydrochloride may complicate the clinical assessment of patients with acute abdominal conditions. Use in Renal and Hepatic Disease Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, dosing reduction is recommended. Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. In cirrhotic patients, dosing reduction is recommended. With the prolonged half-life in these conditions, achievement of steady-state is delayed, so that it may take several days for elevated plasma concentrations to develop. Pregnancy: Teratogenic Effects Pregnancy Category C Tramadol has been shown to be embryotoxic and fetotoxic in mice, (120 mg/kg or 360 mg/m2), rats (≥25 mg/kg or 150 mg/m2) and rabbits (≥75 mg/kg or 900 mg/m2) at maternally toxic dosages, but was not teratogenic at these dose levels. These dosages on a mg/m2 basis are 1.4, ≥0.6, and ≥3.6 times the maximum daily human dosage (246 mg/m2) for mouse, rat and rabbit, respectively. No drug-related teratogenic effects were observed in progeny of mice (up to 140 mg/kg or 420 mg/m2), rats (up to 80 mg/kg or 480 mg/m2) or rabbits (up to 300 mg/kg or 3600 mg/m2) treated with tramadol by various routes. Embryo and fetal toxicity consisted primarily of decreased fetal weights, skeletal ossification and increased supernumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups from rat dams allowed to deliver. Embryo and fetal lethality were reported only in one rabbit study at 300 mg/kg (3600 mg/m2), a dose that would cause extreme maternal toxicity in the rabbit. The dosages listed for mouse, rat and rabbit are 1.7, 1.9 and 14.6 times the maximum daily human dosage (246 mg/m2), respectively. Non-teratogenic Effects Tramadol was evaluated in peri- and post-natal studies in rats. Progeny of dams receiving oral (gavage) dose levels of 50 mg/kg (300 mg/m2 or 1.2 times the maximum daily human tramadol dosage) or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg (480 mg/m2 or 1.9 times the maximum daily human dose). There are no adequate and well-controlled studies in pregnant women. Tramadol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported during post-marketing. Labor and Delivery Tramadol hydrochloride should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn. Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor. The effect of tramadol hydrochloride, if any, on the later growth, development, and functional maturation of the child is unknown. Nursing Mothers: Tramadol hydrochloride is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within16 hours postdose was 100 mcg of tramadol (0.1% of the maternal dose) and 27 mcg of M1.


Product Type
Human

Tramadol capsules Dosage

"The dosage should be adjusted to the intensity of pain. Unless otherwise prescribed, tramadol should be taken as follows – independent of meals single dose for adults and adolescents over 14 years of age:
1-2 capsules to be taken with liquid.This is usually sufficient to relieve the pain. If however, pain relief is unsatisfactory, a further TRAMADOL capsule may be taken after about 30-60 minutes.
Duration of treatment:
During long-term treatment with TRAMADOL the possibility of dependence cannot be entirely excluded. Therefore the physician is to decide on the duration of treatment and whether the preparation is to be withdrawn temporarily. Tramadol should not be given for longer than therapeutically necessary

Tramadol capsules Adverse Reactions

"Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. Table1 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to tramadol hydrochloride administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these trials were similar for tramadol hydrochloride and the active control groups, TYLENOL® with Codeine #3 (acetaminophen 300 mg with codeine phosphate 30 mg), and aspirin 325 mg with codeine phosphate 30 mg. However, the rates of withdrawals due to adverse events appeared to be higher in the tramadol hydrochloride groups.
Table 1
Cumulative Incidence of Adverse Reactions for Tramadol Hydrochloride in Chronic Trials of Nonmalignant Pain (N = 427)
Up to Up to Up to
7 days 30 days 90 days
Dizziness/Vertigo 26% 31% 33%
Nausea 24% 34% 40%
Constipation 24% 38% 46%
Headache 18% 26% 32%
Somnolence 16% 23% 25%
Vomiting 9% 13% 17%
Pruritus 8% 10% 11%
“CNS Stimulation” 1 7% 11% 14%
Asthenia 6% 11% 12%
Sweating 6% 7% 9%
Dyspepsia 5% 9% 13%
Dry mouth 5% 9% 10%
Diarrhea 5% 6% 10%

1 “CNS Stimulation” is a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability and hallucinations.
Incidence 1% to less than 5%, possibly causally related: The following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials, and for which the possibility of a causal relationship with tramadol hydrochloride exists.
Body as a Whole: Malaise.
Cardiovascular: Vasodilation.
Central Nervous System: Anxiety, Confusion, Coordination disturbance, Euphoria, Miosis, Nervousness, Sleep disorder.
Gastrointestinal: Abdominal pain, Anorexia, Flatulence.
Musculoskeletal: Hypertonia.
Skin: Rash.
Special Senses: Visual disturbance.
Urogenital: Menopausal symptoms, Urinary frequency, Urinary retention.
Incidence less than 1%, possibly causally related: The following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials and/or reported in post-marketing experience.
Body as a Whole: Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome (mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma).
Cardiovascular: Orthostatic hypotension, Syncope, Tachycardia.
Central Nervous System: Abnormal gait, Amnesia, Cognitive dysfunction, Depression, Difficulty in concentration, Hallucinations, Paresthesia, Seizure (see WARNINGS), Tremor.
Respiratory: Dyspnea.
Skin: Stevens-Johnson syndrome/Toxic epidermal necrolysis, Urticaria, Vesicles.
Special Senses: Dysgeusia.
Urogenital: Dysuria, Menstrual disorder.
Other adverse experiences, causal relationship unknown:
A variety of other adverse events were reported infrequently in patients taking tramadol hydrochloride during clinical trials and/or reported in post-marketing experience. A causal relationship between tramadol hydrochloride and these events has not been determined. However, the most significant events are listed below as alerting information to the physician.
Cardiovascular: Abnormal ECG, Hypertension, Hypotension, Myocardial ischemia, Palpitations, Pulmonary edema, Pulmonary embolism.
Central Nervous System: Migraine, Speech disorders.
Gastrointestinal: Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure.
Laboratory Abnormalities: Creatinine increase, Elevated liver enzymes, Hemoglobin decrease, Proteinuria.
Sensory: Cataracts, Deafness, Tinnitus.

Tramadol capsules Contra Indications

"Acute intoxication with alcohol, hypnotics, analgesics or psychotropic drugs.Hypersensitivity to tramadol, narcotic withdrawal treatment.
Tramadol should not be used in patients receiving MAO inhibitors or in patients who have taken them within the last two weeks.
Note : In accordance with currently prevailing recommendations, medication with the preparation during pregnancy should only be resorted to, after careful consideration of the risks.During lactation approx 0.1% of maternal dose is secreted into the milk. The preparation should be used with care in patients with head injury, shock, respiratory disorders, epilepsy, increased sensitivity to opiates or in opioid dependent patients.

Tramadol capsules Drug Interactions

Carbamazepine may reduce the pain relieving effect of TRAMADOL and the length of time it acts. Drugs which lower seizure threshold may induce convulsions when given together with TRAMADOL. On the concomitant administration of TRAMADOL with substances which also act on the central nervous system ( e.g. tranquillizers, hypnotics) the sedative effect (fatigue)may be intensified. At the same time, however combining TRAMADOL with a tranquillizer, for example, will probably have a favourable effect on pain sensation.
5 EgyDrug Index: September 2013 Tramadol Tramadol HCl 50 mg Company Name Memphis Therapeutic Group NON-NARCOTIC ANALGESICS Pharmaceutical form Capsule P...

Cidolut depot 250 mg/Ampoule | hydroxy-progesterone- 17 caproate 250 mg

Cidolut depot - hydroxy-progesterone

Cidolut depot 250 mg/Ampoule

Each ampoule one ml contains: 17-alpha-hydroxy-progesterone- 17 caproate 250 mg (in oily solution)
Company Name
CID

Therapeutic Group
PROGESTOG.EXCL G3A.G3F

Pharmaceutical form
Ampoule

Package
Box of : one ampoules each of 1 cc containing 250 mg .

Cidolut depot Indications

- Habitual abortion . - Primary and secondary amenorrhea . - Functional uterine bleeding ( Puberty and preclimacteric bleeding ) . - Polymenorrhoea .

Cidolut depot Warning & Precautions

- Cidolut depot should be used with caution in patients with cardiovascular diseases or renal impairment , diabetes mellitus , asthma , epilepsy , and migraine . - High doses of Cidolut depot should be used with caution in patients susceptible to thromboembolism . - Sometimes a local reaction may occur at the site of injection . - Rarely occurring : coughing , dyspnoea , and circulatory disturbance during or immediately after injection , but that can be avoided by injecting the drug very slowly .

Product Type
human

Cidolut depot Dosage

The high concentration contained in Cidolut depot takes into account the latest scientific discoveries about corpus luteum therapy. These have shown that it is often only possible to obtain a successful result using large doses . Over-dosage of progesterone and its derivatives is practically speaking not possible .The administration of Cidolut depot is always indicated if it is desired to obtain a corpus luteum effect extending over at least one week or longer. This is especially the case in the second half of the menstrual cycle and during pregnancy . I-Abortion : In cases of the tendency to habitual abortion , it is often advisable to administer larger doses of progesterone over a longer time than has either to been usual in order to preserve the pregnancy. In the tendency of habitual abortion . 125 to 250 mg of Cidolut depot should be injected at weekly intervals for at least the first half of pregnancy. II-Amenorrhea : Primary amenorrhea and secondary amenorrhea of relatively long duration: It is recommended that a cyclical treatment as described by Kaufmann be carried out over several months . Frequently a spontaneous cycle occurs subsequently . If this does not take place the treatment must be repeated over a few months. Using estradiol valerate and Cidolut depot it is found possible to carry out a cyclically correct treatment in a simple manner. At the beginning of treatment 10mg estradiol valerate are injected intramuscularly. Next either 10mg estradiol valerate are injected on the 14th day as well as 125 mg. Cidolut depot intramuscularly on the 14th and 22nd days or alternatively 10mg estradiol valerate together with 250mg Cidolut depot intramuscularly on the 18thday of treatment. Following the bleeding which resembles a menstruation and occurs approximately on the 28th day 10mg estradiol valerate intramuscularly are administered and on the 18th day of the artificial cycle 10mg estradiol valerate and 125mg Cidolut depot intramuscularly are given. III-Functional bleeding : (Cyclical glandular hyperplasia ) Especially puberty bleeding and pre-climacteric bleeding . Progesterone has a haemostatic action on the endometrium . the duration of the bleeding and the condition of endometrium are of great significance in the mechanism of this action . Estrogen should be injected simultaneously with : 125mg Cidolut depot - 10 mg Estradiol valerate . A few days later a menstruation like bleeding of limited duration may occur ( medical curettage) . When the bleeding is of long duration the desquamated endometrium should first of all be built up to the stage of proliferation by means of estrogen and then transformed by means of Cidolut depot . IV-Polymenorrhoea: In shortening of the phase of secretion, the time of ovulation may be easily determined by regular measurement of the morning temperature. 65 to 125mg of Cidolut depot should be injected intramuscularly between 20th and 22nd days.

Cidolut depot Adverse Reactions

17 alpha-hydroxy progesterone 17 caproate may cause gastro intestinal disturbances , fluid retention , edema , allergic skin rashes , breast changes including discomfort , changes in libido , hair loss , headache , premenstrual syndrome like symptoms and altered menstrual cycles or irregular menstrual bleeding .

Cidolut depot Contra Indications

- Undiagnosed vaginal bleeding . - Patients with a history or recurrent high risk of arterial disease . - Breast or genital carcinoma . - Hepatic impairment , especially if it is severe . - Diagnostically for pregnancy test . - Missed or incomplete abortion .

Cidolut depot Drug Interactions

- Enzyme inducing drugs such as carbamazepine , grisofulivin , phenobarbiton , phenytoin , and rifampicin may enhances the metabolism and clearance of progesterone . - Since hydroxyprogesterone caprote can influence the diabetic control, an adjustment in anti-diabetic dosage should be required . - Progesterone may inhibit cyclosporine concentration and increase a risk of toxicity .
5 EgyDrug Index: September 2013 Cidolut depot 250 mg/Ampoule Each ampoule one ml contains: 17-alpha-hydroxy-progesterone- 17 caproate 250 mg (in oily solution) Company...

B12 Depot | Hydroxocobalamin acetate

B12 Depot | Hydroxocobalamin acetate

B12 Depot

Hydroxocobalamin acetate 1000 mcg/1ml

Company Name
ADCO

Pharmaceutical form

Ampoule

Package

1 ampoule (1 ml ) 1000 mcg.2 ampoule (1 ml ) 1000 mcg. 5ampoules (1 ml )1000 mcg.25ampoules (1 ml )1000 mcg.

B12 Depot Indications (usage)

Pernicious anaemia, other causes of vitamin B12 deficiency and subacute combined degeneration of the spinal cord.

B12 Depot Warning & Precautions

Cyanocobalamine or Hydroxocobalamine not given to patients with suspected vitamin B12 deficiency

Product TypeHuman

B12 Depot Dosage

In severe cases one i. m. Injection of 1000 mcg. Every second or third day. For long-term treatment 1 ampoule i. m. per week or fortnight. The treatment of anaemia requires individual observation. The reaction must be checked up clinically (blood-count, ect.)

B12 Depot Adverse Reactions
Allergic hypersensitivity reaction have occurred rarely following the parenteral administration Arrhythmias secondary to hypocalcaemia have occurred at the beginning of parenteral treatment

Contra IndicationsNone

B12 Depot Drug Interactions

Absorption of Vitamin B12 from the gastrointestinal tract may be reduced by neomycin aminosalicylic acid histamine h2-antagonists and colchicines Serum concentrations may be decreased by concurrent administration of oral contraceptives Parenteral chloraphenicol may attenuate the effect of Vitamin B12 in anaemia
5 EgyDrug Index: September 2013 B12 Depot Hydroxocobalamin acetate 1000 mcg/1ml Company Name ADCO Pharmaceutical form Ampoule Package 1 ampoule (1 ml ) 1000 mcg.2...

DIPROSONE Cream - betamethasone dipropionate


Diprosone Cream - betamethasone dipropionate

Diprosone Cream

Each gram contains betamethasone dipropionate equivalent to 0.5 mg of betamethasone

Company Name

Memphis/Schering

Therapeutic Group

TOP CORTICOSTEROIDS PLAIN

Pharmaceutical form
Cream

Package

Tubes of 10 grams

Diprosone Cream Indications

DIPROSONE Cream are indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Diprosone Cream Warning & Precautions

If irritation or sensitization develops with the use of DIPROSONE Cream , treatment should be discontinued and appropriate therapy instituted. In the presence of an infection, an appropriate antifungal or antibacterial agent should be administered. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been controlled adequately. Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children. Systemic absorption of topical corticosteroids will be increased if extensive skin surfaces are treated or if occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children. DIPROSONE Cream and Ointment are not for ophthalmic use. Pediatric Use: Pediatric patients may demonstrate greater susceptibility than mature patients to topical corticosteroid¬induced HPA axis suppression and to exogenous corticosteroid effects because of greater absorption due to a larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilledema. USE DURING PREGNANCY AND IN NURSING WOMEN: Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit Justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients. Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Product Type
Human

Diprosone Cream Dosage

A thin film of DIPROSONE Cream should be applied to cover completely the affected area once or twice daily, morning and night.

Diprosone Cream Adverse Reactions

The following local adverse reactions have been infrequently reported with the use of topical corticosteroids especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria

Diprosone Cream Contraindications

DIPROSONE Cream are contraindicated in those patients with a history of sensitivity reactions to any of its components.

Drug Interactions

NA

5 EgyDrug Index: September 2013 Diprosone Cream Each gram contains betamethasone dipropionate equivalent to 0.5 mg of betamethasone Company Name Memphis/Schering ...

Monday, September 2, 2013

Ampicillin 1gm vial

Ampicillin

Ampicillin 1gm vial
Ampicillin sodium eq. To 1gm ampicillin anhydrous

Company Name
Misr

Therapeutic Group
BROAD SPECT PENICILL INJ

Pharmaceutical form
vial

Package
A cartoon box contains a glass vial of 250mg or 500mg or 1000mg. ampicillin With insert.

Indications
urinary-tract infections, otitis media, sinusitis, oral infections, bronchitis, uncomplicated community-acquired pneumonia ,Haemophilus influenzae infections, invasive salmonellosis; listerial meningitis

Warning & Precautions
Patients known to be hypersensitive to penicillins should be given an antibacterial of another class Maculopapular rashes commonly occur with ampicillin but are not usually related to true penicillin allergy. erythematous rashes common in glandular fever, cytomegalovirus infection, and acute or chronic lymphocytic leukaemia. broad-spectrum penicillins should not therefore be used for ‘blind’ treatment of a sore throat. Care is necessary if very high doses of penicillins are given, especially if renal function is poor, because o the risk of neurotoxicity Renal, hepatic, and haematological status should be monitored during prolonged and high-dose therapy. Skin contact with penicillins should be avoided since sensitisation may occur Penicillin therapy changes the normal bacterial flora and can lead to supra-infection with penicillin-resistant organisms including Clostridium difficile or Candida, particularly with prolonged use.

Product Type
Human

Dosage
500 mg every 4–6 hours; child under 10 years, half adult dose *Endocarditis (in combination with another antibiotic if necessary), by intravenous infusion, 2 g every 6 hours, increased to 2 g every 4 hours e.g. in enterococcal endocarditis or if ampicillin used alone *Listerial meningitis (in combination with another antibiotic), by intravenous infusion, 2 g every 4 hours for 10–14 days; neonate 50 mg/kg every 6 hours; infant (1–3 months), 50–100 mg/kg every 6 hours; child( 3 months–12 years), 100 mg/kg every 6 hours (max. 12 g daily)

Adverse Reactions
hypersensitivity reactions including urticaria, fever, nausea, vomiting, joint pains, rashes, angioedema, anaphylaxis, serum sickness-like reaction; rarely CNS toxicity including convulsions (especially with high doses or in severe renal impairment), interstitial nephritis, haemolytic anaemia, leucopenia, thrombocytopenia, and coagulation disorders; also reported diarrhea (including antibiotic-associated colitis

Contra Indications
penicillin hypersensitivity or to any other ingrediants.

Drug Interactions
increased risk of rash when ampicillin given with allopurinol INR can be altered by a course of broad-spectrum penicillins such as ampicillin, although studies have failed to demonstrate an interaction with coumarins& phenindione penicillins reduce excretion of methotrexate (increased risk of toxicity) excretion of penicillins reduced by probenecid & sulfinpyrazone (increased plasma concentration) -antibacterials that do not induce liver enzymes possibly reduce contraceptive effect of oestrogens (risk probably small) antibacterials inactivate oral typhoid vaccin
5 EgyDrug Index: September 2013 Ampicillin 1gm vial Ampicillin sodium eq. To 1gm ampicillin anhydrous Company Name Misr Therapeutic Group BROAD SPECT PENICILL INJ ...

Amoxycillin sodium 1000 mg injection


Amoxycillin sodium 1000 mg for injection B.P 2009
Each vial contains:- Amoxycillin 
(As sodium ) 1000 mg

Company Name
CID

Pharmaceutical form
vials

Package
Amoxycillin sodium vials : box contains one vial or 50 vials.

Indications
Amoxycillin is indicated in the treatment of all infections caused by susceptible micro-organism mainly: • Respiratory tract infections: bronchitis, Pharyngitis, uncomplicated community-acquired pneumonia, otitis media and H-influenza infection. • Gastrointestinal tract infections: Enteritis ,bacillary dysentery . Abdominal typhoid and paratyphoid, invasive salmonellosis and in Helicobacter pylori eradication. • Genitourinary tract infections: Cystitis, pyelonephritis, prostatitis, urethritis and gonorrhea. • Skin and soft tissue infection: pyoderma, erysipelas, cellulitis and wound infections. • Listerial meningitis (in combination with other antibiotic). • Endocarditis prophylaxis and treatment. • Anthrax.

Warning & Precautions
Caution is required when using Amoxicid in the following cases: • Known history of allergy (serious and fatal anaphylactic reactions have been reported). • Patients with impaired renal function (dose should be reduced ) . * SGOT and SGPT should be measured during therapy to monitor for liver function abnormalities . * Amoxicid is not known to be harmful during pregnancy or lactation .

Product Type
human

Dosage
For upper respiratory tract, genitourinary tract, skin and soft tissue infections: Adults: 250 mg every 8 hours Children weighing under 20 kg: 20 mg/kg/day in divided doses. These doses may be doubled in severe infections. For lower respiratory tract infections: Adults: 500 mg every 8 hours . These doses may be increased to 1 g in severe infections . Children weighing under 20 kg: 40 mg/kg/day in divided doses.

Adverse Reactions
• Hypersensitivity reactions like skin rashes and urticaria may occur. • Antibiotic-associated colitis may rarely occur.

Contra Indications
History of hypersensitivity to penicillins or cephalosporin .

Drug Interactions
• Allopurinol: increase risk of developing skin rashes. • Bacteriostatic antibiotics (I.e.: tetracycline, Erythromycin): diminish the bactericidal effect of amoxicillin. • Estrogen-containing oral contraceptives: amoxicillin may decrease the contraceptive effect. • Probenecid: blocks the renal tubular excretion of amoxicillin and prolongs its blood level.


5 EgyDrug Index: September 2013 Amoxycillin sodium 1000 mg for injection B.P 2009 Each vial contains:- Amoxycillin  (As sodium ) 1000 mg Company Name CID Pharmaceuti...

Amoxycillin 500 mg

Amoxycillin 500 mg

Amoxycillin 500 mg
Amoxycillin 500 mg/cap.

Company Name
Alexandria

Pharmaceutical form
Capsule

Package
12 or 36 Capsules

Indications
amoxycillin is indicated in the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below: Infections of the ear, nose, and throat due to Streptococcus spp. ((alpha)- and (beta)-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp., or H. influenzae Infections of the genitourinary tract due to E. coli, P. mirabilis , or E. faecalis Infections of the skin and skin structure due to Streptococcus spp. ((alpha)- and (beta)-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract due to Streptococcus spp. ((alpha)- and (beta)-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp., or H. influenzae Gonorrhea, acute uncomplicated (ano-genital and urethral infections) due to N. gonorrhoeae (males and females) H. pylori eradication to reduce the risk of duodenal ulcer recurrence Triple therapy: Amoxycillin /clarithromycin/lansoprazole amoxycillin , in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy: Amoxycillin /lansoprazole Amoxycillin , in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected .

Warning & Precautions
Before initiating therapy with amoxycillin careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxycillin should be discontinued and appropriate therapy instituted. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxycillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “ antibiotic- associated colitis. “ After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.






















Product Type
Human

Dosage
As directed by the physician or as follows: Amoxycillin capsules may be given without regard to meals. For gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes a symptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days, treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Triple therapy: Amoxycillin/Clarithromycin/Lansoprazole The recommended adult dose is 1 g amoxycillin, 500 mg clarithromycin and 30 mg lansoprazole all given twice daily (every 12 hours) for 14 days. Dual therapy :Amoxycillin / Lansoprazole The recommended adult oral dose is 1 g amoxycillin and 30 mg lansoprazole, each given three times daily ( q 8 h ) for 14 days . Dosing recommendations for adults with impaired renal function: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with glomerular filtration rate < 30 ml / minute should not receive the 750 mg amoxycillin. Patients with a glomerular filtration rate of 10 to 30 mL / minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/ minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours , depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. Adults patients: Adult patients: Infection Severity Usual adult dose Ear/ nose/ throat Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours Severe 750 mg every 12 hours or 500 mg every 8 hours Lower respiratory tract Mild/Moderate or severe 750 mg every 12 hours or 500 mg every 8 hours Skin/skin structure Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours Severe 750 mg every 12 hours or 500 mg every 8 hours Genitourinary tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours Severe 750 mg every 12 hours or 500 mg every 8 hours Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Dosing for infections caused by less susceptible organisms should follow the recommendation for severe infections Children weighing 40 kg or more should be dosed according to the adult recommendations.

Adverse Reactions
Gastrointestinal :nausea, vomiting, diarrhea, and hemorrhagic/pseudomembranous colitis. Hypersensitivity Reactions: erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and urticaria have been reported. Hemic and Lymphatic Systems: Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia . These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Contra Indications
/

Drug Interactions
Probenecid decreases the renal tubular secretion of amoxycillin. Concurrent use of amoxycillin and probenecid may result in increased and prolonged blood levels of amoxycillin. Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin.






5 EgyDrug Index: September 2013 Amoxycillin 500 mg Amoxycillin 500 mg/cap. Company Name Alexandria Pharmaceutical form Capsule Package 12 or 36 Capsules Indications a...

Amoxicid 250mg Capsule

Amoxicid 250mg Capsule

Amoxicid 250mg Capsule

"* Each capsule of Amoxicid 250 mg capsules contains:
Amoxicillin trihydrate 287 mg 
(Equivalent to 250 mg Amoxicillin activity)

* Each capsule of Amoxicid 500 mg capsules contains:
Amoxicillin trihydrate 574 mg 
(Equivalent to 500 mg Amoxicillin activity)
Inactive ingredients:
Magnesium stearate, Gelatin, Titanium dioxide, Brilliant blue, Erythrosine, Quinoline yellow.

* Each 5 ml of Amoxicid 125 mg suspension contains:
Amoxicillin trihydrate 144 mg 
(Equivalent to 125 mg Amoxicillin activity)

* Each capsule of Amoxicid 250 mg suspension contains:
Amoxicillin trihydrate 286 mg 
(Equivalent to 250 mg Amoxicillin activity)

Company Name
CID

Therapeutic Group
BROAD SPECT PENICILL ORAL

Pharmaceutical form
Capsule

Package
"• Amoxicid 250 capsules: Box of 12 capsules (2 strips(Al/PVC) each contain 6 capsules). • Amoxicid 500 mg capsule: Box of 12 capsules (2 strips(Al/PVC) each contain 6 capsules). OR : Box of 1000 capsules (100 strips (Al/PVC) each contain 10 capsules).(Tender and Export) • Amoxicid powder for suspension: Bottle of 60 or 80 or 100 ml (after reconstitution). N.B: For reconstitution: add the amount of water written on the label, shake well to obtain homogenous suspension.

Indications
"Amoxicid is indicated in the treatment of infections due to susceptible (only β-lactamase-negative) strains of the designated microorganisms in the conditions listed below:
• Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. 
• Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. 
• Infections of the skin and skin structure - due to Streptococcus spp. (α- and β- hemolytic strains only) , Staphylococcus spp., or E. coli 
• Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. 
• Gonorrhea, acute uncomplicated (anogenital and urethral infections) - due to N. gonorrhoeae (males and females)
• H. pylori eradication to reduce the risk of duodenal ulcer recurrence:
* Triple Therapy: 
(Amoxicillin/clarithromycin / lansoprazole)
Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. 
* Dual Therapy:
(Amoxicillin/lansoprazole)
Amoxicillin in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. 
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. 
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 
Indicated surgical procedure should be performed.


Warning & Precautions
"Precautions: The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted. Prescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients: Amoxicillin may be taken every 8 hours or every 12 hours, depending on the strength of the product prescribed. Patients should be counseled that antibacterial drugs including amoxicillin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin or other antibacterial drugs in the future. Warnings: • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. there have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with amoxicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate therapy instituted. serious anaphylactic reactions require immediate emergency treatment with epinephrine. oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated. • Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild to life-threatening.Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. • Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of ""antibiotic-associated colitis"". • After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate-to-severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis Pregnancy and Lactation: The safety of this medicinal product for use in human pregnancy has not been established by well controlled studies in pregnant women. Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment. Amoxicillin may be given durin lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant. Effects on Ability to Drive and Use Machines Adverse effects on the ability to drive or operate machinery have not been observed.

Product Type
human

Dosage
"• Adult dosage (including elderly patients):
* Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections. 
* High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract. 
* Short Course therapy: 
o Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses. 
o Dental abscess: two 3 g doses with 8 hours between the doses.
o Gonorrhoea: single 3 g dose. 
o Helicobacter eradication in peptic (duodenal and gastric) ulcer disease: 
AMOXICILLIN is recommended at a dose of twice daily in association with a proton pump inhibitor and antimicrobial agents as detailed below:
Omeprazole 40 mg daily, Amoxicillin 1gm twice daily, Clarithromycin 500 mg twice daily 
for 7days 
or Omeprazole 40 mg daily, Amoxicillin 750 mg-1gm twice daily, Metronidazole 400 mg three time daily for 7days 
• Children's dosage: (up to 10 years of age):
* Standard children's dosage: 125 mg three times daily, increasing to 250 mg three times daily for more severe infections. 
AMOXICILLIN Paediatric Suspension is recommended for children under six months 
of age. 
* In severe or recurrent acute otitis media: especially where compliance may be a problem, 
750 mg twice a day for two days may be used as an alternative Course of treatment in children aged 3 to 10 years. 
• Patients with renal impairment: 
In renal impairment the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage according to the following scheme:
o Adults and children over 40 kg: 
Mild impairment (creatinine clearance >30 ml/min) - No change in dosage. 
Moderate impairment (creatinine clearance 10-30 ml/min) - 500 mg twice daily maximum 
Severe impairment (creatinine clearance <10 -="" 500="" day="" div="" maximum="" mg="" min="" ml="" nbsp="">
o Children under 40kg:
Mild impairment (creatinine clearance >30 ml/min) - No change in dosage 
Moderate impairment (creatinine clearance 10-30 ml/min) - 15 mg/kg twice daily
( maximum 500 mg twice daily)
Severe impairment (creatinine clearance <10 -="" 15="" daily="" div="" kg="" mg="" min="" ml="" nbsp="" once="">
( maximum 500 mg)
o Patients receiving peritoneal dialysis: 
Dosing as for patients with severe renal impairment (creatinine clearance <10 amoxicillin="" by="" dialysis.="" div="" is="" min="" ml="" nbsp="" not="" peritoneal="" removed="">
o Patients receiving haemodialysis:
Dosing as for patients with severe renal impairment (creatinine clearance <10 div="" min="" ml="" nbsp="">
Amoxicillin is removed from the circulation by haemodialysis. Therefore, one additional dose (500 mg for adults or 15 mg/kg for children under 40 kg) may be administered during dialysis and at the end of each dialysis. 
• Prophylaxis of endocarditis: see below:
I) Dental procedures:
Prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues and who have not received a penicillin in the previous month.
(N.B .Patients with prosthetic heart, prosthetic heart valves should be referred to hospital-see below).
a) Patient not having general anesthetic:
For adults (including elderly): the dose is 3g Amoxicillin orally 1 hour before procedure. A second dose may be given 6 hours later if considered necessary.
For children under 10 years: Half adult dose 
For children under 5 years: Quarter adult dose. 
b) Patient having general anesthetic :if oral antibiotics considered to be appropriate:
For adults (including elderly): Initially 3g Amoxicillin Orally 4 hours prior to anaesthesia , followed by 3g orally (or 1g IV or IM if oral dose not tolerated) as soon as possible after the operation.
For children under 10 years: Half adult dose 
For children under 5 years: Quarter adult dose.
Note 1: If prophylaxis with Amoxicillin is given twice within one month emergence of resistant streptococci is unlikely to be a problem. Alternative antibiotics are recommended if more frequent prophylaxis is required, or if the patient has received a course of treatment with a penicillin during the previous month.
c) Patient having general anaesthetic. If oral antibiotics not appropriate:
For adults (including elderly): the dose is 1g Amoxicillin IV or IM immediately before induction ; with 500mg orally 6 hours later.
Note 2: To minimise pain on injection , Amoxicillin may be given as two injections of 500mg dissolved in sterile 1% lignocaine solution .
II) Dental procedures : patients for whom referral to hospital is recommended, e.g.
A) Patients to be given a general anaesthetic who have been given a penicillin in the previous month.
B) Patients to be given a general anaesthetic who have a prosthetic heart valve. 
C) Patients who have had one or more attacks of endocarditis. 
For adults (including elderly): Initially : 1g Amoxicillin IV or IM with 120mg gentamicin IV or IM immediately prior to anaesthesia (if given) or 15 minutes prior to dental procedure followed by 
(6 hours later): 500mg Amoxicillin orally .
For children under 10 years: The doses of Amoxicillin should be half the adult dose ; the dose of gentamicin should be 2 mg/kg.
For children under 5 years: the doses of Amoxicillin should be quarter the adult dose ; the dose of gentamicin should be 2mg/kg.
See Note 2 
Note3:
Amoxicillin and gentamicin should not be mixed in the same syringe. 
III) Genitourinary surgery or instrumentation: Prophylaxis for patients who have no urinary tract infection and who are to have genitor-urinary surgery or instrumentation under general anaesthesia. Or Obstetric and gynecological procedures: Routine prophylaxis is recommended only for patients with prosthetic heart valves:
For adults (including elderly):
Initially 1g Amoxicillin IV or IM with 120mg gentamicin IV or IM immediately before induction followed by (6 hours later): 500mg Amoxicillin orally or IV or IM according to clinical condition. 
For children under 10years : 
The doses of Amoxicillin should be half the adult dose ; the dose of gentamicin should be 2 mg/kg .
For children under 5 years : 
The doses of Amoxicillin should be quarter the adult dose ; the dose of gentamicin should be 2mg/kg.
See Notes 2 and 3.
IV) Surgery or instrumentations of the upper respiratory tract:
a) Patients other than those with prosthetic heart valves:
For adults (including elderly):
1g Amoxicillin IV or IM immediately before induction; 500 mg Amoxicillin IV or IM 6 hours later
For children under 10 years: Half adult dose 
For children under 5 years: Quarter adult dose.
See Notes 2
Note 4:
The second dose of Amoxicillin may be administered orally as Amoxicillin suspension.
b) Patients with prosthetic heart valves:
For adults (including elderly):
Initially 1g Amoxicillin IV or IM with 120mg gentamicin IV or IM immediately before induction; followed by (6 hours later): 500mg Amoxicillin orally or IV or IM.
For children under 10years : 
The doses of Amoxicillin should be half the adult dose ; the dose of gentamicin should be 2 mg/kg 
For children under 5 years : the doses of Amoxicillin should be quarter the adult dose ; the dose of gentamicin should be 2mg/kg.
See Notes 2, 3 and 4 
Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, and particularly for the urgent treatment of severe infection. 
In renal impairment the excretion of the antibiotic will be delayed and depending on the degree of impairment, it may be necessary to reduce the total daily dosage. 


Adverse Reactions
"As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of penicillins:
• Gastrointestinal: Nausea, vomiting, diarrhea, and hemorrhagic/pseudomembranous colitis. onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
• Hypersensitivity Reactions: Serum sickness-like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.
NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is lifethreatening and amenable only to amoxicillin therapy.
• Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
• Renal: Crystalluria has also been reported .
• Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
• Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely. 
• Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
• Combination Therapy with Clarithromycin and Lansoprazole: In clinical trials using combination therapy with amoxicillin plus clarithromycin and lansoprazole, and amoxicillin plus lansoprazole, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with amoxicillin, clarithromycin, or lansoprazole
* Triple Therapy :
Amoxicillin/Clarithromycin/Lansoprazole: The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.
*Dual Therapy 
moxicillin/Lansoprazole 
The most frequently reported adverse events for patients who received amoxicillin three times daily plus lansoprazole three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with amoxicillin three times daily plus lansoprazole three times daily dual therapy than with lansoprazole alone

Contra Indications
Amoxicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (eg. penicillins, cephalosporins).

Drug Interactions
"• Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with AMOXICILLIN may result in increased and prolonged blood levels of amoxicillin. 
• In common with other antibiotics, AMOXICILLIN may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives. 
• Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. 
• It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods. 
5 EgyDrug Index: September 2013 Amoxicid 250mg Capsule "* Each capsule of Amoxicid 250 mg capsules contains: Amoxicillin trihydrate 287 mg  (Equivalent to 250...