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.
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