Cipro 500
"Ciprofloxacin hydrochloride monohydrate 582.25 mg
(Equivalent to 500 mg Ciprofloxacin)Company Name
Memphis
Therapeutic Group
ORAL FLUOROQUINOLONES
Pharmaceutical form
Film coated tablets
Package
"carton box containing one (Al/PVC) blister each of of 10 film coated tablets with an inner leaflet.
Indications
Adults:
For the treatment of uncomplicated and complicated infections caused by organisms susceptible to Ciprofloxacin:- Infections
- Of the respiratory tract. Many of the organisms known as ""problem germs"" (e.g. Klebsiella , Enterobacter , Proteus, Pseudomonas, Legionella , Staphylococcus , Escherichia coli) react very sensitively to Cipro 500 mg. Most cases of pneumonia which do not require hospital treatment are caused by Streptococcus pneumoniae. In such cases Cipro 500 mg is not the drug of first choice.
- Of the middle ear (otitis media) and the paranasal sinuses (sinusitis), particularly when they are caused by problem germs such as Pseudomonas or Staphylococcus. A different antibiotic should be used for acute tonsillitis.
- Of the eyes.- Of the kidneys and/or efferent urinary tract.
- Of the reproductive organs, including inflammation of the ovaries and fallopian tubes (adnexitis), gonorrhoea and infections of the prostate gland (prostatitis). Cipro 500 mg is not effective against Treponema pallidum (the causative organism in syphilis).
- Of the abdominal cavity, e.g. the gastrointestinal tract, the biliary tract and peritoneum (peritonitis).
- Of the skin and soft tissues.
- Of the bones and joints.
- Blood poisoning (sepsis)
- Infections or the risk of infection (prophylaxis) in patients with a compromised immune system, e.g. who are being treated with drugs that suppress the body's natural immune defences(immunosuppressants) or whose blood contains a reduced number of certain white blood cells (neutropenia).
- Targeted elimination of gut bacteria (selective gut decontamination) during treatment with drugs that suppress the body's immune system (immunosuppressants).
For children and adolescents aged between 5 and 17 years:
- For acute infection episodes of cystic fibrosis (mucoviscidosis, an inherited metabolic disorder with increased production and increased viscosity of glandular secretions in the bronchi and digestive tract) caused by P.aeruginosa, Provided that oral therapy seems sufficient or more effective parenteral treatment options do not appear practicable. Cipro 500 mg is not recommended for other indications.
Anthrax:
For immediate therapy and for treatment of anthrax following inhalation of anthrax bacilli (Bacillus Anthracis). The efficacy of Cipro 500 mg in anthrax has been confirmed in studies.
Warning & Precautions
"Particular caution is required when using Cipro 500:- If you suffer from seizures (epilepsy) or any other form of prior damage to the central nervous system (e.g. an increased tendency to seizures, a history of seizures , reduced blood flow in the brain , altered brain structure or a stroke in the past), patients in this category are at risk of side effects in the central nervous system. In isolated cases, psychotic reactions (psychological impairment with altered perception ranging up to the point of self- endangerment) occurred, in some cases after first use. In these cases stop using Cipro 500 mg immediately and inform the attending doctor.
- If severe and persistent diarrhea develops during or after therapy, a doctor should be consulted in such cases as this may be a sign of a serious, possibly life-threatening intestinal disease (Pseudomembranous colitis) which requires immediate treatment. Use of Cipro 500 mg must be discontinued in this case and suitable therapy should be implemented (e.g. vancomycin oral , 4 x 250 mg daily). Do not take drugs that inhibit gastric motility (peristalsis).
- In isolated cases, inflammation of tendons (tendinitis) and rupturing of tendons (e.g. the Achilles tendon) have been observed following treatment with fluoroquinolones (the substance group to which Cipro 500 mg belongs). These occurrences were mainly observed in elderly patients who had been previously treated with corticosteroids. If inflammation of a tendon is suspected , treatment with Cipro 500 mg must be discontinued immediately, physical strain must be avoided and appropriate therapy may have to be given.
- Although photosensitivity only occurs very rarely following treatment with Ciprofloxacin, patients undergoing treatment with Cipro 500 mg should not be exposed unnecessarily to sunlight and should avoid exposure to UV light (high- altitude sun, soladriums). Treatment must be discontinued if light-sensitivity reactions (e.g. skin reactions similar to sunburn) are observed.
- In isolated cases , severe immediate allergic reactions occurred involving swelling (oedema) of the face, blood vessels and larynx and difficulty in breathing (dyspnea) ranging up to life- threatening shock (anaphylactic/anaphyl- actoid reactions), in some cases after first use of the product. In these cases, stop using Cipro 500 mg immediately and inform the attending doctor.
Children and adolescents:
In common with other gyrase inhibitors , Ciprofloxacin , the active ingredient in Cipro 500 mg is known to cause damage to the weight-bearing joints of juvenile animals. Evaluation of the safety Data of patients aged less than 18 years who were mainly suffering from cystic fibrosis (mucoviscidosis) did not reveal evidence of joint/cartilage damage.
Current findings support the use of Cipro 500 mg for treatment of acute infection episodes of cystic fibrosis caused by P. aeruginosa in children and adolescents aged between 5 and 17 years; at present, only inadequate experience is available in regard to its use in children and adolescents with other infections and children aged less than 5 years, Ciprofloxacin should therefore not be used for other infections and not for children aged less than 5 years in general.
Pregnancy:
Cipro 500 mg must not be used at any stage during pregnancy because no experience has been gained regarding its safety in pregnant women. Animal experiments have not produced any evidence of malformation of the fetus (teratogenic effects), but it is not entirely improbable that damage to cartilage may be caused in organisms which have not reached maturity.
Breast-feeding:
It is also recommended on principle that Cipro 500 mg should not be used while breast-feeding.
Driving and operating machinery:
Do not drive or operate power tools or machinery while taking this medicine; even when used correctly , this medicine may impair reaction speed so much that the ability to drive , operate machinery or work without a secure foothold may be reduced , or the patient may not be capable of doing these things at all. This applies particularly at the start of treatment, when the dose is increased. where medication is changed and in conjunction with alcohol.
Product Type
HumanDosage
"Always take Cipro 500 in accordance with your doctor's instructions. Pleaseask your doctor or pharmacist if you are unsure how to take this medicine,
unless otherwise prescribed by your doctor, the usual dose is:
Adults: Single/daily dose for adults
indications Single dose Total daily dose Number of Cipro 500 mg Quantity of active Number of Cipro 500 mg Quantity of active
film coated tablets ingredient ( mg ciprofloxacin) film coated tablets ingredient ( mg ciprofloxacin) Respiratory tract infection ½ - 1 Tablet 250 - 500 mg 1 - 2 Tablets 500 - 1000 mg
(e.g.bronchitis)*
- depending on the
severity and pathogen
Urinary tract infections:
- uncomplicated Up to 1 Tablet Up to 1 Tablet Up to 1 Tablet ( single dose ) Up to 500 mg
- Cystitis in women (before ½ Tablet 250 mg ½ Tablet 250 mg
menopause).
- Complicated ½ - 1 Tablet 250 - 500 mg 1 - 2 Tablets 500 - 1000 mg Gonorrhea, acute, ½ Tablet 250 mg ½ Tablet (single dose) 250 mg
uncomplicated Diarrhea Up to 1 Tablet Up to 500 mg Up to 1 - 2 tablet Up to 500 - 1000 mg
Other infections* 1 Tablet 500 mg 2 Tablets 1000 mg
(cf. indications) Table 1: Recommended single/daily dose for adults * Patients with particularly severe, life-threatening infections (especially those involving Pseudomonas, Staphylococcus or Streptococcus), e.g. pneumonia caused by Streptococcus, recurrent infection episodes in mucoviscidosis patients (an inherited metabolic disorder with increased production and increased viscosity of glandular secretions in the bronchi and digestive tract), infections of bones and joints, blood poisoning (sepsis) and infections of the peritoneum(peritonitis) are generally given Cipro 500 mg intravenously. Alternatively, the patient can be treated by administering 2x750 mg (equivalent to 2x 1.5 film-coated tablets Cipro 500 mg. For patients with infections of the urinary tract or reproductive organs caused by Chlamydia, the daily dose can be increased to 2x750 mg ciprofloxacin (equivalent to 2 x 1.5 film coated tablets Cipro 500 mg if necessary.Anthrax:
- Adults: 1 film-coated tablet Cipro 500 (500mg ciprofloxacin) twice daily.
- Children: 15 mg/kg body weight twice daily.
The maximum single dose for children must not exceed 500 mg.
Treatment should commence immediately after the suspected or confirmed
inhalation of anthrax pathogens.
Elderly patients
Elderly patients should receive as low a dose as is compatible with the severity
of the infection and their kidney function (Creatinine clearance).
Children and adolescents
The recommended oral dose for acute infection episodes caused by P.
aeruginosa in mucoviscidosis patients (an inherited metabolic disorder with
increased production and increased viscosity of glandular secretion in the
bronchi and digestive tract) is 15-20 mg/kg twice daily (maximum 1500 mg/day).
Patients with impaired renal hepatic function:
Adults
1) The following doses are recommended for moderate to severe impairment of
renal function:
- For patients with a creatinine clearance between 31 ml/min and 60 ml/min
(serum creatinine between 1.4 mg/100 ml and 1.9 mg/100 ml), the maximum dose
for oral administration is 1000 mg ciprofloxacin per day.
- For patients with a creatinine clearance ≤ 30 ml/min (serum creatinine ≥
2 mg/100 ml), the maximum dose for oral administration is 500 mg ciprofloxacin
per day.
2) Patients with impaired renal function who are undergoing hemodialysis
should receive the same dose after each dialysis session as patients with
moderate to severe impairment of renal function (see point 1).
3) In patients with impaired renal function who use continuous ambulatory
peritoneal dialysis (CAPD),500 mg ciprofloxacin (equivalent to 1 film-coated
tablets Cipro 500 mg ) is required 4 times daily at 6-hour intervals for peritonitis.
High doses of Cipro 500 mg should be used in order to attain sufficiently high
concentrations of ciprofloxacin in the peritoneum, as a result, patients must be
closely monitored for side effects.
If clinically relevant side effect or symptoms of an overdosage occur, the
dosage must be lowered or use of Cipro 500 mg discontinued.
4) It is not necessary to adjust the dosage for patients with impaired hepatic
function.
5) In patients with impaired renal and hepatic function, the dosage should be
adjusted as for impaired renal function; it may be necessary to monitor the
concentration of ciprofloxacin in the blood.
Children and adolescents
No information is available on the influence of impaired renal and hepatic
function on the dosage for children and adolescents. .
Adverse Reactions
"Like all medicines Cipro 500 mg can have side effects. The frequency is indicatedas follows:
Frequently: ≥ 1 % to < 10 %
Occasionally: ≥ 0.1 % to < 1 %
Rarely :≥ 0.01 % to < 0.1 %
Very rarely: < 0.01%
General:
Occasionally: A sensation of weakness. Long-term or repeated use of Cipro 500
mg can reduce the susceptibility of disease-causing organisms to ciprofloxacin;
this means that the patient may become infected again by the same organism
or, yeast-like organism before the initial infection has been eradicated.
Rarely: Allergic reactions, drug fever, hypersensitivity reactions
(anaphylactic/anaphylactoid reactions, e.g., facial, vascular and laryngeal
oedema; dyspnea ranging up to life threatening shock), in some instances after
the first administration; pain (e.g. pain in the limbs, back, chest).
Very rarely: Reactions similar to those associated with serum sickness (with, for
example, fever, swelling of lymph nodes, reddening of the skin, urticaria, swelling
(oedema), worsening of the symptoms of myasthenia gravis (load-related fatigue
of the muscular system, particularly the muscles of the face, pharynx and
respiratory tract).
Central nervous system
Occasionally: Headache, dizziness, fatigue, insomnia, agitation, confusion.
Rarely: Hallucinations, sweating, peripheral paraesthesia, anxiety, nightmares,
depression, tremor, convulsions, decreased sensitivity to touch.
Very rarely: Unsteady gait, increased intracranial pressure, psychotic reactions
(psychological impairment with altered perception ranging up to the point of
self-endangerment),in some cases after first use, impaired coordination,
increased sensitivity to touch,
increased muscular tone, muscular twitching.
Gastrointestinal tract
Frequently: Nausea, diarrhea.
Occasionally: Vomiting, impaired digestion, abdominal pain, flatulence, loss of
appetite.
Rarely: Jaundice, inflammation of the large bowel (pseudomembranous colitis).
Very rarely: Liver damage (hepatitis, liver cell necrosis ranging up to life- threatening liver failure), inflammation of the pancreas (pancreatitis).
Cardiovascular
Rarely: Palpitations, migraine, unconsciousness, hot flushes, swelling in legs
(peripheral oedema), and low blood pressure.
Blood
Occasionally: Increased levels of a certain type of white blood cells
(eosinophilia), reduced levels of white blood cells (leucocytopenia),
Rarely: Reduced levels of red or certain white blood cells (anaemia,
granulocytopenia) or blood platelets (thrombocytopenia), increased levels of
white blood cells (leukocytosis) or blood platelets (thrombocytosis), changed
blood coagulation factors (prothrombin values).
Very rarely: Increased degradation of red blood corpuscles (haemolytic
anaemia), a reduction in all blood cells (pancytopenia, possibly life-
threatening),a severe decrease in a certain type of white blood cells with the
possible symptoms of shivering, fever, blisters in the oral and throat mucosa
(agranulocytosis), reduced bone marrow function (possibly life-threatening).
Locomotor system
Occasionally: Joint pain.
Rarely: Muscle pain, swelling in the joints.
Very rarely: Inflammation of the tendons (tendinitis), inflammation of the tendon
sheath (tendovaginitis) and torn tendons (e.g. the Achilles tendon), muscular
weakness (myasthenia).
Skin:
Frequently: skin rash.
Occasionally: Itching, elevated blotchy skin rash (maculopapular exanthem),
nettle rash (urticaria).
Rarely: Light sensitivity with reddening of the skin(photosensitivity).
Very rarely: Punctate skin haemorrhages (petechiae), blister formation with
accompanying haemorrhages (haemorrhagic bullae) and small nodules
(papules) with crust formation showing vascular involvement (vasculitis),
erythema nodosum, rash on the skin and mucous membranes close to the skin
(fixed drug eruption), erythema exsudativuin multiforme (minor) ranging up to
severe forms (Stevens-Johnson syndrome), blister-like loss of the skin and
oral/nasal mucosa (Lyell's syndrome).
Sensory organs
Occasionally: Impaired sense of taste and smell.
Rarely: Tinnitus, transient loss of hearing, particularly with high tones, visual
disturbances (e.g. double vision, colored vision), loss of the sense of taste
which is usually reversible after discontinuation of therapy.
Very rarely: Loss of the sense of smell which is usually reversible after
discontinuation of therapy.
Urogenital tract
Rarely: Inflammation of the kidney (interstitial nephritis), transient impairment
in kidney function ranging up to transient kidney failure.
Laboratory findings
Occasionally: Particularly in patients with pre-existing liver damage, temporary
effect on liver function with an increase in liver enzymes (transaminases,
alkaline phosphatase) ranging up to jaundice; transient increase in the levels of
urea, creatinine and bilirubin (a bile pigment in the blood).
Rarely: Raised levels of blood glucose (hyperglycaemia) ;and blood or crystals
in the urine (haematuria and crystalluria).
Very rarely: Increased levels of certain enzymes (amylase, lipase).
Inform your doctor or pharmacist if you notice any side effects that are not
listed in the patient information leaflet.
Contra Indications
"Particular caution is required when using Cipro 500:- If you suffer from seizures (epilepsy) or any other form of prior damage to the
central nervous system (e.g. an increased tendency to seizures, a history of seizures
, reduced blood flow in the brain , altered brain structure or a stroke in the past),
patients in this category are at risk of side effects in the central nervous system.
In isolated cases, psychotic reactions (psychological impairment with altered perce-
ption ranging up to the point of self- endangerment) occurred, in some cases after
first use. In these cases stop using Cipro 500 mg immediately and inform the
attending doctor.
- If severe and persistent diarrhea develops during or after therapy, a doctor
should be consulted in such cases as this may be a sign of a serious, possibly
life-threatening intestinal disease (Pseudomembranous colitis) which requires
immediate treatment. Use of Cipro 500 mg must be discontinued in this case
and suitable therapy should be implemented (e.g. vancomycin oral , 4 x 250 mg
daily). Do not take drugs that inhibit gastric motility (peristalsis).
- In isolated cases, inflammation of tendons (tendinitis) and rupturing of
tendons (e.g. the Achilles tendon) have been observed following treatment with
fluoroquinolones (the substance group to which Cipro 500 mg belongs). These
occurrences were mainly observed in elderly patients who had been previously
treated with corticosteroids. If inflammation of a tendon is suspected , treatment
with Cipro 500 mg must be discontinued immediately, physical strain must be
avoided and appropriate therapy may have to be given.
- Although photosensitivity only occurs very rarely following treatment with
Ciprofloxacin, patients undergoing treatment with Cipro 500 mg should not be
exposed unnecessarily to sunlight and should avoid exposure to UV light (high-
altitude sun, soladriums). Treatment must be discontinued if light-sensitivity
reactions (e.g. skin reactions similar to sunburn) are observed.
- In isolated cases , severe immediate allergic reactions occurred involving
swelling (oedema) of the face, blood vessels and larynx and difficulty in
breathing (dyspnea) ranging up to life- threatening shock (anaphylactic/anaphyl-
actoid reactions), in some cases after first use of the product. In these cases,
stop using Cipro 500 mg immediately and inform the attending doctor.
Children and adolescents:
In common with other gyrase inhibitors , Ciprofloxacin , the active ingredient in
Cipro 500 mg is known to cause damage to the weight-bearing joints of juvenile
animals. Evaluation of the safety Data of patients aged less than 18 years who
were mainly suffering from cystic fibrosis (mucoviscidosis) did not reveal
evidence of joint/cartilage damage. Current findings support the use of
Cipro 500 mg for treatment of acute infection episodes of cystic fibrosis
caused by P. aeruginosa in children and adolescents aged between 5 and 17
years; at present, only inadequate experience is available in regard to its use
in children and adolescents with other infections and children aged less than
5 years, Ciprofloxacin should therefore not be used for other infections and not
for children aged less than 5 years in general.
Pregnancy:
Cipro 500 mg must not be used at any stage during pregnancy because no
experience has been gained regarding its safety in pregnant women. Animal
experiments have not produced any evidence of malformation of the fetus
(teratogenic effects), but it is not entirely improbable that damage to cartilage
may be caused in organisms which have not reached maturity.
Breast-feeding:
It is also recommended on principle that Cipro 500 mg should not be used while
breast-feeding.
Driving and operating machinery:
Do not drive or operate power tools or machinery while taking this medicine;
even when used correctly , this medicine may impair reaction speed so much
that the ability to drive , operate machinery or work without a secure foothold
may be reduced , or the patient may not be capable of doing these things at all.
This applies particularly at the start of treatment, when the dose is increased.
where medication is changed and in conjunction with alcohol.
Drug Interactions
"Cipro 500 /products containing iron/antacids and products with a
high buffering capacity which contain magnesium, aluminium or
calcium.
Simultaneous use of Cipro 500 mg and any of the above-mentioned products
reduces the absorption of Ciprofloxacin: the same applies , for example , to
sucralfate , drugs containing the antiviral agent didanosine , oral nutrient
solutions , drinks enriched with minerals and large quantities of dairy products.
For this reason, Cipro 500 mg must be taken either 1 - 2 hours before or at least
4 hours after these products.This restriction does not apply to antacid
medications of the H2-receptor blocker type.
Cipro 500/xanthines
Taking Cipro 500 mg and theophylline (an asthma treatment) at the same time can
lead to an unwanted increase in the concentration of theophylline in the blood
and accordingly to an increase in the rate of side effects caused by theophylline
which, in isolated cases , may be life-threatening or fatal. If it is imperative to use
both medicines at the same time, the theophylline concentration in the blood
should be monitored and the dosage should be reduced as required.There have
been reports of raised concentrations of the xanthine derivatives caffeine and
pentoxifylline (a medicine that promotes blood circulation) in the blood when
these substances are administered at the same time as Cipro 500 mg.
Cipro 500/non- steroidal anti-inflammatory drugs
Animal studies have shown that using a combination of very high doses of
quinolones (gyrase inhibitors)
and certain drugs which inhibit inflammation (non-steroidal anti-inflammation
agents) can trigger seizures. This does not apply to medicines containing
acetylsalicylic acid.
Cipro 500/cyclosporin
Temporary impairment of kidney function associated with an increase in the
concentration of Creatinine in the blood has been observed in isolated cases
when Cipro 500 mg is taken at the same time as cyclosporin (a drug that
suppresses the body's defense mechanisms). Your Creatinine concentration
should be monitored closely (twice a week) if you are taking both medicines
at the same time.
Cipro 500/warfarin
Simultaneous use of Cipro 500 and warfarin (a drug that inhibits the
coagulation of blood) may increase the action of warfarin.
Cipro 500 / Glibenclamide
In isolated cases concomitant use of Cipro 500 and Glibenclamide
(a treatment for diabetes) may increase the action of glibenclamide to such
an extent that hypoglycemia may occur.
Cipro 500/probenecid
Probenecid (a treatment for gout) affects the excretion of ciprofloxacin in
urine (renal secretion).
Simultaneous use of Cipro 500 and probenecid increases the concentration
of ciprofloxacin in the blood (serum).
Cipro 500/metoclopramide
Metoclopramide (a gastrointestinal medicine) accelerates the absorption of
ciprofloxacin into the blood and causes the maximum concentration in the
blood (plasma) to be reached more rapidly than usual. No effect on the
bioavailability of Cipro 500 in the human body has been observed.
Cipro 500/mexiletine
Simultaneous use of these two medicines may lead to a raised concentration
of mexiletine in the body.
Cipro 500/phenytoin
Elevated or lowered serum concentrations of phenytoin have been reported
following the simultaneous use of these two medicines.
Cipro 500/diazepam
There have been reports that concomitant use of Cipro 500 and diazepam
delays the decomposition of diazepam in the body (reduced clearance,
extended half-life). Accordingly, careful monitoring of diazepam treatment is
recommended.
Cipro 500/ methotrexate
Simultaneous use of these two substances can lead to delayed excretion of
methotrexate and thus to increased plasma levels of methotrexate. These
patients should be carefully monitored, as this condition can lead to an
increased risk of toxic reactions induced by methotrexate.
Cipro 500/omeprazole
Simultaneous use of ciprofloxacin and omeprazole can lead to a slight
decrease in the peak plasma concentrations (Cmax) and bioavailability (AUC)
of ciprofloxacin.Please inform your doctor or pharmacist if you are taking
other medicines , or have taken other medicines recently, even -if they are
non-prescription medicines.
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