COMPOSITION
Each 5mL of reconstituted suspension contains: Clarithromycin coated eq. to Clarithromycin USP, 125 mg; Excipients,qs.
INDICATIONS
It is used for infections from respiratory pathogens(e.g., S. pyogenes, S pneumonia, other streptococci, M. catarrhalis, C. tracheomatis, C. pneumoonia,Legionella sp.,Mycoplasma pneumonia, S. aureus, and H. influenza);treatment and prevention of M. avium complex in patients with AIDS and anti- Helicobacter pylori in conjunction with bismuth subcitrate or proton pump inhibitor in the treatment of gastric ulcer and duodenal ulcer relapses.
The recommended daily dosage of Clarithromycin Suspension in children is 7.5 mg/kg b.i.d. up to a maximum dose of 500 mg b.i.d. The usual duration of treatment is for 5 to 10 days depending on the pathogen involved and the severity of the conditon. The prepared suspension can be taken with or without meals, and can be taken with milk.
OVERDOSAGE
Reports indicate that the ingestion of large amounts of Clarithromycin can be expected to produce gastro-instestinal symptoms. Adverse reactions accompanying overdosage should be treated by gastric lavage and general supportive measures. One patient who had a history of bipolar disorders ingested 8 grams of Clarithromycin and showed altered mental status, paranoid behavior, hypokalaemia. As with other macrolides, Clarithromycin serum levels are not expected to be appropriately affected by hemodialysis or peritoneal dialysis.
Clarithromycin is contraindicated in patients with known hypersensitivity to clarithromycin, erythromycin or any of the macrolide antibiotics. Clarithromycin is contraindicated in patients receiving terfenadine therapy who have pre-existing cardiac abnormalities (arrhythmia, bradycardia, QT interval prolongation, ischemic heart disease, congestive heart failure) or electrolyte disturbances.
Caution is required in patients with impaired renal or hepatic function. It should not be used during pregnancy if possible: high doses have been associated with embryotoxicity in animal studies.
Ciprofloxacin is generally well-tolerated. The commonly reported side effects are diarrhea, vomiting, abdominal pain, headache, restlessness and rash. Other side effects reported very rarely are arthralgia, and increase in serum transaminase level.
DRUG INTERACTIONS
Ciprofloxacin absorption when co-administered with magnesium-aluminum antacids. Other cations, such as calcium and probably zinc appear to interact in similar manner. Theophylline serum concentration have been found to be markedly elevated when co-administered with Ciprofloxacin. At doses used for systematic infections, Ciprofloxacin decreases theopylline clearance by approximately 30%. A decreased Ciprofloxacin absorption.
GERMANY
KOHLENHFSTR
67663 KAISERSLAUTERN
GERMANY
ASIA PACIFIC – PHILIPPINES
18 Malumanay St.,
Brgy. Sikatuna Village
Diliman Quezon City
EMAIL
msd@ivppharma.com
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