Active Substance: Clarithromycin (as citrate).
Overview
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This medicine contains an important and useful components, as it consists of
Clarithromycin (as citrate)is available in the market in concentration
Clarithromycin
Renal and hepatic impairment; macrolide cross-resistance; lactation, children. Lactation: Drug is excreted in breast milk; use with caution
Respiratory tract infections, Skin and soft tissue infections, Leprosy, peptic ulcer disease, pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia, legionellosis, Helicobacter pylori, lyme disease, Community-Acquired Pneumonia.
Hypersensitivity. Patients receiving terfenadine, astemizole, pimozide, cisapride and ergot derivatives. Pregnancy; history of acute porphyria.
>10% Gastrointestinal (GI) effects, general (13%) 1-10% Abnormal taste (adults, 3-7%),Diarrhea (3-6%),Nausea (adults, 3-6%),Vomiting (adults, 1%; children, 6%),Elevated blood urea nitrogen (BUN; 4%),Abdominal pain (adults, 2%; children, 3%),Rash (children, 3%),Dyspepsia (2%),Heartburn (adults, 2%),Headache (2%),Elevated prothrombin time (PT; 1%) <1% Anaphylaxis,Anorexia,Anxiety,Clostridium difficile colitis,Dizziness,Dyspnea,Elevated liver function tests,Glossitis,Hallucinations,Hepatic dysfunction,Hepatitis,Hypoglycemia,Increased alkaline phosphatase,Increased aspartate aminotransferase,Increased bilirubin,Increased serum creatinine,Jaundice,Leukopenia,Manic behavior,Neuromuscular blockade,Neutropenia,Pancreatitis,Psychosis,QT prolongation,Seizures,Stevens-Johnson syndrome,Thrombocytopenia Potentially Fatal: Pseudomembranous colitis, anaphylaxis, Stevens-Johnson syndrome.
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Clarithromycin inhibits protein synthesis by binding to 50s ribosomal subunits of susceptible organisms. It has activity against susceptible streptococci and staphylococci as well as other species including B. catarrhalis, L. spp, C. trachomatis and U. urealyticum.
Reduced efficacy w/ CYP3A inducers (e.g. phenytoin, carbamazepine). Strong inducers of CYP450 system (e.g. efavirenz, rifampicin) may accelerate metabolism, thus lower plasma levels of clarithromycin. Inhibition of metabolism w/ ritonavir. Torsades de pointes may result from concomitant quinidine or disopyramide. Increased phosphodiesterase inhibitor exposure w/ sildenafil, tadalafil or vardenafil. Increased risk of digoxin toxicity. Decreased concentration of zidovudine. Concomitant use w/ atazanavir, itraconazole or saquinavir may result to bi-directional drug interactions. Hypotension, bradyarrhythmias, and lactic acidosis may result when taken w/ verapamil. Increased risk of myopathy, including rhabdomyolysis w/ HMG-CoA reductase inhibitors. Increased risk of hypoglycaemia w/ oral hypoglycaemic drugs (e.g. pioglitazone) and insulin. Risk of serious haemorrhage and elevation of INR and prothrombin time w/ oral anticoagulants. Increased ototoxicity w/ aminoglycosides. Increased and prolonged sedation w/ triabenzodiazepines (e.g. midazolam). Potentially Fatal: Concurrent use w/ ergot alkaloids (e.g. ergotamine or dihydroergotamine) is associated w/ acute ergot toxicity characterised by vasospasm and ischaemia of the extremities. Concomitant use w/ astemizole, cisapride, pimozide and terfenadine may result in QT prolongation or ventricular cardiac arrhythmia.
Information not available