RiteMED Clarithromycin

Tab: Upper & lower resp tract (including streptococcal pharyngitis, tonsillitis & atypical pneumonia, bronchitis), skin & skin structure & odontogenic infections, acute otitis media & maxillary sinusitis. H. pylori infections (in combination w/ other drugs). Disseminated or localized mycobacterial infections due to Mycobacterium intracellulare or Mycobacterium avium. Susp: Adult: Pharyngitis/tonsillitis; acute maxillary sinusitis & bacterial exacerbations; community acquired pneumonia (CAP); uncomplicated skin & skin infections; disseminated mycobacterial infections. Childn: Pharyngitis/tonsillitis; CAP; acute maxillary sinusitis/otitis media; uncomplicated skin & skin structure infections; disseminated mycobacterial infections; resp tract infections (including otitis media) & skin & soft tissue infections; prophylaxis & treatment of opportunistic mycobacterial infections; leprosy; H. pylori eradication for PUD.

Tab Adult Non-mycobacterial infections 250-500 mg every 12 hr for 7-14 days. Disseminated or localized mycobacterial infections 500 mg every 12 hr. Prophylaxis & treatment of M. avium complex (MAC) infections in HIV +ve/AIDs patients 500 mg every 12 hr & continue treatment while CD₄ count is <100/mm³. MAC infections in HIV+/AIDS patients 500 mg every 12 hr & until clinically improved. Should be used in combination w/ other antimycobacterial drugs w/ activity against MAC. H. pylori infections Triple therapy regimen: Clarithromycin 500 mg + amoxicillin 1,000 mg + omeprazole 20 mg, all bid for 7-10 days or clarithromycin 500 mg + amoxicillin 1,000 mg + pantoprazole 40 mg, all bid for 1 wk. Dual therapy regimen: Clarithromycin 500 mg tid + omeprazole 40 mg once daily for 14 days, followed by omeprazole 20 or 40 mg once daily for additional 14 days. Odontogenic infections 250 mg every 12 hr for 5 days. Childn ≥7 yr Non-mycobacterial infections 250 mg every 12 hr for 5-10 days. Renal impairment (CrCl <30 mL/min) Adult Reduce dose by ½ ie, 250 mg once daily or 250 mg every 12 hr. Childn Reduce by ½ ie, up to max of 250 mg once daily or 250 mg every 12 hr. Dose should not exceed for 14 days. Susp Childn Recommended dose: 15 mg/kg/day divided every 12 hr for 10 days. Mycobacterial infection prophylaxis 500 mg bid. Disseminated infection due to MAC Adult 500 mg bid; childn 7.5 mg/kg bid.

May be taken with or without food.

Hypersensitivity to clarithromycin, erythromycin or any macrolides. Concomitant use w/ cisapride, pimozide, astemizole, terfenadine & ergotamine or dihydroergotamine.

Severe renal impairment w/ or w/o coexisting hepatic impairment. Avoid use of ranitidine bismuth citrate in patients w/ history of acute porphyria & w/ CrCl <25 mL/min. Pregnancy & lactation.

Diarrhea, nausea. Tab: Abnormal taste, dyspepsia, abdominal discomfort, oral candidiasis, dry mouth, glossitis, stomatitis, vomiting, flatulence, diaper dermatitis, constipation, pseudomembranous colitis, tongue discoloration, anorexia, pancreatitis, laryngismus, tooth discoloration; headache, acute psychosis, nervousness, anxiety, behavioral changes, confusional states, depression, depersonalization, disorientation, dizziness, hallucinations, insomnia, convulsions, manic behavior, nightmares, somnolence, tinnitus, tremor, vertigo; QT interval prolongation, ventricular arrhythmias eg, ventricular tachycardia, Torsades de pointes; rhinitis, pharyngitis, cough, dyspnea, asthma; allergic reactions (anaphylaxis, pruritus & rash, hyperhydrosis, leukocytoclastic vasculitis, toxic epidermal necrolysis, SJS; back pain, asthenia, arthralgia, myalgia; elevated AST, ALT, γ-glutamyl transferase, alkaline phosphatase, lactate dehydrogenase, LDH &/or total bilirubin conc, hepatomegaly & hepatic dysfunction; thrombocytopenia, thrombocytopenic purpura, increased prothrombin time, anemia, eosinophilia, leukopenia, neutropenia; elevated BUN, serum creatinine conc, interstitial nephritis, acute renal failure, hematuria. Susp: Abnormal taste, dyspepsia, abdominal pain, headache, allergic reactions, CNS effects.

May potentiate the effect of anticoagulant (eg, warfarin). Manifest carbamazepine toxicity & increased risk of colchicine, cyclosporine & tacrolimus toxicity. May increase cardiac arrhythmia w/ non-sedating antihistamines, astemizole, terfenadine; ergot alkaloids; cisapride, pimozide. May elevate serum level of digoxin, theophylline, zidovudine. Increased elimination t_½ w/ disopyramide & metabolism w/ rifampicin, rifabutin. May increase CNS effects w/ triazolam. Increased AUC w/ delavirdine & conc w/ lopinavir & indinavir. Decreased conc & AUC w/ ritonavir. May increase conc & AUC of amprenavir & atazanavir. Increased plasma conc w/ saquinavir. May cause delirium w/ fluoxetine; rash w/ efavirenz; rhabdomyolysis, sometimes w/ acute renal failure w/ HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin) & Torsades de pointes w/ quinidine. Increased C_max & AUC w/ omeprazole & fluconazole; AUC w/ sildenafil. May inhibit the metabolism & increase serum level of CYP3A isoenzyme eg, alfentanil, alprazolam, bromocriptine, cilostazol, darifenacin, hexobarbital, methylprednisolone, midazolam, phenytoin, valproate & vinblastine.

Macrolides

J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.

Rx