Clarin Tablet

Clarin Tablet is used for: Acute bacterial exacerbation of chronic bronchitis, Acute maxillary sinusitis, Community-Acquired Pneumonia, Pharyngitis, Tonsillitis, Uncomplicated Skin and Skin Structure Infections, Acute Otitis Media, Disseminated Mycobacterial Infections, Helicobacter pylori Infection and Duodenal Ulcer Disease

Oral Acute Exacerbation of Chronic Bronchitis 250-500 mg PO every 12 hours for 7-14 days Extended release: 1000 mg PO once daily for 7 days Mycobacterial Infection Prophylaxis and treatment 500 mg PO every 12 hours for 7-14 days Use with antimycobacterial drugs such as rifampin and ethambutol Peptic Ulcer Disease 500 mg PO every 8-12 hours for 10-14 days Administer as part of 2- or 3-drug combination regimen with bismuth subsalicylate, amoxicillin, H2 receptor antagonist, or proton pump inhibitor Pharyngitis, Tonsillitis 250 mg PO every 12 hours for 10 days Community-Acquired Pneumonia, Skin/Skin Structure Infection 250 mg PO every 12 hours for 7-14 days Extended release: 1000 mg PO once daily for 7 days H. pylori eradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole): 500 mg every 8 or 12 hours for 10–14 days. Intravenous Respiratory tract infections; Skin and soft tissue infections; Susceptible infections Adult: 500 mg bid for 2-5 days. Infuse over 60 min using a 0.2% soln. Revert to oral therapy whenever possible.

Child: Oral 15 mg/kg/day divided every 12 hours for 10 days Otitis Media Indicated for treatment of acute otitis media caused by H influenzae, M catarrhalis, or S pneumoniae Because of increased resistance to S Pneumoniae and H Influenzae, not routinely recommended as treatment option <6 months: Safety and efficacy not established >6 months: 15 mg/kg/day PO divided every 12 hours for 10 days; not to exceed 500 mg/dose Community-Acquired Pneumonia Indicated for community-acquired pneumonia caused by Mycoplasma pneumoniae, S pneumoniae, or Chlamydophila pneumoniae <3 months: Safety and efficacy not established >3 months: 15 mg/kg/day PO divided every 12 hours for 10 days; not to exceed 500 mg/dose Sinusitis Indicated for the treatment of mild-to-moderate infections caused by susceptible isolates caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae <6 months: Safety and efficacy not established >6 months: 15 mg/kg/day PO divided every 12 hours for 10 days; not to exceed 500 mg/dose Bronchitis Indicated for treatment of mild-to-moderate infections caused by susceptible isolates caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae <6 months: Safety and efficacy not established >6 months: 15 mg/kg/day PO divided every 12 hoursfor 10 days; not to exceed 500 mg/dose Skin Infections Indicated for uncomplicated skin and skin structure infections caused by S aureus or S pyogenes <6 months: Safety and efficacy not established >6 months: 15 mg/kg/day PO divided every 12 hours for 10 days; not to exceed 250 mg/dose Mycobacterial Infection Indicated treatment and prophylaxis of mycobacterial infections When used for treatment of disseminated infection caused by mycobacterium avium complex (MAC), administer in combination with other antimycobacterial drugs (eg, ethambutol) <20 months: Safety and efficacy not established >20 months: 7.5 mg/kg PO every 12 hours; individual dose not to exceed 500 mg Streptococcal Pharyngitis Indicated for pharyngitis/tonsillitis caused by susceptible S pyogenes <6 months: Safety and efficacy not established >6 months: 7.5 mg/kg every 12 hours for 10 days; individual dose not to exceed 250 mg

Renal impairment Moderate CrCl 30-60 mL/min: No dosage adjustment necessary CrCl 30-60 mL/min and concomitant atazanavir or ritonavir-containing regimens: Decrease clarithromycin dose by 50% Severe CrCl <30 mL/min: Decrease clarithromycin dose by 50% CrCl <30 mL/min and concomitant atazanavir or ritonavir-containing regimens: Decrease clarithromycin dose by 75%.

Standard release tab & oral susp: May be taken with or without food. XL & MR tab: Should be taken with food. Swallow whole, do not chew/crush.

Hypersensitivity to clarithromycin or any macrolide drug Coadministration with pimozide, cisapride, ergotamine, and dihydroergotamine History of cholestatic jaundice or hepatic dysfunction associated with previous use of clarithromycin Coadministration with colchicine in patients with renal or hepatic impairment Coadministration with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin, simvastatin), due to the increased risk of myopathy, including rhabdomyolysis

Severe acute hypersensitivity reactions: Discontinue Clarithromycin if occur QT prolongation: Avoid Clarithromycin in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia (torsade de pointes), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics Hepatotoxicity: Discontinue if signs and symptoms of hepatitis occur Serious adverse reactions can occur due to drug interactions of Clarithromycin with colchicine, some HMG CoA reductase inhibitors, some calcium channel blockers, and other drugs Risk of all-cause mortality one year or more after the end of treatment in patients with coronary artery disease Clostridium difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs Embryofetal toxicity: Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate Exacerbation of myasthenia gravis

Pregnancy Based on findings from animal studies, drug is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate; if pregnancy occurs while taking drug, patient should be apprised of potential hazard to fetus Limited data from a small number of published human studies with therapy use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes Animal data In animal reproduction studies, administration of oral clarithromycin to pregnant mice, rats, rabbits, and monkeys during the period of organogenesis produced malformations in rats (cardiovascular anomalies) and mice (cleft palate) at clinically relevant doses based on body surface area comparison; fetal effects in mice, rats, and monkeys (e.g., reduced fetal survival, body weight, body weight gain) and implantation losses in rabbits were generally considered to be secondary to maternal toxicity Lactation Based on limited human data, clarithromycin and its active metabolite 14-OH clarithromycin are present in human milk at less than 2% of the maternal weight-adjusted dose; in a separate observational study, reported adverse effects on breast-fed children (rash, diarrhea, loss of appetite, somnolence) were comparable to amoxicillin; no data are available to assess effects of clarithromycin or 14-OH clarithromycin on milk production Development and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breast-fed child from therapy or from underlying maternal condition

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. Contraindicated (35) alfuzosin chloroquine cisapride clofazimine cobimetinib conivaptan dihydroergotamine dihydroergotamine intranasal dofetilide eliglustat ergoloid mesylates ergonovine ergotamine finerenone flibanserin gepirone ibutilide indapamide ivabradine lomitapide lonafarnib lovastatin lurasidone methylergonovine naloxegol pacritinib pentamidine pimozide quinidine regorafenib rifabutin simvastatin suzetrigine venetoclax voclosporin

Side effects of Clarithromycin : >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.

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.

Clarin 250mg Tablet manufactured by Drug International Ltd.. Its generic name is Clarithromycin. Clarin is availble in Bangladesh. Farmaco BD drug index information on Clarin Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.