United States - English - NLM (National Library of Medicine)

avpak - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 250 mg - clarithromycin tablets, usp are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below: pharyngitis/tonsillitis due to streptococcus pyogenes (the usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. clarithromycin is generally effective in the eradication of s. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present). acute maxillary sinusitis due to haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae. acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae , haemophilus parainfluenzae , moraxella catarrhalis , or streptococcus pneumoniae. community-acquired pneumonia due to haemophilus influenzae , mycoplasma pneumoniae , streptococcus pneumoniae , or chlamydophila pneumoniae (twar). uncomplicated skin and skin structure infections due to staphylococcus aureus , or streptococcus pyogenes (abscesses usually require surgical drainage). disseminated mycobacterial infections due to mycobacterium avium , or mycobacterium intracellulare clarithromycin tablets, usp in combination with amoxicillin and prevacid (lansoprazole) or prilosec (omeprazole) delayed-release capsules, as triple therapy, are indicated for the treatment of patients with helicobacter pylori  infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate h. pylori . clarithromycin tablets, usp in combination with prilosec (omeprazole) capsules or tritec (ranitidine bismuth citrate) tablets are also indicated for the treatment of patients with an active duodenal ulcer associated with h. pylori   infection. however, regimens which contain clarithromycin as the single antimicrobial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. in patients who fail therapy, susceptibility testing should be done if possible. if resistance to clarithromycin is demonstrated, a non-clarithromycin-containing therapy is recommended. (for information on development of resistance see microbiology   section.) the eradication of h. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence. pharyngitis/tonsillitis due to streptococcus pyogenes. community-acquired pneumonia due to mycoplasma pneumoniae , streptococcus pneumoniae , or chlamydophila pneumoniae (twar) acute maxillary sinusitis due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae acute otitis media due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae note: for information on otitis media, see clinical studies - otitis media. uncomplicated skin and skin structure infections due to staphylococcus aureus , or streptococcus pyogenes (abscesses usually require surgical drainage.) disseminated mycobacterial infections due to mycobacterium avium , or mycobacterium intracellulare clarithromycin tablets, usp are indicated for the prevention of disseminated mycobacterium avium complex (mac) disease in patients with advanced hiv infection. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics. clarithromycin tablets are contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin. concomitant administration of clarithromycin and any of the following drugs is contraindicated: cisapride, pimozide, astemizole, terfenadine, and ergotamine or dihydroergotamine (see drug interactions ). there have been post-marketing reports of drug interactions when clarithromycin and/or erythromycin are coadministered with cisapride, pimozide, astemizole, or terfenadine resulting in cardiac arrhythmias (qt prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of metabolism of these drugs by erythromycin and clarithromycin. fatalities have been reported. concomitant administration of clarithromycin and colchicine is contraindicated in patients with renal or hepatic impairment. clarithromycin should not be given to patients with history of qt prolongation or ventricular cardiac arrhythmia, including torsades de pointes . clarithromycin should not be used concomitantly with hmg-coa reductase inhibitors (statins) that are extensively metabolized by cyp3a4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis (see warnings ). for information about contraindications of other drugs indicated in combination with clarithromycin tablets, refer to the contraindications  section of their package inserts.

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - clarithromycin tablets, usp are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , haemophilus parainfluenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage (1.9)] . clarithromycin tablets, usp are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage (1.9)] . clarithromycin tablets, usp are indicated [see indications and usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: - haemophilus influenzae (in adults) - mycoplasma pneumoniae , streptococcus pneumoniae , chlamydophila pneumoniae clarithromycin tablets, usp are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. clarithromycin tablets, usp are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to staphylococcus aureus , or streptococcus pyogenes . clarithromycin tablets, usp are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see clinical studies (14.2)] . clarithromycin tablets, usp are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to mycobacterium avium or mycobacterium intracellulare in patients with advanced hiv infection [see clinical studies (14.1)] . clarithromycin tablet, usp is given in combination with other drugs in adults as described below to eradicate h. pylori . the eradication of h. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.3)] . - clarithromycin tablets, usp in combination with amoxicillin and prevacid (lansoprazole) or prilosec (omeprazole) delayed-release capsules, as triple therapy, are indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate h. pylori . - clarithromycin tablets, usp in combination with prilosec (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with h. pylori infection. regimens which contain clarithromycin tablets, usp as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. there is resistance to macrolides in certain bacterial infections caused by streptococcus pneumoniae and staphylococcus aureus . susceptibility testing should be performed when clinically indicated. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see warnings and precautions (5.1)] . concomitant administration of clarithromycin with cisapride and pimozide is contraindicated [see drug interactions (7)] . there have been postmarketing reports of drug interactions when clarithromycin is co-administered with cisapride or pimozide, resulting in cardiac arrhythmias (qt prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes ) most likely due to inhibition of metabolism of these drugs by clarithromycin. fatalities have been reported. clarithromycin is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin. concomitant administration of clarithromycin and colchicine is contraindicated in patients with renal or hepatic impairment. do not use clarithromycin concomitantly with hmg-coa reductase inhibitors (statins) that are extensively metabolized by cyp3a4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis [see warnings and precautions (5.4) and drug interactions (7)] . concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated [see drug interactions (7)] . for information about contraindications of other drugs indicated in combination with clarithromycin, refer to their full prescribing information (contraindications section). teratogenic effects pregnancy category c clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5.6)] . four teratogenicity studies in rats (three with oral doses and one with intravenous doses up to 160 mg/kg/day administered during the period of major organogenesis) and two in rabbits at oral doses up to 125 mg/kg/day (approximately twice the recommended maximum human dose based on mg/m 2 ) or intravenous doses of 30 mg/kg/day administered during gestation days 6 to 18 failed to demonstrate any teratogenicity from clarithromycin. two additional oral studies in a different rat strain at similar doses and similar conditions demonstrated a low incidence of cardiovascular anomalies at doses of 150 mg/kg/day administered during gestation days 6 to 15. plasma levels after 150 mg/kg/day were twice the human serum levels. four studies in mice revealed a variable incidence of cleft palate following oral doses of 1000 mg/kg/day (2 and 4 times the recommended maximum human dose based on mg/m 2 , respectively) during gestation days 6 to 15. cleft palate was also seen at 500 mg/kg/day. the 1000 mg/kg/day exposure resulted in plasma levels 17 times the human serum levels. in monkeys, an oral dose of 70 mg/kg/day produced fetal growth retardation at plasma levels that were twice the human serum levels. caution should be exercised when clarithromycin is administered to nursing women. the development and health benefits of human milk feeding should be considered along with the mother’s clinical need for clarithromycin and any potential adverse effects on the human milk fed child from the drug or from the underlying maternal condition. clarithromycin and its active metabolite 14-hydroxy clarithromycin are excreted in human milk. serum and milk samples were obtained after 3 days of treatment, at steady state, from one published study of 12 lactating women who were taking clarithromycin 250 mg orally twice daily. based on the limited data from this study, and assuming milk consumption of 150 ml/kg/day, an exclusively human milk fed infant would receive an estimated average of 136 mcg/kg/day of clarithromycin and its active metabolite, with this maternal dosage regimen. this is less than 2% of the maternal weight-adjusted dose (7.8 mg/kg/day, based on the average maternal weight of 64 kg), and less than 1% of the pediatric dose (15 mg/kg/day) for children greater than 6 months of age. a prospective observational study of 55 breastfed infants of mothers taking a macrolide antibacterial (6 were exposed to clarithromycin) were compared to 36 breastfed infants of mothers taking amoxicillin. adverse reactions were comparable in both groups. adverse reactions occurred in 12.7% of infants exposed to macrolides and included rash, diarrhea, loss of appetite, and somnolence. the safety and effectiveness of clarithromycin tablets have been established for the treatment of the following conditions or diseases in pediatric patients 6 months and older. use in these indications is based on clinical trials in pediatric patients or adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients: - pharyngitis/tonsillitis - community-acquired pneumonia - acute maxillary sinusitis - acute otitis media [see clinical studies (14.2)] - uncomplicated skin and skin structure infections the safety and effectiveness of clarithromycin tablets have been established for the prevention of disseminated mycobacterium avium complex (mac) disease in pediatric patients 20 months and older with advanced hiv infection. no studies of clarithromycin for mac prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from mac pediatric treatment studies. safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established. the safety of clarithromycin has not been studied in mac patients under the age of 20 months. in a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-oh clarithromycin were increased compared to those achieved in healthy young adults. these changes in pharmacokinetics parallel known age-related decreases in renal function. in clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients. consider dosage adjustment in elderly patients with severe renal impairment. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [see warnings and precautions (5.3)] . most reports of acute kidney injury with calcium channel blockers metabolized by cyp3a4 (e.g., verapamil, amlodipine, diltiazem, nifedipine) involved elderly patients 65 years of age or older [see warnings and precautions (5.4)] . especially in elderly patients, there have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, some of which occurred in patients with renal insufficiency. deaths have been reported in some patients [see contraindications (4.4) and warnings and precautions (5.4)] . clarithromycin is principally excreted via the liver and kidney. clarithromycin may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. however, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate [see dosage and administration (2.5)] .

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , haemophilus parainfluenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage (1.9)]. clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage (1.9)]. clarithromycin tablets are indicated [see indications and usage (1.9)]  for the treatment of mild to moderate infections caused by susceptible isolates due to: - haemophilus influenzae (in adults) - mycoplasma pneumoniae , streptococcus pneumoniae , chlamydophila pneumoniae (clarithromycin tablets [in adults and pediatric patients]) clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to staphylococcus aureus , or streptococcus pyogenes . clarithromycin tablets are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see clinical studies (14.2)] . clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to mycobacterium avium or mycobacterium intracellulare in patients with advanced hiv infection [see clinical studies (14.1)] . clarithromycin tablets are given in combination with other drugs in adults as described below to eradicate h. pylori . the eradication of h. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.3)] . - clarithromycin tablets in combination with amoxicillin and prevacid (lansoprazole) or prilosec (omeprazole) delayed-release capsules, as triple therapy, are indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate h. pylori . - clarithromycin tablets in combination with prilosec (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with h. pylori infection. regimens which contain clarithromycin tablets as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. there is resistance to macrolides in certain bacterial infections caused by streptococcus pneumoniae and staphylococcus aureus . susceptibility testing should be performed when clinically indicated. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see warnings and precautions (5.1)] . concomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated [see drug interactions (7)] . there have been postmarketing reports of drug interactions when clarithromycin is co-administered with cisapride or pimozide, resulting in cardiac arrhythmias (qt prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes ) most likely due to inhibition of metabolism of these drugs by clarithromycin tablets. fatalities have been reported. clarithromycin tablets are contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin. concomitant administration of clarithromycin tablets and colchicine is contraindicated in patients with renal or hepatic impairment. concomitant administration of clarithromycin tablets with lomitapide is contraindicated due to potential for markedly increased transaminases [see  warnings and precautions (5.4)and drug interactions (7)] . concomitant administration of clarithromycin tablets with hmg-coa reductase inhibitors (statins) that are extensively metabolized by cyp3a4 (lovastatin or simvastatin) is contraindicated, due to the increased risk of myopathy, including rhabdomyolysis [see  warnings and precautions (5.4)and drug interactions (7)] . concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated [see drug interactions (7)] . concomitant administration ofclarithromycin and lurasidone is contraindicated since it may result in an increase in lurasidone exposure and the potential for serious adverse reactions [see drug interactions (7)]. for information about contraindications of other drugs indicated in combination with clarithromycin tablets, refer to their full prescribing information (contraindications section). risk summary based on findings from animal studies, clarithromycin is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. if pregnancy occurs while taking clarithromycin, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5.7)]. limited data from a small number of published human studies with clarithromycin use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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 (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data animal reproduction studies were conducted in mice, rats, rabbits, and monkeys with oral and intravenously administered clarithromycin. in pregnant mice, clarithromycin was administered during organogenesis (gestation day [gd] 6 to 15) at oral doses of 15, 60, 250, 500, or 1000 mg/kg/day. reduced body weight observed in dams at 1000 mg/kg/day (3 times the maximum recommended human dose [mrhd] based on body surface area comparison) resulted in reduced survival and body weight of the fetuses. at ≥ 500 mg/kg/day, increases in the incidence of postimplantation loss and cleft palate in the fetuses were observed. no adverse developmental effects were observed in mice at ≤ 250 mg/kg/day (≤ 1 times mrhd based on body surface area comparison). in pregnant sprague dawley rats, clarithromycin was administered during organogenesis (gd 6 to 15) at oral doses of 15, 50, or 150 mg/kg/day. reductions in body weight and food consumption was observed in dams at 150 mg/kg/day. increased resorptions and reduced body weight of the fetuses at this dose were considered secondary to maternal toxicity. additionally, at 150 mg/kg/day (1 times mrhd based on body surface area comparison), a low incidence of cardiovascular anomalies (complete situs inversus, undivided truncus, iv septal defect) was observed in the fetuses. clarithromycin did not cause adverse developmental effects in rats at 50 mg/kg/day (0.3 times mrhd based on body surface area comparison). intravenous dosing of clarithromycin during organogenesis in rats (gd 6 to 15) at 15, 50, or 160 mg/kg/day was associated with maternal toxicity (reduced body weight, body-weight gain, and food consumption) at 160 mg/kg/day but no evidence of adverse developmental effects at any dose (≤ 1 times mrhd based on body surface area comparison). in pregnant wistar rat, clarithromycin was administered during organogenesis (gd 7 to 17) at oral doses of 10, 40, or 160 mg/kg/day. reduced body weight and food consumption were observed in dams at 160 mg/kg/day but there was no evidence of adverse developmental effects at any dose (≤ 1 times mrhd based on body surface area comparison). in pregnant rabbits, clarithromycin administered during organogenesis (gd 6 to 18) at oral doses of 10, 35, or 125 mg/kg/day resulted in reduced maternal food consumption and decreased body weight at the highest dose, with no evidence of any adverse developmental effects at any dose (≤ 2 times mrhd based on body surface area comparison). intravenously administered clarithromycin to pregnant rabbits during organogenesis (gd 6 to 18) in rabbits at 20, 40, 80, or 160 mg/kg/day (≥ 0.3 times mrhd based on body surface area comparison) resulted in maternal toxicity and implantation losses at all doses. in pregnant monkeys, clarithromycin was administered (gd 20 to 50) at oral doses of 35 or 70 mg/kg/day. dose-dependent emesis, poor appetite, fecal changes, and reduced body weight were observed in dams at all doses (≥ 0.5 times mrhd based on body surface area comparison). growth retardation in 1 fetus at 70 mg/kg/day was considered secondary to maternal toxicity. there was no evidence of primary drug related adverse developmental effects at any dose tested. in a reproductive toxicology study in rats administered oral clarithromycin late in gestation through lactation (gd 17 to post-natal day 21) at doses of 10, 40, or 160 mg/kg/day (≤ 1 times mrhd based on body surface area comparison), reductions in maternal body weight and food consumption were observed at 160 mg/kg/day. reduced body-weight gain observed in offspring at 160 mg/kg/day was considered secondary to maternal toxicity. no adverse developmental effects were observed with clarithromycin at any dose tested. risk summary 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 (see data). in a separate observational study, reported adverse effects on breast-fed children (rash, diarrhea, loss of appetite, somnolence) were comparable to amoxicillin (see data). no data are available to assess the effects of clarithromycin or 14-oh clarithromycin on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for clarithromycin and any potential adverse effects on the breast-fed child from clarithromycin or from the underlying maternal condition. data human serum and milk samples were obtained after 3 days of treatment, at steady state, from one published study of 12 lactating women who were taking clarithromycin 250 mg orally twice daily. based on the limited data from this study, and assuming milk consumption of 150 ml/kg/day, an exclusively human milk fed infant would receive an estimated average of 136 mcg/kg/day of clarithromycin and its active metabolite, with this maternal dosage regimen. this is less than 2% of the maternal weight-adjusted dose (7.8 mg/kg/day, based on the average maternal weight of 64 kg), and less than 1% of the pediatric dose (15 mg/kg/day) for children greater than 6 months of age. a prospective observational study of 55 breastfed infants of mothers taking a macrolide antibacterial (6 were exposed to clarithromycin) were compared to 36 breastfed infants of mothers taking amoxicillin. adverse reactions were comparable in both groups. adverse reactions occurred in 12.7% of infants exposed to macrolides and included rash, diarrhea, loss of appetite, and somnolence. males administration of clarithromycin resulted in testicular atrophy in rats, dogs and monkeys [see nonclinical toxicology (13.1)] . the safety and effectiveness of clarithromycin tablets have been established for the treatment of the following conditions or diseases in pediatric patients 6 months and older. use in these indications is based on clinical trials in pediatric patients or adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients: - pharyngitis/tonsillitis - community-acquired pneumonia - acute maxillary sinusitis - acute otitis media [see clinical studies (14.2)] - uncomplicated skin and skin structure infections the safety and effectiveness of clarithromycin tablets have been established for the prevention of disseminated mycobacterium avium complex (mac) disease in pediatric patients 20 months and older with advanced hiv infection. no studies of clarithromycin for mac prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from mac pediatric treatment studies. safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established. the safety of clarithromycin has not been studied in mac patients under the age of 20 months. in a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-oh clarithromycin were increased compared to those achieved in healthy young adults. these changes in pharmacokinetics parallel known age-related decreases in renal function. in clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients. consider dosage adjustment in elderly patients with severe renal impairment. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [see warnings and precautions (5.3)] . most reports of acute kidney injury with calcium channel blockers metabolized by cyp3a4 (e.g., verapamil, amlodipine, diltiazem, nifedipine) involved elderly patients 65 years of age or older [see warnings and precautions (5.4)] . especially in elderly patients, there have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, some of which occurred in patients with renal insufficiency. deaths have been reported in some patients [see  contraindications (4.4)and warnings and precautions (5.4)] . clarithromycin is principally excreted via the liver and kidney. clarithromycin may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. however, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate [see dosage and administration (2.6)] .

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , haemophilus parainfluenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage ( 1.9)] . clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage ( 1.9)] . clarithromycin tablets are indicated [see indications and usage ( 1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: - haemophilus influenzae (in adults) - mycoplasma pneumoniae, streptococcus pneumoniae, chlamydophila pneumoniae (in adults and pediatric patients) clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to staphylococcus aureus , or s treptococcus pyogenes . clarithromycin tablets are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see clinical studies ( 14.2)] . clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to mycobacterium avium or myc obacterium intracellulare in patients with advanced hiv infection [see clinical studies ( 14.1 )] . clarithromycin tablets are given in combination with other drugs in adults as described below to eradicate h. pylori . the eradication of h. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see clinical studies ( 14.3 )] . - clarithromycin tablets in combination with amoxicillin and prevacid (lansoprazole) or prilosec (omeprazole) delayed-release capsules, as triple therapy, are indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate h. pylori . - clarithromycin tablets in combination with prilosec (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with h. pylori infection. regimens which contain clarithromycin tablets as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. there is resistance to macrolides in certain bacterial infections caused by streptococcus pneumoniae and staphylococcus aureus . susceptibility testing should be performed when clinically indicated. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see warnings and precautions ( 5.1)] . concomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated [see drug interactions ( 7)] . there have been postmarketing reports of drug interactions when clarithromycin is co‑administered with cisapride or pimozide, resulting in cardiac arrhythmias (qt prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes ) most likely due to inhibition of metabolism of these drugs by clarithromycin tablets. fatalities have been reported. clarithromycin tablets are contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin. concomitant administration of clarithromycin tablets and colchicine is contraindicated in patients with renal or hepatic impairment. concomitant administration of clarithromycin tablets with lomitapide is contraindicated due to potential for markedly increased transaminases [see warnings and precautions ( 5.4) and drug interactions ( 7)]. concomitant administration of clarithromycin tablets with hmg-coa reductase inhibitors (statins) that are extensively metabolized by cyp3a4 (lovastatin or simvastatin) is contraindicated, due to the increased risk of myopathy, including rhabdomyolysis [see warnings and precautions ( 5.4) and drug interactions ( 7)]. concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated [see drug interactions ( 7)] . concomitant administration of clarithromycin and lurasidone is contraindicated since it may result in an increase in lurasidone exposure and the potential for serious adverse reactions [see drug interactions ( 7) ]. for information about contraindications of other drugs indicated in combination with clarithromycin tablets, refer to their full prescribing information (contraindications section). risk summary based on findings from animal studies, clarithromycin tablets are not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. if pregnancy occurs while taking clarithromycin tablets, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions ( 5.7)]. limited data from a small number of published human studies with clarithromycin tablets use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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 (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data animal reproduction studies were conducted in mice, rats, rabbits, and monkeys with oral and intravenously administered clarithromycin. in pregnant mice, clarithromycin was administered during organogenesis (gestation day [gd] 6 to 15) at oral doses of 15, 60, 250, 500, or 1000 mg/kg/day. reduced body weight observed in dams at 1000 mg/kg/day (3 times the maximum recommended human dose [mrhd] based on body surface area comparison) resulted in reduced survival and body weight of the fetuses. at ≥ 500 mg/kg/day, increases in the incidence of post-implantation loss and cleft palate in the fetuses were observed. no adverse developmental effects were observed in mice at ≤ 250 mg/kg/day (≤ 1 times mrhd based on body surface area comparison). in pregnant sprague dawley rats, clarithromycin was administered during organogenesis (gd 6 to 15) at oral doses of 15, 50, or 150 mg/kg/day. reductions in body weight and food consumption was observed in dams at 150 mg/kg/day. increased resorptions and reduced body weight of the fetuses at this dose were considered secondary to maternal toxicity. additionally, at 150 mg/kg/day (1 times mrhd based on body surface area comparison), a low incidence of cardiovascular anomalies (complete situs inversus, undivided truncus, iv septal defect) was observed in the fetuses. clarithromycin did not cause adverse developmental effects in rats at 50 mg/kg/day (0.3 times mrhd based on body surface area comparison). intravenous dosing of clarithromycin during organogenesis in rats (gd 6 to 15) at 15, 50, or 160 mg/kg/day was associated with maternal toxicity (reduced body weight, body-weight gain, and food consumption) at 160 mg/kg/day but no evidence of adverse developmental effects at any dose (≤ 1 times mrhd based on body surface area comparison). in pregnant wistar rat, clarithromycin was administered during organogenesis (gd 7 to 17) at oral doses of 10, 40, or 160 mg/kg/day. reduced body weight and food consumption were observed in dams at 160 mg/kg/day but there was no evidence of adverse developmental effects at any dose (≤ 1 times mrhd based on body surface area comparison). in pregnant rabbits, clarithromycin administered during organogenesis (gd 6 to 18) at oral doses of 10, 35, or 125 mg/kg/day resulted in reduced maternal food consumption and decreased body weight at the highest dose, with no evidence of any adverse developmental effects at any dose (≤ 2 times mrhd based on body surface area comparison). intravenously administered clarithromycin to pregnant rabbits during organogenesis (gd 6 to 18) in rabbits at 20, 40, 80, or 160 mg/kg/day (≥ 0.3 times mrhd based on body surface area comparison) resulted in maternal toxicity and implantation losses at all doses. in pregnant monkeys, clarithromycin was administered (gd 20 to 50) at oral doses of 35 or 70 mg/kg/day. dose-dependent emesis, poor appetite, fecal changes, and reduced body weight were observed in dams at all doses (≥ 0.5 times mrhd based on body surface area comparison). growth retardation in 1 fetus at 70 mg/kg/day was considered secondary to maternal toxicity. there was no evidence of primary drug related adverse developmental effects at any dose tested. in a reproductive toxicology study in rats administered oral clarithromycin late in gestation through lactation (gd 17 to post-natal day 21) at doses of 10, 40, or 160 mg/kg/day (≤ 1 times mrhd based on body surface area comparison), reductions in maternal body weight and food consumption were observed at 160 mg/kg/day. reduced body-weight gain observed in offspring at 160 mg/kg/day was considered secondary to maternal toxicity. no adverse developmental effects were observed with clarithromycin at any dose tested. risk summary 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 (see data). in a separate observational study, reported adverse effects on breast-fed children (rash, diarrhea, loss of appetite, somnolence) were comparable to amoxicillin (see data). no data are available to assess the effects of clarithromycin or 14-oh clarithromycin on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for clarithromycin tablets and any potential adverse effects on the breast-fed child from clarithromycin tablets or from the underlying maternal condition. data human serum and milk samples were obtained after 3 days of treatment, at steady state, from one published study of 12 lactating women who were taking clarithromycin tablets 250 mg orally twice daily. based on the limited data from this study, and assuming milk consumption of 150 ml/kg/day, an exclusively human milk fed infant would receive an estimated average of 136 mcg/kg/day of clarithromycin and its active metabolite, with this maternal dosage regimen. this is less than 2% of the maternal weight-adjusted dose (7.8 mg/kg/day, based on the average maternal weight of 64 kg), and less than 1% of the pediatric dose (15 mg/kg/day) for children greater than 6 months of age. a prospective observational study of 55 breastfed infants of mothers taking a macrolide antibacterial (6 were exposed to clarithromycin) were compared to 36 breastfed infants of mothers taking amoxicillin. adverse reactions were comparable in both groups. adverse reactions occurred in 12.7% of infants exposed to macrolides and included rash, diarrhea, loss of appetite, and somnolence. males administration of clarithromycin resulted in testicular atrophy in rats, dogs and monkeys [see nonclinical toxicology ( 13.1)]. the safety and effectiveness of clarithromycin tablets have been established for the treatment of the following conditions or diseases in pediatric patients 6 months and older. use in these indications is based on clinical trials in pediatric patients or adequate and well- controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients: - pharyngitis/tonsillitis - community-acquired pneumonia - acute maxillary sinusitis - acute otitis media [see clinical studies ( 14.2 )] - uncomplicated skin and skin structure infections the safety and effectiveness of clarithromycin tablets have been established for the prevention of disseminated mycobacterium avium complex (mac) disease in pediatric patients 20 months and older with advanced hiv infection. no studies of clarithromycin tablets for mac prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from mac pediatric treatment studies. safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established. the safety of clarithromycin has not been studied in mac patients under the age of 20 months. in a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin tablets every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-oh clarithromycin were increased compared to those achieved in healthy young adults. these changes in pharmacokinetics parallel known age-related decreases in renal function. in clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients. consider dosage adjustment in elderly patients with severe renal impairment. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [see warnings and precautions ( 5.3)] . most reports of acute kidney injury with calcium channel blockers metabolized by cyp3a4 (e.g., verapamil, amlodipine, diltiazem, nifedipine) involved elderly patients 65 years of age or older [see warnings and precautions ( 5.4)] . especially in elderly patients, there have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, some of which occurred in patients with renal insufficiency. deaths have been reported in some patients [see contraindications ( 4.4) and warnings and precautions ( 5.4)] . clarithromycin tablets are principally excreted via the liver and kidney. clarithromycin tablets may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. however, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate [see dosage and administration ( 2.5 )] .

United States - English - NLM (National Library of Medicine)

rising pharma holdings, inc. - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 250 mg - clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , haemophilus parainfluenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage (1.9)]. clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage (1.9)]. clarithromycin tablets are indicated [see indications and usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: - haemophilus influenzae (in adults)  - mycoplasma pneumoniae , streptococcus pneumoniae , chlamydophila pneumoniae (clarithromycin tablets [in adults and pediatric patients]) clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to staphylococcus aureus , or streptococcus pyogenes . clarithromycin tablets are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see clinical studies (14.2)] . clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to mycobacterium avium or mycobacterium intracellulare in patients with advanced hiv infection [see clinical studies (14.1)] . clarithromycin tablets are given in combination with other drugs in adults as described below to eradicate h. pylori . the eradication of h. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.3)] . - clarithromycin tablets in combination with amoxicillin and prevacid (lansoprazole) or prilosec (omeprazole) delayed-release capsules, as triple therapy, are indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate h. pylori . - clarithromycin tablets in combination with prilosec (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with h. pylori infection. regimens which contain clarithromycin tablets as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. there is resistance to macrolides in certain bacterial infections caused by streptococcus pneumoniae and staphylococcus aureus . susceptibility testing should be performed when clinically indicated. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see warnings and precautions (5.1)] . concomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated [see drug interactions (7)] . there have been postmarketing reports of drug interactions when clarithromycin is co-administered with cisapride or pimozide, resulting in cardiac arrhythmias (qt prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes ) most likely due to inhibition of metabolism of these drugs by clarithromycin tablets. fatalities have been reported. clarithromycin tablets are contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin. concomitant administration of clarithromycin tablets and colchicine is contraindicated in patients with renal or hepatic impairment. concomitant administration of clarithromycin tablets with lomitapide is contraindicated due to potential for markedly increased transaminases [see warnings and precautions (5.4) and drug interactions (7)] . concomitant administration of clarithromycin tablets with hmg-coa reductase inhibitors (statins) that are extensively metabolized by cyp3a4 (lovastatin or simvastatin) is contraindicated, due to the increased risk of myopathy, including rhabdomyolysis [see warnings and precautions (5.4) and drug interactions (7)] . concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated [see drug interactions (7)] . concomitant administration of clarithromycin and lurasidone is contraindicated since it may result in an increase in lurasidone exposure and the potential for serious adverse reactions [see drug interactions (7)]. for information about contraindications of other drugs indicated in combination with clarithromycin tablets, refer to their full prescribing information (contraindications section). risk summary based on findings from animal studies, clarithromycin is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. if pregnancy occurs while taking clarithromycin, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5.7)]. limited data from a small number of published human studies with clarithromycin use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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 (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data animal reproduction studies were conducted in mice, rats, rabbits, and monkeys with oral and intravenously administered clarithromycin. in pregnant mice, clarithromycin was administered during organogenesis (gestation day [gd] 6 to 15) at oral doses of 15, 60, 250, 500, or 1000 mg/kg/day. reduced body weight observed in dams at 1000 mg/kg/day (3 times the maximum recommended human dose [mrhd] based on body surface area comparison) resulted in reduced survival and body weight of the fetuses. at ≥ 500 mg/kg/day, increases in the incidence of postimplantation loss and cleft palate in the fetuses were observed. no adverse developmental effects were observed in mice at ≤ 250 mg/kg/day (≤ 1 times mrhd based on body surface area comparison). in pregnant sprague dawley rats, clarithromycin was administered during organogenesis (gd 6 to 15) at oral doses of 15, 50, or 150 mg/kg/day. reductions in body weight and food consumption was observed in dams at 150 mg/kg/day. increased resorptions and reduced body weight of the fetuses at this dose were considered secondary to maternal toxicity. additionally, at 150 mg/kg/day (1 times mrhd based on body surface area comparison), a low incidence of cardiovascular anomalies (complete situs inversus, undivided truncus, iv septal defect) was observed in the fetuses. clarithromycin did not cause adverse developmental effects in rats at 50 mg/kg/day (0.3 times mrhd based on body surface area comparison). intravenous dosing of clarithromycin during organogenesis in rats (gd 6 to 15) at 15, 50, or 160 mg/kg/day was associated with maternal toxicity (reduced body weight, body-weight gain, and food consumption) at 160 mg/kg/day but no evidence of adverse developmental effects at any dose (≤ 1 times mrhd based on body surface area comparison). in pregnant wistar rat, clarithromycin was administered during organogenesis (gd 7 to 17) at oral doses of 10, 40, or 160 mg/kg/day. reduced body weight and food consumption were observed in dams at 160 mg/kg/day but there was no evidence of adverse developmental effects at any dose (≤ 1 times mrhd based on body surface area comparison). in pregnant rabbits, clarithromycin administered during organogenesis (gd 6 to 18) at oral doses of 10, 35, or 125 mg/kg/day resulted in reduced maternal food consumption and decreased body weight at the highest dose, with no evidence of any adverse developmental effects at any dose (≤ 2 times mrhd based on body surface area comparison). intravenously administered clarithromycin to pregnant rabbits during organogenesis (gd 6 to 18) in rabbits at 20, 40, 80, or 160 mg/kg/day (≥ 0.3 times mrhd based on body surface area comparison) resulted in maternal toxicity and implantation losses at all doses. in pregnant monkeys, clarithromycin was administered (gd 20 to 50) at oral doses of 35 or 70 mg/kg/day. dose-dependent emesis, poor appetite, fecal changes, and reduced body weight were observed in dams at all doses (≥ 0.5 times mrhd based on body surface area comparison). growth retardation in 1 fetus at 70 mg/kg/day was considered secondary to maternal toxicity. there was no evidence of primary drug related adverse developmental effects at any dose tested. in a reproductive toxicology study in rats administered oral clarithromycin late in gestation through lactation (gd 17 to post-natal day 21) at doses of 10, 40, or 160 mg/kg/day (≤ 1 times mrhd based on body surface area comparison), reductions in maternal body weight and food consumption were observed at 160 mg/kg/day. reduced body-weight gain observed in offspring at 160 mg/kg/day was considered secondary to maternal toxicity. no adverse developmental effects were observed with clarithromycin at any dose tested. risk summary 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 (see data). in a separate observational study, reported adverse effects on breast-fed children (rash, diarrhea, loss of appetite, somnolence) were comparable to amoxicillin (see data). no data are available to assess the effects of clarithromycin or 14-oh clarithromycin on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for clarithromycin and any potential adverse effects on the breast-fed child from clarithromycin or from the underlying maternal condition. data human serum and milk samples were obtained after 3 days of treatment, at steady state, from one published study of 12 lactating women who were taking clarithromycin 250 mg orally twice daily. based on the limited data from this study, and assuming milk consumption of 150 ml/kg/day, an exclusively human milk fed infant would receive an estimated average of 136 mcg/kg/day of clarithromycin and its active metabolite, with this maternal dosage regimen. this is less than 2% of the maternal weight-adjusted dose (7.8 mg/kg/day, based on the average maternal weight of 64 kg), and less than 1% of the pediatric dose (15 mg/kg/day) for children greater than 6 months of age. a prospective observational study of 55 breastfed infants of mothers taking a macrolide antibacterial (6 were exposed to clarithromycin) were compared to 36 breastfed infants of mothers taking amoxicillin. adverse reactions were comparable in both groups. adverse reactions occurred in 12.7% of infants exposed to macrolides and included rash, diarrhea, loss of appetite, and somnolence. males administration of clarithromycin resulted in testicular atrophy in rats, dogs and monkeys [see nonclinical toxicology (13.1)] . the safety and effectiveness of clarithromycin tablets have been established for the treatment of the following conditions or diseases in pediatric patients 6 months and older. use in these indications is based on clinical trials in pediatric patients or adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients: - pharyngitis/tonsillitis - community-acquired pneumonia - acute maxillary sinusitis - acute otitis media [see clinical studies (14.2)] - uncomplicated skin and skin structure infections the safety and effectiveness of clarithromycin tablets have been established for the prevention of disseminated mycobacterium avium complex (mac) disease in pediatric patients 20 months and older with advanced hiv infection. no studies of clarithromycin for mac prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from mac pediatric treatment studies. safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established. the safety of clarithromycin has not been studied in mac patients under the age of 20 months. in a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-oh clarithromycin were increased compared to those achieved in healthy young adults. these changes in pharmacokinetics parallel known age-related decreases in renal function. in clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients. consider dosage adjustment in elderly patients with severe renal impairment. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [see warnings and precautions (5.3)] . most reports of acute kidney injury with calcium channel blockers metabolized by cyp3a4 (e.g., verapamil, amlodipine, diltiazem, nifedipine) involved elderly patients 65 years of age or older [see warnings and precautions (5.4)] . especially in elderly patients, there have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, some of which occurred in patients with renal insufficiency. deaths have been reported in some patients [see contraindications (4.4) and warnings and precautions (5.4)] . clarithromycin is principally excreted via the liver and kidney. clarithromycin may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. however, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate [see dosage and administration (2.6)] .

United States - English - NLM (National Library of Medicine)

blenheim pharmacal, inc. - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablet and other antibacterial drugs, clarithromycin tablet should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin tablet is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed below: pharyngitis/tonsillitis due to streptococcus pyogenes (the usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. clarithromycin is generally effective

United States - English - NLM (National Library of Medicine)

rebel distributors corp - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablet and other antibacterial drugs, clarithromycin tablet should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin tablet is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed below: pharyngitis/tonsillitis due to streptococcus pyogenes (the usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. clarithromycin is generally effective

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablet and other antibacterial drugs, clarithromycin tablet should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin tablet is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed below: pharyngitis/tonsillitis due to streptococcus pyogenes (the usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. clarithromycin is generally effective

United States - English - NLM (National Library of Medicine)

wockhardt limited - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablet and other antibacterial drugs, clarithromycin tablet should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin tablet is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed below: pharyngitis/tonsillitis due to streptococcus pyogenes (the usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. clarithromycin is generally effective

United States - English - NLM (National Library of Medicine)

department of state health services, pharmacy branch - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets, usp and other antibacterial drugs, clarithromycin extended-release tablets, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin extended-release tablets, usp are indicated for the treatment of adults with mild to moderate infection caused by susceptible strains of the designated microorganisms in the conditions listed below: acute maxillary sinusitis due to haemophilus influenzae, moraxella catarrhalis , or streptococcus pneumoniae. acute bacterial exacerbation of chronic bronchitis due to