美国 - 英文 - NLM (National Library of Medicine)

remedyrepack 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 c

美国 - 英文 - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - clarithromycin extended-release 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 extended-release tablets (in adults) 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 extended-release 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) - haemophilus parainfluenzae (in adults) - moraxella catarrhalis (in adult

美国 - 英文 - NLM (National Library of Medicine)

aurobindo pharma limited - 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 indiv

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - clarithromycin, quantity: 500 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; hypromellose; titanium dioxide; iron oxide yellow; magnesium stearate; macrogol 8000; microcrystalline cellulose - clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 1. acute streptococcal pharyngitis 2. community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophilia and streptococcus pneumoniae 3. uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes 4. disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare and skin and skin structure infections due to mycobacterium chelonae. clarithromycin should be used in combination with other antimycobacterial agents. 5. prevention of disseminated mycobacterium avium complex infection in hiv-infected adults with cd4 lymphocyte counts < 75 cells/mm3 (see precautions). disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis 6. acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae. 7. combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 1. acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes 2. community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila 3. skin and skin structure infections (e.g. impetigo) 4. disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. 5. acute otitis media. note: 1. penicillins are the drug of first choice in the treatment of acute otitis media. 2. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3 there is insufficient evidence of efficacy to support the use of clarithromycin in acute bronchitis in young children. 4. the data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - clarithromycin, quantity: 250 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; iron oxide yellow; macrogol 8000; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; titanium dioxide - clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 1. acute streptococcal pharyngitis 2. community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophilia and streptococcus pneumoniae 3. uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes 4. disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare and skin and skin structure infections due to mycobacterium chelonae. clarithromycin should be used in combination with other antimycobacterial agents. 5. prevention of disseminated mycobacterium avium complex infection in hiv-infected adults with cd4 lymphocyte counts < 75 cells/mm3 (see precautions). disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis 6. acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae. 7. combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 1. acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes 2. community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila 3. skin and skin structure infections (e.g. impetigo) 4. disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. 5. acute otitis media. note: 1. penicillins are the drug of first choice in the treatment of acute otitis media. 2. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3 there is insufficient evidence of efficacy to support the use of clarithromycin in acute bronchitis in young children. 4. the data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

美国 - 英文 - 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

美国 - 英文 - NLM (National Library of Medicine)

redpharm drug, inc. - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - 1.1 acute bacterial exacerbation of chronic bronchitis 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)] . 1.2 acute maxillary sinusitis 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)] . 1.3 community-acquired pneumonia 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 1.4 pharyngitis/tonsillitis clarithromycin tablets, usp are indicated for the treatment of mild to moderate

美国 - 英文 - NLM (National Library of Medicine)

redpharm drug, inc. - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - 1.1 acute bacterial exacerbation of chronic bronchitis 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)]. 1.2 acute maxillary sinusitis 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)]. 1.3 community-acquired pneumonia 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 1.4 pharyngitis/tonsillitis clarithromycin tablets are indicated for the treatment of mild to moderate infections

美国 - 英文 - NLM (National Library of Medicine)

dispensing solutions, inc. - 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 haemophilus influenzae, haemophilus parainflu

美国 - 英文 - NLM (National Library of Medicine)

a-s medication solutions - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 250 mg in 5 ml - clarithromycin is 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 is 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 is indicated [see indications and usage (1.9) ] for the treatment of mild to moderate infections caused by susceptible isolates due to: clarithromycin is 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 is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to staphylococcus aureus , or streptococcus pyogenes . clarithromycin is 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 is 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) ]. 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. concomitant administration of clarithromycin 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 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, 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 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 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 for oral suspension 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 for oral suspension 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) ].