Tissue and Serum Concentrations of ClarithromycinSpecific Populations for Clarithromycin Granules FormulationsTable 10.
The most frequently reported adverse reactions excluding those due to the patient’s concurrent conditions were consistent with those observed in adult patients.In the first 12 weeks of starting on clarithromycin 500 mg twice a day, 3% of patients has SGOT increases and 2% of patients has SGPT increases >5 times the upper limit of normal in trial 2 (469 enrolled adult patients) while trial 1 (154 enrolled patients) had no elevation of transaminases. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
Follow all instructions closely.
Middle Ear Fluid and Serum Concentrations of Clarithromycin and 14-OH-Clarithromycin in Pediatric PatientsCONCENTRATION (after 7.5 mg/kg every 12 hours for 5 doses)Clarithromycin Tissue Concentrations 2 hours after Dose (mcg/mL)/(mcg/g)Figure 3. All possible dosages and drug forms may not be included here. taken, how much, and when it happened.
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. In clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients.
This medication can also be used in combination with anti-ulcer medications to treat certain types of stomach ulcers. Clarithromycin oral tablet (Biaxin) is used to prevent and treat certain bacterial infections. Outcome with the Different Dosing Regimens of ClarithromycinTable 15. 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).
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:The safety and effectiveness of clarithromycin for oral suspension have been established for the prevention of disseminated Safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Selected Treatment-Related* Adverse Reaction Incidence Rates (%) in Immunocompromised Adult Patients During the First 12 Weeks of Therapy with 500 mg Twice a Day Clarithromycin DoseTable 7. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by clarithromycin or other antibacterial drugs in the future.There are no data on the effect of clarithromycin on the ability to drive or use machines. For clarithromycin, the mean CIn two studies in which theophylline was administered with clarithromycin (a theophylline sustained-release formulation was dosed at either 6.5 mg/kg or 12 mg/kg together with 250 or 500 mg q12h clarithromycin), the steady-state levels of CWhen a single dose of midazolam was co-administered with clarithromycin tablets (500 mg twice daily for 7 days), midazolam AUC increased 174% after intravenous administration of midazolam and 600% after oral administration.For information about other drugs indicated in combination with clarithromycin, refer to their full prescribing information, CLINICAL PHARMACOLOGY section.Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible bacteria resulting in inhibition of protein synthesis.The major routes of resistance are modification of the 23S rRNA in the 50S ribosomal subunit to insensitivity or drug efflux pumps.
Data are reported separately for trial 1 (randomized, double-blind) and trial 2 (open‑ labeled, compassionate use) and also combined. Shake well before use. While only 19 of the 341 patients randomized to clarithromycin developed MAC, 11 of these cases were resistant to clarithromycin.
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