Sunshine Lake Pharma Co., Ltd.

Sunshine Lake Pharma Co., Ltd. Drugs

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  Clarithromycin tablets may be given with or without food.

  Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.

  ADULT DOSAGE GUIDELINES   Clarithromycin Tablets Infection Dosage(q12h) Duration(days) Pharyngitis/Tonsillitis due to          S. pyogenes 250 mg 10 Acute maxillary sinusitis due to 500 mg 14      H. influenzae          M. catarrhalis          S. pneumoniae     Acute exacerbation of chronic bronchitis due to          H. influenzae 500 mg 7-14      H. parainfluenzae 500 mg 7      M. catarrhalis 250 mg 7-14      S. pneumoniae 250 mg 7-14 Community-Acquired Pneumonia due to          H. influenzae 250 mg 7      H. parainfluenzae - -      M. catarrhalis - -      S. pneumoniae 250 mg 7-14      C. pneumoniae 250 mg 7-14      M. pneumoniae 250 mg 7-14 Uncomplicated skin and skin structure 250 mg 7-14      S. aureus     S. pyogenes    

  H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

  Triple therapy: clarithromycin/lansoprazole/amoxicillin

  The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

  Triple therapy: clarithromycin/omeprazole/amoxicillin

  The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual therapy: clarithromycin/omeprazole

  The recommended adult dose is 500 mg clarithromycin given three times daily (q8h) and 40 mg omeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

  Dual therapy: clarithromycin/ranitidine bismuth citrate

  The recommended adult dose is 500 mg clarithromycin given twice daily (q12h) or three times daily (q8h) and 400 mg ranitidine bismuth citrate given twice daily (q12h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

  Children

  The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.

  PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q12h Weight Dose     Kg lbs (q12h) 125 mg/5 mL 250 mg/5 mL 9172533 20375573 62.5 mg125 mg187.5 mg250 mg 2.5 mL q12h 5 mL q12h7.5 mL q12h 10 mL q12h 1.25 mL q12h2.5 mL q12h3.75 mL q12h5 mL q12h

  Mycobacterial Infections

  Prophylaxis

  The recommended dose of clarithromycin tablets for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

  Treatment

  Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

  Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

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