Clarithromycindosage

Adults: clarithromycin tablets 250 mg or 500 mg every 12 hours for 7 to 14 days H. pylori eradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole): clarithromycin tablets 500 mg every 8 or 12 hours for 10 to 14 days. See full prescribing information (FPI) for additional information.

Pediatric Patients: clarithromycin 15 mg/kg/day divided every 12 hours for 10 days Mycobacterial Infections: clarithromycin tablets 500 mg every 12 hours; clarithromycin tablets 7.5 mg/kg up to 500 mg every 12 hours in pediatric patients Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir-containing regimens and in severe renal impairment

2.1 Important

Administration Instructions Clarithromycin tablets may be given with or without food.

2.2 Adult Dosage

The recommended dosages of clarithromycin tablets for the treatment of mild to moderate infections in adults are listed in Table 1. Table 1. Adult Dosage Guidelines Infection Clarithromycin Tablets Dosage (every 12 hours) Duration (days) Acute bacterial exacerbation of chronic bronchitis 250 to 500 mg 7 † -14 Acute maxillary sinusitis 500 mg 14 Community-acquired pneumonia 250 mg 7 ǂ -14 Pharyngitis/Tonsillitis 250 mg 10 Uncomplicated skin and skin structure infections 250 mg 7-14 Treatment and prophylaxis of disseminated Mycobacterium avium disease 500 mg § - H.pylori eradication to reduce the risk of duodenal ulcer recurrence with amoxicillin and omeprazole or lansoprazole 500 mg 10-14 H.pylori eradication to reduce the risk of duodenal ulcer recurrence with omeprazole 500 mg every 8 hours 14 * For M. catarrhalis and S. pneumoniae use 250 mg. For H. influenzae and H. parainfluenzae, use 500 mg. † For H parainfluenzae, the duration of therapy is 7 days. ǂ For H. influenzae, the duration of therapy is 7 days. § Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

2.3 Combination

Dosing Regimens for H. pylori Infection Triple therapy: clarithromycin/lansoprazole/amoxicillin The recommended adult dosage is 500 mg clarithromycin tablets, 30 mg lansoprazole, and 1 gram amoxicillin, all given every 12 hours for 10 or 14 days.

Triple therapy: clarithromycin/omeprazole/amoxicillin The recommended adult dosage is 500 mg clarithromycin tablets, 20 mg omeprazole, and 1 gram amoxicillin; all given every 12 hours for 10 days. 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 dosage is 500 mg clarithromycin tablets given every 8 hours and 40 mg omeprazole given once every morning for 14 days. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

2.4 Pediatric

Dosage The recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days (up to the adult dose). Refer to dosage regimens for mycobacterial infections in pediatric patients for additional dosage information.

2.5 Dosage Regimens for

Mycobacterial Infections For the treatment of disseminated infection due to Mycobacterium avium complex (MAC), clarithromycin tablets are recommended as the primary agents. Clarithromycin tablets should be used in combination with other antimycobacterial drugs (e.g. ethambutol) that have shown in vitro activity against MAC or clinical benefit in MAC treatment. Adult Patients For treatment and prophylaxis of mycobacterial infections in adults, the recommended dose of clarithromycin tablets is 500 mg every 12 hours. Pediatric Patients For treatment and prophylaxis of mycobacterial infections in pediatric patients, the recommended dose is 7.5 mg/kg every 12 hours up to 500 mg every 12 hours.. Clarithromycin tablets therapy should continue if clinical response is observed. Clarithromycin tablets can be discontinued when the patient is considered at low risk of disseminated infection.

2.6 Dosage Adjustment in

Patients with Renal Impairment See Table 2 for dosage adjustment in patients with moderate or severe renal impairment with or without concomitant atazanavir or ritonavir-containing regimens. Table 2. Clarithromycin Tablets Dosage Adjustments in Patients with Renal Impairment Recommended Clarithromycin Tablets Dosage Reduction Patients with severe renal impairment (CL cr of <30 mL/min) Reduce the dosage of clarithromycin tablets by 50% Patients with moderate renal impairment (CL cr of 30 to 60 mL/min) taking concomitant atazanavir or ritonavir-containing regimens Reduce the dosage of clarithromycin tablets by 50% Patients with severe renal impairment (CL cr of <30 mL/min) taking concomitant atazanavir or ritonavir-containing regimens Reduce the dosage of clarithromycin tablets by 75%

2.7 Dosage Adjustment

Due to Drug Interactions Decrease the dose of clarithromycin tablets by 50 % when co-administered with atazanavir. Dosage adjustments for other drugs when co-administered with clarithromycin tablets may be recommended due to drug interactions.