Clarithromycin instructions for administration

# Instructions for administration
Adult dosage
H. pylori eradication to reduce the risk of duodenal ulcer recurrence
- Clarithromycin/Lansoprazole/Amoxicillin
- Clarithromycin/Omeprazole/Amoxicillin
- Clarithromycin/Omeprazole
- Clarithromycin/Ranitidine Bismuth Citrate
Pediatric dosage
Myobacterial infections
- Prophylaxis
- Treatment
Constituting instructions

## Adult dosage
BIAXIN Filmtab (clarithromycin tablets, USP) and BIAXIN Granules (clarithromycin for oral suspension, USP) may be given with or without food. BIAXIN XL Filmtab (clarithromycin extended-release tablets) should be taken with food. BIAXIN XL tablets should be swallowed whole and not chewed, broken or crushed.
Adult dosage guidelines
For pharyngitis/tonsillitis due to S. pyogenes:
- 250 mg (q12h) of BIAXIN tablets should be given for a duration of 10 days.
For acute maxillary sinusitis due to H. influenzae, M. catarrhalis, and/or S. pneumonia:
- 500 mg (q12h) of BIAXIN tablets should be given for a duration of 14 days or
- 2 x 500 mg (q24h) of BIAXIN XL tablets should be given for a duration of 14 days.
For acute exacerbation of chronic bronchitis due to H. influenzae, M catarrhalis, and/or S. pneumoniae:
- 500 mg (q12h) of BIAXIN tablets should be given for a duration of 7-14 days or
- 2 x 500 mg (q24h) of BIAXIN XL tablets should be given for a duration of 7 days.
For acute exacerbation of chronic bronchitis due to H. parainfluenzae:
- 500 mg (q12h) of BIAXIN tablets should be given for a duration of 7 days or
- 2 x 500 mg (q24h) of BIAXIN XL tablets should be given for a duration of 7 days.
For community-acquired pneumonia due to H. influenzae:
- 250 mg (q12h) of BIAXIN tablets should be given for a duration of 7 days or
- 2 x 500 mg (q24h) of BIAXIN XL tablets should be given for a duration of 7 days.
For community-acquired pneumonia due to H. parainfluenzae and/or M. catarrhalis:
- 2 x 500 mg (q24h) of BIAXIN XL tablets should be given for a duration of 7 days.
For community-acquired pneumonia due to S. pneumoniae, C. pneumoniae, and/or M. pneumoniae:
- 250 mg (q12h) of BIAXIN tablets should be given for a duration of 7-14 days or
- 2 x 500 mg (q24h) of BIAXIN XL tablets should be given for a duration of 7 days.
For uncomplicated skin and skin structure due to S. aureus and/or S.pyogenes:
- 250 mg (q12h) of BIAXIN tablets should be given for a duration of 7 days.
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## H. pylori eradication to reduce the risk of duodenal ulcer recurrence

### 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. Return to top

### 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. 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. Return to top

### 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. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief. Return to top

### 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. Return to top

## Pediatric dosage
The usual recommended daily dosage is 15 mg/kg/day divided q12h for 10 days.
Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. However, in the presence of severe renal impairment (CRCL <30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled. Return to top

## Myobacterial infections

### Prophylaxis
The recommended dose of Clarithromycin 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. Return to top

### 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. 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 for life if clinical and mycobacterial improvements are observed. Return to top

## Constituting instructions
The table below indicates the volume of water to be added when constituting:
Add half the volume of water to the bottle and shake vigorously. Add the remainder of water to the bottle and shake.
Shake well before each use. Oversize bottle provides shake space. Keep tightly closed. Do not refrigerate. After mixing, store at 15 to 30C (59 to 86F) and use within 14 days. Return to top
Adapted from the FDA Package Insert.