Clarithromycin

Usual Dosing (Adults)

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.Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function.

ADULT DOSAGE GUIDELINES

	BIAXIN Tablets		BIAXIN XL Tablets
Infection	Dosage (q12h)	Duration (days)	Dosage (q24h)	Duration (days)
Pharyngitis/Tonsillitis due to
S. pyogenes	250 mg	10	-	-
Acute maxillary sinusitis due to	500 mg	14	2 x 500 mg	14
H. influenzae
M. catarrhalis
S. pneumoniae
Acute exacerbation of chronic bronchitis due to
H. influenzae	500 mg	7-14	2 x 500 mg	7
H. parainfluenzae	500 mg	7	2 x 500 mg	7
M. catarrhalis	250 mg	7-14	2 x 500 mg	7
S. pneumoniae	250 mg	7-14	2 x 500 mg	7
Community-Acquired Pneumonia due to
H. influenzae	250 mg	7	2 x 500 mg	7
H. parainfluenzae	-	-	2 x 500 mg	7
M. catarrhalis	-	-	2 x 500 mg	7
S. pneumoniae	250 mg	7-14	2 x 500 mg	7
C. pneumoniae	250 mg	7-14	2 x 500 mg	7
M. pneumoniae	250 mg	7-14	2 x 500 mg	7
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: BIAXIN/lansoprazole/amoxicillin
The recommended adult dose is 500 mg BIAXIN, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q12h) for 10 or 14 days.

Triple therapy: BIAXIN/omeprazole/amoxicillin
The recommended adult dose is 500 mg BIAXIN, 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.

Dual therapy: BIAXIN/omeprazole
The recommended adult dose is 500 mg BIAXIN 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.
Dual therapy: BIAXIN/ranitidine bismuth citrate
The recommended adult dose is 500 mg BIAXIN 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. BIAXIN and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min.

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
9 17 25 33	20 37 55 73	62.5 mg 125 mg 187.5 mg 250 mg	2.5 mL q12h 5 mL q12h 7.5 mL q12h 10 mL q12h	1.25 mL q12h 2.5 mL q12h 3.75 mL q12h 5 mL q12h

Mycobacterial Infections

Prophylaxis
The recommended dose of BIAXIN 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. 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.

Renal Dosing

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.

Hemodialysis

See above. Schedule dose after HD on dialysis days.

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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