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Drug Information

Drug Information for CLARITHROMYCIN (KAISER FOUNDATION HOSPITALS): DOSAGE AND ADMINISTRATION

Clarithromycin Tablets, USP and Clarithromycin for Oral Suspension, USP may be given with orwithout 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
	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 RecurrenceTriple 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 STUDIESsections.) In patients with an ulcer present at the time of initiation of therapy, an additional 18 days ofomeprazole 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 mgomeprazole given once daily (qAM) for 14 days. (See INDICATIONS AND USAGE and CLINICALSTUDIES sections.) An additional 14 days of omeprazole 20 mg once daily is recommended for ulcerhealing 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 14days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin andranitidine bismuth citrate combination therapy is not recommended in patients with creatinineclearance less than 25 mL/min. (See INDICATIONS AND USAGE and CLINICAL STUDIESsections.)

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

Clarithromycin may be administered without dosage adjustment in the presence of hepaticimpairment if there is normal renal function. However, in the presence of severe renal impairment(CR_CL less than 30 mL/min), with or without coexisting hepatic impairment, the dose should be halved or the dosing interval doubled.

Mycobacterial Infections

Prophylaxis

The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium aviumdisease 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. Nostudies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and thedoses recommended for prophylaxis are derived from MAC treatment studies in children. Dosingrecommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection dueto Mycobacterium avium complex. Clarithromycin should be used in combination with otherantimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MACtreatment. (See CLINICAL STUDIES.) The recommended dose for mycobacterial infections in adultsis 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. Dosingrecommendations for children are in the table above.

Clarithromycin therapy should continue for life if clinical and mycobacterial improvements areobserved.

Drug Information Provided by National Library of Medicine (NLM).

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