Biaxin

INDICATIONS

Clarithromycin and granules for oral suspension are indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

Adults

Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyrogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present.)

Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR).

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes. (Abscesses usually require surgical drainage.)

Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare.

Clarithromycin Filmtab tablets in combination with amoxicillin and lansoprazole (Prevacid) or omeprazole (Prilosec) delayed-release capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori.

Clarithromycin Filmtab tablets in combination with omeprazole (Prilosec) capsules or ranitidine bismuth citrate (Tritec) tablets are also indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. However, regimens which contain clarithromycin as the single antimicrobial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting.

In patients who fail therapy, susceptibility testing should be done if possible. If resistance to clarithromycin is demonstrated, a non-clarithromycin-containing therapy is recommended. (For information on development of resistance (see CLINICAL PHARMACOLOGY, Microbiology). The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence.

Children

Pharyngitis/Tonsillitis due to Streptococcus pyogenes.

Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR).

Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

NOTE: For information on otitis media, see CLINICAL STUDIES, Otitis Media.

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage.)

Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare.

Prophylaxis

Clarithromycin tablets and granules for oral suspension are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

DOSAGE AND ADMINISTRATION

Clarithromycin tablets and clarithromycin for oral suspension may be given with or without food.

TABLE 29 Adult Dosage Guidelines

Infection Dosage (q12h) Normal Duration (days)

Pharyngitis/Tonsillitis 250 mg 10

Acute maxillary sinusitis 500 mg 14

Acute exacerbation of chronic bronchitis due to:

S. pneumoniae 250 mg 7 to 14

M. catarrhalis 250 mg 7 to 14

H. influenzae 500 mg 7 to 14

Pneumonia due to:

S. pneumoniae 250 mg 7 to 14

M. pneumoniae 250 mg 7 to 14

Uncomplicated skin and skin structure 250 mg 7 to 14

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.)

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

Based on Body Weight
TABLE 30 Pediatric Dosage Guidelines
Dosing Calculated on 7.5 mg/kg q12h
Weight		Dose
kg	lbs	(q12h)	125 mg/5 ml	187.5 mg/5 ml	250 mg/5 ml
9	20	62.5 mg	2.5 ml q12h	1.67 ml q12h	1.25 ml q12h
17	37	125 mg	5 ml q12h	3.33 ml q12h	2.5 ml q12h
25	55	187.5 mg	7.5 ml q12h	5.0 ml q12h	3.75 ml q12h
33	73	250 mg	10 ml q12h	6.67 ml q12h	5 ml q12h

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.

Mycobacterial Infections

Prophylaxis: The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg bid. In children, the recommended dose is 7.5 mg/kg bid up to 500 mg bid. 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 bid. In children, the recommended dose is 7.5 mg/kg bid up to 500 mg bid. Dosing recommendations for children are in the table above.

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

Constituting Instructions

TABLE 31 indicates the volume of water to be added when constituting:

Total volume after constitution	Clarithromycin concentration after constitution	Amount of water to be added*
TABLE 31
50 ml	125 mg/5 ml	27 ml
100 ml	125 mg/5 ml	55 ml
50 ml	250 mg/5 ml	27 ml
100 ml	250 mg/5 ml	55 ml
* See instructions below.

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 15-30°C (59-86°F) and use within 14 days.

HOW SUPPLIED

Biaxin Filmtab are supplied as yellow oval film-coated tablets imprinted (on one side) in blue with the Abbott logo and a two-letter Abbo-Code designation, KT for the 250 mg tablet and KL for the 500 mg tablet.

Storage: Store tablets and granules for oral suspension at controlled room temperature 15-30° C (59-86° F) in a well-closed container. Protect from light. Do not refrigerate Biaxin suspension.

PRODUCT LISTING

*Powder For Reconstitution - Oral - 125 mg/5 ml*
50 ml	Biaxin, Abbott	00074-3163-50
100 ml	Biaxin, Abbott	00074-3163-13
*Powder For Reconstitution - Oral - 250 mg/5 ml*
50 ml	Biaxin, Abbott	00074-3188-50
100 ml	Biaxin, Abbott	00074-3188-13
*Tablet - Oral - 250 mg*
60's	Biaxin, Abbott	00074-3368-60
*Tablet - Oral - 500 mg*
60's	Biaxin, Abbott	00074-2586-60

REFERENCES

1. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically -Fourth Edition. Approved Standard NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS, Wayne, PA, January 1997.

2. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests -Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1, NCCLS, Wayne, PA, January 1997.

3. Hachem, C. Y., J. E. Claridge, R. Reddy, R. Flamm, D. G. Evans, S. K. Tanaka, and D. Y. Graham. Antimicrobial susceptibility testing of Helicobacter pylori: comparison of E-test, broth microdilution, and disk diffusion for ampicillin, clarithromycin, and metronidazole. Diagnost. Microbiol Infect. Dis.1996: 24:37-41.

4. Chaisson RE, et al. Clarithromycin and Ethambutol with or without Clofazimine for the Treatment of Bacteremic Mycobacterium avium Complex Disease in patients with HIV Infection. AIDS. 1997;11:311-317.

5. Kemper CA, et al. Treatment of Mycobacterium avium Complex Bacteremia in AIDS with a Four-Drug Oral Regimen. Ann Intern Med. 1992;116:466-472.

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