Biaxin (Clarithromycin) - Indications and Dosage

INDICATIONS AND USAGE

BIAXIN Filmtab (clarithromycin tablets, USP) and BIAXIN Granules (clarithromycin for oral suspension, USP) are indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed below:

Adults (BIAXIN Filmtab Tablets and Granules for Oral Suspension)

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. pyogenes 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, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Community-Acquired Pneumonia due to Haemophilus influenzae, 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

BIAXIN (clarithromycin) Filmtab tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) 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.

BIAXIN Filmtab tablets in combination with PRILOSEC (omeprazole) capsules or TRITEC (ranitidine bismuth citrate) 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 Microbiology section.) The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence.

Children (BIAXIN Filmtab Tablets and Granules for Oral Suspension)

Pharyngitis/Tonsillitis due to Streptococcus pyogenes.

Community-Acquired 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

Adults (BIAXIN XL Filmtab Tablets)

BIAXIN XL Filmtab (clarithromycin extended-release tablets) are indicated for the treatment of adults with mild to moderate infection caused by susceptible strains of the designated microorganisms in the conditions listed below:

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

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

Community-Acquired Pneumonia due to Haemophilus influenzae, Haemophilus parainfluenzae , Moraxella catarrhalis, Streptococcus pneumoniae , Chlamydia pneumoniae (TWAR), or Mycoplasma pneumoniae

THE EFFICACY AND SAFETY OF BIAXIN XL IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF BIAXIN ARE APPROVED HAVE NOT BEEN ESTABLISHED.

Prophylaxis

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

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BIAXIN and other antibacterial drugs, BIAXIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

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

	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. (See INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

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. (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: 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. (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: 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. (See  INDICATIONS AND USAGE and CLINICAL STUDIES sections.)

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

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 (CR_CL< 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 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. (See CLINICAL STUDIES.) 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.

Constituting Instructions

The table below indicates the volume of water to be added when constituting:

Total Volume After Constitution	Clarithromycin Concentration After Constitution	Amount of Water to be Added*
*   see instructions below.
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

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

HOW SUPPLIED

BIAXIN Filmtab (clarithromycin tablets, USP) are supplied as yellow oval film-coated tablets in the following packaging sizes:

250 mg tablets: (imprinted in blue with the Abbott logo and Abbo-Code KT)

Bottles of 60 (NDC 0074-3368-60) and ABBO-PAC unit dose strip packages of 100 (NDC 0074-3368-11).

Store BIAXIN 250 mg tablets at controlled room temperature 15° to 30°C (59° to 86°F) in a well-closed container. Protect from light.

500 mg tablets: (debossed with the Abbott logo on one side and Abbo-Code KL on the opposite side)

Bottles of 60 (NDC 0074-2586-60) and ABBO-PAC unit dose strip packages of 100 (NDC 0074-2586-11).

Store BIAXIN 500 mg tablets at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container.

BIAXIN XL Filmtab (clarithromycin extended-release tablets) are supplied as yellow oval film-coated 500 mg tablets debossed (on one side) with the Abbott logo and a two-letter Abbo-Code designation, KJ in the following packaging sizes:

500 mg tablets:

Bottles of 60 (NDC 0074-3165-60), ABBO-PAC unit dose strip packages of 100 (NDC  0074-3165-11), and BIAXIN XL PAC carton of 4 blister packages 14 tablets each (NDC 0074-3165-41).

Store BIAXIN XL tablets at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

BIAXIN Granules (clarithromycin for oral suspension, USP) is supplied in the following strengths and sizes:

Total Volume After Constitution	Clarithromycin Concentration After Constitution	Clarithromycin Contents Per Bottle	NDC
50 mL	125 mg/5 mL	1250 mg	0074-3163-50
100 mL	125 mg/5 mL	2500 mg	0074-3163-13
50 mL	250 mg/5 mL	2500 mg	0074-3188-50
100 mL	250 mg/5 mL	5000 mg	0074-3188-13

Store BIAXIN granules for oral suspension at controlled room temperature 15° to 30°C (59° to 86°F) in a well-closed container. Do not refrigerate BIAXIN suspension.