CLARITHROMYCIN tablet, film coated CLARITHROMYCIN granule, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)

Available from:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

CLARITHROMYCIN

Composition:

CLARITHROMYCIN 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clarithromycin tablets, USP and clarithromycin for oral suspension, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below: Adults (clarithromycin immediate-release tablets and clarithromycin 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

Product summary:

Clarithromycin Tablets, USP 250 mg and 500 mg are light yellow, capsule shaped, biconvex, film coated tablets. They are supplied as follows: 250 mg tablets: are printed in black ink with ‘RX 725 ’ on one side and plain on the other side. They are supplied as follows: NDC 63304-725-82 Bottles of 12 NDC 63304-725-60 Bottles of 60 NDC 63304-725-01 Bottles of 100 NDC 63304-725-05 Bottles of 500 NDC 63304-725-77 Blister unit-dose of 100 (10 x 10) 500 mg tablets: are printed in black ink with ‘RX 726 ’ on one side and plain on the other side. They are supplied as follows: NDC 63304-726-82 Bottles of 12 NDC 63304-726-60 Bottles of 60 NDC 63304-726-01 Bottles of 100 NDC 63304-726-05 Bottles of 500 NDC 63304-726-77 Blister unit-dose of 100 (10 x 10) Store at 20 - 25° C (68 - 77° F) (see USP Controlled Room Temperature) in a well-closed container. Clarithromycin For Oral Suspension, USP is a white to off-white granular powder forming white to off-white suspension on constitution with water. The resulting suspension has a sweet taste and fruity flavor. They are supplied as follows: 125 mg/5 mL NDC 63304-821-03 50 mL Bottles NDC 63304-821-04 100 mL Bottles 250 mg/5 mL NDC 63304-822-03 50 mL Bottles NDC 63304-822-04 100 mL Bottles Store clarithromycin for oral suspension at 20 - 25° C (68 - 77° F) (see USP Controlled Room Temperature) in a well-closed container. Do not refrigerate clarithromycin for oral suspension

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
CLARITHROMYCIN- CLARITHROMYCIN GRANULE, FOR SUSPENSION
RANBAXY PHARMACEUTICALS INC.
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CLARITHROMYCIN TABLETS, USP AND CLARITHROMYCIN FOR ORAL SUSPENSION,
USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin
and other antibacterial drugs, clarithromycin should be used only to
treat or prevent infections that are
proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically,
it is 6-_0_-methylerythromycin. The
molecular formula is C
H NO , and the molecular weight is 747.95. The structural formula is:
Clarithromycin is a white to off-white crystalline powder. It is
soluble in acetone, slightly soluble in
methanol, ethanol, and acetonitrile, and practically insoluble in
water.
Clarithromycin is available as immediate-release tablets, USP and
granules for oral suspension, USP.
Each light yellow capsule-shaped film-coated immediate-release
clarithromycin tablet contains 250 mg
or 500 mg of clarithromycin, USP and the following inactive
ingredients: ammonium hydroxide,
colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10
lake, iron-oxide black,
38
69
13
hydroxypropyl cellulose, hypromellose, magnesium stearate,
microcrystalline cellulose, povidone,
propylene glycol, shellac glaze, stearic acid, talc, and titanium
dioxide.
After constitution, each 5 mL of clarithromycin for oral suspension
contains 125 mg or 250 mg of
clarithromycin, USP. Each bottle of clarithromycin for oral
suspension, contains 1250 mg (50 mL size),
2500 mg (50 and 100 mL sizes) or 5000 mg (100 mL size) of
clarithromycin and the following inactive
ingredients: alginic acid, aspartame , castor oil, citric acid
anhydrous, colloidal silicon dioxide,
croscarmellose sodium, tutti fruitti flavor, hydroxypropyl cellulose,
hypromellose, hypromellose
phthalate, maltodextrin, povidone, peppermint flavor, sodium benzoate,
sodium chloride, sodium citrate
di