clarithromycin extended release- Clarithromycin tablet, film coated, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Clarithromycin (UNII: H1250JIK0A) (Clarithromycin - UNII:H1250JIK0A)

Prieinama:

Ranbaxy Pharmaceuticals Inc.

INN (Tarptautinis Pavadinimas):

Clarithromycin

Vaisto forma:

TABLET, FILM COATED, EXTENDED RELEASE

Sudėtis:

1000 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets and other antibacterial drugs, clarithromycin extended-release tablets 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. THE EFFICACY AND SAFETY OF CLARITHROMYCIN EXTENDED-RELEASE TABLETS IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF CLARITHROMYCIN ARE APPROVED HAVE NOT BEEN ESTABLISHED. Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibiotics. Concomitant administration of clarithromycin and any of the following drugs is contraindicated: cisapride, p

Produkto santrauka:

Clarithromycin extended-release tablets, 1000 mg are yellow-colored, oval-shaped, film coated tablets imprinted with ‘RB 36’ in black ink on one side and plain on the other side. They are supplied as follows: NDC 63304-971-03 Bottles of 10 NDC 63304-971-54 Blister unit-dose of 14 NDC 63304-971-05 Bottles of 500 NDC 63304-971-70 Blister unit-dose of 70 Store at 20 - 25° C (68 - 77° F) (See USP Controlled Room Temperature)

Prekės savybės

CLARITHROMYCIN EXTENDED RELEASE- CLARITHROMYCIN TABLET, FILM COATED,
EXTENDED
RELEASE
RANBAXY PHARMACEUTICALS INC.
----------
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin
extended-release tablets and other antibacterial drugs, clarithromycin
extended-release tablets 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 747.96. 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 extended-release tablets.
Each yellow oval-shaped film-coated clarithromycin extended-release
tablet for oral administration
contains 1 gram clarithromycin, USP and the following inactive
ingredients: ammonium hydroxide,
colloidal silicon dioxide, D&C yellow no. 10 aluminum lake,
hydroxypropyl cellulose, hypromellose,
iron oxide black, lactose monohydrate, magnesium stearate,
polyethylene glycol, polysorbate,
povidone, propylene glycol, shellac, sodium stearyl fumarate, talc,
titanium dioxide.
Meets USP Dissolution Test 3.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Clarithromycin is rapidly absorbed from the gastrointestinal tract
after oral administration. The absolute
bioavailability of 250 mg clarithromycin tablets was approximately
50%. For a single 500 mg dose of
clarithromycin, food slightly delays the onset of clarithromycin
absorption, increasing the peak time
from approximately 2 to 2.5 hours. Food also increases the
clarithromycin peak plasma concentration by
about 24%, but does not affect the extent of clarithromycin
bioavailability. Food does not affect the
onset of formation of the antimicrobially active metabolite, 14-OH
clarithromycin or its peak plasm