MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO)

Prieinama:

Ranbaxy Pharmaceuticals Inc.

INN (Tarptautinis Pavadinimas):

MINOCYCLINE HYDROCHLORIDE

Sudėtis:

MINOCYCLINE 50 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Minocycline hydrochloride tablets, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobac

Produkto santrauka:

Minocycline hydrochloride tablets, USP equivalent to 50 mg minocycline are yellow colored, oval-shaped, film-coated tablets, debossed with “RI89” on one side and plain on the other side. They are supplied as follows: NDC 63304-697-01 Bottles of 100 NDC 63304-697-05 Bottles of 500 Minocycline hydrochloride tablets, USP equivalent to 75 mg minocycline are yellow colored, oval-shaped, film-coated tablets, debossed with “RI90” on one side and plain on the other side. They are supplied as follows: NDC 63304-698-01 Bottles of 100 NDC 63304-698-05 Bottles of 500 Minocycline hydrochloride tablets, USP equivalent to 100 mg minocycline are yellow colored, oval-shaped, film-coated tablets, debossed with “RI91” on one side and plain on the other side. They are supplied as follows: NDC 63304-699-50 Bottles of 50 NDC 63304-699-05 Bottles of 500 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Protect from light, moisture, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE TABLET, FILM
COATED
RANBAXY PHARMACEUTICALS INC.
----------
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of minocycline
hydrochloride tablets, USP and other antibacterial drugs, minocycline
hydrochloride tablets, USP
should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by
bacteria.
DESCRIPTION
Minocycline hydrochloride, USP is a semisynthetic derivative of
tetracycline, 4,7-Bis(dimethylamino)-
1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide
monohydrochloride.
Its structural formula is:
C H N O •HCL M.W. 493.94
Minocycline hydrochloride tablets, USP for oral administration,
contains minocycline hydrochloride,
USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition,
each film-coated tablet contains
the following inactive ingredients: colloidal silicon dioxide,
crospovidone, hypromellose, iron oxide
yellow, lactose monohydrate, magnesium stearate, polyethylene glycol
6000, silicified
microcrystalline cellulose, stearic acid, and titanium dioxide.
CLINICAL PHARMACOLOGY
Following a single dose of one 100 mg tablet of minocycline
hydrochloride administered to 28 normal
fasting adult volunteers, maximum serum concentrations were attained
in 1 to 3 hours (average 1.71
hours) and ranged from 491.71 to 1292.70 ng/mL (average 758.29 ng/mL).
The serum half-life in the
normal volunteers ranged from 11.38 to 24.31 hours (average 17.03
hours).
When minocycline hydrochloride tablets were given concomitantly with a
meal, which included dairy
products, the extent of absorption of minocycline hydrochloride
tablets was slightly decreased (6%).
The peak plasma concentrations were slightly decreased (12%) and
delayed by 1.09 hours when
administered with food, compared to dosing under fasting conditions.
In previous studies with other minocycline dosage forms, the
minocycline serum half-life ranged from
11 to 16 hours in 7 patient