MINOCYCLINE HYDROCHLORIDE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Torrent Pharmaceuticals Limited

DCI (Dénomination commune internationale):

MINOCYCLINE HYDROCHLORIDE

Composition:

MINOCYCLINE 50 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 Chlamydophila 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

Descriptif du produit:

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 13668-485-01                                    Bottles of 100 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 13668-486-01                                    Bottles of 100 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 13668-487-50                                    Bottles of 50 Store 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]. Protect from light, moisture and excessive heat. Dispense in a tight, light-resistant container with child-resistant closure.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE TABLET
TORRENT PHARMACEUTICALS LIMITED
----------
MINOCYCLINE HYDROCHLORIDE TABLETS, USP
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:
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 two 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 1,292.70
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. Minocycline hydrochloride tablets may be
administered with or
without food.
In previous studies with other minocycline dosage