MINOCYCLINE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Par Pharmaceutical, Inc.

INN (International ime):

MINOCYCLINE HYDROCHLORIDE

Sastav:

MINOCYCLINE 50 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Minocycline hydrochloride tablets 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 in

Proizvod sažetak:

Minocycline hydrochloride tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline. The 50 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed “Par” on one side and “511" on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows: NDC 49884-511-01 Bottle of 100 The 75 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed “Par" on one side and “512" on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline, supplied as follows: NDC 49884-512-01 Bottle of 100 The 100 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed “Par" on one side and “513" on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows: NDC 49884-513-03 Bottle of 50 Store at 20° to 25°C (68° to 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.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

MINOCYCLINE- MINOCYCLINE TABLET
PAR PHARMACEUTICAL, INC.
----------
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF MINOCYCLINE HYDROCHLORIDE TABLETS AND OTHER
ANTIBACTERIAL
DRUGS, MINOCYCLINE HYDROCHLORIDE TABLETS SHOULD BE USED ONLY TO TREAT
OR
PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED
BY
BACTERIA.
DESCRIPTION
Minocycline hydrochloride, 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 for oral administration contain
minocycline HCl
equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, 50
mg, 75 mg and
100 mg tablets contain the following inactive ingredients:
Microcrystalline Cellulose NF,
Lactose Anhydrous NF, Povidone USP, Colloidal Silicon Dioxide NF,
Magnesium Stearate
NF, and Sodium Starch Glycolate NF. The 50 mg, 75 mg and 100 mg
tablets also contain
Opadry White which contains: Titanium Dioxide USP, Hypromellose Type
2910 USP,
Polyethylene Glycol 400 NF, and Polysorbate 80 NF.
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. Minocycline HCl may be administered with or
without food.
In previous studies with other minocycline dosage forms,