MINOCYCLINE- minocycline hydrochloride tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

MINOCYCLINE HYDROCHLORIDE

Sammensætning:

MINOCYCLINE 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Minocycline hydrochloride tablets, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Minocycline hydrochloride tablets, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: In acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides. In severe acne , minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline i

Produkt oversigt:

Minocycline hydrochloride tablets 50 mg are dark grey colored, capsule-shaped, film-coated tablets debossed with ‘854’ on one side and plain on the other side available as follows: Minocycline hydrochloride tablets 75 mg are grey colored, capsule-shaped, film-coated tablets debossed with ‘855’ on one side and plain on the other side available as follows: Minocycline hydrochloride tablets 100 mg are dark grey colored, capsules-shaped, film-coated tablets debossed with ‘856’ on one side and plain on the other side available as follows: Store at 20 to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from light, moisture and excessive heat. Dispense in a tight, light-resistant container as defined in the USP with child resistant closure.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MINOCYCLINE- MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
MINOCYCLINE HYDROCHLORIDE TABLETS, USP
50 MG, 75 MG AND 100 MG
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 contain
minocycline hydrochloride
equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, each
tablet contains the following
inactive ingredients: lactose monohydrate, microcrystalline cellulose,
povidone, sodium starch
glycolate, colloidal silicon dioxide and magnesium stearate. In
addition the coaling contains
hypromellose, titanium dioxide, polyethylene glycol and iron oxide
black.
CLINICAL PHARMACOLOGY
Following a single dose of two minocycline hydrochloride 100 mg
tablets administered to 18 normal
fasting adult volunteers, maximum serum concentrations were attained
in 1 to 4 hours (average 2.1
hours) and ranged from 2.1 to 5.1 mcg/mL (average 3.5 mcg/mL). The
serum half-life in the normal
volunteers ranged from 11.1 to 22.1 hours (average 15.5 hours).
When minocycline hydrochloride tablets were given concomitantly with a
high-fat meal, which included
dairy products, the extent of absorption of minocycline hydrochloride
tablets was unchanged compared
to dosing under fasting conditions. The mean Tmax was delayed by one
hour when administered with
food, compared to dosing under fasting conditions. Minocycline tablets
may be administered with or
without food.
C
H N O ·HCl M.W. 493.94
23
27
3
7
In previous studies