MINOCYCLINE HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NuCare Pharmaceuticals,Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Minocycline hydrochloride capsules 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 Y

Produkt oppsummering:

Minocycline hydrochloride capsules USP equivalent to 50 mg minocycline are opaque yellow capsules imprinted “ MINOCYCLINE 50 ” and “ DAN 5694 ” supplied in bottles of 60 and 100. Minocycline hydrochloride capsules USP equivalent to 75 mg minocycline are opaque white and opaque yellow capsules imprinted “ MINOCYCLINE 75 ” and “ WPI ” supplied in bottles of 100. Minocycline hydrochloride capsules USP equivalent to 100 mg minocycline are opaque dark gray and opaque yellow capsules imprinted “ MINOCYCLINE 100 ” and “ DAN 5695 ”supplied in bottles 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 with child-resistant closure.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
MINOCYCLINE
HYDROCHLORIDE
CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
minocycline hydrochloride capsules and other antibacterial drugs,
minocycline
hydrochloride capsules 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:
C
H
N
O
•HCl M.W. 493.94
Each minocycline hydrochloride capsule, USP for oral administration,
contains the
equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition each
capsule contains
the following inactive ingredients: magnesium stearate and starch
(corn).
The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28,
D&C Yellow No.
10, gelatin, silicon dioxide, sodium lauryl sulfate and titanium
dioxide.
The 100 mg capsule shell also contains black iron oxide.
CLINICAL PHARMACOLOGY
Following a single dose of two 100 mg capsules of minocycline HCl
administered to 18
23
27
3
7
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 capsules were given concomitantly with
a high-fat meal,
which included dairy products, the extent of absorption of minocycline
hydrochloride
capsules was unchanged compared to dosing under fasting conditions.
The mean T
was delayed by one hour when administered with food, compared to
dosing under
fasting conditions. Minocycline hydrochloride capsules may be
administered with or
without food.
In previous studies with other minocycline dosage form