MINOCYCLINE HYDROCHLORIDE capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Minocycline hydrochloride capsules 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 - Pla

Каталог на резюме:

Minocycline hydrochloride capsules USP equivalent to 50 mg minocycline are opaque white capsules imprinted “CL47” and “50 mg” and are supplied as follows: NDC 70934-097-20 Bottles of 20 Dispense in tight, light-resistant container with child-resistant closure. Store at 20º–25ºC (68º–77ºF). [See USP Controlled Room Temperature]. Protect from light, moisture and excessive heat. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
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, 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. The structural formula is represented below:
C
H
N
O
•HCl
M. W. 493.94
Each minocycline hydrochloride capsule, for oral administration,
contains the equivalent of 50 mg, 75
mg or 100 mg of minocycline hydrochloride. 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: gelatin, silicon
dioxide, sodium lauryl sulfate and
titanium dioxide.
The 75 mg and 100 mg capsule shells also contain: black iron oxide.
CLINICAL PHARMACOLOGY
Following a single dose of two minocycline hydrochloride capsules, 100
mg 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 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 min