MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Preferred Pharmaceuticals Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 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

Rezumat produs:

Minocycline HCl Capsules, USP equivalent to 100 mg* minocycline with a gray opaque cap and white opaque body imprinted "RX 696 " on cap and body in black ink and supplied as follows: NDC 68788-7370-1              Bottles of 14 NDC 68788-7370-2               Bottles of 20 NDC 68788-7370-3               Bottles of 30 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 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. * The appearance of the product may vary depending on the source of the ingredients filled in the capsule. ANIMAL PHARMACOLOGY AND TOXICOLOGY Minocycline hydrochloride has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs, and monkeys). In the rat, chronic treatment with minocycline hydrochloride has resulted in goiter accompanied by elevated radioactive iodine uptake and evidence of thyroid tumor production. Minocycline hydrochloride has also been found to produce thyroid hyperplasia in rats and dogs.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
PREFERRED PHARMACEUTICALS INC.
----------
MINOCYCLINE HYDROCHLORIDE
CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of minocycline
hydrochloride capsules, USP and other antibacterial drugs, minocycline
hydrochloride capsules, 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:
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:
corn starch and magnesium stearate.
The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and
titanium dioxide.
The 75 mg and 100 mg capsule shells also contain black iron oxide. The
imprinting ink contains: black
iron oxide, potassium hydroxide, propylene glycol, and shellac.
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 µg/mL (average 3.5 µg/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