MINOCYCLINE HYDROCHLORIDE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Clinical Solutions Wholesale, LLC

INN (Διεθνής Όνομα):

MINOCYCLINE HYDROCHLORIDE

Σύνθεση:

MINOCYCLINE 100 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Minocycline HCl Capsules, USP equivalent to 50 mg* minocycline are white opaque capsules imprinted " RX 694 " on cap and body in black ink and supplied as follows: NDC 13668-482-01               Bottles of 100 Minocycline HCl Capsules, USP equivalent to 75 mg minocycline are gray opaque capsules imprinted " RX 695 " on cap and body in black ink and supplied as follows: NDC 13668-483-01               Bottles of 100 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 13668-484-50               Bottles of 50 NDC 13668-484-05               Bottles of 500 NDC 58118-0484-08 Blister pack 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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
CLINICAL SOLUTIONS WHOLESALE, LLC
----------
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 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