DYNACIN- minocycline hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

MINOCYCLINE HYDROCHLORIDE

Composition:

MINOCYCLINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Minocycline hydrochloride tablets are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Minocycline is indicated for treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Minocycline hydrochloride tablets 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 the meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the tre

Product summary:

Minocycline hydrochloride tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline. The 50 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed with “Par” on one side and “511” on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows: NDC49884-096-01 Bottle of 100 The 75 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed with “Par” on one side and “512” on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline, supplied as follows: NDC49884-097-01 Bottle of 100 The 100 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed with “Par” on one side and “513” on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows: NDC49884-098-03 Bottle of 50 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. Text Here

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DYNACIN- MINOCYCLINE HYDROCHLORIDE TABLET
PAR PHARMACEUTICAL, INC.
----------
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of minocycline
hydrochloride tablets and other antibacterial drugs, minocycline
hydrochloride tablets 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
Minocycline hydrochloride tablets for oral administration contain
minocycline HCl equivalent to 50 mg,
75 mg or 100 mg of minocycline. In addition, 50 mg, 75 mg and 100 mg
tablets contain the following
inactive ingredients: Microcrystalline Cellulose NF, Lactose Anhydrous
NF, Povidone USP, Colloidal
Silicon Dioxide NF, Magnesium Stearate NF, and Sodium Starch Glycolate
NF. The 50 mg, 75 mg and
100 mg tablets also contain Opadry White which contains: Titanium
Dioxide USP, Hypromellose Type
2910 USP, Polyethylene Glycol 400 NF, and Polysorbate 80 NF.
CLINICAL PHARMACOLOGY
Following a single dose of one 100 mg tablet of minocycline
hydrochloride administered to 28 normal
fasting adult volunteers, maximum serum concentrations were attained
in 1 to 3 hours (average 1.71
hours) and ranged from 491.71 to 1292.70 ng/mL (average 758.29 ng/mL).
The serum half-life in the
normal volunteers ranged from 11.38 to 24.31 hours (average 17.03
hours).
When minocycline hydrochloride tablets were given concomitantly with a
meal, which included dairy
products, the extent of absorption of minocycline hydrochloride
tablets was slightly decreased (6%).
The peak plasma concentrations were slightly decreased (12%) and
delayed by 1.09 hours when
administered with food, compared to dosing under fasting conditions.
Minocycline HCl may be
administered with or without food.
In previous studies with ot