MINOCYCLINE HYDROCHLORIDE tablet, film coated, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Ascend Laboratories, LLC

DCI (Denominação Comum Internacional):

MINOCYCLINE HYDROCHLORIDE

Composição:

MINOCYCLINE 45 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Minocycline hydrochloride extended-release tablets is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. Safety of Minocycline hydrochloride extended-release tablets has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)] . To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Minocycline hydrochloride extended-release tablets should be used only as indicated [see Warnings and Precautions (5.11)] . This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. Teratogenic Effects: Pregnancy category D [see Warnings and Precautions (5.1)] Minocycline hydrochloride extended-release tablets should not be

Resumo do produto:

Minocycline hydrochloride extended-release tablets, USP are supplied as aqueous film coated tablets containing Minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg minocycline, are supplied as follows. The 45 mg extended release tablets are grey coloured capsule shaped film coated tablets, debossed with “45” on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 45 mg minocycline, supplied as follows: The 55 mg extended release tablets are Pink colored capsule shaped film coated tablets, debossed with "55" on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 55 mg minocycline, supplied as follows: The 65 mg extended release tablets are blue coloured capsule shaped film coated tablets, debossed with “65” on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 65 mg minocycline, supplied as follows: The 80 mg extended release tablets are Greyish brown colored capsule shaped film coated tablets, debossed with "80'' on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows: The 90 mg extended release tablets are yellow coloured capsule shaped film coated tablets, debossed with “90” on one side, plain on other side.  Each tablet contains Minocycline hydrochloride equivalent to 90 mg minocycline, supplied as follows: The 105 mg extended release tablets are Purple colored capsule shaped film coated tablets, debossed with "105'' on one side, plain on other side.Each tablet contains Minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows: The 115 mg extended release tablets are green coloured capsule shaped film coated tablets, debossed with “115” on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 115 mg minocycline, supplied as follows: The 135 mg extended release tablets are pink (orange brown) coloured capsule shaped film coated tablets, debossed with “135” on one side, plain on other side.  Each tablet contains Minocycline hydrochloride equivalent to 135 mg minocycline, supplied as follows: Store at 20˚ to 25˚C (68˚ to 77˚ F) [See USP Controlled Room Temperature]. Keep out of reach of children. Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED RELEASE
ASCEND LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MINOCYCLINE
HYDROCHLORIDE EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS
MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Minocycline hydrochloride extended-release tablets is a
tetracycline-class drug indicated to treat only
inflammatory lesions of non-nodular moderate to severe acne vulgaris
in patients 12 years of age and
older. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage of Minocycline hydrochloride extended-release
tablets is approximately 1
mg/kg once daily for 12 weeks. (2)
DOSAGE FORMS AND STRENGTHS
Extended release tablets: 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg,
115 mg, and 135 mg (3) (3)
CONTRAINDICATIONS
This drug is contraindicated in persons who have shown
hypersensitivity to any of the tetracyclines.(4)
WARNINGS AND PRECAUTIONS
The use of Minocycline hydrochloride extended-release tablets during
tooth development (last half of
pregnancy, infancy, and childhood up to the age of 8 years) may cause
permanent discoloration of the
teeth (yellow-gray-brown). (5.1)
If pseudomembranous colitis occurs, discontinue Minocycline
hydrochloride extended-release
tablets.(5.2)
If liver injury is suspected, discontinue Minocycline hydrochloride
extended-release tablets. (5.3)
If renal impairment exists, Minocycline hydrochloride extended-release
tablets doses may need to be
adjusted to avoid excessive systemic accumulations of the drug and
possible liver toxicity. (5.4)
Minocycline may cause central nervous system side effects including
light- headedness, dizziness, or
vertigo. Advise patients. (5.5)
Minocycline may cause pseudotumor cerebri (benign intracranial
hypertension) in adults and
adolescents. Discontinue Minocy