MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride tablet, film coated, extended release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Mylan Pharmaceuticals Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Minocycline hydrochloride extended-release tablets are 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. [see Warnings and Precautions (5.1) ]. Minocycline hydrochloride extended-release tablets should not be used during pregnancy. If the patient beco

Resumen del producto:

Minocycline Hydrochloride Extended-Release Tablets, USP are available containing minocycline hydrochloride, USP equivalent to 80 mg or 105 mg of minocycline. The 80 mg extended-release tablets are pink, film-coated, round, unscored tablets imprinted with MX100 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4293-93 bottles of 30 tablets NDC 0378-4293-01 bottles of 100 tablets The 105 mg extended-release tablets are brown, film-coated, capsule shaped, unscored tablets imprinted with MX101 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4294-93 bottles of 30 tablets NDC 0378-4294-01 bottles of 100 tablets 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 a tight, light-resistant container as defined in the USP using a child-resistant closure.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
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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 are 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: 80 mg and 105 mg (3)
CONTRAINDICATIONS
This drug is contraindicated in persons who have shown
hypersensitivity to any of the tetracyclines. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most commonly observed adverse reactions (incidence ≥ 5%) are
headache, fatigue, dizziness, and pruritus. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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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
tablet doses may need to be adjusted to
avoid excessive