MINOCYCLINE HYDROCHLORIDE tablet, film coated, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

minocycline hydrochloride (UNII: 0020414E5U) (minocycline - UNII:FYY3R43WGO)

Tilgjengelig fra:

Oceanside Pharmaceuticals

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Minocycline HCl is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Minocycline HCl did not demonstrate any effect on non-inflammatory acne lesions. Safety of Minocycline HCl 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 HCl 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 HCl should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately.

Produkt oppsummering:

Minocycline HCl, USP Extended Release Tablets are supplied as aqueous film-coated tablets containing minocycline hydrochloride equivalent to 55 mg, 80 mg, or 105 mg minocycline, as follows. The 55 mg extended release tablets are pink, unscored, coated, and debossed with “DYN-055” on one side. Each tablet contains minocycline hydrochloride equivalent to 55 mg minocycline, supplied as follows: NDC 68682-467-30 Bottle of 30 The 80 mg extended release tablets are dark gray, unscored, coated, and debossed with “DYN-080” on one side. Each tablet contains minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows: NDC 68682-466-30 Bottle of 30 The 105 mg extended release tablets are purple, unscored, coated, and debossed with “DYN-105” on one side. Each tablet contains minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows: NDC 68682-468-30 Bottle of 30 Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°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.

Autorisasjon status:

New Drug Application Authorized Generic

Preparatomtale

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
OCEANSIDE PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MINOCYCLINE HCL SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR MINOCYCLINE HCL.
MINOCYCLINE HCL EXTENDED RELEASE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Minocycline HCl 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 HCl is approximately 1 mg/kg
once daily for 12 weeks. (2)
DOSAGE FORMS AND STRENGTHS
Extended release tablets: 55, 80, 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 VALEANT PHARMACEUTICALS
NORTH AMERICA LLC AT 1-800-
321-4576 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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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 6/2018
The use of Minocycline HCl 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 HCl. (5.2)
If liver injury is suspected, discontinue Minocycline HCl. (5.3)
If renal impairment exists, Minocycline HCl 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.