MINOCYCLINE HYDROCHLORIDE tablet, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Lupin Pharmaceuticals, Inc.

INN (שם בינלאומי):

MINOCYCLINE HYDROCHLORIDE

הרכב:

MINOCYCLINE 45 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Minocycline hydrochloride extended-release tablets USP 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 USP did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets USP have 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 USP 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 s

leaflet_short:

Minocycline hydrochloride extended-release tablets USP are supplied as aqueous film coated tablets containing minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 90 mg, or 135 mg minocycline. The 45 mg extended-release tablets are pink colored, round shaped, biconvex, film-coated tablets debossed with "F21" on one side and "LU" on the other side. Each tablet contains minocycline hydrochloride USP equivalent to 45 mg minocycline, supplied as follows: NDC        68180-379-06     Bottle of 30 NDC        68180-379-01     Bottle of 100 The 55 mg extended-release tablets are green colored, round shaped, biconvex, film-coated tablets debossed with "F26" on one side and "LU" on the other side. Each tablet contains minocycline hydrochloride equivalent to 55 mg minocycline, supplied as follows: NDC   68180-460-06              Bottle of 30 NDC   68180-460-01              Bottle of 100 The 90 mg extended-release tablets are pale yellow colored, round shaped, biconvex, film-coated tablets debossed with "F22" on one side and "LU" on the other side. Each tablet contains minocycline hydrochloride USP equivalent to 90 mg minocycline, supplied as follows: NDC        68180-380-06     Bottle of 30 NDC        68180-380-01     Bottle of 100 The 135 mg extended-release tablets are brown colored, capsule shaped, biconvex, film-coated tablets debossed with "F23" on one side and "LU" on the other side. Each tablet contains minocycline hydrochloride USP equivalent to 135 mg minocycline, supplied as follows: NDC        68180-381-06     Bottle of 30 NDC        68180-381-01     Bottle of 100 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.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MINOCYCLINE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP SAFELY AND EFFECTIVELY. SEE
FULL
PRESCRIBING INFORMATION FOR MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS
USP.
MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Minocycline hydrochloride extended-release tablets USP are
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 USP are approximately
1 mg/kg once daily for 12 weeks. (2)
DOSAGE FORMS AND STRENGTHS
Extended release tablets: 45, 55 mg, 90, and 135 mg (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 minocycline hydrochloride extended-re