MINOCYCLINE HYDROCHLORIDE tablet, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Sandoz Inc

INN (Διεθνής Όνομα):

MINOCYCLINE HYDROCHLORIDE

Σύνθεση:

MINOCYCLINE 45 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. Teratogenic Effects: Pregnancy Category D [ see WARNINGS AND PRECAUTIONS (5.1)] Minocycline hydrochloride extended-release tablets should not

Περίληψη προϊόντος:

Minocycline hydrochloride extended-release tablets are available as follows: The 45 mg extended-release tablets are grey colored, capsule shaped, biconvex, film-coated, debossed with ‘I113’ on one side and plain on the other side. NDC 0781-5385-31, bottle of 30 tablets NDC 0781-5385-01, bottle of 100 tablets NDC 0781-5385-10, bottle of 1000 tablets The 90 mg extended-release tablets are light orange colored, capsule shaped, biconvex, film coated, debossed with ‘I112’ on one side and plain on the other side. NDC 0781-5386-31, bottle of 30 tablets NDC 0781-5386-01, bottle of 100 tablets NDC 0781-5386-10, bottle of 1000 tablets The 135 mg extended-release tablets are light yellow colored, capsule shaped, biconvex film coated, debossed with ‘I111’ on one side and plain on the other side. NDC 0781-5387-31, bottle of 30 tablets NDC 0781-5387-01, bottle of 100 tablets NDC 0781-5387-10, bottle of 1000 tablets Store at 20º to 25ºC (68º to 77ºF) [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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
SANDOZ 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 is
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, 90 mg, and 135 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 SANDOZ INC., AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
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 dose