MINOCYCLINE HYDROCHLORIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals (USA) Inc.

INN (International Name):

MINOCYCLINE HYDROCHLORIDE

Composition:

MINOCYCLINE 45 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Minocycline hydrochloride extended-release tablets should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the

Product summary:

Minocycline Hydrochloride Extended-release Tablets, 45 mg are grey colored, modified capsule shaped, biconvex, coated tablets, debossed with "531" on one side and plain on other side and are supplied as follows: NDC 68382-531-06 in bottles of 30 tablets NDC 68382-531-16 in bottles of 90 tablets NDC 68382-531-01 in bottles of 100 tablets NDC 68382-531-05 in bottles of 500 tablets NDC 68382-531-10 in bottles of 1000 tablets NDC 68382-531-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Minocycline Hydrochloride Extended-release Tablets, 80 mg are whitish blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "551" on one side and plain on other side and are supplied as follows: NDC 68382-551-06 in bottles of 30 tablets NDC 68382-551-16 in bottles of 90 tablets NDC 68382-551-01 in bottles of 100 tablets NDC 68382-551-05 in bottles of 500 tablets NDC 68382-551-10 in bottles of 1000 tablets NDC 68382-551-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Minocycline Hydrochloride Extended-release Tablets, 90 mg are light yellow colored, modified capsule shaped, biconvex, coated tablets, debossed with "533" on one side and plain on other side and are supplied as follows: NDC 68382-533-06 in bottles of 30 tablets NDC 68382-533-16 in bottles of 90 tablets NDC 68382-533-01 in bottles of 100 tablets NDC 68382-533-05 in bottles of 500 tablets NDC 68382-533-10 in bottles of 1000 tablets NDC 68382-533-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Minocycline Hydrochloride Extended-release Tablets, 105 mg are light blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "552" on one side and plain on other side and are supplied as follows: NDC 68382-552-06 in bottles of 30 tablets NDC 68382-552-16 in bottles of 90 tablets NDC 68382-552-01 in bottles of 100 tablets NDC 68382-552-05 in bottles of 500 tablets NDC 68382-552-10 in bottles of 1000 tablets NDC 68382-552-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Minocycline Hydrochloride Extended-release Tablets, 135 mg are light pink colored, modified capsule shaped, biconvex, coated tablets, debossed with "535" on one side and plain on other side and are supplied as follows: NDC 68382-535-06 in bottles of 30 tablets NDC 68382-535-16 in bottles of 90 tablets NDC 68382-535-01 in bottles of 100 tablets NDC 68382-535-05 in bottles of 500 tablets NDC 68382-535-10 in bottles of 1000 tablets NDC 68382-535-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children. Protect from light, moisture and excessive heat. Dispense in a tight, light-resistant container as defined in the USP with child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED
RELEASE
ZYDUS PHARMACEUTICALS (USA) INC.
----------
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 are approximately 1 mg/kg once daily
for 12 weeks. (2)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 45 mg, 80 mg, 90 mg, 105 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
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 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-rel