MINOCYCLINE HYDROCHLORIDE tablet, film coated, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Aurobindo Pharma Limited

INN (Nome Internazionale):

MINOCYCLINE HYDROCHLORIDE

Composizione:

MINOCYCLINE 45 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 n

Dettagli prodotto:

Minocycline Hydrochloride Extended-Release Tablets USP, 45 mg are gray colored, round shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘95’ on the other side.             Bottles of 30                                       NDC 65862-554-30             Bottles of 100                                     NDC 65862-554-01             Bottles of 1,000                                   NDC 65862-554-99 Minocycline Hydrochloride Extended-Release Tablets USP, 55 mg are pink colored, round shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘6’ on the other side.          Bottles of 30                                       NDC 65862-883-30          Bottles of 100                                     NDC 65862-883-01          Bottles of 500                                     NDC 65862-883-05          Bottles of 1,000                                   NDC 65862-883-99 Minocycline Hydrochloride Extended-Release Tablets USP, 65 mg are blue colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘26’ on the other side.             Bottles of 30                                       NDC 65862-555-30             Bottles of 1,000                                  NDC 65862-555-99 Minocycline Hydrochloride Extended-Release Tablets USP, 80 mg are grey colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘7’ on the other side.             Bottles of 30                                       NDC 65862-884-30             Bottles of 100                                     NDC 65862-884-01             Bottles of 500                                     NDC 65862-884-05             Bottles of 1,000                                   NDC 65862-884-99 Minocycline Hydrochloride Extended-Release Tablets USP, 90 mg are yellow colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘27’ on the other side.             Bottles of 30                                       NDC 65862-556-30             Bottles of 100                                     NDC 65862-556-01             Bottles of 1,000                                   NDC 65862-556-99 Minocycline Hydrochloride Extended-Release Tablets USP, 105 mg are purple colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘8’ on the other side.             Bottles of 30                                       NDC 65862-885-30             Bottles of 100                                     NDC 65862-885-01             Bottles of 500                                     NDC 65862-885-05             Bottles of 1,000                                   NDC 65862-885-99 Minocycline Hydrochloride Extended-Release Tablets USP, 115 mg are green colored, capsule shaped, biconvex, film-coated tablets debossed with ‘F81’ on one side and plain on the other side.             Bottles of 30                                       NDC 65862-557-30             Bottles of 1,000                                  NDC 65862-557-99 Minocycline Hydrochloride Extended-Release Tablets USP, 135 mg are red colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘93’ on the other side.             Bottles of 30                                       NDC 65862-558-30             Bottles of 100                                     NDC 65862-558-01             Bottles of 1,000                                  NDC 65862-558-99 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 tight, light-resistant container with child-resistant closure.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED RELEASE
AUROBINDO PHARMA LIMITED
----------
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 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 hydrochloride extended-release
tablets is approximately 1
mg/kg once daily for 12 weeks. (2)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg,
115 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-