MINOCYCLINE HYDROCHLORIDE tablet, film coated, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

PruGen Pharmaceuticals

INN (Kansainvälinen yleisnimi):

MINOCYCLINE HYDROCHLORIDE

Koostumus:

MINOCYCLINE 45 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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 42546-771-30             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 42546-774-30             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 42546-777-30            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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED RELEASE
PRUGEN PHARMACEUTICALS
----------
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, 90 mg, or 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-release
tablets if symptoms occur. (5.6)