País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
Minocycline Hydrochloride (UNII: 0020414E5U) (Minocycline - UNII:FYY3R43WGO)
Dr. Reddys Laboratories Inc
Minocycline Hydrochloride
Minocycline 105 mg
PRESCRIPTION DRUG
New Drug Application
MINOLIRA- MINOLIRA TABLET, EXTENDED RELEASE DR. REDDYS LABORATORIES INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MINOLIRA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MINOLIRA. MINOLIRA (MINOCYCLINE HYDROCHLORIDE) EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL:1971 INDICATIONS AND USAGE MINOLIRA 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) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug- resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, MINOLIRA should be used only as indicated [see Warnings and Precautions (5.13)]. DOSAGE AND ADMINISTRATION Recommended dosage: Approximately 1 mg/kg once daily for 12 weeks. (2) DOSAGE FORMS AND STRENGTHS Extended- release tablets: 105 mg and 135 mg of minocycline, functionally scored (3) CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. (4) WARNINGS AND PRECAUTIONS • · The use of MINOLIRA during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. (5.1, 5.2, 5.3, 8.1, 8.4) · • If pseudomembranous colitis occurs, discontinue MINOLIRA. (5.4) · • If liver injury is suspected, discontinue MINOLIRA. (5.5). • If renal impairment exists, MINOLIRA doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. (5.6) · • Minocycline may cause central nervous system side effects including light-headedness, dizziness, or vertigo. (5.7) · • Minocycline may cause intracranial hypertension in adults and adolescents. Discontinue MINOLIRA if symptoms occur. (5.8) · Leer el documento completo