MINOLIRA tablet extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Minocycline Hydrochloride (UNII: 0020414E5U) (Minocycline - UNII:FYY3R43WGO)

Dostupné z:

Dr. Reddys Laboratories Inc

INN (Medzinárodný Name):

Minocycline Hydrochloride

Zloženie:

Minocycline 105 mg

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

MINOLIRA- MINOLIRA TABLET, EXTENDED RELEASE
DR. REDDYS LABORATORIES INC
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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) ·
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