RIOMET- metformin hydrochloride solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Fáanlegur frá:

Sun Pharmaceutical Industries, Inc.

INN (Alþjóðlegt nafn):

METFORMIN HYDROCHLORIDE

Samsetning:

METFORMIN HYDROCHLORIDE 500 mg in 5 mL

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

RIOMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

Vörulýsing:

Flavor Appearance Size NDC Cherry clear, colorless solution 4 ounce (118 mL) 10631-206-01 16 ounce (473 mL) 10631-206-02 Strawberry clear, colorless to light yellow solution 4 ounce (118 mL) 10631-238-01 16 ounce (473 mL) 10631-238-02

Leyfisstaða:

New Drug Application

Vara einkenni

RIOMET- METFORMIN HYDROCHLORIDE SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIOMET SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RIOMET.
RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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INDICATIONS AND USAGE
RIOMET is a biguanide indicated as an adjunct to diet and exercise to
improve glycemic control in adults and pediatric
patients 10 years of age and older with type 2 diabetes mellitus. (1)
(1)
DOSAGE AND ADMINISTRATION
Adult Dosage for RIOMET: (2)
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•
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Pediatric Dosage for RIOMET: (2)
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•
Renal Impairment: (2)
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Discontinuation for Iodinated Contrast Imaging Procedures: (2)
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DOSAGE FORMS AND STRENGTHS
Oral Solution: 500 mg per 5 mL (100 mg/mL) in cherry and strawberry
flavor (3) (3)
CONTRAINDICATIONS
®
POSTMARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE
RESULTED IN DEATH, HYPOTHERMIA,
HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. SYMPTOMS INCLUDED
MALAISE, MYALGIAS, RESPIRATORY
DISTRESS, SOMNOLENCE, AND ABDOMINAL PAIN. LABORATORY ABNORMALITIES
INCLUDED ELEVATED BLOOD LACTATE
LEVELS, ANION GAP ACIDOSIS, INCREASED LACTATE/PYRUVATE RATIO; AND
METFORMIN PLASMA LEVELS GENERALLY >
5 MCG/ML. (5.1)
RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN
DRUGS, AGE ≥ 65 YEARS OLD,
RADIOLOGICAL STUDIES WITH CONTRAST, SURGERY AND OTHER PROCEDURES,
HYPOXIC STATES, EXCESSIVE ALCOHOL
INTAKE, AND HEPATIC IMPAIRMENT. STEPS TO REDUCE THE RISK OF AND MANAGE
METFORMIN-ASSOCIATED LACTIC
ACIDOSIS IN THESE HIGH RISK GROUPS ARE PROVIDED IN THE FULL
PRESCRIBING INFORMATION. (5.1)
IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE RIOMET AND INSTITUTE
GENERAL SUPPORTIVE MEASURES IN A
HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1)
Starting dose: 500 mg (5 mL) orally twice a day or 850 mg (8.5 mL)
once a day, wit