RIOMET- metformin hydrochloride solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Sun Pharmaceutical Industries, Inc.

INN (Tên quốc tế):

METFORMIN HYDROCHLORIDE

Thành phần:

METFORMIN HYDROCHLORIDE 500 mg in 5 mL

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

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_
•
•
•
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)
•
•
•
Pediatric Dosage for RIOMET: (2)
•
•
Renal Impairment: (2)
•
•
•
•
•
Discontinuation for Iodinated Contrast Imaging Procedures: (2)
•
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