REPAGLINIDE AND METFORMIN HYDROCHLORIDE- repaglinide and metformin hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N), REPAGLINIDE (UNII: 668Z8C33LU) (REPAGLINIDE - UNII:668Z8C33LU)

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Repaglinide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a glinide and metformin or who have inadequate glycemic control on a glinide alone or metformin alone. Limitation of Use Repaglinide and metformin hydrochloride tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Repaglinide and metformin hydrochloride tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) [see WARNINGS AND PRECAUTIONS (5.1)] - Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin [see WARNINGS AND PRECAUTIONS (5.1)] . - Concomitant use of gemfibrozil [see DRUG INTERACTIONS (7.2)] - Known hypersensitivity to repaglinide, metformin or any inactive ingredients Pregnancy Category C. There are no adequate and well-control

Product summary:

Repaglinide and metformin hydrochloride tablets are supplied as biconvex tablets available in 1 mg/500 mg (yellow) and 2 mg/500 mg (pink) strengths. 1 mg/500 mg tablets are debossed with 'V41' on one side and 'LU' on the other side and 2 mg/500 mg tablets are debossed with 'V42' on one side and 'LU' on the other side. The tablets are colored to indicate strength. Store at 25°C (77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed. Dispense in tight containers with safety closures.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

REPAGLINIDE AND METFORMIN HYDROCHLORIDE- REPAGLINIDE AND METFORMIN
HYDROCHLORIDE TABLET
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REPAGLINIDE AND METFORMIN
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR REPAGLINIDE AND
METFORMIN HYDROCHLORIDE TABLETS.
REPAGLINIDE AND METFORMIN HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
POST-MARKETING 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 REPAGLINIDE AND METFORMIN
HYDROCHLORIDE TABLETS AND
INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT
HEMODIALYSIS IS RECOMMENDED.
(5.1)
RECENT MAJOR CHANGES
Boxed Warning 4/2017
Dosing and Administration (2.2) 4/2017
Contraindications (4) 4/2017
Warnings and Precautions (5.1) 4/2017
INDICATIONS AND USAGE
Repaglinide and metformin hydrochloride tablets are a combination of
repaglinide, a glinide, and metformin, a biguanide,
indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus who are
already treated with a glinide and metformin or who have inadequate
glycemic co