GLUCOPHAGE- metformin hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

GLUCOPHAGE 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. GLUCOPHAGE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. GLUCOPHAGE and GLUCOPHAGE XR are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2) [see Warnings and Precautions ( 5.1)]. - Hypersensitivity to metformin. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Risk Summary Limited data with GLUCOPHAGE/GLUCOPHAGE XR in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data ]. There are risks to the mother and fetus associated with poorly controlled diabetes mell

Product summary:

Store at 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F). [See USP Controlled Room Temperature] Dispense in light-resistant containers.

Authorization status:

New Drug Application

Summary of Product characteristics

GLUCOPHAGE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLUCOPHAGE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR GLUCOPHAGE.
GLUCOPHAGE (METFORMIN HYDROCHLORIDE) TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL:1995
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 GLUCOPHAGE/ GLUCOPHAGE XR
and institute general supportive
measures in a hospital setting. Prompt hemodialysis is recommended. (
5.1)
INDICATIONS AND USAGE
GLUCOPHAGE 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)
GLUCOPHAGE XR is a biguanide indicated as an adjunct to diet and
exercise to improve glycemic control in adults with
type 2 diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
Adult Dosage for GLUCOPHAGE:
Starting dose: 500 mg orally twice a day or 850 mg once a day, with
meals
Increase the dose in increments of 500 mg weekly or 850 mg every 2
weeks, up to a maximum dose of 2550 mg per
day, given in divid