METFORMIN HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin hydrochloride tablets are 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. 8.1 Pregnancy Risk Summary Limited data with metformin hydrochloride tablets 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 mellitus in pregnancy [see Clinical Considerations]. No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 2- and 5-times, respectively, a 2550 mg clinical dose, based on body surface area [see Data]. The estimated background risk of major birth defects is 6 to 10% in wo

Product summary:

16.1 How Supplied Table 13: Metformin Hydrochloride Tablets, USP Available Strengths, Units, and Appearance Metformin hydrochloride Tablets, USP 500 mg Bottles of 60 White to off-white, round, biconvex, film coated tablets debossing "H/102" on one side and plain on the other side Bottles of 90 Bottles of 100 Bottles of 500 Bottles of 1000 850 mg Bottles of 60 White to off-white, round, biconvex, film coated tablets debossing "H/103" on one side and plain on the other side. Bottles of 100 Bottles of 500 Bottles of 1000 1000 mg Bottles of 60 White to off-white, oval, biconvex, film coated tablets debossing "H/104" on one side with score line between H and 104 and plain on the other side. Bottles of 90 Bottles of 100 Bottles of 500 Bottles of 1000 16.2 Storage Store at 20º to 25º C (68º to 77º F); excursions permitted to 15º to 30º C (59º to 86º F). [see USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
DIRECT_RX
----------
METFROMIN HCL
WARNING: LACTIC ACIDOSIS
Postmarketing cases of metformin-associated lactic acidosis have
resulted in
death, hypothermia, hypotension, and resistant bradyarrhythmias. The
onset of
metformin associated lactic acidosis is often subtle, accompanied only
by
nonspecific symptoms such as malaise, myalgias, respiratory distress,
somnolence, and abdominal pain. Metformin associated lactic acidosis
was
characterized by elevated blood lactate levels (>5 mmol/Liter), anion
gap acidosis
(without evidence of ketonuria or ketonemia), an increased
lactate/pyruvate ratio;
and metformin plasma levels generally >5 mcg/mL [see Warnings and
Precautions
(5.1)].
Risk factors for metformin-associated lactic acidosis include renal
impairment,
concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors
such as
topiramate), age 65 years old or greater, having a radiological study
with contrast,
surgery and other procedures, hypoxic states (e.g., acute congestive
heart
failure), 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 [see Dosage and Administration
(2.3), (2.7),
Contraindications (4), Warnings and Precautions (5.1)].
If metformin-associated lactic acidosis is suspected, immediately
discontinue
metformin hydrochloride tablets and institute general supportive
measures in a
hospital setting. Prompt hemodialysis is recommended [see Warnings and
Precautions (5.1)].
Metformin hydrochloride tablets are 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.
2.1 Adult Dosage
Metformin Hydrochloride Tablets
The recommended starting dose of metformin hydrochloride tablets are
500 mg orally
twice a day or 850 mg once a day, given with meals.
Increase the dose in increments of 500 mg weekly or 850 mg every 2
weeks on the
basi