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:

REMEDYREPACK INC.

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. Metformin Hydrochloride Tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [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 Metformin Hydrochloride 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 5times, respectively, a 2550 mg clinical dose, based on body surface area [see Data]. The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes mellitus with an HbA1C >7 and has been reported to be as high as 20–25% in women with a HbA1C >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. However, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. Animal Data Metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day. This represents an exposure of about 2 and 5 times a 2550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin. Risk Summary Limited published studies report that metformin is present in human milk [see Data]. However, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Metformin Hydrochloride and any potential adverse effects on the breastfed child from Metformin Hydrochloride or from the underlying maternal condition. Data Published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. However, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants. Discuss the potential for unintended pregnancy with premenopausal women as therapy with Metformin Hydrochloride Tablets may result in ovulation in some anovulatory women. Metformin Hydrochloride Tablets The safety and effectiveness of Metformin Hydrochloride Tablets for the treatment of type 2 diabetes mellitus have been established in pediatric patients 10 to 16 years old. Safety and effectiveness of Metformin Hydrochloride have not been established in pediatric patients less than 10 years old. Use of Metformin Hydrochloride Tablets in pediatric patients 10 to 16 years old for the treatment of type 2 diabetes mellitus is supported by evidence from adequate and well-controlled studies of Metformin Hydrochloride Tablets in adults with additional data from a controlled clinical study in pediatric patients 10 to 16 years old with type 2 diabetes mellitus, which demonstrated a similar response in glycemic control to that seen in adults [see Clinical Studies (14.1)]. In this study, adverse reactions were similar to those described in adults. A maximum daily dose of 2000 mg of Metformin Hydrochloride Tablets are recommended. [See Dosage and Administration (2.2).] Controlled clinical studies of Metformin Hydrochloride Tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patients [see Warnings and Precautions (5.1)]. Metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment. Metformin Hydrochloride is contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m 2 [see Dosage and Administration (2.3), Contraindications (4), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)]. Use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. Metformin Hydrochloride is not recommended in patients with hepatic impairment. [see Warnings and Precautions (5.1)].

Product summary:

500 mg Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with 'SG' on one side '105' on other side. NDC: 70518-1951-00 NDC: 70518-1951-01 PACKAGING: 28 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK Store at 20°to 25° C (68°to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.] Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METFORMIN HYDROCHLORIDE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METFORMIN
HYDROCHLORIDE TABLETS.
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 METFORMIN HYDROCHLORIDE
TABLETS AND INSTITUTE GENERAL SUPPORTIVE
MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (
5.1)
INDICATIONS AND USAGE
Metformin 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)
DOSAGE AND ADMINISTRATION
Adult Dosage for Metformin Hydrochloride Tablets: (2)
Starting dose: 500 mg orally twice a day or 850 mg once a day, with
meals ( 2.1)
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
divided doses ( 2.1)
Doses above 2000 mg may be better tolerated given 3 times a da