METFORMIN HYDROCHLORIDE tablet, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

REMEDYREPACK INC.

INN (Διεθνής Όνομα):

METFORMIN HYDROCHLORIDE

Σύνθεση:

METFORMIN HYDROCHLORIDE 500 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release 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 extended-release 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 2,550 mg clinical dose, based on body surface area [see Data]. The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes mellitus with an HbA 1C > 7 and has been reported to be as high as 20% to 25% in women with a HbA 1C > 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% to 4% and 15% to 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 2,550 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 extended-release tablets and any potential adverse effects on the breastfed child from metformin hydrochloride extended-release tablets 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 extended-release tablets may result in ovulation in some anovulatory women. Metformin Hydrochloride Extended-Release Tablets Safety and effectiveness of metformin hydrochloride extended-release tablets in pediatric patients have not been established. Controlled clinical studies of metformin hydrochloride extended-release 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 extended-release tablets are 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 extended-release tablets are not recommended in patients with hepatic impairment. [see Warnings and Precautions (5.1)] .

Περίληψη προϊόντος:

Metformin hydrochloride extended-release tablets USP, 500 mg are oval white tablets, with "OE" debossed on one side and "584" debossed on the other side. NDC: 70518-0512-00 NDC: 70518-0512-01 NDC: 70518-0512-02 NDC: 70518-0512-03 NDC: 70518-0512-04 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 100 in 1 BOTTLE PLASTIC PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in light-resistant containers. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METFORMIN
HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE 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 METFORMINASSOCIATED LACTIC ACIDOSIS IN THESE HIGH RISK
GROUPS ARE
PROVIDED IN THE FULL PRESCRIBING INFORMATION. ( 5.1)
IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE METFORMIN HYDROCHLORIDE
EXTENDED-
RELEASE TABLETS AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A
HOSPITAL SETTING.
PROMPT HEMODIALYSIS IS RECOMMENDED. ( 5.1)
INDICATIONS AND USAGE
Metformin hydrochloride extended-release tablets are 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 Metformin Hydrochloride Extended-Release Tablets:
Swallow metformin hydrochloride extended-release tablets whole and
never crush, cut or chew ( 2.1)
Starting dose: 500 mg orally once daily with the evening meal ( 2.1)
Increase the dose in increments of 500 m