METFORMIN ER 500 MG tablet METFORMIN ER 750 MG tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Granules India Ltd

INN (שם בינלאומי):

METFORMIN HYDROCHLORIDE

הרכב:

METFORMIN HYDROCHLORIDE 500 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets, USP are contraindicated in patients with: - Severe Renal Impairment (eGFR below 30mL/min/1.73m 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

leaflet_short:

16.1 How Supplied Table 13: Metformin Hydrochloride Extended-Release Tablets, USP Available Strengths, Units, and Appearance Bottles of 90 NDC 62207-491-57 Bottles of 100 NDC 62207-491-43 Bottles of 500 Bottles of 90 NDC 62207-492-57 Bottles of 100 NDC 62207-492-43 Bottles of 500 NDC 62207-492-47 Bottles of 1000 NDC 62207-492-49 16.2 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted within 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in light-resistant container.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

METFORMIN ER 500 MG- METFORMIN ER 500 MG TABLET
METFORMIN ER 750 MG- METFORMIN ER 750 MG TABLET
GRANULES INDIA LTD
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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 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 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 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)
• Inc