METFORMIN HYDROCHLORIDE tablet, film coated, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

NorthStar RxLLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Metformin hydrochloride extended-release tablets, USP 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/minute/1.73 m2 ) [see Warnings and Precautions (5.1)] . ·   Known 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 w

Povzetek izdelek:

Metformin hydrochloride extended-release tablets, USP - 500 mg are available as white to off-white, circular, biconvex, film-coated tablets imprinted with "305" in black ink on one side and plain on the other side. Metformin hydrochloride extended-release tablets, USP  - 1000 mg are available as white to off-white, circular, biconvex, film-coated tablets imprinted with "306" in black ink on one side and plain on the other side. They are supplied as follows: 500 mg tablets: Bottles of 100’s with Child Resistant Cap…..................NDC 16714-938-01 1000 mg tablets: Bottles of 90’s with Child Resistant Cap…....................NDC 16714-939-01 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
NORTHSTAR RXLLC
----------
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 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
Starting dose: 500 mg orally once daily with the evening meal (2.1)
Increase the dose in increments of 500 mg every 1 to 2 weeks, up to a
maximum of 2,000 mg once daily with the
evening meal. (2.1)
Patients receiving metformin hydrochloride (HCl) tablets may be
switched to metformin hydrochl