METFORMIN HYDROCHLORIDE tablet, film coated METFORMIN HYDROCHLORIDE tablet, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Macleods Pharmaceuticals Limited

INN (nemzetközi neve):

METFORMIN HYDROCHLORIDE

Összetétel:

METFORMIN HYDROCHLORIDE 500 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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 tablets  and metformin hydrochloride extended-release tablets  are contraindicated in patients with: • Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) [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 tablets / 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 repo

Termék összefoglaló:

Metformin hydrochloride tablets USP and metformin hydrochloride extended-release tablets USP Available Strengths, Units, and Appearance Metformin Hydrochloride Tablets,USP 500mg tablet: White to off white, circular, biconvex, film coated, beveled edge tablets, debossed with "C74" on one side and plain on other side. Bottles of 90's                            NDC 33342-141-10 Bottles of 100's                          NDC 33342-141-11 Bottles of 1000's                        NDC 33342-141-44 850mg tablet: White to off white, circular, biconvex, film coated, beveled edge tablets, debossed with  "C75" on one side and plain on other side. Bottles of 90's                            NDC 33342-142-10 Bottles of 100's                          NDC 33342-142-11 Bottles of 1000's                        NDC 33342-142-44 1000mg tablet: White to off white, oval shaped, biconvex, film coated tablet, debossed with "C" and "76"separated by breakline on both sides (functional scoring). Bottles of 90's                            NDC 33342-143-10 Bottles of 100's                          NDC 33342-143-11 Bottles of 1000's                        NDC 33342-143-44 Metformin Hydrochloride Extended-Release Tablets,USP 500mg tablet: White to off white, capsule shaped, biconvex, film coated tablets debossed with 'ML 30' on one side and plain on the other side. Bottles of 100's                          NDC 33342-239-11 750mg tablet: Pink capsule shaped, biconvex, film coated tablets debossed with 'ML 31' on one side and plain on the other side. Bottles of 100's                          NDC 33342-240-11 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]. Dispense in light-resistant containers.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED
METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
MACLEODS PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METFORMIN
HYDROCHLORIDE TABLETS AND METFORMIN HYDROCHLORIDE EXTENDED- RELEASE
TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METFORMIN
HYDROCHLORIDE
TABLETS AND
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE TABLETS .
METFORMIN HYDROCHLORIDE TABLETS, FOR ORAL USE
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
_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/
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 tablets are 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)
Metformin hydrochloride extended-release tablets