METFORMIN HYDROCHLORIDE tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

McKesson Corporation dba SKY Packaging

INN（国际名称）:

METFORMIN HYDROCHLORIDE

组成:

METFORMIN HYDROCHLORIDE 850 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 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 tablets or metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published

產品總結:

Product: 63739-702 NDC: 63739-702-10 10 TABLET, FILM COATED in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

授权状态:

Abbreviated New Drug Application

资料单张

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
McKesson Corporation
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PATIENT INFORMATION
Metformin Hydrochloride Tablets, USP
Metformin Hydrochloride Extended-release Tablets, USP
Rx only
Read this information carefully before you start taking this medicine
and each time you refill your
prescription. There may be new information. This information does not
take the place of your doctor's
advice. Ask your doctor or pharmacist if you do not understand some of
this information or if you want to
know more about this medicine.
WHAT ARE METFORMIN HYDROCHLORIDE TABLETS AND METFORMIN
HYDROCHLORIDE EXTENDED-RELEASE TABLETS?
Metformin hydrochloride tablets and metformin hydrochloride
extended-release tablets are used to treat
type 2 diabetes. This is also known as non-insulin-dependent diabetes
mellitus. People with type 2
diabetes are not able to make enough insulin or respond normally to
the insulin their bodies make. When
this happens, sugar (glucose) builds up in the blood. This can lead to
serious medical problems including
kidney damage, amputations, and blindness. Diabetes is also closely
linked to heart disease. The main
goal of treating diabetes is to lower your blood sugar to a normal
level.
High blood sugar can be lowered by diet and exercise, by a number of
medicines taken by mouth, and by
insulin shots. Before you take metformin hydrochloride tablets or
metformin hydrochloride extended-
release tablets, try to control your diabetes by exercise and weight
loss. While you take your diabetes
medicine, continue to exercise and follow the diet advised for your
diabetes. No matter what your
recommended diabetes management plan is, studies have shown that
maintaining good blood sugar
control can prevent or delay complications of diabetes, such as
blindness.
Metformin hydrochloride tablets and metformin hydrochloride
extended-release tablets have the same
active ingredient. However, metformin hydrochloride extended-release
tablets work longer in your body.
Both of these medicines help co

产品特点

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
MCKESSON CORPORATION DBA SKY PACKAGING
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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
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 OR 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 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 are biguanide
indicated as an adjunct to diet and exerc