SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE tablet, film coated, extended release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

SAXAGLIPTIN (UNII: 9GB927LAJW) (SAXAGLIPTIN ANHYDROUS - UNII:8I7IO46IVQ), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Inapatikana kutoka:

Dr.Reddys Laboratories Inc

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Saxagliptin and 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 when treatment with both saxagliptin and metformin is appropriate [see Clinical Studies ( 14)]. Saxagliptin and metformin hydrochloride extended-release tablets are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Saxagliptin and metformin hydrochloride extended-release tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) - Hypersensitivity to metformin hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin. - History of a serious hypersensitivity reaction to saxagliptin and metformin hydrochloride extended-release tablets or saxagliptin, such as anaphylaxis, angioedema, or exfoliative skin conditions [see Warnings and Precautions ( 5.7) and Adverse Reactions

Bidhaa muhtasari:

How Supplied   Saxagliptin and metformin hydrochloride extended-release tablets are available as follows:   Saxagliptin and metformin hydrochloride extended-release tablets 5 mg/500 mg are light brown to brown colored, capsule shaped film-coated tablets imprinted with SM3 on one side and plain on other side and free from physical defects. They are available in packages as listed below. Bottles of 30 43598-620-30 Bottles of 100 43598-620-01  Saxagliptin and metformin hydrochloride extended-release tablets 5 mg/1,000 mg are pink, colored, modified oval shaped film-coated tablets imprinted with SM2 on one side and plain on other side and free from physical defects. They are available in packages as listed below. Bottles of 30 43598-619-30 Bottles of 100 43598-619-01 Saxagliptin and metformin hydrochloride extended-release tablets 2.5 mg/1,000 mg are pale yellow to light yellow colored, modified oval shaped film-coated tablets imprinted with SM1 on one side and plain on other side and free from physical defects. They are available in packages as listed below.   Bottles of 30 43598-618-30 Bottles of 60 43598-618-60 Bottles of 100 43598-618-01 Storage and Handling   Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature].

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE- SAXAGLIPTIN AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Dr.Reddys Laboratories Inc
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MEDICATION GUIDE
Saxagliptin and Metformin Hydrochloride (sax-a-GLIP-tin and
met-FOR-min hye-droe-KLOR-ide)
Extended-Release Tablets, for oral use
What is the most important information I should know about saxagliptin
and metformin hydrochloride
extended-release tablets?
Serious side effects can happen in people taking saxagliptin and
metformin hydrochloride extended-release
tablets, including:
1. Lactic acidosis. Metformin, one of the medicines in saxagliptin and
metformin hydrochloride extended-
release tablets, can cause a rare but serious condition called lactic
acidosis (a build-up of an acid in the
blood) that can cause death. Lactic acidosis is a medical emergency
and must be treated in the hospital.
Call your doctor right away if you have any of the following symptoms,
which could be signs of lactic
acidosis:
• you feel cold in your hands or feet
• you feel dizzy or lightheaded
• you have a slow or irregular heartbeat
• you feel very weak or tired
• you have unusual (not normal) muscle pain
• you have trouble breathing
• you feel sleepy or drowsy
• you have stomach pains, nausea or vomiting
Most people who have had lactic acidosis with metformin have other
things that, combined with the
metformin, led to the lactic acidosis. Tell your doctor if you have
any of the following, because you have a
higher chance for getting lactic acidosis with saxagliptin and
metformin hydrochloride extended-release
tablets if you:
• have severe kidney problems or your kidneys are affected by
certain x-ray tests that use injectable dye
• have liver problems
• drink alcohol very often, or drink a lot of alcohol in short-term
"binge" drinking
• get dehydrated (lose a large amount of body fluids). This can
happen if you are sick with a fever, vomiting,
or diarrhea. Dehydration can also happen when you sweat a lot with
activity or exercise and do not d

Tabia za bidhaa

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE- SAXAGLIPTIN AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
DR.REDDYS LABORATORIES INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAXAGLIPTIN AND
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
EXTENDED-
RELEASE TABLETS.
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
• POST-MARKETING 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 SAXAGLIPTIN AND
METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE TABLETS AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN
A HOSPITAL
SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1)
INDICATIONS AND USAGE
Saxagliptin and metformin hydrochloride extended-release tablets are a
combination of saxagliptin, a
dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin, a biguanide,
indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes
mellitus when treatment with both
saxagliptin and metformin is appropriate. (1, 14)