מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
saxagliptin hydrochloride (UNII: Z8J84YIX6L) (saxagliptin anhydrous - UNII:8I7IO46IVQ), metformin hydrochloride (UNII: 786Z46389E) (metformin - UNII:9100L32L2N)
AstraZeneca Pharmaceuticals LP
saxagliptin hydrochloride
saxagliptin anhydrous 2.5 mg
ORAL
PRESCRIPTION DRUG
KOMBIGLYZE XR is 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) ]. KOMBIGLYZE XR is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. KOMBIGLYZE XR is contraindicated in patients with: Limited available data with KOMBIGLYZE XR or saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and 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 ]. No adverse developmental effects independent of maternal toxicity were observed when saxagliptin and metformin were administered separately or in combination to pregnant rats and rabbits during the period of organogenesis [see Data ]. The estimated background risk of major birth defects is 6 to 10% in women w
How Supplied KOMBIGLYZE® XR (saxagliptin and metformin HCl extended-release) tablets have markings on both sides and are available in the strengths and packages listed in Table 15. 5 mg/500 mg light brown to brown, biconvex, capsule-shaped “5/500” on one side and “4221” on the reverse, in blue ink Bottles of 30 0310-6135-30 5 mg/1000 mg pink, biconvex, capsule-shaped “5/1000” on one side and “4223” on the reverse, in blue ink Bottles of 30 0310-6145-30 2.5 mg/1000 mg pale yellow to light yellow, biconvex, capsule-shaped “2.5/1000” on one side and “4222” on the reverse, in blue ink Bottles of 60 0310-6125-60 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
New Drug Application
AstraZeneca Pharmaceuticals LP ---------- MEDICATION GUIDE KOMBIGLYZE® XR (kom-be-glyze X-R) (saxagliptin and metformin HCl extended-release) tablets, for oral use What is the most important information I should know about KOMBIGLYZE XR? Serious side effects can happen in people taking KOMBIGLYZE XR, including: 1. Lactic acidosis. Metformin, one of the medicines in KOMBIGLYZE XR, 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 KOMBIGLYZE XR 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 drink enough fluids • have surgery • have a heart attack, severe infection, or stroke The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your KOMBIGLYZE XR for a while if you have any of these things. KOMBIGL קרא את המסמך השלם
KOMBIGLYZE XR- SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ASTRAZENECA PHARMACEUTICALS LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE KOMBIGLYZE XR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KOMBIGLYZE XR. KOMBIGLYZE XR (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._ • • • INDICATIONS AND USAGE KOMBIGLYZE XR is 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) Limitations of Use: • DOSAGE AND ADMINISTRATION • • • • • • • ® 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 KOMBIGLYZE XR AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1) Not used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. (1.1) Administer once daily with the evening meal. קרא את המסמך השלם