Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
DAPAGLIFLOZIN (UNII: 1ULL0QJ8UC) (DAPAGLIFLOZIN - UNII:1ULL0QJ8UC), SAXAGLIPTIN HYDROCHLORIDE (UNII: Z8J84YIX6L) (SAXAGLIPTIN ANHYDROUS - UNII:8I7IO46IVQ), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
AstraZeneca Pharmaceuticals LP
ORAL
PRESCRIPTION DRUG
QTERNMET XR (dapagliflozin, saxagliptin, and metformin hydrochloride) extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use QTERNMET XR is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. QTERNMET XR initiation is intended only for patients currently taking metformin. QTERNMET XR is contraindicated in patients with: Risk Summary Based on animal data showing adverse renal effects, from dapagliflozin, QTERNMET XR is not recommended during the second and third trimesters of pregnancy. The limited available data with QTERNMET XR or components (dapagliflozin and saxagliptin) 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 moth
How Supplied QTERNMET XR (dapagliflozin, saxagliptin, and metformin HCl) extended-release tablets are available in packages as listed: 2.5 mg dapagliflozin /2.5 mg saxagliptin /1000 mg metformin HCl Light brown to brown biconvex, oval “3001” debossed on one side Bottles of 60 0310‑6925‑60 5 mg dapagliflozin /2.5 mg saxagliptin /1000 mg metformin HCl Green biconvex, oval “3002” debossed on one side Bottles of 60 0310‑6950‑60 5 mg dapagliflozin /5 mg saxagliptin /1000 mg metformin HCl Pink biconvex, oval “3003” debossed on one side Bottles of 30 0310‑6975‑30 10 mg dapagliflozin /5 mg saxagliptin /1000 mg metformin HCl Gray biconvex, oval “3004” debossed on one side Bottles of 30 0310‑6990-30 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
New Drug Application
AstraZeneca Pharmaceuticals LP ---------- MEDICATION GUIDE QTERNMET® XR (CUE-turnmet) (dapagliflozin, saxagliptin, and metformin hydrochloride) extended-release tablets, for oral use What is the most important information I should know about QTERNMET XR? Serious side effects can happen to people taking QTERNMET XR, including: • Lactic Acidosis. Metformin, one of the medicines in QTERNMET 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 healthcare provider 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 unusual sleepiness or sleep longer than usual ∘ you have stomach pains, nausea, or vomiting Most people who have had lactic acidosis with metformin have other things that, combined with the metformin use, led to the lactic acidosis. Tell your healthcare provider if you have any of the following, because you have a higher chance for getting lactic acidosis with QTERNMET 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 healthcare provider if you have any of the problems in the list above. Your healthcare Pročitajte cijeli dokument
QTERNMET XR- DAPAGLIFLOZIN SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED ASTRAZENECA PHARMACEUTICALS LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QTERNMET XR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QTERNMET XR. QTERNMET XR (DAPAGLIFLOZIN, SAXAGLIPTIN, AND METFORMIN HYDROCHLORIDE) EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2019 WARNING: LACTIC ACIDOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • RECENT MAJOR CHANGES Warnings and Precautions (5.5, 5.6) 01/2020 Warnings and Precautions (5.13, 5.14) Removed 01/2020 INDICATIONS AND USAGE QTERNMET XR is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a dipeptidyl peptidase-4 (DPP-4) inhibitor and a biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Limitations of Use • • DOSAGE AND ADMINISTRATION • • • • • • • DOSAGE FORMS AND STRENGTHS • • • • ® 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 QTERNMET XR AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1) Is not Pročitajte cijeli dokument