Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Merck Sharp & Dohme LLC
ERTUGLIFLOZIN PIDOLATE
ERTUGLIFLOZIN 2.5 mg
ORAL
PRESCRIPTION DRUG
SEGLUROMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2)]. - Hypersensitivity to ertugliflozin, metformin, or any excipient in SEGLUROMET, reactions such as angioedema or anaphylaxis have occurred [see Adverse Reactions (6.2)]. - Patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2 ), end stage-renal disease (ESRD), or on dialysis [see Use in Specific Populations (8.6)] . - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Risk Summary Based on animal data showing adverse renal effects, from ertugliflozin, SEGLUROMET is not recommended during the second and third trimesters of pregnancy. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage r
SEGLUROMET (ertugliflozin and metformin hydrochloride) tablets are available as follows: Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (between 59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Store in a dry place.
New Drug Application
Merck Sharp & Dohme LLC ---------- MEDICATION GUIDE SEGLUROMET® [SEG-LUR-OH-MET] (ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLETS, FOR ORAL USE This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 09/2023 Read this Medication Guide carefully before you start taking SEGLUROMET and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about SEGLUROMET? SEGLUROMET may cause serious side effects, including: Lactic Acidosis. Metformin, one of the medicines in SEGLUROMET, can cause a rare but serious condition called lactic acidosis (a buildup 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 very weak or tired • you have trouble breathing • you have stomach pains, nausea or vomiting • you have a slow or irregular heartbeat • you have unusual (not normal) muscle pain • you have unusual sleepiness or sleep longer than usual • you feel dizzy or lightheaded Most people who have had lactic acidosis had other conditions that, in combination with 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 SEGLUROMET 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 the 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 Olvassa el a teljes dokumentumot
SEGLUROMET- ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED MERCK SHARP & DOHME LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SEGLUROMET SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEGLUROMET. SEGLUROMET (ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2017 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 SEGLUROMET AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1) RECENT MAJOR CHANGES Indications and Usage (1) Dosage and Administration (2.1, 2.4) Warnings and Precautions (5.2) 09/2023 09/2023 09/2023 INDICATIONS AND USAGE SEGLUROMET is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. (1) DOSAGE AND ADMINISTRATION Assess renal function prior to initiation and as clin Olvassa el a teljes dokumentumot