SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(三)
atients with renal impairment: Higher incidence of adverse reactions related to reduced renal function (2.2, 5.4, 8.6)
Hepatic Impairment: Avoid use in patients with hepatic impairment. (8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: LACTIC ACIDOSIS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Recommended Dosage in Patients with Renal Impairment
2.3 Discontinuation for Iodinated Contrast Imaging Procedures
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Lactic Acidosis
5.2 Hypotension
5.3 Ketoacidosis
5.4 Acute Kidney Injury and Impairment in Renal Function
5.5 Urosepsis and Pyelonephritis
5.6 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
5.7 Genital Mycotic Infections
5.8 Vitamin B12 Levels
5.9 Increased Low-Density Lipoprotein Cholesterol (LDL-C)
5.10 Macrovascular Outcomes
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Drug Interactions with Empagliflozin
7.2 Drug Interactions with Metformin Hydrochloride
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 SYNJARDY XR Glycemic Control Studies
14.2 Empagliflozin Cardiovascular Outcome Study in Patients with Type 2 Diabetes Mellitus and Atherosclerotic Cardiovascular Disease
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
SYNJARDY XR is a combination of empagliflozin and metformin hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate.
Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see CLINICAL STUDIES (14.2)]. However, the effectiveness of SYNJARDY XR on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established.
Limitations of Use
SYNJARDY XR is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis [see WARNINGS AND PRECAUTIONS (5.3)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
In patients with volume depletion not previously treated with empagliflozin, correct this condition before initiating SYNJARDY XR [see WARNINGS AND PRECAUTIONS (5.2)].
Individualize the starting dose of SYNJARDY XR |
