GTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Lactic Acidosis
5.2 Pancreatitis
5.3 Impaired Hepatic Function
5.4 Assessment of Renal Function
5.5 Vitamin B12 Levels
5.6 Alcohol Intake
5.7 Surgical Procedures
5.8 Change in Clinical Status of Patients with Previously Controlled Type 2 Diabetes
5.9 Use with Medications Known to Cause Hypoglycemia
5.10 Concomitant Medications Affecting Renal Function or Metformin Disposition
5.11 Radiologic Studies with Intravascular Iodinated Contrast Materials
5.12 Hypoxic States
5.13 Loss of Control of Blood Glucose
5.14 Hypersensitivity Reactions
5.15 Macrovascular Outcomes
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Cationic Drugs
7.2 Digoxin
7.3 Glyburide
7.4 Furosemide
7.5 Nifedipine
7.6 The Use of Metformin with Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
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
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Instructions
17.2 Laboratory Tests
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FULL PRESCRIBING INFORMATION
WARNING: LACTIC ACIDOSIS
Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure.
The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.
Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
If acidosis is suspected, JANUMET1 should be discontinued and the patient hospitalized immediately. [See Warnings and Precautions (5.1).]
1 INDICATIONS AND USAGE
JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. [See Clinical Studies (14).]
Important Limitations of Use
JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET. [See Warnings and Precautions (5.2).]
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
The dosage of JANUMET should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider.
JANUMET should generally be given twice d
