ituitary-gonadal axis in pre-menopausal women are unknown.
16 HOW SUPPLIED/STORAGE AND HANDLING
JUVISYNC 100 mg/10 mg tablets are pink-beige, bi-convex round, film-coated tablets, coded with the Merck logo and "753" on one side and plain on the other. They are supplied as follows:
NDC 0006-0753-31 unit of use bottles of 30
NDC 0006-0753-54 unit of use bottles of 90
NDC 0006-0753-82 bottles of 1000.
JUVISYNC 100 mg/20 mg tablets are pink-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and "757" on one side and plain on the other. They are supplied as follows:
NDC 0006-0757-31 unit of use bottles of 30
NDC 0006-0757-54 unit of use bottles of 90
NDC 0006-0757-82 bottles of 1000.
JUVISYNC 100 mg/40 mg tablets are orange-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and "773" on one side and plain on the other. They are supplied as follows:
NDC 0006-0773-31 unit of use bottles of 30
NDC 0006-0773-54 unit of use bottles of 90
NDC 0006-0773-82 bottles of 1000.
JUVISYNC 50 mg/10 mg tablets are red, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and "533" on one side and plain on the other. They are supplied as follows:
NDC 0006-0533-31 unit of use bottles of 30
NDC 0006-0533-54 unit of use bottles of 90
JUVISYNC 50 mg/20 mg tablets are orange-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and "535" on one side and plain on the other. They are supplied as follows:
NDC 0006-0535-31 unit of use bottles of 30
NDC 0006-0535-54 unit of use bottles of 90
JUVISYNC 50 mg/40 mg tablets are red, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and "537" on one side and plain on the other. They are supplied as follows:
NDC 0006-0537-31 unit of use bottles of 30
NDC 0006-0537-54 unit of use bottles of 90
Storage
Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Store in a dry place with cap tightly closed.
Storage of 1000 count bottles
Dispense into a USP tightly closed, moisture-resistant container.
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (Medication Guide).
17.1 Instructions
Patients should be informed of the potential risks and benefits of JUVISYNC and of alternative modes of therapy. Patients should also be informed about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.
Patients should be informed that acute pancreatitis has been reported during postmarketing use of sitagliptin. Patients should be informed that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed to promptly discontinue JUVISYNC and contact their physician if persistent severe abdominal pain occurs [see Warnin