| HOME >> MEDICINE >> TECHNOLOGY |
Prescribing information and patient product information for JANUVIA and JANUMET are attached.
JANUVIA(TM) and JANUMET(TM) are trademarks of Merck & Co., Inc. -0-
JANUVIA(TM)(sitagliptin) Tablets 9762701
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
JANUVIA safely and effectively. See full prescribing information for
JANUVIA.
JANUVIA(TM) (sitagliptin) Tablets
Initial U.S. Approval: 2006
INDICATIONS AND USAGE
JANUVIA is indicated as an adjunct to diet and exercise to improve
glycemic control in patients with type 2 diabetes mellitus (type 2
diabetes). JANUVIA is indicated for:
-- Monotherapy (1.1)
-- Combination therapy with metformin or a peroxisome
proliferator-activated receptor gamma (PPAR-gamma) agonist
(e.g., thiazolidinediones) when the single agent does not
provide adequate glycemic control. (1.2)
Important Limitations of Use: JANUVIA should not be used in
patients with type 1 diabetes mellitus (type 1 diabetes) or for the
treatment of diabetic ketoacidosis. (1.3)
DOSAGE AND ADMINISTRATION
The recommended dose of JANUVIA is 100 mg once daily as
monotherapy or as combination therapy with metformin or a PPAR-gamma
agonist (e.g., thiazolidinediones). (2.1)
JANUVIA can be taken with or without food. (2.1)
Dosage Adjustment in Patients With Moderate, Severe and End Stage
Renal Disease (ESRD) (2.2)
----------------------------------------------------------------------
50 mg once daily 25 mg once daily
--------------------------------------------------------------------
'"/>
Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32
Related medicine technology :
1. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral
Anticoagulant, Presented Today at the XXIst Congress of the
International Society on Thrombosis and Haemostasis
2. Late Breaking Data Released at ADA Showed that the Investigational
Use of Januvia and Metformin as Initial Combination Therapy
Provided Significant Glucose Lowering Efficacy over 54 Weeks in
Patients with Type 2 Diabetes
3. Investigational Study Demonstrated a Re-Establishment of Clinical
Improvement with Orencia (Abatacept) in Children with Juvenile
Idiopathic Arthritis upon Re-Introduction of Therapy
4. Mercks Investigational Migraine Treatment MK-0974 Significantly
Improved Migraine Pain on Several Efficacy Measures in a Phase II
Study
5. Data Demonstrated Metastatic Melanoma Response to Investigational
Immunotherapy Ipilimumab
6. Investigational Drug Cediranib (AZD2171) Shows Promise in Patients
With Recurrent Glioblastoma (GBM)
7. Additional New Data from Satraplatin SPARC Phase 3 Investigational
Trial Presented at ASCO Annual Meeting
8. Additional New Data from Satraplatin SPARC Phase 3 Investigational
Trial Presented at ASCO Annual Meeting
9. Investigational Cancer Drug Pertuzumab Shows Promising Results in
Advanced Breast Cancer When Combined with Herceptin
10. Shire Announces Positive Results of Studies With Guanfacine
Extended Release, An Investigational Nonstimulant Medication Filed
for the Treatment of ADHD in Children and Adolescents
11. Investigational Study Evaluates the Effectiveness of Aripiprazole
in Adolescents With Schizophrenia