Adult Dosing
Type II diabetes mellitus (Janumet)
Currently on sitagliptin plus metformin
- 50 mg/1000 mg PO bid, gradually increase the dose as required [Max: 100 mg/2000 mg daily]
Currently not treated with metformin
- TABS: 50 mg/500 mg PO bid, gradually increase the dose as required [Max: 100 mg/2000 mg daily]
Already on metformin therapy
- 50 mg sitagliptin plus current metformin dose PO bid
- 50 mg/1000 mg PO bid, if current metformin dose 850 mg [Max: 100 mg/2000 mg daily]
Type II diabetes mellitus (Janumet XR)
Currently on sitagliptin and metformin immediate release
- Maintain same total daily dose while switching to extended release, gradually increase the dose as required [Max: 100 mg/2000 mg daily]
Currently not treated with metformin
- 100 mg/1000 mg PO qd, gradually increase the dose as required [Max: 100 mg/2000 mg daily]
Already on metformin therapy
- 100 mg sitagliptin plus previously prescribed metformin dose PO qd
- 100 mg/2000 mg PO qd, if current metformin dose 850 mg or 1000 mg bid [Max: 100 mg/2000 mg daily]
Notes:- Janumet XR must be administered once a day, preferably with a meal in the evening
- The tablet with highest strength of sitagliptin must be taken once daily. If 2 lower strength tablets are to be taken, both tablets must be taken together once daily
- Tablets should not be crushed, split, broken, or chewed prior to swallowing and gradually escalate the dose to reduce the gastrointestinal side effects due to metformin
Pediatric Dosing
- Safety and effectiveness in pediatric patients <18 yrs have not been established
[Outline]
- Serious metabolic complications including lactic acidosis may occur due to metabolic accumulation during metformin/sitagliptin therapy [US Black Box Warning]
- Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported during post-marketing study. Carefully monitor patients for signs and symptoms of pancreatitis, if suspected, discontinue therapy and provide appropriate management
- Impaired hepatic function is associated with lactic acidosis, avoid metformin/sitagliptin therapy in patients with clinical or laboratory evidence of hepatic disease
- Impairment of renal function increases the risk of metformin accumulation and lactic acidosis. Monitor renal function prior to initiation of therapy and periodically thereafter, carefully titrated to establish the minimum dose for adequate glycemic effect. Discontinue the therapy on the evidence of renal dysfunction
- Metformin therapy decreases Vitamin B12 to subnormal level, Monitor hematologic parameters annually and any apparent abnormalities should be investigated and managed
- Warn patients against the excessive alcohol intake as alcohol potentiates effect of metformin on lactate metabolism
- Temporarily discontinue therapy in patients undergoing major surgical procedure associated with restricted intake of food and fluids
- Evaluate serum electrolytes and ketones, blood glucose, pyruvate and metformin levels in type 2 diabetic patients who were previously well controlled on metformin who developed laboratory abnormalities or clinical illness. If acidosis, stop therapy and start alternative treatment
- Be cautious if concomitant administration of drug that may affect renal function or result in significant hemodynamic change or may interfere with the disposition of metformin such as cationic drugs
- Temporarily discontinue therapy in patients undergoing intravascular contrast studies with iodinated materials as it is associated with increased risk of renal dysfunction and lactic acidosis
- Immediately discontinue therapy in case of cardiovascular collapse, acute CHF, acute MI and other conditions of hypoxemia associated with lactic acidosis and prerenal azotemia
- Temporary loss of glycemic control occurs in stabilized diabetic patients exposed to stress such as fever, trauma, infection, or surgery, withhold metformin/sitagliptin therapy and temporarily administer insulin
- Metformin/sitagliptin therapy and other anti-diabetic drugs have no clinical evidence of reducing macrovascular risk
- Postmarketing reports regarding serious hypersensitivity reactions such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome has been reported with sitagliptin therapy.Discontinue the treatment if symptoms suspected and assess for other potential causes, and institute alternative treatment for diabetes
Cautions: Use cautiously in
Pregnancy Category:B
Breastfeeding: Safety unknown. No information available on sitagliptin use during breastfeeding; therefore, an alternate drug may be preferred, especially while nursing a newborn or preterm infant based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 6 Jan 2011). Well-conducted studies indicate a very low level of metformin in milk and less than 0.5% of the mother's dosage received in infants. Metformin levels in milk are relatively constant during maternal use, so breastfeeding timing with respect to the administration times is of little benefit. No adverse effects were found in breastfed infants in one prospective study. Use cautiously when nursing newborn and premature infants and those with renal impairment. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 6 Jan 2011). No studies available as a combined drug in lactating animals, however as both sitagliptin and metformin are secreted in the milk of lactating rats. Manufacturer advises caution while administering nursing women.
US Trade Name(s)
US Availability
Janumet (metformin/sitagliptin)
- TABS
- 500 mg/50 mg
- 1000 mg/50 mg
Janumet XR (metformin/sitagliptin)
- ETABS
- 500 mg/50 mg
- 1000 mg/50 mg
- 1000 mg/100 mg
Canadian Trade Name(s)
Canadian Availability
Janumet (metformin/sitagliptin)
- TABS
- 500 mg/50 mg
- 850 mg/50 mg
- 1000 mg/50 mg
UK Trade Name(s)
UK Availability
Janumet (metformin/sitagliptin)
Australian Trade Name(s)
Australian Availability
Janumet (metformin/sitagliptin)
- TABS
- 500 mg/50 mg
- 850 mg/50 mg
- 1000 mg/50 mg
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Janumet 50-1000 MG TABS [Bottle] (MERCK SHARP & DOHME)
60 mg = $224.99
180 mg = $645.95 - Janumet 50-500 MG TABS [Bottle] (MERCK SHARP & DOHME)
60 mg = $220.99
180 mg = $639.96
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Janumet 50 mg/1000 mg Oral Tablet
Ingredient(s): Metformin mixture with sitagliptin
Imprint: 577
Color(s): Red
Shape: Oval
Size (mm): 21.00
Score: 1
Inactive Ingredient(s): ferrosoferric oxide / cellulose, microcrystalline / polyethylene glycol / polyvinyl alcohol / povidone k29/32 / ferric oxide red / sodium lauryl sulfate / sodium stearyl fumarate / talc / titanium dioxide
Drug Label Author:
Merck Sharp & Dohme Corp.
DEA Schedule:
Non-Scheduled
Drug Name: Janumet 50 mg/500 mg Oral Tablet
Ingredient(s): Metformin mixture with sitagliptin
Imprint: 575
Color(s): Pink
Shape: Oval
Size (mm): 17.00
Score: 1
Inactive Ingredient(s): ferrosoferric oxide / cellulose, microcrystalline / polyethylene glycol / polyvinyl alcohol / povidone k29/32 / ferric oxide red / sodium lauryl sulfate / sodium stearyl fumarate / talc / titanium dioxide
Drug Label Author:
Merck Sharp & Dohme Corp.
DEA Schedule:
Non-Scheduled
