Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets)

1. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) © Clearsky Pharmacy ( www.clearskypharmacy.biz )

2. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) are used to treat high blood sugar levels caused by type 2 diabetes. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better. Sitagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood. This medicine does not help patients who have insulin-dependent or type 1 diabetes. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

3. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Active Ingredients The active ingredients present in Janumet tablets are Sitagliptin Phosphate and Metformin Hydrochloride. Each tablet contains Sitagliptin Phosphate Monohydrate equivalent to 50 mg of Sitagliptin (fixed) whereas the quantity of Metformin Hydrochloride is 500 mg or 1000 mg. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

4. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Chemical Structure The structure of Sitagliptin Phosphate is given below: © Clearsky Pharmacy ( www.clearskypharmacy.biz )

5. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Chemical Structure The structure of Metformin Hydrochloride is given below: © Clearsky Pharmacy ( www.clearskypharmacy.biz )

6. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Janumet Tablets are manufactured by MSD Pharmaceuticals India Private Limited in the strengths of 550 mg (Sitagliptin 50mg and Metformin Hydrochloride 500mg) and 1050 mg (Sitagliptin 50mg and Metformin Hydrochloride 1000mg) ( Website: https://www.msdindia.in/ ) URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

7. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Sitagliptin Phosphate and Metformin Hydrochloride Tablets – Brand Names Sitagliptin Phosphate and Metformin Hydrochloride tablets are available under various brand names such as Janumet, Istamet, Zita-met, Sepamet-XR, Siglimepol, Ulsita, Sitacip, Sitared, Sitawok, Sitalembic, Sitar-M and Sitason-M. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

8. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Uses of Janumet Tablets Janumet tablets (Metformin and Sitagliptin combination) are used to treat high blood sugar levels caused by type 2 diabetes. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better. Sitagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood. This medicine does not help patients who have insulin-dependent or type 1 diabetes. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

9. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Janumet Tablets Dosage The dosage of Janumet tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) is given below: The dose should be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to Metformin. The starting dose of Janument must be individualized based on the patient’s current regimen. The dosing could be adjusted based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg Sitagliptin and 2000 mg Metformin. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

10. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Contraindications Janumet tablets are contraindicated in patients with a hypersensitivity to Sitagliptin Phosphate, Metformin Hydrochloride or any other component of this medication. Renal dysfunction, e.g., serum creatinine (1.5 mg/dL or greater [males]), (1.4 mg/dL or greater [females]) or abnormal creatinine clearance. Temporarily discontinue Janumet tablets in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

11. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Storage Instructions Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

12. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Warnings Do not use Janumet tablets (Sitagliptin Phosphate and Metformin Hydrochloride tablets) in patients with hepatic disease. Lactic acidosis 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. Symptoms include 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, discontinue Janumet and hospitalize the patient immediately. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

13. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Warnings There have been postmarketing reports of acute renal failure, sometimes requiring dialysis. Before initiating Janumet tablets and at least annually thereafter, assess renal function and verify as normal. There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue Janumet. Measure hematologic parameters annually. Warn patients against excessive alcohol intake. May need to discontinue Janumet and temporarily use insulin during periods of stress and decreased intake of fluids and food as may occur with fever, trauma, infection or surgery. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

14. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Warnings Promptly evaluate patients previously controlled on Janumet who develop laboratory abnormalities or clinical illness for evidence of ketoacidosis or lactic acidosis. There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with Sitagliptin (one of the components of Janumet), such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly stop Janumet, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

15. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Warnings When used with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Janumet or any other anti-diabetic drug. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

16. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Side Effects The most common side effects reported in 5% or greater of patients simultaneously started on Sitagliptin and Metformin and more commonly than in patients treated with placebo were diarrhea, upper respiratory tract infection, and headache. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

17. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Overdose In the event of an overdose, it is reasonable to employ supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as indicated by the patient's clinical status. Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if Sitagliptin is dialyzable by peritoneal dialysis. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

18. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Overdose Overdose of Metformin has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with Metformin has been established. Lactic acidosis has been reported in approximately 32% of Metformin overdose cases. Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom Metformin overdosage is suspected. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

19. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Janumet Tablets During Pregnancy Metformin Hydrochloride has been classified by the US FDA as Pregnancy Category B. Metformin Hydrochloride is not currently approved by US Food and Drug Administration (FDA) for the management of diabetes during pregnancy. Do not use this medicine without your doctor's consent in case you are pregnant. Animal studies have not demonstrated a risk to the fetus but there is lack of adequate well-controlled human studies. It is advised that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

20. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) Janumet Tablets During Pregnancy Sitagliptin Phosphate has been classified by the US FDA as Pregnancy Category B. Reproduction studies have been performed in rats and rabbits. Doses of Sitagliptin up to 125 mg/kg (approximately 12 times the human exposure at the maximum recommended human dose) did not impair fertility or harm the fetus. There are, however, no adequate and well- controlled studies in pregnant women. The use of this medicine during pregnancy is not recommended. Stop using this medication and inform your doctor immediately if you become pregnant during treatment. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

21. Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) For more details on Janumet Tablets click here Janumet Tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) by MSD Pharmaceuticals India Private Limited. URL: https://www.clearskypharmacy.biz/janumet-tablets.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )