Janumet Tablets

Janumet (Sitagliptin and Metformin Tablets) - Product Information

Janumet tablets are a combination of Sitagliptin Phosphate, and Metformin Hydrochloride, which are used along with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Janumet can be used alone, or in combination with insulin, or sulfonylurea medicines such as Glimepiride, Gliclazide and Glibenclamide.

Janumet (Sitagliptin and Metformin tablets) are manufactured by Merck Sharp and Dohme in the strengths of 550 mg (Sitagliptin 50mg and Metformin 500mg) and 1050 mg (Sitagliptin 50mg and Metformin 1000mg). We also have in stock Generic Glucophage (Glycomet Tablets) which is used to treat type 2 diabetes mellitus (non-insulin dependent diabetes) in adults, when a special diet and exercise alone does not result in adequate control of blood glucose levels.

Name of the Drug

We supply original Janumet tablets manufactured by Merck Sharp and Dohme.

Manufacturer of Janumet Tablets

Merck Sharp & Dohme (MSD)  
Website: merck.com

Active Ingredients present in Janumet Tablets

The active ingredients present in Janumet tablets are Sitagliptin Phosphate and Metformin Hydrochloride. Each tablet contains 50 mg of Sitagliptin (fixed) whereas the quantity of Metformin is 500 mg or 1000 mg.

Uses of Janumet Tablets

Janumet (Sitagliptin and Metformin Tablets) helps to lower blood sugar levels in patients with type 2 diabetes mellitus along with diet and exercise. Janumet canbe used alone, or in combination with insulin, or sulfonylurea medicines such as Glimepiride, Gliclazide and Glibenclamide.

Janumet Tablets - Mechanism of Action

The mechanism of action of Janumet tablets is due to the combined action of it's constituents namely Sitagliptin Phosphate and Metformin Hydrochloride. Metformin Hydrochloride is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, Metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects and does not cause hyperinsulinemia. With Metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.
Sitagliptin Phosphate is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by Sitagliptin Phosphate, thereby increasing and prolonging the action of these hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, JANUVIA increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.

Janumet Tablets - Dosage

The starting dose of Janumet has to be individualized based on the patient's current regimen. The dosing has to be adjusted based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg Sitagliptin and 2000mg Metformin. Janumet tablets have to be administered twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal effects due to Metformin HCl.
Before initiation, assess renal function with estimated glomerular filtration rate (eGFR) Do not use in patients with eGFR below 30mL/min/1.73m2. This medicine is not recommended in patients with eGFR between 30 and less than 45mL/min/1.73m2.
Janumet tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures

Janumet Tablets Storage

Store Janumet tablets (Sitagliptin Phosphate and Metformin Hydrochloride Tablets) at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Do not store it or any other medicine in the bathroom or near a sink.Do not leave it in the car or on window sills.Heat and dampness can destroy some medicines.

Janumet Tablets Contraindications

Janumet tablets are contraindicated in patients with a hypersensitivity to Sitagliptin Phosphate, Metformin Hydrochloride or any inactive ingredient present in Janumet tablets. Janumet tablets are also contraindicated in the following cases:

• Renal dysfunction, e.g., serum creatinine equal to or more than 1.5 mg/dL [males], equal to or more than 1.4 mg/dL [females] or abnormal creatinine clearance.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma

Warnings and Precautions

• Lactic acidosis: Patients must be warned regarding excessive alcohol intake. Janumet tablets are not recommended in hepatic impairment and is contraindicated in renal impairment. Ensure normal renal function before initiating and at least annually thereafter.
• Temporarily discontinue Janumet tablets in patients undergoing radiologic studies with intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food or fluids.
• There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue Janumet tablets.
• There have been postmarketing reports of acute renal failure, sometimes requiring dialysis. Before starting Janumet tablets and at least annually thereafter, assess renal function and verify as normal.
• Vitamin B12 deficiency: Metformin HCl may lower Vitamin B12 levels. Measure hematologic parameters annually.
• 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 postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with Sitagliptin (one of the components of Janumet tablets), such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly stop Janumet tablets, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes.
• Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.
• There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Janumet tablets or any other anti-diabetic drug.

Janumet (Sitagliptin and Metformin Tablets) - Side Effects

The most common side effects reported in 5% or more of patients simultaneously started on Sitagliptin Phosphate and Metformin Hydrochloride and more commonly than in patients treated with placebo were diarrhea, upper respiratory tract infection, and headache.
Side effects reported in in 5% or more of patients treated with Sitagliptin in combination with Sulfonylurea and Metformin and more commonly than in patients treated with placebo in combination with Sulfonylurea and Metformin HCl were hypoglycemia and headache.
Hypoglycemia was the only side effect reported in 5% or more of patients treated with sitagliptin in combination with insulin and metformin and more commonly than in patients treated with placebo in combination with insulin and Metformin Hydrochloride.

Janumet (Sitagliptin and Metformin Tablets) Overdosage

Overdose of Metformin Hydrochloride 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.
During controlled clinical trials in healthy subjects, single doses of up to 800 mg Sitagliptin Phosphate were administered. Maximal mean increases in QTc of 8.0 msec were observed in one study at a dose of 800 mg Sitagliptin Phosphate, a mean effect that is not considered clinically important. There is no experience with doses above 800 mg in clinical studies.
During multiple-dose studies, there were no dose-related clinical adverse reactions observed with Sitagliptin Phosphate with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for up to 28 days.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated 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.
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.

Risk Of Lactic Acidosis

Janumet (Sitagliptin and Metformin Tablets) may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration, liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease). In case any of the above apply to you, talk to your doctor for further instructions.
Stop taking Janumet tablets for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Sitagliptin Phosphate and Metformin Hydrochloride (Janumet Tablets) During Pregnancy

Metformin Hydrochloride has been classified by the US FDA as Pregnancy Category B. Metformin HCl 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.
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. Because animal reproduction studies are not always predictive of human response, this medicine should be used during pregnancy only if clearly needed.
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.

Sitagliptin Phosphate and Metformin Hydrochloride (Janumet Tablets) - Nursing Considerations

Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1. It is not known whether Sitagliptin is excreted in human milk. Since many medicines are excreted in human milk, caution should be exercised when Sitagliptin Phosphate is administered to a nursing woman.
Limited published medical studies report that Metformin is present in human milk. However, there is insufficient knowledge available at present to determine the effects of Metformin on the breastfed infant and no available information on the effects of Metformin on milk production. Therefore, the developmental and health benefits of breastfeeding must be considered along with the mother's clinical requirement for Metformin Hydrochloride and any potential adverse effects on the breastfed infant from Metformin Hydrochloride or from the underlying maternal condition.
Do not use this medication without telling your doctor if you are breast-feeding a baby.

Buy Janumet Pills (Sitagliptin Phosphate and Metformin Hydrochloride Tablets)Online at Only $1.03 per Pill

You can buy Sitagliptin Phosphate and Metformin Hydrochloride tablets online from Clear Sky Pharmacy at a cheap price. Janumet 550 mg (Sitagliptin 50mg and Metformin 500mg) and 1050 mg (Sitagliptin 50mg and Metformin 1000mg) pills, manufactured by Merck Sharp and Dohme (MSD), are supplied in a blister strip of 15 tablets. The 550 mg tablets cost only $0.97 per unit when you place an order for 300 tablets.

Disclaimer

The above information is provided to the best of our knowledge and in good faith, it is without a warrant of any kind, expressed or implied.

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