Janmet 50/500 mg Tab

Description

Janmet is an oral anti-diabetic drug that helps control blood sugar levels. Janmet contains a combination of Metformin and Sitagliptin.

Metformin and Sitagliptin are oral diabetes medicines that help control blood sugar levels. Janmet is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes (NIDDM).

Composition

Janmet 500 : Each film-coated tablet contains Sitagliptin Phosphate

Monohydrate INN 64.25 mg equivalent to 50 mg of Sitagliptin and Metformin Hydrochloride BP 500 mg. Janmet 1000 : Each film-coated tablet contains Sitagliptin Phosphate

Monohydrate INN 64.25 mg equivalent to 50 mg of Sitagliptin and Metformin Hydrochloride BP 1000 mg.

Indication

Janmet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Sitagliptin and Metformin is appropriate.

Dosage and Administration

Janmet should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to

Metformin.

The recommended starting dose in patients not currently treated with

Metformin is 50 mg Sitagliptin/500 mg Metformin hydrochloride twice daily.

The starting dose in patients already treated with Metformin should provide Sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of Metformin already being taken. For patients taking

Metformin 850 mg twice daily, the recommended starting dose of

Janmet is 50 mg Sitagliptin/1000 mg Metformin twice daily. Patients treated with an insulin secretagogue or insulin

Co-administration of Janmet with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

Use in Specific Populations

Pediatric population- There is no data on the use of Sitagliptin in patients younger than 18 years of age and therefore not recommended.

Geriatric Use- Janmet should be used with caution as age increases.

Care should be taken in dose selection and should be based on careful and regular monitoring of renal function.

Renal Insufficiency- A dosage adjustment is recommended in patients

with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis.

Impaired Hepatic Function- Janmet should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.

Use in Pancreatitis: Janmet has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking Janmet.

OR AS DIRECTED BY THE PHYSICIAN.

Side Effects

Most common side effects of Janmet are diarrhea, gas, headache, indigestion, nausea, sore throat, stomach upset, stuffy or runny nose, vomiting, and weakness.

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain or discomfort; decreased urination; dizziness or light-headedness; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or weakness; red, blistered, swollen, or peeling

skin; slow or irregular heartbeat; symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting); unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.

Contraindication

Janmet is contraindicated in patients with hypersensitivity to the active substances or to any of the excipients, diabetic ketoacidosis, diabetic pre-coma, moderate and severe renal impairment [serum creatinine levels  1.5 mg/dL (males),  1.4 mg/dL (Females)].

Precaution

Janmet may cause lactic acidosis, low blood sugar, and decreased vitamin B12 levels. Janmet warnings and precautions also extend to those who are allergic to any components of the drug, have metabolic or diabetic ketoacidosis, have kidney disease, or are about to have an x-ray procedure with contrast dye.

Use in Pregnancy and Lactation

Pregnancy

Pregnancy Category : B. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.

Sitagliptin-Metformin is only recommended for use during pregnancy when the benefit outweighs the risk.

Lactation

There are no data on the excretion of Sitagliptin-Metformin into human milk. It is recommended that caution should be used when administering Sitagliptin-Metformin to nursing women.

Drug Interaction

Cationic agents that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with Metformin by competing for common renal tubular transport systems. So, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic agents that are eliminated by renal tubular secretion are co-administered. Janmet may also have some drug interactions with Digoxin, Glyburide, Furosemide and Nifedipine and need close monitoring when treating NIDDM patient.

The Use of Metformin with Other Drugs

Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Janmet the patient should be closely observed to maintain adequate glycemic control.

Supply

Janmet 500 : Each box contains 1x6 tablets in Alu-Alu blister strip.

Janmet 1000 : Each box contains 1x6 tablets in Alu-Alu blister strip.

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