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Manufacturer |
MSD |
Distributor |
Hong Kong: DKSH/Macau: Four Star |
Contents |
Per 50/500 mg tab Sitagliptin 50 mg, metformin HCl 500 mg. Per 50/1000 mg tab Sitagliptin 50 mg, metformin HCl 1,000 mg |
Indications |
Adjunct to diet & exercise to improve glycemic control in adult w/ type 2 DM when treatment w/ both sitagliptin & metformin is appropriate.
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Dosage |
Individualised dosage not exceeding max daily dose of 100 mg sitagliptin & 2,000 mg metformin. Generally given bd. Patients inadequately controlled on metformin alone Usual starting dose: Sitagliptin 50 mg bd, plus the dose of metformin already being taken. For patients taking metformin 850 mg bd, the recommended starting dose is 50 mg sitagliptin/1,000 mg metformin HCl bd. Patients inadequately controlled on sitagliptin alone Usual starting dose: 50 mg sitagliptin/500 mg metformin HCl bd. Dose may be titrated up to 50 mg sitagliptin/1,000 mg metformin HCl bd. Switching from co-administration of sitagliptin & metformin May be initiated at the dose of sitagliptin & metformin already being taken.
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Overdosage |
View Janumet overdosage for action to be taken in the event of an overdose. |
Administration |
Should be taken with food |
Contraindications |
Renal disease or renal dysfunction (serum creatinine levels ≥1.5 mg/dL for males, ≥1.4 mg/dL for females or abnormal CrCl) which may also result from conditions eg CV collapse (shock), acute MI & septicemia. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma. Temporarily discontinue in radiologic studies involving intravascular administration of iodinated contrast materials. Type 1 diabetes. Lactation.
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Special Precautions |
Monitor renal function. Debilitated, malnourished patients & w/ adrenal or pituitary insufficiency or alcohol intoxication in which patients are susceptible to hypoglycaemia. Hypoglycaemia (in combination w/ a sulfonylurea or insulin), lactic acidosis, hypoxic states, surgery, impaired hepatic function, decreased vit B12 absorption. Pregnancy. Elderly.
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Adverse Drug Reactions |
Diarrhea, nausea, dyspepsia, flatulence, vomiting, abdominal discomfort, indigestion, asthenia, headache, hypoglycaemia, nasopharyngitis, fungal skin infection, peripheral edema. Hypersensitivity reaction. Pancreatitis, worsening of renal function, constipation, upper resp tract infection.
View ADR Monitoring Form |
Side Effects |
View Janumet side effects |
Drug Interactions |
Alcohol intake. Sitagliptin: Digoxin, cyclosporin. Metformin: Furosemide, nifedipine, cationic drugs (eg amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim or vancomycin), cimetidine. Drugs producing hyperglycaemia eg thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OC, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers & INH.
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Pregnancy Category (US FDA) |
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters). |
Description |
View Janumet description for details of the chemical structure and excipients (inactive components). |
Mechanism of Action |
View Janumet mechanism of action for pharmacodynamics and pharmacokinetics details. |
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