Velmetia

Velmetia

metformin + sitagliptin

Manufacturer:

Merck Sharp & Dohme

Distributor:

Natrapharm
Concise Prescribing Info
Contents
Per 50 mg/500 mg FC tab Sitagliptin phosphate monohydrate 64.25 mg (equiv to sitagliptin 50 mg as free base), metformin HCl 500 mg. Per 50 mg/1 g FC tab Sitagliptin phosphate monohydrate 64.25 mg (equiv to sitagliptin 50 mg as free base), metformin HCl 1 g
Indications/Uses
Initial therapy in Type 2 DM to improve glycemic control when diet & exercise alone do not provide adequate glycemic control, or inadequately controlled w/ metformin or sitagliptin alone or in patients being treated w/ combination of metformin & sitagliptin. As part of triple combination therapy w/ a sulfonylurea as an adjunct to diet & exercise in patients w/ type 2 DM inadequately controlled w/ any 2 of the 3 agents: metformin, sitagliptin, or a sulfonylurea. As part of triple combination therapy w/ PPAR-γ agonist as an adjunct to diet & exercise in patients w/ type 2 DM inadequately controlled w/ any 2 of the 3 agents: metformin, sitagliptin, or a PPAR-γ agonist. Type 2 DM as an adjunct to diet & exercise to improve glycemic control in combination w/ insulin.
Dosage/Direction for Use
Individualized dosing. Initial therapy: Starting dose 50 mg/500 mg bid. May be titrated up to 50 mg/1 g bid. Patient inadequately controlled on metformin monotherapy Sitagliptin 50 mg bid + metformin already taken. Patient inadequately controlled on sitagliptin monotherapy 50 mg/500 mg tab bid. May be titrated up to 50 mg/1 g tab bid. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or a PPAR-γ agonist (ie thiazolidinediones) Sitagliptin 50 mg bid (100 mg total daily dose). In determining the starter dose of the metformin component, the patient's level of glycemic control & current dose (if any) of metformin should be considered. Gradual dose escalation to reduce GI effects associated w/ metformin should be considered. Patient switching from sitagliptin co-administered w/ metformin Initiate w/ dose of sitagliptin & metformin already being taken. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or sulfonylurea Sitagliptin 50 mg bid (100 mg total daily dose) + metformin dose based on glycemic control level. Patients currently on or initiating sulfonylurea may require lower doses of sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia. Gradual dose escalation to reduce GI effects associated w/ metformin should be considered. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or insulin Sitagliptin 50 mg bid + metformin dose based on glycemic control level & current dose (if any) of metformin. Gradual dose escalation to reduce GI effects associated w/ metformin should be considered. Patients currently on or initiating insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to sitagliptin phosphate or metformin HCl. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma. Discontinue treatment in patients undergoing radiologic studies. Severe renal impairment (eGFR <30 mL/min/1.73 m2). Pregnancy & lactation.
Special Precautions
Do not use in type 1 diabetes or treatment of diabetic ketoacidosis. Inform patients of the characteristic symptom of acute pancreatitis. Assess renal function before initiation of therapy & at least annually thereafter. Hypoglycemia in combination w/ sulfonylurea or insulin. Temporarily discontinue therapy at the time or prior the procedure & w/held 48 hr in patients who will be administered w/ intra-arterial iodinated contrast, w/ an eGFR ≥30-60 mL/min/1.73 m2, history of hepatic impairment, alcoholism, heart failure. Hypoxic states. Suspend therapy prior to surgical procedure until resumption of oral intake. Avoid excessive alcohol intake. Impaired hepatic function. Monitor vit B12 levels. Change in clinical status of patients w/ previously controlled type 2 diabetes. Loss of glycemic control may occur. Sitagliptin: Hypersensitivity. Discontinue if bullous pemphigoid is suspected. Metformin: Lactic acidosis. W/held in any condition associated w/ hypoxemia, dehydration or sepsis. Hypoglycemic effects in elderly, debilitated or malnourished patients, & those w/ adrenal or pituitary insufficiency or alcohol intoxication. Concomitant use of medications that may affect renal function. Childn <18 yr. Elderly.
Adverse Reactions
Combination therapy w/ sitagliptin & metformin: Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycemia; abdominal pain. Sitagliptin in combination w/ metformin & a sulfonylurea: Hypoglycemia, constipation. Sitagliptin in combination w/ metformin & a PPARγ agonist: Headache, diarrhea, nausea, hypoglycemia, vomiting; upper resp tract infection, cough, fungal skin infection, peripheral edema, vomiting. Sitagliptin in combination w/ metformin & insulin: hypoglycemia, vomiting.
Drug Interactions
May lead to loss of glycemic control w/ drugs tend to produce hyperglycemia eg, thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs & INH. Sitagliptin: Increased AUC & Cmax w/ cyclosporine (a potent probe inhibitor of p-glycoprotein). Metformin HCl: Increased plasma & blood Cmax & blood AUC w/ furosemide. Increased plasma Cmax & AUC & increased amount excreted in the urine w/ nifedipine. Increased systemic exposure & risk for lactic acidosis w/ concomitant use of drugs that interfere w/ common renal tubular transport system (eg, organic cationic transporter-2 [OCT2]/multidrug & toxin extrusion [MATE] inhibitors eg, ranolazine, vandetanib, dolutegravir & cimetidine).
MIMS Class
ATC Classification
A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Velmetia 50 mg/1 g FC tab
Packing/Price
28's (P702.8/box)
Form
Velmetia 50 mg/500 mg FC tab
Packing/Price
28's (P701.4/box)
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