Galvus Met Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Per 50 mg/500 mg FC tab Vildagliptin 50 mg, metformin HCl 500 mg. Per 50 mg/1,000 mg FC tab Vildagliptin 50 mg, metformin HCl 1,000 mg

Indications/Uses

Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM as initial therapy when diabetes is not adequately controlled by diet & exercise alone or as therapy in patients inadequately controlled w/ metformin HCl or vildagliptin alone or who are already treated w/ combination of vildagliptin & metformin HCl as separate tab. In combination w/ other medicinal products for diabetes, including insulin, when these do not provide adequate glycemic control.

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Dosage/Direction for Use

Individualized dose. Max vildagliptin dose: 100 mg. Inadequately controlled on vildagliptin monotherapy Initially 50 mg/500 mg bid & titrate gradually after assessing adequacy of therapeutic response. Inadequately controlled on metformin HCl monotherapy Initially 1 tab bid, based on current metformin dose. Switching from combination of vildagliptin plus metformin as separate tab 1 tab, based on current dose of vildagliptin or metformin. Treatment naive patient Initially 50 mg/500 mg once daily & titrate gradually to a max dose of 50 mg/1,000 mg bid after assessing adequacy of therapeutic response. In combination w/ SU or insulin 50 mg bid vildagliptin dose & the current metformin dose.

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Overdosage

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Administration

Should be taken with food: Take w/ or immediately after meals to reduce GI discomfort.

Contraindications

Hypersensitivity. Renal disease or dysfunction (GFR <30 mL/min), CHF, metabolic acidosis.

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Special Precautions

Discontinue in case of hypoxic states. Not to be used in type 1 DM or diabetic ketoacidosis, hepatic impairment, pre-treatment ALT or AST >2.5x ULN, lactic acidosis, surgical procedures, hypoglycaemia, loss of blood glucose control. Monitor hepatic enzyme, renal function & serum vit B₁₂. Avoid excessive alcohol intake. Pregnancy & lactation. Childn <18 yr. Elderly (monitor renal function).

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Use In Pregnancy & Lactation

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Adverse Reactions

Nausea, vomiting, diarrhea, abdominal pain, decreased appetite, GERD, tremor, dizziness, headache, asthenia, hypoglycemia, hyperhidrosis, chills, decreased blood glucose, dysgeusia, flatulence.

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Drug Interactions

Metformin: Increased exposure w/ furosemide, nifedipine, ranolazine, vandetanib, dolutegravir, cimetidine. Concomitant use w/ iodinated contrast agents. May lead to loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OC, phenytoin, nicotinic acid, sympathomimetics, Ca-channel blockers, INH.

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Storage

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Description

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Action

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MIMS Class

Antidiabetic Agents

ATC Classification

A10BD08 - metformin and vildagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Thai FDA Category

Presentation/Packing

Form

Galvus Met FC tab 50 mg/1,000 mg

Packing/Price

6 × 10's

Form

Galvus Met FC tab 50 mg/500 mg

Packing/Price

6 × 10's

Galvus Met

vildagliptin + metformin

Manufacturer:

Novartis

Distributor:

Zuellig Pharma

Marketer:

A.Menarini