Galvus 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 Caution For Usage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Vildagliptin

Indications/Uses

Type 2 DM as monotherapy or initial combination therapy w/ metformin when diabetes is inadequately controlled by diet & exercise alone. In combination w/ other antidiabetics including insulin when these do not provide adequate glycaemic control.

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Dosage/Direction for Use

Adult Monotherapy, in combination w/ metformin, thiazolidinedione, metformin & sulphonylurea or insulin (w/ or w/o metformin) 100 mg daily as 1 dose of 50 mg in the morning & evening. Dual combination w/ sulphonylurea 50 mg once daily in the morning. Initial combination therapy w/ metformin 50 mg once or bd. Max: 100 mg. Moderate or severe renal impairment or ESRD 50 mg once daily.

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Overdosage

View Galvus overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity.

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Special Precautions

Discontinue use if acute pancreatitis, severe & disabling arthralgia are suspected; jaundice or other signs of liver dysfunction develops. Not an insulin substitute. Not to be used in type 1 diabetes or diabetic ketoacidosis. Not recommended in NYHA class IV. Hypoglycaemia. Perform LFTs prior to & during treatment at 3-mth intervals for the 1st yr & periodically thereafter. Routine care for diabetic patients & monitor for skin disorders. Not to be used in galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. ESRD on haemodialysis. Not to be used in hepatic impairment & if AST or ALT increased >3 x ULN. Not to be used during pregnancy & lactation. Not recommended in childn & adolescents <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycaemia, increased wt, decreased blood glucose; dizziness, tremor, headache, asthenia, chills; nausea, GERD; peripheral oedema; hyperhidrosis.

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Drug Interactions

Increased risk of angioedema w/ ACE inhibitors. Reduced hypoglycaemic effect w/ thiazides, corticosteroids, thyroid products & sympathomimetics.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Galvus detailed prescribing information

Description

View Galvus description for details of the chemical structure and excipients (inactive components).

Action

View Galvus mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Antidiabetic Agents

ATC Classification

A10BH02 - vildagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.

Regulatory Classification

Presentation/Packing

Form

Galvus tab 50 mg

Packing/Price

1 × 7's;2 × 14's;4 × 14's

Galvus

vildagliptin

Manufacturer:

Novartis

Distributor:

DKSH