Viglaz: Side Effects & Dosing

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

Concise Prescribing Info

Contents

Vildagliptin

Indications/Uses

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM as monotherapy. Initial combination w/ metformin when diabetes is inadequately controlled by diet & exercise alone. In combination w/ other medicinal products, including insulin, for treatment of diabetes when these do not provide adequate glycaemic control.

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Dosage/Direction for Use

50 mg once daily or bid. Max dose: 100 mg daily. Monotherapy & in combination w/ metformin/thiazolidinedione/insulin (w/ or w/o metformin) 50 mg or 100 mg daily. Dual combination w/ sulfonylurea 50 mg once daily. Triple combination w/ metformin & sulfonylurea 100 mg daily. If tighter glycaemic control is required on top of max recommended daily dose, consider addition of other antidiabetics eg, sulfonylurea, thiazolidinedione or insulin. Moderate or severe renal impairment or ESRD 50 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity.

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Warnings

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Special Precautions

Discontinue treatment if an increase in AST/ALT ≥3x ULN continues; in patients who develop jaundice or other symptoms of liver dysfunction. Not a substitute for insulin. Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis; severe infection or serious accident. May increase risk of severe joint pain. Not recommended in patients w/ NYHA functional class IV. Perform LFTs prior initiation & check while on treatment at 3-mth intervals for 1st yr & at an event after that. Follow up w/ a 2nd liver function evaluation in patients who develop increased transaminase levels. Not to be used concomitantly w/ alcohol. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients w/ ESRD. Not recommended in patients w/ hepatic impairment including w/ pre-treatment ALT/AST >2.5x ULN. Not to be used during pregnancy. Not to be administered to breastfeeding woman. Not recommended in ped patients <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Monotherapy: Dizziness. Combination w/ metformin: Tremor, dizziness, headache. Combination w/ sulfonylureas: Tremor, headache, dizziness, asthenia. Combination w/ thiazolidinediones: Increased wt; peripheral edema. Combination w/ insulin: Headache, nausea, GERD; chills; decreased blood glucose. Combination w/ metformin & sulfonylureas: Dizziness, tremor, asthenia, hypoglycemia; hyperhidrosis.

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Drug Interactions

May increase risk of angioedema w/ ACE inhibitors. May reduce hypoglycaemic effect w/ thiazides, corticosteroids, thyroid products & sympathomimetics.

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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

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

Thai FDA Category

Presentation/Packing

Form

Viglaz tab 50 mg

Packing/Price

6 × 10's

Viglaz

vildagliptin

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical