Dayvus 50: 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 patients w/ type 2 DM as monotherapy, in combination w/ metformin, sulfonylurea, thiazolidinedione, or insulin, or in triple combination w/ sulfonylurea & metformin, when diet, exercise & single agent or dual therapy do not provide adequate glycemic control. Initial combination therapy w/ metformin in patients w/ type 2 DM whose diabetes is not adequately controlled by diet & exercise alone.

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Dosage/Direction for Use

Adult Monotherapy or in combination w/ metformin or thiazolidinedione or insulin (w/ or w/o metformin) 50 mg once daily in the morning or bid (morning & evening). Triple therapy in combination w/ sulfonylurea & metformin 50 mg bid. In combination w/ sulfonylurea 50 mg once daily. Moderate to severe renal impairment or ESRD Initial & max dose: 50 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Ketoacidosis.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Dayvus 50 detailed prescribing information

Special Precautions

Discontinue therapy if ALT or AST is persistently >3x ULN or if jaundice or other signs of hepatic dysfunction (eg, hepatitis) occur. Not to reinitiate therapy even after hepatic function normalizes. Not to be used in type 1 DM, diabetic ketoacidosis, severe infection & injury. May increase risk of severe joint pain. Not to be used w/ alcohol. Not recommended in galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in preexisting hepatic impairment including patients w/ pre-treatment ALT or AST >2.5 x ULN. Avoid use during pregnancy & lactation. Childn <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dizziness, headache, nausea, tremor; nasopharyngitis, URTI; acute pancreatitis, constipation, hepatic dysfunction; arthralgia, peripheral oedema, asthenia; hypoglycemia; hyperhidrosis, skin lesions (exfoliative & bullous pemphigoid).

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Drug Interactions

Impaired glucose regulation w/ somatostatin analogues. Changes in blood glucose & increased risk of hypo-/hyperglycemia w/ fluoroquinolones. Hypoglycemia w/ hydroxychloroquine or chloroquine. Increased risk of hypoglycemia w/ thioctic acid. Hypo-/hyperglycemia or decreased symptoms of hypoglycemia w/ β-blockers.

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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

Dayvus 50 tab 50 mg

Packing/Price

8 × 7's

Dayvus 50

vildagliptin

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma