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Galvus

Galvus

vildagliptin

Manufacturer:

Novartis Pharmaceutical Manufacturing LLC

Distributor:

Novartis Healthcare
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 Storage MIMS Class ATC Classification Regulatory Classification 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; as initial combination w/ metformin when diabetes is not adequately controlled by diet & exercise alone; as combination therapy w/ other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycemic control.
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Dosage/Direction for Use
Indiviualized dose. Adult ≥18 yr 50 mg once daily (in the morning) or bid (in the morning & evening). Max: 100 mg daily. Monotherapy & in combination w/ metformin/thiazolidinedione/insulin (w/ or w/o metformin) 50 or 100 mg daily. In dual combination w/ sulfonylurea 50 mg once daily. Triple combination w/ metformin & sulfonylurea 100 mg daily. Patient w/ 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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Special Precautions
Not a substitute for insulin. Should not be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Not recommended in patients w/ NYHA functional class IV. Limited clinical experience & inconclusive results in patients w/ NYHA functional class III. Perform LFTs prior to treatment initiation, & monitor at 3-mth intervals during the 1st yr of treatment & periodically thereafter. W/draw therapy if an increase in AST/ALT ≥3 times ULN persist. Discontinue in patients who develop jaundice or other signs suggestive of liver dysfunction. Not recommended in patients w/ hepatic impairment, including patients w/ pre-treatment ALT/AST >2.5 times ULN. Should not be used during pregnancy unless benefit to the mother outweighs potential risk to fetus. Should not be administered to breast-feeding women. 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/ sulfonylurea: Tremor, headache, dizziness; asthenia. Combination w/ thiazolidinedione: Peripheral edema; increased wt. Combination w/ insulin (w/ or w/o metformin): Headache; nausea, GERD; chills; decreased blood glucose. Combination w/ metformin & sulfonylurea: Hypoglycemia; dizziness, tremor; hyperhidrosis; asthenia.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Galvus detailed prescribing information
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.
Regulatory Classification
Rx
Presentation/Packing
Form
Galvus tab 50 mg
Packing/Price
28's