Vilagli 50 mg (Tablet)

Indications

• Adjunct to diet and exercise
• Improves glycemic control
• Type 2 diabetes mellitus
• Monotherapy
• Dual combination with Metformin
• Dual combination with Sulphonylurea
• Dual combination with Thiazolidinedione
• Dual combination with Insulin
• Inadequate glycemic control

Pharmacology

• Dipeptidyl peptidase-4 (DPP-4) inhibitor
• Slows inactivation of incretin hormones
• GLP-1
• GIP
• Endogenous system for glucose homeostasis
• Insulin release
• Glucagon levels
• Glucose-dependent manner

Dosage & Administration

• 50 mg daily for monotherapy
• 100 mg daily for monotherapy
• 50 mg twice daily in dual combination with Metformin
• 50 mg once daily in dual combination with Sulphonylurea
• No dosage adjustment in the elderly
• No dosage adjustment in patients with mild renal impairment
• Not recommended in patients under 18 years of age

Interaction

• No interactions with pioglitazone
• No interactions with metformin
• No interactions with glibenclamide
• No interactions with digoxin
• No interactions with warfarin
• Possible reduced glucose-lowering effect with thiazides
• Possible reduced glucose-lowering effect with corticosteroids
• Possible reduced glucose-lowering effect with thyroid products
• Possible reduced glucose-lowering effect with sympathomimetics

Contraindications

• Hypersensitivity to the active substance or excipients
• Moderate to severe renal impairment
• Hepatic impairment with ALT or AST >3xULN
• Type 1 diabetes

Side Effects

• Majority of adverse reactions are mild and transient
• Rare case of hepatic dysfunction
• No additional safety signals in long-term trials

Pregnancy & Lactation

• Not to be used in pregnancy
• Not to be used during lactation

Precautions & Warnings

• Caution in patients aged 75 years and older
• LFT monitoring prior to initiation and periodically thereafter
• Discontinuation if transaminase levels are increased
• Discontinuation in case of jaundice or signs of liver dysfunction
• Caution in patients with congestive heart failure
• Not to be used in NYHA functional class III or IV

Therapeutic Class

• Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Storage Conditions

• Store below 30°C temperature
• Keep away from light and moisture
• Keep out of reach of children

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