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VildNox™ 50

Vildagliptin Tablets I.P. 50 mg

PACKING SIZE / TYPE

10x10 Tablets

Summary

VildNox™ 50 contains Vildagliptin, a potent DPP-4 inhibitor (dipeptidyl peptidase-4 inhibitor) that enhances the body’s natural ability to regulate blood sugar. It is primarily prescribed for Type 2 Diabetes Mellitus as monotherapy or in combination with other oral antidiabetic agents. By increasing the levels of incretin hormones (GLP-1 and GIP), VildNox™ 50 promotes insulin secretion in response to meals and reduces glucagon production, resulting in improved glycemic control without significant risk of hypoglycemia.

Side Effects

Most side effects are mild to moderate and may resolve with continued use. Commonly reported include:

  • Headache

  • Dizziness

  • Tremors

  • Hypoglycemia (especially with sulfonylureas)

  • Constipation

  • Nausea

  • Peripheral edema

  • Mild increase in liver enzymes

Serious but rare:

  • Pancreatitis (abdominal pain radiating to back, nausea, vomiting)

  • Severe hypersensitivity reactions

  • Hepatic dysfunction

Usage

  • Taken orally with or without food.

  • Used as long-term therapy for T2DM.

  • Must be combined with dietary changes and physical activity for best results.

Concerns

  • Not effective for Type 1 Diabetes Mellitus.

  • Does not replace insulin therapy in patients with insulin-dependent diabetes.

  • Should not be abruptly stopped without medical supervision.

When not to use?

  • Type 1 Diabetes Mellitus

  • Diabetic ketoacidosis

  • Severe hepatic impairment (ALT/AST >3 times ULN)

  • History of pancreatitis

  • Known hypersensitivity to Vildagliptin or any tablet component

Warnings

  • Liver Monitoring: Regular liver function tests recommended.

  • Cardiac Risk: Use with caution in patients with congestive heart failure.

  • Pancreatitis Risk: Discontinue immediately if symptoms occur.

  • Pregnancy & Lactation: Safety not established; use only if clearly needed.

  • Renal Impairment: Dose adjustment required in moderate to severe kidney dysfunction.

Dosage

  • Monotherapy or in combination therapy:

    • Usual dose: 50 mg once or twice daily (max 100 mg/day).

  • Renal Impairment:

    • Moderate/Severe (CrCl <50 mL/min): 50 mg once daily.

  • Dose adjustment required based on clinical response and tolerability.

Interactions

  • Sulfonylureas & Insulin: Increased risk of hypoglycemia.

  • Rifampicin, Phenytoin, Carbamazepine: May reduce effectiveness.

  • ACE inhibitors: Rare risk of angioedema.

  • Alcohol: May interfere with blood sugar control.

General Instructions

  • Take at the same time daily.

  • Do not skip meals while on therapy.

  • Regular monitoring of blood glucose, HbA1c, and liver function tests is advised.

  • Report unusual abdominal pain, jaundice, or severe weakness immediately.

  • Store in a cool, dry place away from direct sunlight.

Other Details

  • Strength: 50 mg

  • Packaging: As per market requirements (e.g., Blister strips)

  • Storage: Store below 25°C, protected from moisture

References

  • Drucker DJ. Dipeptidyl peptidase-4 inhibition and the treatment of type 2 diabetes. Diabetes Care. 2007;30(6):1335-1343.

  • Scheen AJ. Pharmacokinetics and clinical use of vildagliptin. Clin Pharmacokinet. 2010;49(3):147-168.

  • Garber AJ. Incretin-based therapies in the management of type 2 diabetes: rationale and clinical applications. J Clin Endocrinol Metab. 2011;96(1):13-22.

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