Dibavally Plus 50 mg/1000 mg 28 tablets

Dibavally Plus 50 mg/1000 mg 28 tablets

Composition:
Each film-coated tablet contains:
- Vildagliptin - 50 mg
- Metformin hydrochloride - 1000 mg.
Excipients:
Mannitol DC, Microcrystalline cellulose (Avicel PH102), Sodium starch glycolate, Magnesium stearate, Colloidal silicon dioxide, Hypromellose E5, Polyethylene glycol 6000, Talc, Titanium dioxide.
Description:
DIBAVALLY PLUS is a combination of vildagliptin, a DPP-4 inhibitor, and metformin, a biguanide, used for the treatment of type 2 diabetes mellitus.
- Vildagliptin enhances glucose-dependent insulin secretion and suppresses glucagon release by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4), leading to improved glycemic control.
- Metformin reduces hepatic glucose production, increases insulin sensitivity, and improves glucose uptake by peripheral tissues.
- The combination effectively lowers both fasting and postprandial glucose levels, improves glycemic control, and carries a low risk of hypoglycemia.
Indications for Use:
DIBAVALLY PLUS is indicated for:
- Treatment of adults with type 2 diabetes mellitus insufficiently controlled with metformin monotherapy at the maximum tolerated dose.
- Replacement therapy for patients already treated with vildagliptin and metformin as separate tablets.
- Triple combination therapy with a sulphonylurea when glycemic control is inadequate with metformin and sulphonylurea.
- Triple combination therapy with insulin when stable insulin doses and metformin do not provide sufficient glycemic control.
Dosage and Method of Administration:
- Recommended dose: One tablet twice daily, in the morning and evening, taken with or just after meals to reduce gastrointestinal side effects.
- The dose should be individualized based on patient response and tolerability.
- Do not exceed 100 mg of vildagliptin per day.
- DIBAVALLY PLUS should not be used in patients with creatinine clearance < 60 mL/min.
- Not recommended for use in children and adolescents under 18 years of age.
Contraindications:
- Hypersensitivity to vildagliptin, metformin, or any excipients.
- Diabetic ketoacidosis or pre-coma.
- Renal failure or renal dysfunction (creatinine clearance < 60 mL/min).
- Hepatic impairment or elevated ALT/AST > 3× ULN.
- Acute conditions affecting renal function (dehydration, infection, shock).
- Cardiac or respiratory failure, recent myocardial infarction.
- Alcohol intoxication or chronic alcoholism.
- Breastfeeding.
Precautions:
- Lactic acidosis: a rare but potentially fatal metabolic complication due to metformin accumulation. Risk increases with renal impairment, liver disease, alcohol use, or hypoxia.
- Hepatic monitoring: check liver enzymes before treatment and periodically thereafter; discontinue if ALT/AST ≥ 3× ULN or jaundice occurs.
- Pancreatitis: discontinue vildagliptin if pancreatitis is suspected or confirmed.
- Skin reactions: monitor for blistering or ulceration; discontinue if bullous lesions develop.
- Surgery and iodinated contrast procedures: discontinue treatment 48 hours before and resume only after renal function normalization.
- Hypoglycemia: risk increases when combined with sulphonylureas or insulin - consider dose reduction of these agents.
Side Effects:
- Common: Headache, dizziness, nausea, tremor, hypoglycemia (with sulphonylurea or insulin), fatigue, metallic taste, diarrhea, abdominal pain, loss of appetite
- Uncommon: Constipation, arthralgia, edema, gastroesophageal reflux, hyperhidrosis.
- Rare: Elevated liver enzymes, hepatitis, angioedema, skin rashes (erythema, pruritus, urticaria).
- Very rare: Lactic acidosis, decreased vitamin B₁₂ absorption.
Pregnancy and Lactation:
- Animal studies show no teratogenicity, but potential fetal risk cannot be excluded.
- Not recommended during pregnancy or breastfeeding due to possible neonatal hypoglycemia and lack of human safety data.
Storage Conditions:
Store in the original package at a temperature not exceeding 30°C, in a dry place protected from light.
Packaging:
Carton box containing 4  strips, each with 7 film-coated tablets, and a package insert.