Product Summary 

Balila 25 mg (Diazoxide 25 mg)

Generic Name: Diazoxide 25 mg
Brand Name: Balila 25 mg
Dosage Form:Oral (capsule)
Strength: 25 mg per capsule 

Therapeutic Class
Antihypoglycemic agent
Vasodilator (used in hypertensive emergencies

Indications
Balila 25 mg (Diazoxide) is primarily used for:

1. Management of hypoglycemia: Particularly in cases due to hyperinsulinism, such as insulinoma (insulin-producing tumors), congenital hyperinsulinism, functional hypoglycemia 
2. Hypertensive emergencies (IV form only): The oral form of Diazoxide 25 mg is not used for acute hypertensive crises but may have a role in chronic management under strict medical supervision.

Mechanism of Action

• Diazoxide works by inhibiting insulin release from pancreatic β-cells, thereby increasing blood glucose levels
• Activating potassium channels in smooth muscle, leading to  vasodilation and a decrease in blood pressure

Dosage and Administration 

• Dosage must be individualized based on the indication, patient's age, weight and clinical response.
• Common oral doses for hypoglycemia may range from 3–8 mg/kg/day, divided into 2 or 3 doses. Always to be used under medical supervision due to the narrow therapeutic index and potential for significant adverse effects.

Warnings and Precautions

Hyperglycemia: Risk of overt hyperglycemia; glucose monitoring is essential
Fluid retention and edema
Hypotension: Especially if used in combination with antihypertensive agents
Hirsutism (excessive hair growth): Common, especially in pediatric patients
Possible cardiac effects: Use cautiously in patients with heart disease.

Common Side Effects

• Hyperglycemia
• Edema
• Nausea or vomiting
• Hirsutism
• Hypotension
• Gastrointestinal upset

Contraindications 

• Known hypersensitivity to diazoxide or any excipients in the formulation
• Functional hypoglycemia without excessive insulin secretion
• Certain types of pulmonary hypertension (in neonates and infants, per caution)

Drug Interactions 

Sulfonylureas: Antagonistic effect
Antihypertensives: Additive hypotensive effects
Diuretics: Increased risk of hyperuricemia or fluid imbalance

Monitoring Parameters: Blood glucose levels, serum electrolytes, renal function, blood pressure, weight (for fluid retention)

Storage: Store in a cool, dry place at temperatures specified on the packaging. Keep out of reach of children.

Note: Balila 25 mg (Diazoxide) should only be used under the guidance of a qualified and registered healthcare professional, with regular monitoring due to its potent pharmacological effects and risk of adverse events.