Gliklazid Actavis (Gliclazide)

Gliklazid Actavis is indicated for the management of hyperglycemia in patients with type 2 diabetes mellitus, typically as an adjunct to diet and exercise.

• Improves glycemic control when used as monotherapy in adults with type 2 diabetes.
• Can be combined with metformin or other oral antidiabetic agents to achieve target HbA1c.
• May be considered in patients who have not achieved adequate control with lifestyle measures alone.
• Used in clinical practice to reduce fasting and post‑prandial blood glucose levels.
• May be prescribed when sulfonylurea therapy is appropriate and renal function is within acceptable limits.

The safety profile of Gliklazid Actavis reflects the typical adverse events reported for sulfonylurea agents.

Common

• Mild hypoglycemia, which may occur if meals are missed, delayed, or carbohydrate intake is insufficient.
• Gastrointestinal discomfort such as nausea, abdominal pain, dyspepsia, or occasional vomiting.
• Headache or dizziness, often transient and mild in intensity.
• Skin reactions including rash, pruritus, or mild erythema.

Serious

• Severe hypoglycemia that can lead to loss of consciousness, seizures, or the need for emergency assistance.
• Allergic reactions ranging from angioedema to severe cutaneous adverse reactions such as Stevens‑Johnson syndrome.
• Hematologic abnormalities, for example leukopenia, neutropenia, or thrombocytopenia, detected on routine blood counts.
• Hepatic dysfunction manifested by jaundice, elevated transaminases, or hepatitis-like symptoms.

When prescribing Gliklazid Actavis, clinicians should consider several precautionary measures to ensure safe use.

• Assess renal and hepatic function before initiation and periodically during therapy.
• Use caution in elderly patients due to increased risk of hypoglycemia.
• Avoid use in patients with known sulfonylurea hypersensitivity.
• Monitor blood glucose closely when initiating therapy or adjusting dose.
• Educate patients on recognizing signs of hypoglycemia and appropriate corrective actions.
• Consider dose reduction in patients with moderate hepatic impairment.
• Review concomitant medications that may potentiate hypoglycemia.

Gliklazid Actavis may interact with other medicines, altering its glucose‑lowering effect or increasing the risk of adverse events.

Avoid

• Concomitant use with other sulfonylureas or meglitinides due to additive hypoglycemia risk.
• Co‑administration with strong CYP2C9 inhibitors (e.g., fluconazole) that can increase gliclazide plasma levels.
• Use with insulin therapy without dose adjustment, as it may cause severe hypoglycemia.

Use with caution

• Combination with beta‑blockers may mask hypoglycemia symptoms.
• Concurrent use of thiazide diuretics may enhance hypoglycemic effect.
• Concurrent administration of oral corticosteroids may reduce gliclazide efficacy.
• Use with antiplatelet agents (e.g., clopidogrel) requires monitoring for rare bleeding interactions.