Gliclazide (Aglic MR) 30mg Modified Release Tablet 30's

Product Description:

Gliclazide (Aglic MR) 30mg Modified Release Tablet is an oral medication used to manage Type 2 Diabetes Mellitus. It belongs to a class of drugs known as sulfonylureas, which help control blood sugar levels by increasing the amount of insulin produced by the pancreas. This medication is formulated as a modified release (MR) tablet, meaning it releases the active ingredient gradually over time, providing more stable blood glucose control and reducing the risk of hypoglycemia.

Each tablet contains 30mg of gliclazide and is available in a pack of 30 tablets.

Indications:

Gliclazide (Aglic MR) is primarily indicated for the management of Type 2 Diabetes Mellitus in the following scenarios:

1. Monotherapy:

   • For patients whose blood sugar is inadequately controlled with diet and exercise alone.

2. Combination Therapy:

   • In combination with other oral anti-diabetic agents or insulin, when blood glucose control is not achieved with monotherapy.

Gliclazide is generally recommended for patients who still produce some insulin but cannot manage their blood glucose levels with lifestyle changes alone.

Dosage and Administration:

• Starting Dose:

  • The usual starting dose of Gliclazide MR is 30mg once daily with breakfast or the first meal of the day to minimize the risk of hypoglycemia.

• Maintenance Dose:

  • The dose can be gradually increased depending on the patient’s blood glucose levels, typically to a maximum of 120mg per day.

  • **The recommended dose for most patients is 30mg to 60mg once daily. Some patients may need up to 120mg daily for optimal blood sugar control.

• Administration:

  • The tablet should be taken whole, not broken or chewed, with a glass of water during the morning meal.

  • It is essential to take Gliclazide MR at the same time each day to help establish a routine and enhance its efficacy.

• Missed Dose:

  • If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not take two doses at once to make up for a missed dose.

Side Effects:

Like all medications, Gliclazide (Aglic MR) can cause side effects, although not everyone experiences them. Common and serious side effects include:

Common Side Effects:

1. Hypoglycemia (Low Blood Sugar):

   • Symptoms include dizziness, shaking, sweating, hunger, confusion, or fainting. This is the most common and significant side effect.

2. Gastrointestinal Issues:

   • Nausea, vomiting, diarrhea, or abdominal discomfort.

3. Weight Gain:

   • Some patients may experience weight gain, especially when used in combination with other anti-diabetic drugs.

4. Skin Reactions:

   • Rashes or itching may occur in some individuals.

5. Headache or dizziness (less common but possible).

Serious Side Effects:

1. Severe Hypoglycemia:

   • In rare cases, severe hypoglycemia may occur, leading to confusion, seizures, or unconsciousness. Immediate treatment is required.

2. Allergic Reactions:

   • Severe allergic reactions such as swelling of the face, lips, tongue, or throat (angioedema), which may cause difficulty breathing. Immediate medical attention is necessary.

3. Liver Problems:

   • Symptoms such as yellowing of the skin or eyes (jaundice), dark urine, or unexplained fatigue may indicate liver dysfunction.

4. Blood Disorders:

   • Rare cases of low white blood cell count (leukopenia) or platelet count (thrombocytopenia) have been reported, leading to symptoms like frequent infections or unusual bleeding.

Contraindications:

Gliclazide (Aglic MR) should not be used in the following situations:

1. Hypersensitivity to Gliclazide or Sulfonylureas:

   • If you are allergic to gliclazide or any other components of the formulation, or to other sulfonylurea drugs.

2. Type 1 Diabetes:

   • Gliclazide is not effective for Type 1 Diabetes, as this condition involves complete insulin deficiency.

3. Severe Liver or Kidney Dysfunction:

   • Contraindicated in patients with severe liver disease or kidney failure, as these conditions may impair the body’s ability to clear the drug, leading to toxicity.

4. Pregnancy:

   • Gliclazide is not recommended during pregnancy as it may cause harm to the fetus. Women who are pregnant or planning to become pregnant should consult their doctor for alternative diabetes management strategies, such as insulin therapy.

5. Breastfeeding:

   • Gliclazide may pass into breast milk and is not recommended during breastfeeding unless advised by a doctor.

6. Severe Infection, Surgery, or Trauma:

   • Use with caution or avoid in situations where the body is under significant stress, such as severe infections, major surgeries, or trauma, as these conditions may require insulin therapy for blood glucose control instead of oral agents like gliclazide.

7. Diabetic Ketoacidosis:

   • Contraindicated in the presence of diabetic ketoacidosis, a serious complication of diabetes.

Precautions:

1. Monitoring Blood Glucose:

   • Regular monitoring of blood glucose is essential to avoid hypoglycemia or hyperglycemia.

2. Alcohol Consumption:

   • Alcohol should be consumed with caution as it can increase the risk of hypoglycemia when taking gliclazide.

3. Kidney and Liver Function:

   • Use with caution in patients with mild-to-moderate liver or kidney impairment. In cases of severe impairment, gliclazide is contraindicated.

4. Pregnancy and Breastfeeding:

   • As mentioned, gliclazide is contraindicated during pregnancy and breastfeeding. Women of childbearing age should ensure effective contraception while taking the drug.

5. Elderly Patients:

   • Elderly patients may be more susceptible to hypoglycemia and should be carefully monitored, especially if they are frail or have other underlying health conditions.

Drug Interactions:

1. Other Anti-Diabetic Drugs:

   • Insulin or other oral hypoglycemics used in combination with gliclazide may increase the risk of hypoglycemia.

2. Beta-Blockers:

   • Beta-blockers (e.g., propranolol) may mask the symptoms of hypoglycemia and affect glucose metabolism.

3. Corticosteroids:

   • Corticosteroids can increase blood glucose levels, reducing the effectiveness of gliclazide.

4. Diuretics (Thiazide diuretics):

   • Thiazide diuretics may raise blood glucose levels and reduce the efficacy of gliclazide.

5. Anticoagulants (e.g., Warfarin):

   • Gliclazide can interact with anticoagulants and may require dose adjustments of either drug.

6. Antifungal Medications (e.g., Fluconazole):

   • Certain antifungal medications can affect the metabolism of gliclazide, leading to an increased risk of hypoglycemia.

Summary:

Gliclazide (Aglic MR) 30mg Modified Release Tablets are used to treat Type 2 Diabetes Mellitus, especially in patients who cannot control their blood sugar levels with diet and exercise alone. The drug works by increasing insulin secretion from the pancreas. The modified release formulation provides consistent blood sugar control with a lower risk of hypoglycemia compared to immediate-release formulations.

It should be used with caution in patients with liver or kidney problems, and regular blood glucose monitoring is essential to prevent hypoglycemia. Pregnancy and breastfeeding women should avoid gliclazide, and caution is advised in elderly patients.

If any serious side effects, such as severe hypoglycemia or allergic reactions, occur, immediate medical attention is necessary.