Azulix Sm Ir 50/2/500

Name

• Brand Name: AZULIX SM IR 50/2/500

Composition AZULIX SM IR 50/2/500 contains a combination of three active ingredients:

• Sitagliptin Phosphate: 50 mg
• Glimepiride: 2 mg
• Metformin Hydrochloride: 500 mg

Uses This medicine is an antidiabetic agent primarily used for the management of Type 2 Diabetes Mellitus in adults. It is prescribed when diet, exercise, and single-drug treatments are insufficient to control blood sugar levels. AZULIX SM IR 50/2/500 helps to control high blood glucose levels, reduce sugar production by the liver, delay sugar absorption from the intestine, and enhance insulin function and release from the pancreas. By managing blood sugar effectively, it helps reduce the risk of diabetes-related complications such as nerve damage, kidney issues, eye problems, and heart conditions.

Dosage and Administration The typical dosage is one tablet daily, taken orally. It can be administered with or without food, and tablets should be swallowed whole without crushing, breaking, or chewing. The exact dose and duration are determined by a physician based on the patient's condition and response to treatment.

Side Effects Common side effects may include:

• Nausea, vomiting, abdominal pain
• Headache
• Frequent urination
• Hypoglycemia (low blood sugar)
• Diarrhea, upset stomach
• Nasopharyngitis, upper respiratory tract infection Serious, though less common, side effects include lactic acidosis, particularly with metformin accumulation, and allergic reactions.

Precautions

• Contraindications: AZULIX SM IR 50/2/500 is not recommended for patients with Type 1 diabetes, diabetic ketoacidosis, severe renal failure (GFR < 30 mL/min), severe liver disease, acute metabolic acidosis, or hypersensitivity to its components.
• Pregnancy and Breastfeeding: Not recommended during pregnancy, especially during the second and third trimesters, and contraindicated for breastfeeding women.
• Alcohol: Avoid alcohol consumption as it increases the risk of hypoglycemia and lactic acidosis.
• Other Conditions: Use with caution in patients with a history of heart disease, and inform your doctor about any pre-existing medical conditions or other medications being taken.
• Driving and Machinery: May impair the ability to concentrate due to the risk of hypoglycemia.

Storage Store in a cool and dry place, away from direct sunlight, at temperatures between 10ºC and 25ºC or below 30ºC. Keep out of the sight and reach of children.

Here are the most frequently asked questions about AZULIX SM IR 50/2/500:

What is AZULIX SM IR 50/2/500 used for?

AZULIX SM IR 50/2/500 is an anti-diabetic medicine used to treat type 2 diabetes mellitus in adults. It is typically prescribed when diet, exercise, and single-agent treatments are not sufficient to adequately control blood sugar levels. This medication helps to improve glycemic control, manage blood glucose levels, and reduce the risk of diabetes-related complications such as kidney damage, eye problems, and nerve issues.

How does AZULIX SM IR 50/2/500 work?

AZULIX SM IR 50/2/500 is a triple-combination medicine containing Sitagliptin (50 mg), Glimepiride (2 mg), and Metformin (500 mg). Each component works differently to lower blood sugar:

• Sitagliptin enhances the body's natural substances (incretins) that increase insulin release from the pancreas when blood sugar is high and signals the liver to stop producing excess sugar.
• Glimepiride stimulates the beta cells in the pancreas to release more insulin.
• Metformin reduces glucose production by the liver, slows down sugar absorption from the intestines, and improves the body's sensitivity to insulin, allowing cells to use glucose more effectively.

What is the usual dosage for AZULIX SM IR 50/2/500?

The usual starting dose is typically one tablet once daily, often taken with breakfast or the first main meal of the day. The dosage is individualized based on the patient's response and tolerability. It should be swallowed whole with water and not chewed, crushed, or broken. The maximum recommended daily doses are generally 8 mg for glimepiride and 2000 mg for metformin, though the specific combination dosage should be as directed by a physician.

What are the possible side effects of AZULIX SM IR 50/2/500?

Common side effects can include low blood sugar (hypoglycemia), stomach pain, nausea, vomiting, diarrhea, headache, dizziness, and a metallic taste. A more serious, but rare, side effect associated with metformin is lactic acidosis, which is a build-up of lactic acid in the blood. It is important to consult a doctor if side effects persist or worsen, or if symptoms of lactic acidosis appear (e.g., abdominal pain, vomiting, muscle cramps, difficulty breathing, severe tiredness).

Is AZULIX SM IR 50/2/500 safe during pregnancy or breastfeeding?

AZULIX SM IR 50/2/500 is generally not recommended during pregnancy or breastfeeding. Abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, and insulin is often the preferred medication to maintain blood glucose levels as close to normal as possible. While metformin can cross the placenta and enter breast milk in small amounts, glimepiride is considered unsafe during these periods. It is crucial to discuss with a healthcare provider to determine the safest treatment options for diabetes during pregnancy and breastfeeding.

Can AZULIX SM IR 50/2/500 be taken with other medications?

This medicine can interact with various other medications. It is important to inform your doctor about all medicines, supplements, and herbal products you are taking. Interactions can occur with other diabetes medications (including insulin), certain blood pressure medicines (like ACE inhibitors), corticosteroids, thyroid medications, antifungals (such as miconazole), fluoroquinolone antibiotics, and alcohol. Alcohol consumption should be avoided as it can increase the risk of lactic acidosis and low blood sugar.

What precautions should be taken while taking AZULIX SM IR 50/2/500?

Precautions include informing your doctor about any liver or kidney problems, severe infections, dehydration, or heart conditions. Patients with type 1 diabetes, diabetic ketoacidosis, or an allergy to any of the components should not take this medicine. Caution is also advised for elderly patients due to potential age-related kidney problems. Regular monitoring of blood sugar levels is essential, especially when starting the medication or in combination with other anti-diabetic drugs.

What happens if a dose of AZULIX SM IR 50/2/500 is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten one, as this can increase the risk of hypoglycemia and severe gastrointestinal reactions.

How should AZULIX SM IR 50/2/500 be stored?

AZULIX SM IR 50/2/500 should be stored in a cool, dry place, away from direct sunlight and moisture. The storage temperature should generally not exceed 30°C. Keep the medicine out of the sight and reach of children.