SITARA DM 500 Tablet by INTAS PHARMACEUTICALS LTD

Name

• Brand Name: SITARA DM 500 Tablet
• Manufacturer: INTAS PHARMACEUTICALS LTD

Composition

SITARA DM 500 Tablet contains a combination of three active ingredients:

• Dapagliflozin (10 mg)
• Metformin Hydrochloride (500 mg)
• Sitagliptin (100 mg)

Uses

SITARA DM 500 Tablet is primarily used in adults for the management of Type 2 Diabetes Mellitus. It helps improve blood sugar control when diet, exercise, and therapy with conventional medicines alone are insufficient. Its actions include reducing glucose production in the liver, enhancing insulin sensitivity, delaying sugar absorption from the intestines, and promoting glucose excretion through urine. It may also offer cardiovascular and kidney protection by improving vascular function and reducing albuminuria.

Dosage and Administration

SITARA DM 500 Tablet should be taken orally as directed by a physician. The dosage is individualized based on specific needs, blood sugar levels, and response to treatment. It can be taken with or without food, but taking it with meals may help reduce stomach upset. Tablets should be swallowed whole and not crushed or chewed. Consistency is key; try to take it at the same time each day.

Side Effects

Common side effects may include:

• Nausea, vomiting, diarrhea, or abdominal discomfort
• Headache
• Genital infections
• Urinary tract infections and increased urination
• Hypoglycemia (low blood glucose level), especially when combined with other antidiabetic medicines or alcohol
• Influenza, back pain, cough, common cold

Serious but rare side effects can include:

• Lactic acidosis, particularly in patients with kidney or liver problems
• Symptoms of acute pancreatitis (severe abdominal pain)
• Allergic reactions (rash, swelling)
• Bullous pemphigoid (blistering of the skin)

Precautions

• Kidney/Liver Problems: Use with caution in individuals with kidney or liver problems, and it is contraindicated in severe cases. Regular monitoring of kidney function is advisable.
• Alcohol: Avoid excessive alcohol consumption, as it may increase the risk of lactic acidosis and affect blood sugar levels.
• Pregnancy/Breastfeeding: Not recommended during pregnancy or breastfeeding unless the potential benefits outweigh the risks; consult a doctor.
• Dehydration: Drink plenty of fluids to prevent dehydration.
• Interactions: Inform your doctor about all medications, including prescription, over-the-counter drugs, and herbal supplements, to avoid potential drug interactions.
• Driving: May cause dizziness or lightheadedness; caution is advised when driving or operating machinery.
• Stopping Medication: Do not stop taking the medication without consulting your doctor, as it can lead to increased blood sugar levels and complications.

Storage

Store SITARA DM 500 tablets in a cool, dry place, away from direct sunlight and moisture. Keep out of reach of children. Store at room temperature (20-25°C or below 30°C).

SITARA DM 500 by INTAS PHARMACEUTICALS LTD is a combination medication used to manage Type 2 Diabetes Mellitus in adults. It contains three active ingredients: Dapagliflozin, Sitagliptin, and Metformin, which work together to help control blood sugar levels.

Here are some frequently asked questions about SITARA DM 500:

What is SITARA DM 500 used for?

SITARA DM 500 is used for the management of Type 2 Diabetes Mellitus in adults. It helps improve blood sugar control, especially when diet, exercise, or other conventional medicines alone are not sufficient. Additionally, it may aid in weight management and help reduce the risk of cardiovascular events and diabetic kidney disease in some patients.

How does SITARA DM 500 work?

SITARA DM 500 combines three different medicines:

• Dapagliflozin: This ingredient works by removing excess sugar from the body through the urine by inhibiting glucose reabsorption in the kidneys.
• Sitagliptin: This helps control blood sugar levels by increasing the body's natural substances (incretins) that stimulate the pancreas to release more insulin and reduce glucagon levels when blood sugar is high.
• Metformin: This reduces the amount of glucose produced by the liver and delays the absorption of sugar from the intestines. It also improves the body's sensitivity to insulin, allowing cells to utilize glucose more effectively.

What is the usual dosage for SITARA DM 500?

The dosage of SITARA DM 500 is individualized and determined by your doctor based on your specific needs, blood sugar levels, and response to treatment. It is typically taken once or twice daily, preferably with or after meals to minimize gastrointestinal side effects. You should always follow your doctor's instructions and not adjust the dosage without consulting them.

What are the possible side effects of SITARA DM 500?

Common side effects may include gastrointestinal symptoms like nausea, vomiting, diarrhea, abdominal pain, and stomach upset. Other common side effects can include headache, genital infections, urinary tract infections, increased or more frequent urination, and flu-like symptoms such as nasal congestion or sore throat. Serious side effects are rare but can include lactic acidosis (symptoms like muscle pain, breathing difficulty, extreme fatigue), ketoacidosis, and pancreatitis. Most common side effects are usually mild and temporary. If any side effects persist, worsen, or if you experience severe symptoms, consult your doctor immediately.

Is SITARA DM 500 safe during pregnancy or breastfeeding?

SITARA DM 500 is generally not recommended for use during pregnancy or breastfeeding. Limited information is available on its effects in pregnant women, and some components may harm the baby or affect milk production. If you are pregnant, planning a pregnancy, or breastfeeding, you should consult your doctor to discuss the risks and benefits or explore safer alternatives.

Can SITARA DM 500 be taken with other medications?

SITARA DM 500 can interact with other medications, including diuretics (water pills), blood pressure drugs, steroids, insulin, and other anti-diabetic medicines (like sulphonylureas). It's crucial to inform your doctor about all prescription, over-the-counter, herbal medicines, and supplements you are currently taking to prevent potential drug interactions and unwanted effects.

What precautions should be taken while taking SITARA DM 500?

Before taking SITARA DM 500, inform your doctor if you have kidney or liver problems, heart failure, a history of lactic acidosis, or are prone to urinary tract infections. Avoid excessive alcohol consumption as it can increase the risk of hypoglycemia and lactic acidosis. Regular monitoring of blood sugar levels and kidney function is important. It is not recommended for individuals with Type 1 diabetes, severe kidney impairment, or diabetic ketoacidosis.

What happens if a dose of SITARA DM 500 is missed?

If you miss a dose of SITARA DM 500, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one, as this might cause your blood sugar level to fall too rapidly.

How should SITARA DM 500 be stored?

SITARA DM 500 should be stored in a cool, dry place, away from direct sunlight and moisture. Keep it out of the sight and reach of children. Ensure the medicine is used before its expiry date.