Sitazit Dm Er 1000/10 Mg Tablet ( 10 Tab )

SITAZIT DM ER 1000/10 MG TABLET

SITAZIT DM ER 1000/10 MG TABLET, manufactured by Glenmark Pharmaceuticals Ltd., is a combination medication prescribed for the management of type 2 diabetes mellitus in adults.

• Name:

  • Brand Name: SITAZIT DM ER 1000/10 MG TABLET
  • Manufacturer: Glenmark Pharmaceuticals Ltd.

• Composition: SITAZIT DM ER 1000/10 MG TABLET contains three active pharmaceutical ingredients:

  • Dapagliflozin (10 mg)
  • Metformin (1000 mg) (Extended-Release - ER)
  • Sitagliptin (100 mg)

• Uses: This medicine is used to manage blood sugar levels in adults with type 2 diabetes mellitus, typically as an adjunct to diet and exercise. It works by removing excess sugar from the body through urine (Dapagliflozin), reducing glucose production by the liver, delaying sugar absorption from the intestines, and increasing insulin sensitivity (Metformin), and increasing insulin release while reducing glucagon levels when blood sugar is high (Sitagliptin). It also helps to reduce the risk of cardiovascular disease and may offer kidney protection in patients with type 2 diabetes.

• Dosage and Administration: SITAZIT DM ER 1000/10 MG TABLET should be taken as advised by a healthcare professional. It can be taken with or without food, though taking it with meals may help reduce gastrointestinal discomfort. It is recommended to take the tablet at the same time each day for optimal benefits. The tablet should be swallowed whole and not crushed, broken, or chewed. Do not stop taking this medication without consulting your doctor, as this could lead to increased blood sugar levels and potential complications.

• Side Effects:

  • Common Side Effects: Female genital mycotic infections, nasopharyngitis (inflammation of the throat and nasal passages), urinary tract infections, diarrhoea, headache, nausea, vomiting, abdominal pain, stomach upset, flatulence, increased or more frequent urination, drowsiness, dizziness, constipation, itching, dry mouth, decreased weight, and thirst.
  • Serious Side Effects (Seek immediate medical attention if experienced): Signs of lactic acidosis (e.g., weakness, breathing difficulty, stomach pain), symptoms of ketoacidosis (e.g., nausea, vomiting, confusion, fruity breath), painful or persistent genital or urinary infections, signs of pancreatitis (e.g., severe and persistent abdominal pain, with or without nausea and vomiting), or allergic reactions (e.g., rash, swelling, breathing problems, blistering of the skin, or bullous pemphigoid).

• Precautions: This medicine is not recommended for individuals with type 1 diabetes, diabetic ketoacidosis, severe kidney or liver disease, metabolic acidosis, severe heart failure, respiratory failure, or a recent myocardial infarction. Caution is advised for pregnant or breastfeeding women; a doctor should be consulted before use. Alcohol consumption should be limited as it can intensify side effects and affect blood glucose levels. Dehydration, kidney problems, and interactions with certain medications (e.g., thiazide diuretics, loop diuretics, carbonic anhydrase inhibitors, insulin, sulphonylureas, ketoconazole, clarithromycin, ritonavir, digoxin) require careful monitoring and potential dose adjustments. Regular monitoring of blood sugar levels and kidney function is crucial during treatment. Maintaining good hygiene is important to help prevent genital fungal infections.

• Storage: Store SITAZIT DM ER 1000/10 MG TABLET at room temperature, ideally below 30°C. Keep it in a dry place, away from light and moisture, and out of the sight and reach of children.

Here are frequently asked questions about SITAZIT DM ER 1000/10 MG TABLET, a medication for managing Type 2 Diabetes Mellitus. This medication is a triple fixed-dose combination containing Dapagliflozin, Metformin (extended-release), and Sitagliptin.

What is SITAZIT DM ER 1000/10 MG TABLET used for?

SITAZIT DM ER 1000/10 MG TABLET is used in adults with Type 2 Diabetes Mellitus to help control high blood sugar levels. It is prescribed as an adjunct to diet and exercise, particularly when blood sugar is not adequately controlled with single agents or dual therapy. This medication aims to improve overall glycemic control and may offer cardiovascular and renal protective benefits, as well as assist with weight management in some patients.

How does SITAZIT DM ER 1000/10 MG TABLET work?

This medicine combines three active ingredients, each working through a different mechanism to lower blood sugar:

• Dapagliflozin (10 mg): This is a Sodium-Glucose Co-transporter 2 (SGLT2) inhibitor. It works by blocking the reabsorption of glucose in the kidneys, leading to more sugar being excreted in the urine, thus reducing blood sugar levels. This action is independent of insulin.
• Metformin (1000 mg): A biguanide, Metformin primarily reduces the amount of glucose produced by the liver and decreases the absorption of glucose from the intestines. It also improves the body's sensitivity to insulin, helping the body use sugar more effectively.
• Sitagliptin (10 mg): This is a Dipeptidyl Peptidase-4 (DPP-4) inhibitor. It works by increasing the levels of natural substances called incretins in the body. Incretins help the pancreas release more insulin, especially after meals, and signal the liver to reduce glucose production when blood sugar levels are high.

What is the usual dosage for SITAZIT DM ER 1000/10 MG TABLET?

The typical starting dose is one tablet once daily, taken with food. The dosage may be adjusted by your doctor based on your response and tolerability, but the maximum recommended dose should not be exceeded. It is important to swallow the extended-release tablet whole and not to crush, chew, or split it.

What are the possible side effects of SITAZIT DM ER 1000/10 MG TABLET?

Common side effects can include genital fungal infections, urinary tract infections, diarrhea, nausea, headache, and common cold symptoms (nasopharyngitis). More serious but less common side effects include lactic acidosis (a serious metabolic complication from metformin accumulation), pancreatitis (inflammation of the pancreas), kidney injury, and severe hypersensitivity reactions. Your doctor will monitor your kidney function regularly.

Is SITAZIT DM ER 1000/10 MG TABLET safe during pregnancy or breastfeeding?

SITAZIT DM ER 1000/10 MG TABLET is generally not recommended for use during pregnancy or while breastfeeding. Sitagliptin and dapagliflozin are not recommended during pregnancy due to limited information on their effects on a developing baby, and metformin passes into breast milk in small amounts. If you are pregnant, planning to become pregnant, or breastfeeding, you should discuss alternative treatments with your doctor.

Can SITAZIT DM ER 1000/10 MG TABLET be taken with other medications?

This medication may interact with certain other drugs. It's especially important for your doctor to know if you are taking insulin, insulin secretagogues (like glipizide or glyburide), or diuretics (such as hydrochlorothiazide or furosemide), as these can increase the risk of hypoglycemia (low blood sugar) or dehydration. Carbonic anhydrase inhibitors may also increase the risk of lactic acidosis. Always inform your healthcare provider about all medicines, vitamins, and herbal products you are taking.

What precautions should be taken when using SITAZIT DM ER 1000/10 MG TABLET?

• Kidney Function: Your doctor will monitor your kidney function before and during treatment, as this medicine is not recommended for individuals with severe kidney impairment.
• Lactic Acidosis: There is a risk of lactic acidosis, a serious condition, especially in patients with impaired kidney or liver function, heart failure, or those who consume excessive alcohol. Seek immediate medical attention if you experience symptoms like unusual muscle pain, unexplained stomach discomfort, difficulty breathing, or unusual sleepiness.
• Dehydration: Dapagliflozin can cause dehydration. Drink plenty of fluids as advised by your doctor, especially if you experience fever, infection, or severe vomiting or diarrhea.
• Pancreatitis: Watch for symptoms of pancreatitis, such as severe stomach pain radiating to your back, with or without vomiting. Discontinue use and seek medical attention if suspected.
• Surgery/Imaging: You may need to temporarily stop taking this medication before major surgery or diagnostic tests involving iodinated contrast agents. Discuss this with your doctor.
• Alcohol Consumption: Limit alcohol intake, as it can increase the risk of lactic acidosis and low blood sugar.

What happens if a dose is missed?

If you miss a dose, 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 double the dose to make up for a missed one.

How should SITAZIT DM ER 1000/10 MG TABLET be stored?

Store the medicine in a closed container at room temperature (typically between 20°C to 25°C or 68°F to 77°F), away from heat, moisture, and direct light. Keep it out of the reach of children. Ensure the container is tightly closed and stored in a dry place.