Sitara D 50/5 Mg Tablet (10 Tab)

SITARA D 50/5 MG TABLET

Name:

• Brand Name: SITARA D 50/5 MG TABLET
• Manufacturer: INTAS PHARMACEUTICALS LTD.

Composition: Each tablet contains:

• Dapagliflozin: 5 mg
• Sitagliptin Phosphate: 50 mg

Uses: SITARA D 50/5 MG TABLET is a fixed-dose combination medication primarily prescribed for the management of Type 2 Diabetes Mellitus in adults. It is used to:

• Control elevated blood sugar levels, especially when diet, exercise, and other medications alone are insufficient.
• Improve insulin production and utilization in the body.
• Lower blood glucose levels by helping the kidneys eliminate glucose through urine.
• Reduce the release of glucagon, a hormone that raises blood sugar levels.
• It may also be used to treat chronic kidney disease in adults with reduced kidney function.

Dosage and Administration:

• Take SITARA D 50/5 MG TABLET orally as prescribed by your doctor.
• It is typically taken once daily, with or without food.
• For optimal benefits, it is recommended to take the medicine at the same time every day.
• Swallow the tablet whole with a glass of water; do not crush or chew it.
• Do not exceed the recommended dose.
• Do not stop taking the medication abruptly without consulting your doctor, as this can lead to increased blood sugar levels and a higher risk of serious complications.

Side Effects: Common side effects may include:

• Nausea
• Dizziness, lightheadedness
• Hypoglycemia (low blood sugar), especially when used with other anti-diabetic medicines or alcohol
• Urinary tract infections (UTIs)
• Increased urination
• Headache
• Upper respiratory tract infection (stuffy or runny nose, sore throat, nasopharyngitis)
• Osteoarthritis, arm or leg pain
• Vaginal yeast infection

Serious side effects or worsening symptoms should be reported to a doctor immediately.

• Symptoms of acute pancreatitis, such as continuous and severe abdominal pain.
• Allergic reactions like swelling of the face, tongue, and lips.
• Itchy skin with large blisters.

Precautions:

• Pregnancy: Use during pregnancy is not recommended unless clearly needed and prescribed by a doctor.
• Breastfeeding: Not recommended during breastfeeding as safety is not well-established.
• Alcohol: Avoid excessive alcohol consumption as it can increase the risk of hypoglycemia and other side effects.
• Elderly Patients: Special precautions or dosage adjustments may be necessary.
• Children: Not indicated for use in children below 18 years of age.
• Kidney or Liver Disease: Use with caution. Regular monitoring and dose adjustments may be necessary for patients with kidney disease. It should not be taken if you have severe kidney or liver disease.
• Type 1 Diabetes: Not suitable for treating Type 1 Diabetes Mellitus or diabetic ketoacidosis.
• Heart Disease: Inform your doctor if you have heart disease.
• Dehydration: Drink plenty of fluids to prevent dehydration, especially as the medicine can cause increased urination.
• Driving and Operating Machinery: Avoid driving or operating machinery if you experience dizziness or lightheadedness.
• Drug Interactions: Inform your doctor about all medications you are taking to avoid potential interactions. Caution is advised with insulin and other anti-diabetic medications (increased risk of hypoglycemia), diuretics (increased risk of dehydration and kidney problems), NSAIDs (increased chance of kidney problems), digoxin, ketoconazole, clarithromycin, and ritonavir.

Storage:

• Store SITARA D 50/5 MG TABLET at room temperature (20-25°C) and protect from moisture, heat, and direct sunlight.
• Keep the medication out of the sight and reach of children.

What is SITARA D 50/5 MG TABLET used for?

SITARA D 50/5 MG TABLET is primarily used to treat type 2 diabetes mellitus in adults. It helps to control high blood sugar levels, especially when diet, exercise, and other medications alone are not sufficient. This medicine also helps reduce the risk of long-term diabetes complications such as kidney damage, nerve issues, eyesight loss (retinopathy), and cardiovascular events like heart attack or stroke. It may also be used in adults with reduced kidney function to treat chronic kidney disease.

How does SITARA D 50/5 MG TABLET work?

SITARA D 50/5 MG TABLET is a combination of two active ingredients: Dapagliflozin (5 mg) and Sitagliptin (50 mg).

• Dapagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT-2). This action prevents the reabsorption of glucose (sugar) back into the blood, leading to increased glucose excretion through urine and thus lowering blood sugar levels.
• Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It increases the levels of natural substances called incretins, which help regulate blood sugar by stimulating insulin release from the pancreas, particularly after meals, and decreasing the amount of glucose produced by the liver.

What is the usual dosage for SITARA D 50/5 MG TABLET?

SITARA D 50/5 MG TABLET is typically taken orally once daily, with or without food, as directed by your doctor. It is recommended to take it at the same time each day for optimal benefits. Do not exceed the recommended dose, and do not stop taking the medicine without consulting your doctor, as this could lead to increased blood sugar levels and potential complications.

What are the possible side effects of SITARA D 50/5 MG TABLET?

Common side effects may include:

• Headache
• Nausea and vomiting
• Dizziness or light-headedness
• Hypoglycemia (low blood sugar), especially when used with other antidiabetic medicines, alcohol, or if meals are delayed or missed
• Urinary tract infections (UTIs)
• Increased urination
• Genital fungal infections
• Upper respiratory tract infections, nasal congestion, or sore throat

If you experience severe side effects, such as severe allergic reactions or persistent stomach pain, seek immediate medical attention.

Is SITARA D 50/5 MG TABLET safe during pregnancy or breastfeeding?

No, SITARA D 50/5 MG TABLET is generally not recommended during pregnancy or while breastfeeding. There is limited information on its effects during pregnancy, and its safety during lactation has not been well-established. Always consult your doctor for guidance if you are pregnant, planning to conceive, or breastfeeding.

Can SITARA D 50/5 MG TABLET be taken with other medications?

SITARA D 50/5 MG TABLET can interact with certain medications. Inform your doctor about all medicines you are currently taking to avoid potential drug interactions.

• Insulin and other anti-diabetic medications (e.g., sulfonylureas like metformin, glimepiride, glibenclamide): Concomitant use can increase the risk of low blood sugar (hypoglycemia).
• Diuretics (e.g., hydrochlorothiazide, furosemide): Taking these with SITARA D 50/5 MG TABLET may increase the risk of dehydration and kidney problems.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (e.g., ibuprofen, naproxen): These may increase the chance of kidney problems when taken with SITARA D 50/5 MG TABLET.
• Medicines for heart failure (e.g., digoxin): Caution should be exercised, as SITARA D 50/5 MG TABLET may slightly increase digoxin plasma concentrations.
• Medicines for fungal infections (e.g., ketoconazole) or bacterial infections (e.g., clarithromycin), or HIV/AIDS (e.g., ritonavir): Particular care should be taken if you have kidney disorders and are taking these medicines.

What precautions should be taken with SITARA D 50/5 MG TABLET?

• Avoid excessive alcohol consumption as it can increase the risk of hypoglycemia and other side effects.
• Inform your doctor if you have type 1 diabetes mellitus, severe kidney or liver disease, heart disease, or a history of urinary tract infections, pancreatitis, or high triglyceride levels.
• Drink plenty of fluids to prevent dehydration, as this medicine can cause increased urination.
• Maintain good hygiene to prevent genital fungal and urinary tract infections.
• Monitor your blood sugar levels regularly.
• If you experience dizziness or light-headedness, avoid driving or operating machinery.
• Do not stop taking the medication abruptly, as it can lead to increased blood sugar levels and potential complications.

What happens if a dose is missed?

If you miss a dose of SITARA D 50/5 MG TABLET, 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 compensate for the missed one.

How should SITARA D 50/5 MG TABLET be stored?

SITARA D 50/5 MG TABLET should be stored at room temperature (between 10ºC to 25ºC or below 30ºC), away from moisture, heat, and direct sunlight. Keep the medicine out of the sight and reach of children.