Sitadapa 50/5

SITADAPA 50/5 by MACLEODS PHARMACEUTICALS LTD

Name

• Brand Name: Sitadapa 50 mg/5 mg Tablet
• Common Name: Dapagliflozin and Sitagliptin combination

Composition

SITADAPA 50/5 contains two active ingredients:

• Dapagliflozin 5 mg
• Sitagliptin 50 mg

Uses

SITADAPA 50/5 is primarily used for the management of type 2 diabetes mellitus in adults. It helps to control high blood sugar levels, especially when diet and exercise alone are not sufficient or when metformin monotherapy is inadequately controlled. This medication also aids in improving insulin sensitivity, reducing glucose production in the liver, and increasing glucose excretion through urine. Additionally, it may reduce the risk of cardiovascular events, including heart attack and heart failure, and is used to treat chronic kidney disease in adults with reduced kidney function.

Dosage and Administration

This medication is typically taken orally, once daily, with or without food, as directed by a physician. It is important to swallow the tablet whole and not to crush or chew it. The dosage may vary based on the patient's medical condition and response to treatment, and it should be taken at the same time each day for consistency.

Side Effects

Common Side Effects:

• Diarrhoea
• Hypoglycemia (low blood sugar), especially when used with other anti-diabetic medicines
• Headache
• Nausea and vomiting
• Frequent urination or increased urination
• Urinary tract infections (UTIs)
• Genital fungal infections
• Stuffy or runny nose, sore throat (upper respiratory tract infection)
• Dizziness or light-headedness
• Flatulence, constipation, abdominal pain
• Arm or leg pain

Serious Side Effects (Seek immediate medical attention if experienced):

• Inflamed pancreas (severe and persistent stomach pain)
• Serious allergic reactions (rash, hives, blisters, swelling of face, lips, tongue, or throat causing difficulty breathing or swallowing)

Precautions

• Contraindications: Not recommended for type 1 diabetes mellitus or diabetic ketoacidosis. Contraindicated in patients with hypersensitivity to its contents.
• Kidney/Liver Issues: Use with caution in patients with kidney or liver problems. Dosage adjustment may be necessary. Not recommended for severe kidney problems or those on dialysis.
• Pregnancy and Breastfeeding: Generally not recommended during pregnancy or breastfeeding, unless clearly necessary and advised by a doctor.
• Drug Interactions: May interact with insulin, other anti-diabetic medications (like metformin), diuretics (e.g., hydrochlorothiazide, furosemide), NSAIDs (e.g., ibuprofen), anti-fungal agents (e.g., ketoconazole), anti-viral agents (e.g., ritonavir), antibiotics (e.g., clarithromycin), immunosuppressants (e.g., ciclosporin), and cardiac glycosides (e.g., digoxin).
• Hydration: Drink plenty of fluids to prevent dehydration.
• Alcohol: Caution advised with alcohol consumption as it may increase the risk of hypoglycemia and other side effects.
• Discontinuation: Do not stop taking the medicine abruptly without consulting a doctor, as it can lead to increased blood sugar levels and serious complications.

Storage

Store in a cool and dry place, away from sunlight and moisture, preferably below 30°C (or between 10°C to 25°C for non-cold chain storage). Keep out of the sight and reach of children.

SITADAPA 50/5 is a medication prescribed for the management of type 2 diabetes mellitus in adults. It combines two active ingredients, sitagliptin and dapagliflozin, to help control blood sugar levels. This medication is typically used in conjunction with a healthy diet and regular exercise.

Here are some frequently asked questions about SITADAPA 50/5:

What is SITADAPA 50/5 used for?

SITADAPA 50/5 is primarily used to manage type 2 diabetes mellitus in adults. It helps to lower high blood sugar levels, especially when diet and exercise alone are not sufficient, and can be used with or without other antidiabetic medications.

How does SITADAPA 50/5 work?

SITADAPA 50/5 contains two active components: Dapagliflozin (5 mg) and Sitagliptin (50 mg). Dapagliflozin works by blocking the reabsorption of glucose in the kidneys, causing excess sugar to be removed from the body through urine. Sitagliptin, a DPP-4 inhibitor, increases the levels of natural hormones called incretins, which enhance insulin release after meals and decrease the amount of glucose produced by the liver.

What is the usual dosage for SITADAPA 50/5?

The usual dosage for SITADAPA 50/5 is typically once daily, taken with or without food. It is crucial to follow your doctor's specific instructions regarding dosage and timing, as this can vary based on your condition and how you respond to the medicine.

What are the possible side effects of SITADAPA 50/5?

Common side effects can include low blood sugar (hypoglycemia), headache, upper respiratory tract infections, stuffy or runny nose, sore throat, urinary tract infections, yeast infections, increased urination, nausea, vomiting, diarrhea, abdominal pain, and dizziness. More serious side effects, though rare, can include severe allergic reactions or pancreatitis (inflammation of the pancreas), which require immediate medical attention.

Is SITADAPA 50/5 safe during pregnancy or breastfeeding?

SITADAPA 50/5 is generally not recommended for use during pregnancy or while breastfeeding due to limited information and potential risks. If you are pregnant, planning to conceive, or breastfeeding, you should consult your doctor to discuss alternative options or if the benefits are deemed to outweigh the risks.

Can SITADAPA 50/5 be taken with other medications?

SITADAPA 50/5 can interact with several medications. Taking it with insulin or other anti-diabetic medications can increase the risk of low blood sugar. Diuretics (water pills) may increase the risk of dehydration and kidney problems. NSAIDs (non-steroidal anti-inflammatory drugs) can also increase the chance of kidney problems. It is important to inform your doctor about all other medicines, supplements, or herbal products you are taking to avoid potential interactions.

What precautions should be taken while using SITADAPA 50/5?

SITADAPA 50/5 is not suitable for individuals with type 1 diabetes or diabetic ketoacidosis. Caution is advised if you have kidney or liver problems, heart failure, a history of low blood pressure, or are elderly. You should avoid excessive alcohol consumption, as it can increase the risk of side effects like hypoglycemia. Regular monitoring of blood sugar levels and kidney function is recommended, and good hygiene should be maintained to prevent genital infections.

What happens if a dose of SITADAPA 50/5 is missed?

If you miss a dose of SITADAPA 50/5, 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 the missed one.

How should SITADAPA 50/5 be stored?

SITADAPA 50/5 should be stored in a cool, dry place at room temperature (20-25°C), away from moisture, heat, and direct sunlight. It should always be kept out of the sight and reach of children.