Dapagliflozin + Metformin + Sitagliptin

Dosage Forms Available

• Dapagliflozin + Metformin + Sitagliptin is available as tablets. In some products, metformin may be present in an extended-release formulation. The amount of each medicine in the product may vary.

Age and Dose Restrictions

• This combination is intended for adults. There is insufficient information regarding its safety and benefits in children younger than 18 years.
• The dose is determined by the doctor based on the patient's current medicines, blood glucose levels, and kidney function. It is generally taken with food. Do not change the dose without your doctor's advice.
• If the tablet is an extended-release formulation, swallow it whole. Do not split, crush, or chew it.

Contraindications

This medicine should not be used in the following situations:

• A severe allergic reaction to dapagliflozin, metformin, sitagliptin, or any other ingredient in the product
• Severely reduced kidney function or a need for dialysis, where the specific product is contraindicated
• Diabetic ketoacidosis, a condition in which ketones build up to dangerously high levels in the blood
• Severe metabolic acidosis associated with metformin, including lactic acidosis
• This medicine is not intended for the treatment of type 1 diabetes. In cases of severe infection, severe dehydration, or repeated vomiting or diarrhoea, your doctor may temporarily stop the medicine.

Other Medications to Use With Caution

• Taking this medicine with insulin or insulin-releasing medicines such as glipizide and glyburide may increase the risk of low blood glucose. Your doctor may reduce the dose of these medicines.
• Medicines that increase urination, such as hydrochlorothiazide and furosemide, may increase the risk of dehydration and low blood pressure.
• Topiramate, acetazolamide, cimetidine, and certain other medicines that affect kidney function may increase the risk of metformin-associated lactic acidosis or alter metformin exposure.
• If you are scheduled to receive an intravenous contrast dye for a medical imaging procedure, inform your doctor beforehand. Your doctor may temporarily stop this medicine before the procedure and restart it when appropriate.
• Consult your doctor or pharmacist before taking any prescription or over-the-counter medicines, Ayurvedic medicines, herbal products, vitamins, or supplements.

Overdose and Missed Dose

• Taking an excessive amount of this medicine may cause nausea, vomiting, abdominal pain, severe weakness, muscle pain, unusual sleepiness, confusion, and rapid or difficult breathing. These may be signs of a serious increase in lactic acid in the blood. If you take more than the prescribed dose, do not wait for symptoms to develop; seek immediate medical attention.
• If you miss a dose, take it when you remember. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Management of Side Effects

• Taking the medicine with food may help reduce nausea, diarrhoea, or stomach upset, particularly when metformin is present.
• If you have diarrhoea or vomiting, maintain adequate fluid intake. If your doctor has advised you to restrict fluids because of a heart or kidney condition, consult them before increasing your fluid intake.
• Keep the genital area clean and dry. Contact your doctor if you develop itching, redness, irritation, or unusual discharge.
• Do not self-treat if you develop pain or burning while urinating, frequent urination, fever, or back pain. Consult your doctor for evaluation.
• Do not change the dose on your own for mild side effects. If you develop severe symptoms, seek immediate medical attention.

Use in Driving and Operating Machinery

• This combination is not generally expected to directly affect alertness. However, dizziness or low blood glucose may occur, particularly when it is taken with insulin or other medicines that increase insulin release.
• Do not drive or operate machinery if you experience sweating, excessive hunger, shaking, dizziness, confusion, or other symptoms of low blood glucose.

Use in Pregnancy and Lactation

• If you become pregnant, contact your doctor. This combination is generally not continued during pregnancy, and dapagliflozin is not recommended during the second and third trimesters. Your doctor may prescribe another medicine to help control blood glucose. Do not stop diabetes treatment on your own.
• The use of this combination during breastfeeding is generally not recommended. Breastfeeding women should consult their doctor about an alternative treatment.

Caution in Other Conditions

Tell your doctor before starting this medicine if you have:

• Kidney or liver disease
• Heart failure
• Low blood pressure
• Dehydration
• Recurrent urinary tract or genital infections
• A history of pancreatitis (inflammation of the pancreas)
• Heavy alcohol use

Contact your doctor before surgery, during prolonged fasting, or during a serious illness. Your doctor may temporarily stop this medicine. Long-term use of metformin may reduce vitamin B12 levels. Your doctor may periodically check your kidney function and vitamin B12 levels.

Special Dietary and Lifestyle Recommendations

• Check your blood glucose regularly as advised by your doctor.
• Follow a balanced diet and limit sweets and sugar-sweetened beverages.
• Engage in regular physical activity according to your ability and your doctor's advice.
• Do not undertake prolonged fasting or a very low-carbohydrate diet without consulting your doctor.
• Avoid excessive alcohol consumption, as it may increase the risk of dehydration and metformin-associated lactic acidosis.
• Drink adequate amounts of water, but follow your doctor's instructions if you have been advised to restrict fluids.
• Check your feet regularly and inform your doctor if you notice wounds, swelling, or changes in skin color.