Precautions and warnings

Do not give Sitagliptin and Metformin together to patients with liver disease. Check the patient’s kidney function before starting this treatment and at least once a year after that, to make sure it is normal. If the patient is sick, not eating or drinking well, or under stress from things like fever, injury, infection, or surgery, it may be necessary to stop this medication for a while and use insulin instead.

Drug Interactions

Taking sulfonylureas with this medication may have an added effect on lowering blood sugar. However, medicines like thiazide diuretics, corticosteroids, phenothiazines, oral contraceptives, drugs that stimulate the nervous system, niacin, calcium channel blockers, and isoniazid can make it harder to control blood sugar levels. ACE inhibitors might help lower fasting blood sugar. Cimetidine may raise the amount of this medication in your blood.

Serious Warning: Using iodinated contrast agents at the same time can greatly increase the risk of dangerous lactic acidosis caused by metformin.

Contraindications

- Kidney problems, such as high serum creatinine (over 1.5 mg/dL for men or over 1.4 mg/dL for women) or poor creatinine clearance.
- Metabolic acidosis, including diabetic ketoacidosis.
- A history of a serious allergic reaction (like anaphylaxis or angioedema) to Sitagliptin + Metformin or any of its ingredients.

Mode of actions

**Sitagliptin:**
Sitagliptin is a DPP-4 inhibitor. It works by blocking the DPP-4 enzyme, which usually breaks down incretin hormones. By stopping this enzyme, sitagliptin increases and prolongs the action of incretins. Incretin hormones help the pancreas make more insulin and release it, and they also lower the release of glucagon, a hormone that raises blood sugar.

**Metformin:**
Metformin is a type of medicine called a biguanide. It lowers blood sugar mainly by reducing how much glucose (sugar) the liver produces. It also decreases how much glucose the intestines absorb and helps the body use insulin better by increasing glucose uptake in the muscles. Metformin helps improve the body’s response to insulin and lowers blood sugar levels both before and after meals.

Dosage & Administration

Dose of this combination should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg Sitagliptin and 2000 mg Metformin.

Sitagliptin/Metformin combination should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to Metformin.

The recommended starting dose in patients not currently treated with Metformin is 50 mg Sitagliptin/500 mg Metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with Metformin.

The starting dose in patients already treated with Metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of Metformin already being taken.

For patients taking Metformin 850 mg twice daily, the recommended starting dose of this combination is 50 mg Sitagliptin/1000 mg Metformin hydrochloride twice daily. May adjust the dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg Sitagliptin and 2000 mg Metformin extended release. Administer once daily with a meal preferably in the evening. Gradually escalate the dose to reduce the gastrointestinal side effects due to Metformin.

Maintain the same total daily dose of Sitagliptin and Metformin when changing between Sitagliptin + Metformin ER, without exceeding the maximum recommended daily dose of 2000 mg Metformin extended release.

Pregnancy & Lactation

Although animal reproduction studies have shown an adverse effect even sometimes unable to demonstrate the risk on the fetus and there are no adequate and well-controlled studies in pregnant women, but during pregnancy, this medicine can be used just when definitely required.

Discuss with your doctors and tell them feedback about this medicine.

There is no specific information about whether this medicine is passed on to the baby through breast milk. Discuss with your doctor before breastfeeding.

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