Radiglip M 50/1000mg Tablet

✔️ Side Effects

• Diarrhea
• Nausea
• Vomiting
• Abdominal discomfort
• Indigestion
• Flatulence
• Headache
• Weakness or fatigue
• Upper respiratory tract infection
• Nasopharyngitis

✔️ Dosage and Administration

The dose should be individualized according to the patient's current diabetes treatment, blood glucose response, kidney function, and tolerance. The maximum recommended daily dose is 100 mg of sitagliptin and 2,000 mg of metformin.

Immediate-Release Film-Coated Tablets

The combination is generally taken twice daily with meals. Gradual dose increases may be used to minimize gastrointestinal side effects associated with metformin.

For patients who are not currently taking metformin, a commonly recommended starting dose is:

• Sitagliptin 50 mg + Metformin 500 mg twice daily

For patients already taking metformin, the starting dose should provide sitagliptin 50 mg twice daily together with an appropriate dose of metformin based on their existing treatment.

For example, patients taking metformin 850 mg twice daily may be switched to:

• Sitagliptin 50 mg + Metformin 1000 mg twice daily

Any change from another oral antidiabetic treatment should be made carefully with appropriate blood glucose monitoring.

Extended-Release Tablets

The extended-release formulation is generally taken once daily with a meal, preferably in the evening. The dose may be increased gradually to improve gastrointestinal tolerance.

The maximum recommended daily dose is:

• Sitagliptin 100 mg
• Metformin extended-release 2,000 mg

When switching between immediate-release and extended-release formulations, the same total daily amounts of sitagliptin and metformin should generally be maintained, without exceeding the maximum recommended metformin dose.

If two extended-release tablets are prescribed, such as two 50/500 mg or two 50/1000 mg tablets, they should generally be taken together once daily.

✔️ Sitagliptin + Metformin should generally not be used in patients with:

• Significant kidney disease or renal dysfunction.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
• A previous serious allergic reaction to sitagliptin or this combination, including anaphylaxis or angioedema.
• Conditions associated with acute deterioration of kidney function, such as shock, acute myocardial infarction, or severe infection.

The medicine should be temporarily discontinued when undergoing certain radiological procedures involving intravenous iodinated contrast, as contrast exposure may cause an acute decline in kidney function.

✔️ Pregnancy & Lactation

There are insufficient well-controlled studies establishing the safety of the sitagliptin + metformin combination during pregnancy. Therefore, it should be used during pregnancy only when clearly considered necessary by a doctor.

It is not known whether sitagliptin passes into human breast milk. Since many medicines can be excreted through breast milk, caution is recommended when this combination is prescribed to breastfeeding women.

✔️ Use With Insulin or Insulin Secretagogues

When this combination is used together with insulin or an insulin secretagogue such as a sulfonylurea, the dose of the insulin or insulin secretagogue may need to be reduced to lower the risk of hypoglycemia.

✔️ Cationic Medicines

Medicines that are eliminated through renal tubular secretion may interact with metformin. Use the combination cautiously when such medicines are taken concurrently.

✔️ Levothyroxine

Levothyroxine may reduce the glucose-lowering effect of metformin. Blood glucose should be monitored when thyroid hormone treatment is started, stopped, or adjusted, and the metformin dose may need to be modified.

✔️ Phenprocoumon

Metformin may reduce the anticoagulant effect of phenprocoumon. Close monitoring of INR is recommended when these medicines are used together.

✔️ Precautions and Warnings

Lactic Acidosis

Metformin can rarely cause lactic acidosis, particularly when it accumulates in the body. The risk may increase in people with:

• Kidney impairment
• Liver impairment
• Severe infection or sepsis
• Dehydration
• Excessive alcohol consumption
• Acute congestive heart failure

Possible symptoms include unusual weakness, muscle pain, difficulty breathing, increasing drowsiness, and unexplained abdominal discomfort. Laboratory findings may include reduced blood pH, increased anion gap, and elevated blood lactate.

If lactic acidosis is suspected, the medicine should be stopped, and the patient should receive urgent medical treatment.

Kidney Function

Kidney function should be assessed before starting treatment and monitored regularly during therapy. Cases of acute kidney injury, including cases requiring dialysis, have been reported after marketing.

Pancreatitis

Acute pancreatitis, including severe hemorrhagic or necrotizing forms, has been reported with sitagliptin. If symptoms suggestive of pancreatitis develop, the medicine should be stopped, and the patient should receive prompt medical evaluation.

Liver Disease

This combination should generally be avoided in patients with significant hepatic disease.

Vitamin B12

Long-term metformin therapy may reduce vitamin B12 levels. Periodic monitoring may be appropriate, particularly in patients who develop symptoms such as anemia or peripheral neuropathy.

Thyroid Function

Patients with hypothyroidism may require regular monitoring of thyroid-stimulating hormone (TSH) levels.

Alcohol

Avoid excessive alcohol consumption because it can increase the risk of metformin-associated lactic acidosis and may also affect blood glucose control.

Illness, Surgery, or Reduced Food and Fluid Intake

During periods of severe illness, fever, infection, trauma, surgery, or significantly reduced food and fluid intake, temporary discontinuation of the medicine and use of insulin may sometimes be necessary. This should be decided by a healthcare professional.

Hypoglycemia

When used together with insulin or sulfonylureas, the risk of low blood glucose may increase. The dose of the accompanying medicine may need to be reduced.

Serious Allergic Reactions

Serious hypersensitivity reactions have been reported with sitagliptin, including:

• Anaphylaxis
• Angioedema
• Severe skin reactions
• Stevens-Johnson syndrome

If a serious allergic reaction occurs, stop the medicine and seek immediate medical attention. Alternative diabetes treatment may be required.

✔️ Storage:

• Store below 25°C.
• Keep in a dry place away from direct light.
• Keep out of reach of children.
• Do not use after the expiry date.
• This medicine should be dispensed only on the prescription of a registered physician.