Sitagil M 100/1000 ER Tablet

What is Sitagil M 100/1000?

Sitagil M ER 100/1000 is a higher-strength fixed-dose combination of Sitagliptin and extended-release Metformin Hydrochloride manufactured by Incepta Pharmaceuticals Ltd. It is intended for patients requiring a more potent combined dose to achieve adequate blood glucose control in type 2 diabetes mellitus.

Generic Name and Composition

Each extended-release tablet contains 100 mg of Sitagliptin (as phosphate monohydrate) and 1000 mg of Metformin Hydrochloride.

Indications

• Type 2 diabetes mellitus in patients not adequately controlled on lower-dose combination therapy or monotherapy
• For patients stabilized on sitagliptin 100mg and metformin 1000mg separately, as a more convenient combined regimen

How It Works — Mechanism of Action

Sitagliptin inhibits the DPP-4 enzyme, increasing incretin hormone levels to enhance glucose-dependent insulin secretion and reduce glucagon release. Metformin reduces hepatic glucose production and improves peripheral insulin sensitivity. The combination provides complementary, dose-optimized glucose control.

Dosage and Administration

• Dosage is individualized by a physician based on current sitagliptin and metformin requirements; this is the maximum-strength combination tablet.
• Typically taken once daily with the evening meal; swallow whole, do not crush, split, or chew.
• Take with food to reduce gastrointestinal side effects.
• Do not exceed the prescribed dose.

Side Effects

Common: Diarrhea, nausea, abdominal discomfort, headache, upper respiratory tract infection — often related to the metformin component, especially at treatment start.

Uncommon: Hypoglycemia (especially when combined with sulfonylureas or insulin), vitamin B12 deficiency with long-term use.

Rare: Lactic acidosis, pancreatitis, severe hypersensitivity reactions, bullous pemphigoid (skin blistering).

Drug Interactions

May enhance hypoglycemia: Insulin, sulfonylureas.

May increase metformin levels / risk of lactic acidosis: Iodinated contrast media.

Other considerations: Alcohol may increase risk of lactic acidosis; inform your doctor of all medicines you are taking.

Contraindications

• Known hypersensitivity to sitagliptin, metformin, or any excipient
• Severe renal impairment
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis
• Conditions predisposing to tissue hypoxia (e.g., severe heart failure, respiratory failure)

Pregnancy and Lactation

Use during pregnancy and breastfeeding should only be under medical supervision; insulin is often preferred for tight glycemic control in pregnancy. Discuss the risks and benefits with your physician.

Precautions and Warnings

• Temporarily discontinue before procedures using iodinated contrast media, as advised by your physician.
• Seek medical attention immediately for symptoms of pancreatitis or lactic acidosis.
• Use with caution in elderly patients and those with impaired kidney or liver function, given the higher metformin dose.
• Monitor renal function periodically during long-term therapy.

Overdose

Overdose may cause hypoglycemia (from sitagliptin component) or lactic acidosis (from metformin component), with higher risk given the elevated strength of this combination. This is a medical emergency requiring immediate hospitalization with supportive care and, if needed, hemodialysis.

Storage Instructions

• Store below 30°C in a dry place, protected from light.
• Keep out of reach of children.
• Do not use after the expiry date printed on the pack.

Frequently Asked Questions

Q1: Who is prescribed the 100/1000 strength instead of 50/500?
Patients who need a higher dose of both sitagliptin and metformin to achieve target blood glucose levels, as determined by their physician, may be prescribed this stronger combination.

Q2: Can I switch directly from 50/500 to 100/1000?
Dose changes should only be made under physician guidance, typically after assessing blood glucose control and tolerance to the lower dose.

Q3: Will this higher dose increase my risk of side effects?
Higher metformin doses can increase the likelihood of gastrointestinal side effects; taking the tablet with food and gradual dose titration help minimize this.

Q4: How does Sitagil M 100/1000 compare to Sitagil M 50/500?
Both contain the same active ingredients; the 100/1000 strength delivers a higher total dose for patients needing more pronounced glucose control, as determined by your physician.

Medical Disclaimer

This product is available by prescription only (Rx). The information provided is for educational purposes and does not replace professional medical advice. Always consult a registered physician before starting, stopping, or changing any diabetes therapy. DiabetesStore.com.bd is a licensed online pharmacy in Bangladesh.