Sigtil
Generic Name
Sitagliptin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sigtil 25 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Sigtil 25 mg Tablet contains Sitagliptin, an oral anti-diabetic medicine used to improve blood sugar control in adults with type 2 diabetes mellitus. This particular strength is often indicated for patients with renal impairment.
Uses & Indications
Dosage
Adults
Typically, the recommended dose is 100 mg once daily. However, 25 mg is used for patients with moderate to severe renal impairment or end-stage renal disease.
Elderly
No dosage adjustment necessary based solely on age, but renal function should be assessed and dosage adjusted accordingly.
Renal_impairment
For mild renal impairment (CrCl ≥ 50 to < 80 mL/min), no dosage adjustment. For moderate (CrCl ≥ 30 to < 50 mL/min), 50 mg once daily. For severe (CrCl < 30 mL/min) or end-stage renal disease (ESRD) requiring dialysis, 25 mg once daily.
How to Take
Oral. Can be taken with or without food, at any time of day.
Mechanism of Action
Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by increasing the levels of incretin hormones (GLP-1 and GIP). These hormones enhance glucose-dependent insulin secretion and suppress glucagon secretion from the pancreas, thereby lowering blood glucose levels.
Pharmacokinetics
Onset
Within 24 hours (for glucose lowering effect)
Excretion
Primarily excreted renally, with about 79% excreted unchanged in urine.
Half life
Approximately 12.4 hours
Absorption
Rapidly absorbed after oral administration, peak plasma concentration reached in 1-4 hours. Absolute bioavailability is approximately 87%.
Metabolism
Limited hepatic metabolism (primarily via CYP3A4, with minor contribution from CYP2C8)
Side Effects
Contraindications
- Hypersensitivity to Sitagliptin or any component of the formulation.
- Patients with type 1 diabetes mellitus.
- Diabetic ketoacidosis.
Drug Interactions
Digoxin
Increased digoxin levels have been observed in some studies; monitor digoxin levels if co-administered.
Cyclosporine
Cyclosporine may slightly increase Sitagliptin exposure, but no dosage adjustment is typically needed.
Strong CYP3A4/2C8 inhibitors/inducers
Sitagliptin's metabolism is minor via these pathways, so significant interactions are unlikely.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, discontinue Sigtil and initiate appropriate supportive care as dictated by the patient’s clinical status. Sitagliptin is modestly dialyzable (13.5% over 3-4 hours of hemodialysis).
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if clearly needed. It is not known whether Sitagliptin is excreted in human milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to Sitagliptin or any component of the formulation.
- Patients with type 1 diabetes mellitus.
- Diabetic ketoacidosis.
Drug Interactions
Digoxin
Increased digoxin levels have been observed in some studies; monitor digoxin levels if co-administered.
Cyclosporine
Cyclosporine may slightly increase Sitagliptin exposure, but no dosage adjustment is typically needed.
Strong CYP3A4/2C8 inhibitors/inducers
Sitagliptin's metabolism is minor via these pathways, so significant interactions are unlikely.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, discontinue Sigtil and initiate appropriate supportive care as dictated by the patient’s clinical status. Sitagliptin is modestly dialyzable (13.5% over 3-4 hours of hemodialysis).
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if clearly needed. It is not known whether Sitagliptin is excreted in human milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated Sitagliptin's efficacy and safety in improving glycemic control in type 2 diabetes, both as monotherapy and in combination with other anti-diabetic agents. Key cardiovascular outcomes trials (e.g., TECOS, CARMELINA) have shown it does not increase the risk of major adverse cardiovascular events.
Lab Monitoring
- Glycated hemoglobin (HbA1c) levels (regularly to assess glycemic control).
- Renal function (e.g., serum creatinine, eGFR) before initiating and periodically during treatment.
Doctor Notes
- Prioritize renal function assessment (eGFR) before initiating Sitagliptin, especially for the 25 mg dose, and periodically thereafter.
- Educate patients on symptoms of acute pancreatitis (severe, persistent abdominal pain) and hypersensitivity reactions (e.g., rash, angioedema).
- Monitor for new onset or worsening joint pain, and consider drug discontinuation if severe.
- Counsel patients on the importance of diet and exercise as adjuncts to therapy.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor, even if you feel well.
- Do not crush, chew, or break the tablet; swallow it whole.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any unusual or severe side effects, especially persistent severe abdominal pain or allergic reactions, immediately to your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Sitagliptin itself is not expected to affect the ability to drive or operate machinery. However, if Sigtil 25 mg is used in combination with a sulfonylurea or insulin, the risk of hypoglycemia may increase, which could impair driving ability. Patients should be aware of this potential risk.
Lifestyle Advice
- Maintain a healthy diet and engage in regular physical activity to help optimize blood sugar control and overall health.
- Monitor your blood glucose levels regularly as advised by your doctor to track your progress and detect any fluctuations.
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