Sitagliptin Tablets

1. Product Introduction

Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used to improve blood glucose control in adults with type 2 diabetes mellitus. The supplied product composition confirms Sitagliptin Tablets 100 mg as a film-coated tablet. Healthy Life Pharma Pvt. Ltd. is named as manufacturer and Healthy Inc as exporter in the supplied description. Facility certification and market authorizations should be independently verified before publishing claims.

2. Product Specifications

3. Manufacturing Technology

Formulation development may consider blend uniformity, granulation or direct compression suitability, tablet mechanical strength, dissolution and moisture protection. Film coating and packaging should be selected on the basis of validated stability studies. Specific manufacturing equipment, coating brands and environmental controls require manufacturer confirmation.

4. Quality Assurance

Batch release should be based on the applicable approved specification, including identity, assay, uniformity of dosage units, dissolution, related substances and microbial requirements where applicable. Numerical acceptance limits must be taken from the current validated monograph or registered dossier rather than assumed for every market.

5. Therapeutic Uses

Sitagliptin inhibits DPP-4, increasing endogenous incretin activity (including GLP-1 and GIP). This enhances glucose-dependent insulin secretion and reduces glucagon release, helping improve glycaemic control in type 2 diabetes. It may be used alone or with other antidiabetic agents when clinically appropriate.

Sitagliptin is generally weight-neutral and has a low intrinsic risk of hypoglycaemia, but that risk increases when combined with insulin or a sulfonylurea. It is not indicated for type 1 diabetes or diabetic ketoacidosis.

6. Export and Regulatory Support

For B2B enquiries, request market-specific registration status, batch COA, approved specifications, stability documentation, packaging configurations and any available CTD/ACTD dossier materials. WHO-GMP status, COPP, FSC and other certificates must be verified for the relevant facility, product and destination country. Supply terms and availability are subject to confirmation.

7. Frequently Asked Questions

Q: Which strength is confirmed in the supplied composition?
A: Sitagliptin 100 mg film-coated tablets. The 25 mg and 50 mg strengths are background references only.

Q: Can sitagliptin be combined with metformin?
A: Yes, clinicians may prescribe the medicines together when appropriate.

Q: Can it cause low blood sugar?
A: The risk is relatively low when used alone, but can increase with insulin or sulfonylureas.

8. Dosage and Administration

A commonly recommended adult dose is 100 mg once daily in patients with adequate renal function, with or without food. Renal function must be assessed before and during treatment: in many prescribing labels, eGFR 30 to less than 45 mL/min/1.73 m² calls for 50 mg once daily; eGFR below 30 mL/min/1.73 m² (including dialysis) calls for 25 mg once daily. These lower strengths are not confirmed in the supplied product listing. Follow the locally approved prescribing information and clinician instructions.

9. Side Effects and Precautions

Potential adverse effects include headache, nasopharyngitis and upper respiratory symptoms. Serious warnings include acute pancreatitis, severe hypersensitivity reactions, severe joint pain and bullous pemphigoid. Seek urgent medical assessment for severe persistent abdominal pain, breathing difficulty or serious skin reactions. Hypoglycaemia risk rises with insulin or sulfonylureas. Review renal function and other medications before use.

10. Storage Instructions

Store in the original packaging according to the approved product label, protected from excessive moisture and heat. The final temperature range and shelf life must be verified from approved stability data. Keep out of reach of children.