Sitagliptin Phosphate Tablet USP is a high-quality antidiabetic medication formulated for the effective management of Type 2 Diabetes Mellitus (T2DM). It is designed in strict compliance with USP (United States Pharmacopeia) standards to ensure superior purity, potency, and safety for patients. Manufactured under Good Manufacturing Practices (GMP), Sitagliptin Tablets are available in 25mg, 50mg, and 100mg strengths, offering flexibility for individualized patient care.
Product Overview
Product Name: Sitagliptin Phosphate Tablet USP
Brand Name: Generics
Available Strengths: 25mg, 50mg, 100mg
Dosage Form: Film-coated Tablets
Route of Administration: Oral
Packaging: 30s, 90s, 100s blister or bottle packs
Regulatory Documentation: COA, MOA, COPP, FSC, Stability Studies, GMP Certificate, CTD Dossier
Therapeutic Class: Antidiabetic, DPP-4 Inhibitor
Therapeutic Use: Management of Type 2 Diabetes Mellitus (T2DM)
Description
Sitagliptin Phosphate Tablets USP belong to the Dipeptidyl Peptidase-4 (DPP-4) inhibitor class of oral antidiabetic agents. These tablets work by increasing incretin levels (GLP-1 and GIP), which in turn enhance insulin secretion and suppress glucagon release, leading to improved blood glucose control. Sitagliptin is not an insulin substitute but complements diet, exercise, and other antidiabetic agents to optimize glycemic management.
Qualitative and Quantitative Composition
Sitagliptin Phosphate Tablet USP 25mg
Each film-coated tablet contains:
- Sitagliptin Phosphate Monohydrate USP equivalent to Sitagliptin 25mg
- Excipients: q.s.
- Color: Iron Oxide Yellow
Sitagliptin Phosphate Tablet USP 50mg
Each film-coated tablet contains:
- Sitagliptin Phosphate Monohydrate USP equivalent to Sitagliptin 50mg
- Excipients: q.s.
- Color: Iron Oxide Red
Sitagliptin Phosphate Tablet USP 100mg
Each film-coated tablet contains:
- Sitagliptin Phosphate Monohydrate USP equivalent to Sitagliptin 100mg
- Excipients: q.s.
- Color: Quinoline Yellow
All formulations meet the quality parameters of USP specifications and are formulated using pharmaceutical-grade excipients to ensure consistency, stability, and bioavailability.
Pharmacological Classification
ATC Classification: A10BH01 – Dipeptidyl Peptidase-4 (DPP-4) Inhibitor
Mechanism of Action: Sitagliptin inhibits the DPP-4 enzyme responsible for the degradation of incretin hormones. By prolonging the activity of incretin hormones, Sitagliptin enhances insulin release and reduces glucagon secretion, effectively controlling blood glucose levels without causing hypoglycemia.
Therapeutic Indications
Sitagliptin Phosphate Tablets USP are indicated for the management of Type 2 Diabetes Mellitus in adults. They are used:
- As monotherapy in patients who cannot tolerate metformin.
- In combination therapy with metformin, sulfonylureas, or thiazolidinediones when monotherapy is insufficient.
- As part of a comprehensive diabetes management plan, including diet control and regular exercise.
By controlling blood sugar levels, Sitagliptin helps prevent diabetes-related complications such as nephropathy, retinopathy, neuropathy, cardiovascular events, and sexual dysfunction.
Dosage and Administration
The dosage should be individualized based on the patient’s medical condition, renal function, and treatment response.
- Recommended Dose: 100mg once daily by mouth, with or without food.
- Renal Impairment Adjustments: Dose reduction may be necessary for patients with moderate to severe renal impairment.
- Dosage Direction: As directed by the physician.
Important: Swallow the tablet whole with water. Do not chew, crush, or break the tablet.
Pharmaceutical Form and Appearance
- Sitagliptin 25mg: Yellow, film-coated round tablet.
- Sitagliptin 50mg: Light red, film-coated round tablet.
- Sitagliptin 100mg: Yellow, film-coated oval tablet.
Each tablet is engraved for easy identification and packaged in moisture-resistant aluminum blisters or HDPE bottles to maintain potency.
Storage and Stability
- Storage Condition: Store below 30°C in a dry place, away from direct sunlight and heat.
- Humidity Protection: Keep the container tightly closed to protect from moisture.
- Shelf Life: 24 months from the date of manufacture.
- Temperature Guidelines: Controlled room temperature between 20°C and 25°C (68°F – 77°F) with permissible excursions between 15°C and 30°C (59°F – 86°F).
Caution and Warning
CAUTION:
- Read the enclosed Patient Information Leaflet (PIL) before use.
- Keep out of reach of children.
- Swallow the tablet whole; do not crush or chew.
WARNING:
To be sold by retail on the prescription of a Registered Medical Practitioner only.
Regulatory and Quality Compliance
Our Sitagliptin Phosphate Tablets USP comply with international quality standards and are backed by comprehensive regulatory documentation, including:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Free Sale Certificate (FSC)
- Certificate of Pharmaceutical Product (COPP)
- Stability Study Data
- Good Manufacturing Practice (GMP) Certification
- Common Technical Document (CTD) Dossier
All production and packaging processes are performed under cGMP-certified and ISO 9001:2015 compliant facilities, ensuring consistent quality and safety.
Clinical Pharmacology
Mechanism of Action: Sitagliptin selectively inhibits DPP-4, preventing the degradation of GLP-1 and GIP. These hormones stimulate insulin release and suppress glucagon secretion, reducing hepatic glucose output.
Pharmacokinetics:
- Absorption: Rapidly absorbed after oral administration, with peak plasma concentration within 1–4 hours.
- Bioavailability: Approximately 87%.
- Metabolism: Minimal hepatic metabolism; primarily excreted unchanged in urine.
- Half-life: Approximately 12 hours.
- Excretion: Primarily renal via active tubular secretion.
Adverse Reactions
Sitagliptin is generally well-tolerated. Possible side effects include:
- Nasopharyngitis
- Headache
- Upper respiratory tract infection
- Hypoglycemia (especially when combined with sulfonylureas)
- Mild gastrointestinal discomfort
Severe adverse events are rare but may include pancreatitis or hypersensitivity reactions. Immediate medical attention is advised if severe abdominal pain or allergic symptoms occur.
Drug Interactions
Sitagliptin has a low potential for drug-drug interactions. However, dose adjustments may be required when used with:
- Sulfonylureas (risk of hypoglycemia)
- Insulin (enhanced glucose-lowering effect)
- Strong CYP3A4 inhibitors or P-gp inhibitors
Therapeutic Advantages
- Provides effective glycemic control without weight gain
- Low risk of hypoglycemia when used as monotherapy
- Suitable for elderly and renal-impaired patients with adjusted dosing
- Can be combined with Metformin or Insulin for synergistic effects
- Promotes better treatment adherence due to once-daily dosing
Packaging and Presentation
Available in various pack sizes for patient convenience and institutional supply:
- 30 Tablets Pack – Hospital and retail use
- 90 Tablets Pack – Long-term therapy pack
- 100 Tablets Pack – Institutional and export packaging
Each package includes a Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) to provide essential drug and usage information.
Sitagliptin Phosphate Tablet USP represents an advanced solution for managing Type 2 Diabetes Mellitus. Its proven efficacy, safety profile, and pharmaceutical reliability make it an essential choice for healthcare professionals worldwide. Manufactured under strict quality control and regulatory compliance, Sitagliptin offers consistency, stability, and patient satisfaction for long-term diabetes management.