Sitagliptin (Philsitz 50) 50mg Film Coated Tablets 30's

Description:
Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally).

Product Description:

Sitagliptin (Philsitz 50) 50mg Film-Coated Tablets are oral antidiabetic medications that belong to the DPP-4 (Dipeptidyl Peptidase-4) inhibitors class. The active ingredient, Sitagliptin, helps control blood sugar levels in people with type 2 diabetes. Sitagliptin works by enhancing the action of incretin hormones, which stimulate insulin release and decrease glucagon levels in the blood, thus helping to lower blood glucose levels after meals. These tablets are film-coated to improve patient compliance, making them easier to swallow.

Each pack contains 30 tablets of 50 mg Sitagliptin, providing a convenient, once-daily treatment option for individuals with type 2 diabetes.

Indications:

Sitagliptin (Philsitz 50) 50mg Tablets are indicated for:

• Type 2 Diabetes Mellitus: To improve blood glucose control in adults with type 2 diabetes, when used in combination with diet and exercise.

• Monotherapy: Sitagliptin can be used as a standalone treatment when diet and exercise alone do not provide sufficient blood sugar control.

• Combination Therapy: It may also be used in combination with other oral antidiabetic agents, such as metformin, sulfonylureas, or thiazolidinediones, when these medications alone do not adequately control blood sugar.

• As an adjunct to insulin: Sitagliptin may be used in combination with insulin therapy to improve blood glucose control.

Dosages:

• Adults (including elderly):

  • The usual starting dose is 50 mg once daily.

  • The dosage may be increased based on individual treatment response and tolerance, but the maximum recommended dose is 100 mg per day.

  Adjustments for Renal Impairment:

  • For patients with mild renal impairment (creatinine clearance ≥50 mL/min), the dose remains 50 mg once daily.

  • For moderate renal impairment (creatinine clearance 30–50 mL/min), the dose should be 50 mg once daily.

  • For severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease, the dose should be 25 mg once daily.

• Pediatric Patients:

  • Sitagliptin is not recommended for use in children under the age of 18 years due to insufficient safety and efficacy data.

Note: The tablets should be taken once daily with or without food. It is important to follow the prescribed dosage by your healthcare provider to avoid underdosing or overdosing.

Side Effects:

Common side effects of Sitagliptin (Philsitz 50) may include:

• Upper Respiratory Tract Infections: These are among the most common side effects reported.

• Headache: Some individuals may experience mild headaches.

• Gastrointestinal Issues: Nausea, abdominal pain, or diarrhea may occur in some patients.

• Nasopharyngitis: Inflammation of the nose and throat.

Less common but more serious side effects include:

• Hypoglycemia (Low Blood Sugar): When used in combination with other diabetes medications, such as sulfonylureas or insulin, hypoglycemia may occur. Symptoms of hypoglycemia may include sweating, trembling, dizziness, or confusion.

• Pancreatitis (Inflammation of the Pancreas): Although rare, there have been reports of pancreatitis in patients taking Sitagliptin. Seek immediate medical attention if symptoms of pancreatitis occur, such as severe abdominal pain, nausea, or vomiting.

• Severe Allergic Reactions: Including skin reactions such as rashes, swelling of the face, lips, or throat, and difficulty breathing.

• Joint Pain: Severe joint pain, which may be a sign of rhabdomyolysis, has been reported in rare cases.

• Kidney Dysfunction: Sitagliptin should be used with caution in patients with renal impairment, and renal function should be monitored during treatment.

If any of the following serious side effects occur, seek immediate medical attention:

• Severe abdominal pain or persistent nausea and vomiting (could indicate pancreatitis).

• Severe allergic reactions: such as difficulty breathing, swelling, rash, or itching.

• Severe joint pain.

Contraindications:

Sitagliptin (Philsitz 50) 50mg Tablets should not be used in the following situations:

• Hypersensitivity: If the patient has a known allergy to Sitagliptin or any of the components of the tablet.

• Type 1 Diabetes: Sitagliptin is not indicated for the treatment of type 1 diabetes.

• Diabetic Ketoacidosis: It should not be used for patients with diabetic ketoacidosis (a severe complication of diabetes).

• Severe Renal Impairment: In patients with severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease, a lower dose (25 mg) is recommended, and careful monitoring is required.

Warnings and Precautions:

• Renal Function: Patients with renal impairment should have their renal function monitored regularly, as Sitagliptin is primarily eliminated by the kidneys. Dose adjustment may be required based on the degree of renal impairment.

• Pancreatitis: Although rare, pancreatitis is a serious risk with Sitagliptin. If symptoms of pancreatitis occur, the medication should be discontinued, and alternative treatment should be considered.

• Hypoglycemia: When used in combination with other medications such as insulin or sulfonylureas, there is an increased risk of hypoglycemia. It is important to monitor blood glucose levels and adjust doses of other medications as necessary.

• Cardiovascular Disease: Sitagliptin should be used cautiously in patients with a history of cardiovascular disease. Some studies have raised concerns about the potential cardiovascular risk with DPP-4 inhibitors, though more research is needed in this area.

• Allergic Reactions: Severe allergic reactions, such as swelling of the face, lips, tongue, or throat, may occur. If any signs of an allergic reaction appear, seek medical attention immediately.

Drug Interactions:

• Insulin and Sulfonylureas: When used in combination with insulin or sulfonylureas, there is an increased risk of hypoglycemia. A dose adjustment of the insulin or sulfonylurea may be necessary to avoid low blood sugar.

• Rifampin: Rifampin (an antibiotic) may decrease the efficacy of Sitagliptin by inducing liver enzymes that metabolize the drug. A higher dose of Sitagliptin may be required in combination with rifampin.

• Other Antidiabetic Medications: Caution should be exercised when using Sitagliptin in combination with other oral antidiabetic medications, particularly those that increase insulin secretion (e.g., sulfonylureas), to minimize the risk of hypoglycemia.

Pregnancy and Breastfeeding:

• Pregnancy: There are no well-controlled studies in pregnant women, and Sitagliptin should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Consult your healthcare provider for advice on the appropriate treatment during pregnancy.

• Breastfeeding: It is not known whether Sitagliptin is excreted in human breast milk. Therefore, caution should be used when administering Sitagliptin to breastfeeding women.

Conclusion:

Sitagliptin (Philsitz 50) 50mg Tablets are an effective treatment for controlling blood glucose levels in individuals with type 2 diabetes. It can be used alone or in combination with other antidiabetic medications. Like all medications, Sitagliptin should be used under the supervision of a healthcare provider, and dosages should be adjusted based on the patient's response and renal function. Monitoring for side effects, including gastrointestinal symptoms and signs of pancreatitis, is important. Regular blood glucose monitoring is essential for effective diabetes management, and any concerns or changes in symptoms should be addressed with a healthcare provider.