Nobesit XR 500

Indications

Nobesit XR tablets are prescribed for managing type 2 diabetes mellitus, especially in overweight individuals when diet and exercise alone fail to achieve sufficient glycemic control.

• Adults: Nobesit can be used as a standalone treatment or in conjunction with other oral antidiabetic medications or insulin.
• Children (10 years and older) and Adolescents: Nobesit may be administered as monotherapy or alongside insulin.

Research has indicated that metformin, as a first-line treatment after dietary interventions, can reduce complications associated with type 2 diabetes in overweight adults.

Always consult a registered healthcare professional before taking any medication.

Pharmacology

Metformin is an oral antihyperglycemic agent classified as a biguanide, primarily utilized in the treatment of type 2 diabetes. It effectively lowers both fasting and post-meal blood glucose levels. Unlike sulfonylureas, metformin does not induce hypoglycemia. Its mechanisms include reducing hepatic glucose production, decreasing intestinal glucose absorption, and enhancing insulin sensitivity by increasing peripheral glucose uptake and utilization.

Dosage & Administration

Immediate Release Metformin Tablets: Dosage should be tailored based on effectiveness and tolerance, ensuring not to exceed the maximum recommended daily amounts.

• Adults: The typical starting dose is 500 mg twice daily or 850 mg once daily, taken with meals. Doses can be increased by 500 mg weekly or 850 mg every two weeks, up to a maximum of 2000 mg per day in divided doses. For patients needing further glycemic control, a maximum daily dose of 2550 mg may be administered. Higher doses over 2000 mg may be better tolerated when taken three times daily with meals.
• Children: The starting dose is usually 500 mg twice daily with meals, with increments of 500 mg weekly up to a maximum of 2000 mg per day in divided doses.

Extended Release Metformin Tablets: Swallow the XR tablet whole; do not crush, cut, or chew.

• Adults: The usual starting dose for Metformin XR is 500 mg once daily with the evening meal, increasing by 500 mg weekly to a maximum of 2000 mg daily, or 1000 mg taken twice daily with meals. Patients on immediate release may transition to extended release at the maximum recommended daily dose.
• Children: Not studied in pediatric populations.
• Renal Impairment: Metformin is contraindicated in patients with an eGFR below 30 mL/min/1.73 m². Assess the risk/benefit if eGFR drops below 45 mL/min/1.73 m².

Always consult a registered healthcare professional before taking any medication.

Interactions

There is limited data on the interaction between Nobesit and Furosemide when administered chronically. Nifedipine may enhance Nobesit absorption, while Nobesit has minimal effects on Nifedipine. Certain cationic drugs eliminated through renal tubular secretion may interact with Nobesit, potentially competing for renal transport systems. Nobesit does not affect Cimetidine pharmacokinetics. Be cautious with medications that can induce hyperglycemia, including thiazides, corticosteroids, and other specified agents.

Contraindications

• Hypersensitivity to the active ingredient or any excipients.
• Acute metabolic acidosis (including lactic acidosis and diabetic ketoacidosis).
• Severe renal impairment (GFR <30 mL/min).
• Conditions that may affect renal function, such as dehydration or severe infections.
• Diseases causing tissue hypoxia, including cardiac or respiratory failure, and acute alcohol intoxication.

Side Effects

Blood and Lymphatic Disorders: Rare cases of hemolytic anemia.

Metabolism Disorders: Very rare incidences of lactic acidosis and vitamin B12 absorption reduction during prolonged use, potentially leading to megaloblastic anemia and peripheral neuropathy in deficient patients.

Nervous System Disorders: Common taste disturbances; rare cases of encephalopathy.

Gastrointestinal Disorders: Very common side effects include nausea, vomiting, diarrhea, and abdominal discomfort, especially at the start of therapy. Taking Metformin with meals can help alleviate these issues.

Hepatobiliary Disorders: Very rare instances of liver function test abnormalities resolving after discontinuation.

Skin Reactions: Very rare skin reactions such as erythema, pruritus, or urticaria.

Pregnancy & Lactation

Pregnancy: Uncontrolled diabetes during pregnancy increases the risk of congenital anomalies. Insulin is recommended over metformin to maintain near-normal blood glucose levels during pregnancy.

Breastfeeding: Metformin is present in human breast milk, though no adverse effects have been reported in breastfed infants. However, due to limited data, breastfeeding during metformin treatment is not advised.

Precautions & Warnings

Nobesit XR is primarily eliminated via the kidneys, and the risk of accumulation and lactic acidosis rises with renal impairment. Regular monitoring of renal function is essential for all diabetic patients. Discontinue Nobesit 2-3 days prior to surgeries and certain clinical evaluations, and only resume after renal function is stable. Monitor vitamin B12 levels annually due to reports of absorption issues. When combined with insulin or insulin secretagogues, blood glucose levels should be closely observed to avoid hypoglycemia.

Use in Special Populations

Elderly: Adjust metformin dosage based on renal function and conduct regular assessments.

Pediatrics: Confirm type 2 diabetes diagnosis before initiating treatment. Limited data on the impact of metformin on growth and puberty in children necessitates careful monitoring.

Renal Function: Regular monitoring of creatinine clearance is advised due to the renal excretion of metformin.

Overdose Effects

Hypoglycemia has not been observed at doses up to 85 grams; however, lactic acidosis is a serious medical condition that requires hospitalization and treatment, often involving hemodialysis to remove lactate and Nobesit.

Therapeutic Class

Biguanides

Storage Conditions

Store below 30°C, away from light and moisture. Keep out of reach of children.