Sugamet XR 500 mg (Tablet (Extended Release))

Indications

• Treatment of type 2 diabetes mellitus in adults
• Treatment of type 2 diabetes mellitus in children and adolescents
• May be used as monotherapy
• May be used in combination with other oral antidiabetic agents
• May be used in combination with insulin
• Reduction of diabetic complications in overweight patients

Pharmacology

• Biguanide type oral antihyperglycemic drug
• Lowers both basal and postprandial plasma glucose
• Different mechanism of action from sulfonylureas
• Does not produce hypoglycemia
• Decreases hepatic glucose production
• Decreases intestinal absorption of glucose
• Improves insulin sensitivity

Dosage & Administration

• Individualized dosage based on effectiveness and tolerance
• Maximum recommended daily doses
• Dosage increases in increments
• Usual starting dose for adults
• Usual starting dose for children
• Dosage for renal impaired patients
• Instructions for swallowing extended release tablet whole

Interaction

• No information available for Sugamet XR and Furosemide interaction
• Nifedipine enhances absorption of Sugamet XR
• Minimal effects of Sugamet XR on Nifedipine
• Potential interaction with cationic drugs
• No effect on Cimetidine pharmacokinetics
• Drugs that may produce hyperglycemia

Contraindications

• Hypersensitivity to active substance or excipients
• Acute metabolic acidosis
• Severe renal failure
• Conditions altering renal function
• Conditions causing tissue hypoxia

Side Effects

• Hemolytic anemia
• Lactic acidosis
• Decrease of vitamin B12 absorption
• Peripheral neuropathy in patients with vitamin B12 deficiency
• Taste disturbance
• Encephalopathy
• Gastrointestinal disorders
• Liver function test abnormalities or hepatitis
• Skin reactions

Pregnancy & Lactation

• Uncontrolled diabetes during pregnancy associated with increased risk of congenital abnormalities and perinatal mortality
• Recommendation to use insulin during pregnancy
• Excretion of Metformin into human breast milk
• No adverse effects observed in breastfed newborns/infants
• Breastfeeding not recommended during Metformin treatment

Precautions & Warnings

• Substantial excretion of Sugamet XR by the kidney
• Lowering of vitamin B12 level
• Increased risk of hypoglycemia
• Regular monitoring of renal function
• Treatment cessation before surgery and clinical investigations
• Annual estimation of Vitamin B-12 levels
• Monitoring blood glucose during combined therapy
• Possible interaction with Cimetidine and anticoagulants

Use in Special Populations

• Adjustment of metformin dosage based on renal function in the elderly
• No effect of metformin on growth and puberty detected during controlled clinical studies
• Caution in prescribing to children aged between 10 and 12 years
• Recommendation for regular assessment of renal function
• Special caution in situations where renal function may become impaired

Overdose Effects

• Hypoglycemia not seen with Sugamet XR doses up to 85 gm
• Lactic acidosis occurred in overdose circumstances
• Hemodialysis for removal of lactate and Sugamet XR

Therapeutic Class

• Biguanides

Storage Conditions

• Keep below 30°C temperature
• Protected from light & moisture
• Keep out of the reach of children

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