Oramet-SR 500 mg (Tablet (Sustained Release))

Indications

• Treatment of type 2 diabetes mellitus
• Management of diabetes in overweight patients
• Reduction of diabetic complications
• Monotherapy for adults
• Combination therapy for adults
• Treatment for children from 10 years of age
• Monotherapy for children and adolescents
• Combination therapy for children and adolescents

Pharmacology

• Biguanide type oral antihyperglycemic drug
• Lowers basal and postprandial plasma glucose
• Different mechanism of action from sulfonylureas
• No production of hypoglycemia
• Decreases hepatic glucose production
• Decreases intestinal absorption of glucose
• Improves insulin sensitivity
• Increases peripheral glucose uptake and utilization

Dosage & Administration

• Individualized dosage based on effectiveness and tolerance
• Maximum recommended daily doses
• Starting dose for adults and children
• Dosage increases
• Maximum daily dose for additional glycemic control
• Instructions for Metformin immediate release tablet
• Instructions for Metformin extended release tablet
• Dosage adjustment for renal impaired patients

Interaction

• No chronic co-administration information with Furosemide
• Enhanced absorption with Nifedipine
• Minimal effects on Nifedipine
• Potential interaction with cationic drugs
• No effect on Cimetidine pharmacokinetics
• Drugs that may produce hyperglycemia and loss of glycemic control

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

• Risk of congenital abnormalities and perinatal mortality
• Recommendation to use insulin during pregnancy
• Excretion into human breast milk
• Limited data on breastfeeding recommendation

Precautions & Warnings

• Substantial excretion by the kidney
• Increased risk of lactic acidosis
• Lower vitamin B12 level
• Increased risk of hypoglycemia
• Monitoring of renal function
• Therapy cessation before surgery and clinical investigations
• Caution in dehydrated patients or those with serious infections
• Regular estimation of Vitamin B-12 levels
• Blood glucose monitoring during combined therapy
• Renal clearance reduction during cimetidine therapy
• Possibility of interaction with anticoagulants

Use in Special Populations

• Dosage adjustment for elderly subjects
• Confirmation of type 2 diabetes mellitus before treatment initiation
• No effect on growth and puberty detected during controlled clinical studies
• Caution in prescribing to children aged between 10 and 12 years
• Creatinine clearance determination before treatment initiation and regularly thereafter
• Caution in situations where renal function may become impaired
• Contradictions in patients with GFR < 30 ml/min

Overdose Effects

• No hypoglycemia seen with Oramet-SR doses
• Occurrence of lactic acidosis
• Medical emergency requiring hospital treatment
• Hemodialysis for removal of lactate and Oramet-SR

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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