Bigsens XR 750

Bigsens XR 750

metformin

Manufacturer:

Zydus Healthcare

Distributor:

Zydus Healthcare
Concise Prescribing Info
Contents
Metformin HCl
Indications/Uses
Type 2 DM in adults, particularly overwt patients when dietary management & exercise alone does not result in adequate glycemic control as monotherapy or in combination w/ other oral antidiabetic agents or insulin.
Dosage/Direction for Use
Monotherapy & combination w/ other oral antidiabetic agents Initially 500 mg ER tab once daily. May be increased in increments of 500 mg every 10-15 days on the basis of blood glucose measurements. Max: 2 g once daily. Patient treated w/ metformin tab Starting dose of ER tab should be equiv to the daily dose of metformin IR tab. Combination w/ insulin Initially 500 mg ER tab once daily. Patient already treated w/ metformin & insulin combination therapy Dose should be equiv to the daily dose of metformin tab up to max of 1.5 g or 2 g respectively while insulin dosage is adjusted on the basis of blood glucose measurements.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Diabetic ketoacidosis/pre-coma; acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock; acute or chronic disease which may cause tissue hypoxia eg, cardiac or resp failure, recent MI, shock. Renal failure or dysfunction (CrCl <60 mL/min). Hepatic insufficiency, acute alcohol intoxication, alcoholism.
Special Precautions
Lactic acidosis. Poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency & any condition associated w/ hypoxia. Determine CrCl before initiating treatment & regularly thereafter at least annually in patients w/ normal renal function & at least 2-4 times a yr in patients w/ CrCl levels at the limit of normal & in the elderly. Discontinue metformin prior to, or at the time of administration of iodinated contrast media in radiological studies & not reinstituted until 48 hr afterwards. Discontinue metformin 48 hr before elective surgery w/ general spinal or peridural anaesth & may be restarted no earlier than 48 hr following surgery or resumption of oral nutrition provided normal renal function has been established. Continue diet w/ regular distribution of carbohydrate intake daily. Concomitant use w/ insulin or other oral antidiabetics (eg, sulfonylurea or meglitinides). Pregnancy & lactation.
Adverse Reactions
GI disorders eg, nausea, vomiting, diarrhoea, abdominal pain & loss of appetite. Taste disturbance.
Drug Interactions
Increased risk of lactic acidosis w/ alcohol & diuretics especially loop diuretics. May lead to renal failure resulting in metformin accumulation & risk of lactic acidosis w/ iodinated contrast media. Medicinal products w/ intrinsic hyperglycaemic activity eg, glucocorticoids (systemic & local routes) & sympathomimetics.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
Presentation/Packing
Form
Bigsens XR 750 ER tab 750 mg
Packing/Price
100's (P9/ER tab)
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