Rhea Metformin Hydrochloride

Rhea Metformin Hydrochloride





Concise Prescribing Info
Metformin HCl
Type 2 DM in adult, particularly in overwt, when dietary management & exercise alone does not result in adequate glycemic control, either as monotherapy or in combination w/ other oral antidiabetics or insulin, in childn from 10 yr & & adolescents. 1st line therapy in overwt type 2 diabetic adult patients that has been shown to reduce diabetes complications. Impaired glucose tolerance for patients in whom lifestyle interventions have failed.
Dosage/Direction for Use
Adult Monotherapy & combination w/ other oral antidiabetics Initially 500 mg or 850 mg bid or tid. May be slowly increased by an increment of 1 tab after 10-15 days depending on blood glucose measurement. Max: 3 g daily in 3 divided doses. Combination w/ insulin Initially 500 mg or 850 mg bid or tid. Childn & adolescent Monotherapy & combination w/ insulin Initially 500 mg or 850 mg once daily. May be slowly increase by an increment of 1 tab after 10-15 days. Max: 2 g daily in 2 or 3 divided doses.
Should be taken with food.
Hypersensitivity. Severe destabilization of diabetes w/ either pre-coma or ketoacidosis; renal insufficiency w/ increased blood creatinine levels or decreased CrCl <60 mL/min; acute conditions w/ the potential to alter renal functions eg, dehydration, severe infection, use of iodinated contrast media; elective major surgery; disease that cause tissue hypoxia eg, cardiac failure, recent MI, shock, resp insufficiency; acute alcohol intoxication, alcoholism; liver impairment.
Special Precautions
Lactic acidosis & hypoglycemia may occur. Determine renal function before treatment, at least annually or 2-4 times a year (in patients w/ CrCl lower at limit of normal & elderly) & regularly thereafter. Continue diet w/ regular carbohydrate intake; energy-restricted diet in overwt patients. Perform tests for diabetes monitoring regularly. Concomitant use w/ insulin & other oral antidiabetics (eg, sulfonylureas or meglitinides); avoid use of alcohol. Renal impairment. Pregnancy & lactation. Childn (pre-pubescent); confirm diagnosis of type 2 DM prior to treatment.
Adverse Reactions
GI disorders eg, nausea, vomiting, diarrhea, abdominal pain & loss of appetite; taste disturbance (metallic taste).
Drug Interactions
Discontinue 48 hr before use of iodinated contrast materials or from the time of use & do not reinstitute until 48 hr afterwards. Increased risk of lactic acidosis w/ diuretics especially loop diuretics, alcohol or alcohol-containing medications. May adjust dose during therapy w/ drugs w/ intrinsic hyperglycemic activity (eg, systemic or local glucocorticoids & sympathomimetics) & upon discontinuation.
MIMS Class
ATC Classification
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
Rhea Metformin Hydrochloride FC tab 500 mg
100's (P325/box)
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