Formit TABLETS
Oral Antihyperglycemic
   
COMPOSITION Formit 500mg : Each film-coated tablet contains Metformin hydrochloride 500mg.
Formit 850mg : Each film-coated tablet contains Metformin hydrochloride 850mg .
   
INDICATIONS Formit is used in the treatment of type 2 diabetes when strict dieting and sulphonylurea treatment have failed to control diabetes, especially in over weight patients, in whom it may be used as first line therapy. It can be used alone or with a sulphonylurea.
   
DOSAGE Formit 500 mg Initiate 500mg tablets with a dosage of 1 tablet two times a day with the morning and evening meals, increase dosage by 500mg/day increments at weekly intervals, to a maximum of 3 g/day.
Formit 850 mg Initiate 850mg tablets with 1 tablet/day with the morning meal. Increase dosage by 850mg/day increments every 2 weeks, to a maximum of 850mg three times daily. Individualize maintenance dosage based on glycemic response. Give all dosages up to 2g/day in 2 divided doses; larger doses require a three times daily regimen to reduce GI discomfort. The objective of therapy is to reduce fasting blood glucose and glycosylated hemoglobin to normal or near normal level using the lowest effective dosage of drug.
   
CONTRAINDICATIONS Individual hypersensitivity to Metformin; serum creatinine level exceeding 12mg/l; renal insufficiency or well characterized hepatic insufficiency (hepatitis, crirrhosis, steatosis); cardiovascular and respiratory diseases with tissue hypoxemia (cardiac decompensation, cardiogenic or toxic shock, peripheral circulatory disturbances); alcoholic intoxication; low-calorie diets; or when intravenous urography is performed (Metformin is to be withheld for 48 hrs before and after intravenous urography). Adrenal insufficiency. Keto-acidotic diabetes. Latent diabetes. Diabetic coma and pregnancy.
   
PRECAUTIONS Biguanides should only be used in cases in which dietary measures and weight reduction have proved insufficient. The use of these drugs, which must only be taken under medical supervision, should be confined to type 2 diabetes with no tendency to ketosis. In the event of injury, surgical operations, infectious diseases and fevers, it may be necessary to give insulin temporarily to maintain adequate metabolic control. The drug may potentiate the action of anticoagulants. Furosemide and nifedipine increases serum levels of Metformin, the clinical relevance of which is unknown. Cimetidine reduces tubular secretion of Metformin and may increase peak serum concentrations by as much as 60%. Patients must follow their physician's instructions both regarding dosage and dietary regimen. Patients on this drug must be checked frequently for any factor or conditions likely to favor the onset of lactic acidosis, patients over 60 years being most at risk. In any case patients must be taught how to recognise the warning symptoms of lactic acidosis, which are : anorexia, nausea, fever, vomiting, increased depth and frequency of breathing, malaise, abdominal pains, diarrhea and possibly dizziness or loss of consciousness.
   
SIDE EFFECTS Hypoglycemic reactions may occur, especially in elderly, debilitated or injured subjects. Biguanides may give rise to adverse effects in particular to lactic acidosis, this is infrequent but there have been fatal cases. Gastrointestinal disturbances may occur e.g. anorexia, nausea, vomiting, diarrhea (usually transient). Allergic reactions varying in degree and site, may occur in some patients. Decreased vitamin-B12 absorption.
   
PRESENTATIONS Formit is available as 500mg & 850mg tablets formulations.