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Formit
TABLETS Oral Antihyperglycemic |
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| COMPOSITION |
Formit 500mg : Each film-coated tablet contains
Metformin hydrochloride 500mg. Formit 850mg :
Each film-coated tablet contains Metformin hydrochloride 850mg . |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| PRESENTATIONS |
Formit is available as 500mg & 850mg tablets formulations. |
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