|
Glucomet Ingredient(s)
Each tablet contains: Metformin HCI ............. 500mg
Pharmacology (Summary of Pharmacodynamic and Pharmacokinetics)
1. The biguanide Metformin is an oral antihyperglycemic agent used in the
management of non-insulin-dependent diabetes mellitus (NIDDM). It reduces
blood glucose levels, predominantly by improving hepatic and peripheral
tissue sensitivity to insulin without affecting the secretion of this
hormone. Since Metformin does not promote weight gain or hypoglycemia, it
should be considered first-line pharmacotherapy in obese patients with NIDDM
that is inadequately controlled by nonpharmacological measures. 2.
Metformin decrease gluconeogenesis from lactate (pyruvate) and elevates the
glucose utilization of peripheral tissues. 3. Metformin reduces elevated
blood glucose concentrations in patients with diabetes, but it does not
increase insulin secretion. This is probably the reason why it does not
cause hypoglycemia. 4. Metformin has no effect on the pancreatic beta
cells. It has been postulated that Metformin may potentiate the effect of
insulin or enhance insulin's effect on peripheral receptor sites. 5. A
lipolytic action of Metformin has been suggested and a lipid-lowering effect
has been demonstrated, including reduction of plasma triglycerides and, to a
lesser degree, of total cholesterol. 6. Metformin improves the blood
lipoprotein profile not only in diabetics but also in non-diabetic subjects
with hyperlipoproteinemia. 7. Metformin oral bioavailability of usual
doses is 50 ~ 60%, and the mean plasma elimination half-life ranges from 1.5
~ 4.5 hours.
Indication(s)
Treatment of type 2 diabetes mellitus in adults, when dietary management and
exercise alone does not result in adequate glycemic control. Metformin may
be used as monotherapy or in combination with other oral antidiabetic
agents, or with insulin. A reduction of diabetic complications has been
shown in overweight type-2 diabetic patients treated with metformin as 1st
line therapy after diet failure. In type 1 diabetes, Metformin may be given
as an adjuvant to patients whose symptoms are poorly controlled.
Dosage and Administration
The usual dose is 500mg three times daily, taken with food or after meals;
maximum 3g daily in divided doses.
Contraindication(s)
1. Hypersensitivity to biguanides.
2. Diabetic coma and serious ketoacidosis.
3. Impaired renal function, impaired hepatic function, and impaired
cardiovascular function including cardiac failure and recent myocardial
infarction.
4. History of, or state associated with lactic acidosis, eg. shock or
pulmonary insufficiency, alcoholism.
5. Condition associated with hypoxaemia.
Precaution(s) / Warning(s)
1. Metformin is excreted by the kidney and regular monitoring of renal
function is advised in all diabetics.
2. Care must be taken when administering this drug in conditions which may
cause dehydrations or in patients suffering from serious infection or
trauma, and in those undergoing surgery.
3. Metformin may impair absorption of Vitamin B12. Patients
receiving Metformin continuously should have an annual check up of vitamin B12
levels.
4. Use in pregnancy and lactation: The use of Metformin during pregnancy is
not advisable. It is not known if Metformin is excreted in
breast milk; however, hypoglycemia in infant is possible.
5. Use in children: Metformin is not recommended for use in children.
6. Use in the elderly: Metformin is indicated in the elderly but not when
renal function is impaired. Drug Interaction(s)
1. Alcohol causes enhanced hypoglycemic effect and risk of lactic acidosis
with Metformin.
2. Concomitant therapy with sulfonylurea may cause hypoglycemia, therefore
blood glucose should be monitored.
3. Reduced renal clearance of Metformin has been reported during Cimetidine
therapy, so a dose reduction should be considered.
4. An interaction of Metformin with anticoagulants is a possibility and the
dosage of anticoagulants may need adjustment.
Side Effect(s) / Adverse Reaction(s)
Concomitant therapy with sulfonylurea may cause hypoglycemia, therefore
blood glucose should be monitored. Metformin may impair absorption of
Vitamin B12. Patients receiving Metformin continuously should
have an annual check up of vitamin B12 levels. Reduced renal
clearance of Metformin has been reported during Cimetidine therapy, so a
dose reduction should be considered.
An interaction of Metformin with anticoagulants is a possibility and the
dosage of anticoagulants may need adjustment.
The most frequently reported adverse effects are: metallic taste in the
mouth, epigastric discomfort, nausea and vomiting, lactic acidosis,
decreased vitamin B12 absorption: rarely diarrhea and anorexia. Most of
these reactions are transient and can be controlled by reducing the dosage
or by discontinuing therapy.
Symptoms and Treatment for Overdosage, and Antidote(s)
Hypoglycemia may occur when Metformin is given concomitantly with a
sulfonylurea, insulin or alcohol. In excessive dosage, lactic acidosis may
develop. Intensive supportive therapy is recommended which should be
particularly directed at correcting fluid loss and metabolic disturbance.
Shelf-Life
3 years from the date of manufacture.
Storage Condition(s)
Keep in a tight container. Store at temperature below 30°C. Protect from
light and moisture.
Product Description & Packing(s)
A white to off-white round tablet, one side impressed with a score and the
other side with a mark
Plastic bottle of 1000's (for export only).
Blister packing of 10's x 10 and
10's x 100. |
