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Diabetmin
Description
Diabetmin 500mg Tablet : Round, white film-coated tablet, bevel-edged and
shallow convex faces.
Diabetmin Retard Tablet Round, white uncoated tablet with convex faces.
Diabetmin 850mg Tablet : Round, white film-coated tablet with deep convex
faces and 'hovid' embossed on one face.
Composition
Diabetmin 500mg Tablet : Metformin Hydrochloride 500mg per tablet.
Diabetmin Retard Tablet : Metformin Hydrochloride 850mg per tablet
(Extended-release).
Diabetmin 850mg Tablet : Metformin Hydrochloride 850mg
per tablet.
Actions and Pharmacology
Metformin is an oral biguanide antidiabetic agent. Its mode of action is
thought to be multifactorial and includes delayed uptake of glucose from the
gastro-intestinal tract; increased peripheral glucose utilization mediated
by increased insulin sensitivity; and inhibition of increased hepatic and
renal gluconeogenesis.
Pharmacokinetics
Metformin Hydrochloride is slowly and incompletely absorbed from the
gastrointestinal tract. The absolute bioavailability of a single 500mg dose
is reported to be about 50 to 60%, although this is reduced somewhat if
taken with food. Plasma protein binding is negligible. It is excreted
unchanged in the urine. The plasma elimination half-life is reported to
range from about 2 to 6 hours after oral administration.
Indications
Metformin is used in the treatment of non-insulin-dependent diabetes
mellitus (type 2) in adults, not responding to exercise and dietary
modification. Diabetmin may be used as monotherapy or in combination with
other oral antidiabetic agents, or with insulin.
Contraindications
This medication is contraindicated in patients with the following medical
problems:
-
Hypersensitivity to metformin.
- Any condition needing close blood glucose control, such as: severe burns,
dehydration, diabetic coma, diabetic ketoacidosis, hyperosmolar nonketotic
coma, severe infection, major surgery, and severe trauma.
- Conditions associated with hypoxemia, such as: cardiorespiratory
insufficiency, cardiovascular collapse, congestive heart failure, acute
myocardial infarction.
- Severe, acute, or chronic hepatic disease.
-
Active or history of lactic acidosis.
-
Renal function impairment or renal disease.
-
Diagnostic or medical examinations using intravascular iodinated contrast
media such as: angiography, intravenous cholangiography, computed tomography
(CT) scan, pyelography and urography.
Precautions
Lactic Acidosis:
Lactic acidosis is a rare, but serious (high mortality in the absence of
prompt treatment), metabolic complication that can occur due to metformin
accumulation. Reported cases of lactic acidosis in patients on metformin
have occurred primarily in diabetic patients with significant renal failure.
The incidence of lactic acidosis can and should be reduced by assessing also
other associated risk factors such as poorly controlled diabetes, ketosis,
prolonged fasting, excessive alcohol intake, hepatic insufficiency and any
condition associated with hypoxia.
Diagnosis: Lactic acidosis is characterized by acidosis dyspnea, abdominal
pain and hypothermia followed by coma. Diagnostic laboratory findings are
decreased blood pH, plasma lactate levels above 5 mmol/L, and an increased
anion gap and lactate/pyrute ratio. If metabolic acidosis is suspected,
metformin should be discontinued and the patient should be hospitalized
immediately.
Renal Function:
As metformin is excreted by the kidney, serum creatinine levels should be
determined before initiating treatment and regularly thereafter:
-
at least annually in patients with normal renal function;
- at least 2 to 4 times a year in patients with serum creatinine levels at
the upper limit of normal and in elderly subjects.
Decreased renal function in elderly subjects is frequent and asymptomatic.
Special caution should be exercised in situations where renal function may
become impaired, for example when initiating antihypertensive therapy or
diuretic therapy and when starting therapy with an NSAID.
Administration of iodinated contrast agent: As the intravascular
administration of iodinated contrast materials in radiologic studies can
lead to renal failure, metformin should be discontinued prior to, or at the
time of the test and not reinstituted until 48 hours afterwards, and only
after renal function has been re-evaluated and found to be normal.
Surgery:
Metformin should be discontinued before elective surgery with general
anaesthesia and should not be usually resumed earlier than 48 hours
afterwards.
Other precautions:
- All patients should continue their diet with a regular distribution of
carbohydrate intake during the day. Overweight patients should continue
their energy-restricted diet.
-
The usual laboratory tests for diabetes monitoring should be performed
regularly.
-
Metformin alone never causes hypoglycaemia, although caution is advised when
it is used in combination with insulin or sulfonylureas.
Use in pregnancy and lactation
For fertility and pregnancy problems, adequate and well-controlled studies
in humans have not been done and documented. For patient plans to become
pregnant or during pregnancy, control of blood glucose with diet alone or a
combination of diet and insulin is recommended, while use of metformin is
discouraged. Metformin is distributed into breast milk, but safety for use
in nursing mothers has not been established.
Main Side/Adverse Effects
Metformin can cause:
- Gastrointestinal adverse effects including anorexia, diarrhea, dyspepsia,
flatulence, nausea, vomiting.
- Headache, metallic taste, weight loss.
- Anemia, megaloblastic, hypoglycemia, lactic acidosis.
-
Long-term metformin therapy may cause a decrease of vitamin B12 absorption
with decrease of serum levels.
Drug Interactions
Concurrent use of this medication with the following may interact with
metformin:
- Acute or chronic ingestion of alcohol.
-
Cimetidine or other cationic medications excreted by renal tubular
transport.
- Furosemide.
-
Hyperglycemia-causing and hypoglycemia-causing medications.
Overdose
Symptoms of overdose: Hypoglycemia and lactic acidosis.
Treatment of overdose:
-
For hypoglycemia: Treating with immediate ingestion of a source of glucose
and counseling patient to obtain emergency medical assistance immediately.
-
For lactic acidosis: Hemodialysis with sodium bicarbonate.
Dosage and Administration
Oral.
Monotherapy and combination with other oral antidiabetic agents:
Usual adult
dose:
Diabetmin 500mg Tablet : Initial dose of one tablet 2 to 3 times daily with
or after meals.
Diabetmin Retard Tablet Initial dose of one tablet 2 times
daily with or after meals.
Diabetmin 850mg Tablet : Initial dose of one
tablet 2 times daily with or after meals.
If necessary, medication can be increased gradually to a maximum of 3g
daily.
If transfer from another oral antidiabetic agent is intended; discontinue
the other agent and initiate metformin at the dose indicated above.
Combination with insulin:
Metformin and insulin may be used in combination therapy to achieve better
blood glucose control. Metformin is given at the usual starting dose of one
tablet 2-3 times daily while insulin dosage is adjusted on the basis of
blood glucose measurements.
Usual children dose : Metformin is not recommended for use in children.
Usual geriatric dose : Please refer to adult dose.
(Due to potential for decreased renal function, the dosage should adjusted
based on renal function and maximum doses are not advised for use in the
elderly.)
Note: The information given here is limited. For further information, kindly
consult your doctor or pharmacist.
Shelf-life : 3 years from the date of manufacture.
Storage : Store below 25°C. Protect from light and moisture.
Presentation/Packing
Diabetmin 500mg Tablet : Plastic bottle of 100's, 500's, 1000's; Blister
pack of 10 x 10's.
Diabetmin Retard Tablet : Plastic bottle of 100's;
Blister pack of 10 x 10's.
Diabetmin 850mg Tablet : Plastic bottle of 100's;
Blister pack of 10 x 10's. |
