(Product Name) MR Tablet 30mg (Product Name) MR Tablet 60mg
(Product Name) MR Tablet 30mg (Product Name) MR Tablet 60mg
(Product Name) MR Tablet 30mg (Product Name) MR Tablet 60mg
Gliclazide 30mg
Gliclazide 60mg
Product Description
[Visual description of the appearance of the product (eg colour, markings etc)
eg :Tablet - White, circular flat beveled edge tablets marked ‘100’ on one side ]
Pharmacodynamics
Pharmacokinetics
After oral administration, plasma levels increase progressively until 6 hours post-dose, reaching
a plateau between 6 and 12 hours post-dose. Intra-individual variability is low. Gliclazide is
completely absorbed. Food intake does not affect the rate or degree of absorption. Up until 120
mg the relationship between the dose administered and the area under the concentration-time
curve is linear (AUC). Plasma protein binding is approximately 95 %. Gliclazide is mainly
metabolised in the liver. Excretion is essentially in the urine; less than 1 % of the unchanged
form is found in the urine. No active metabolites have been detected in plasma. The elimination
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half-life of gliclazide is between 12 and 20 hours. The volume of distribution is approximately
30 litres. In the elderly, no clinically significant modifications in the pharmacokinetic parameters
have been observed. A single daily dose of gliclazide MR tablet maintains effective gliclazide
plasma concentrations over 24 hours.
Indication
Non insulin-dependent diabetes (type 2), in adults, when dietary measures, physical exercise and
weight loss alone are not sufficient to control blood glucose levels.
Recommended Dosage
For adult use only. The daily dose may vary from 30 to 120 mg taken as a single dose at
breakfast time. It is recommended to swallow the whole tablet without crushing or chewing. If a
dose is forgotten, the dose taken on the next day should not be increased. As with all
hypoglycaemic agents, the dose should be adjusted according to the individual patient's
metabolic response (glycaemia, HbA1c).
Initial dose
Replacement can be made provided that there is monitoring of blood glucose levels.
Gliclazide MR tablets can replace another oral antidiabetic treatment. In this case, the dosage and
half-life of the previous antidiabetic must be taken into account. Replacement should generally
be carried out without any transitional period, preferably starting with a dose of 30 mg. The
dosage should then be adapted according to the blood glucose response of each patient, as
described above. If a patient is switched from a sulphonylurea with a prolonged half-life, a
therapeutic window of a few days may prove necessary to avoid an additive effect of the two
products which may cause hypoglycaemia. During this changeover, it is recommended that the
same procedure be followed as for the initiation of treatment with Gliclazide MR tablets, i.e.
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initiate treatment with a dose of 30 mg per day and then increase the dosage by increments,
according to the metabolic response.
Gliclazide MR tablets can be given in combination with biguanides, alpha glucosidase inhibitors
or insulin. In patients not adequately controlled with Gliclazide MR tablets concomitant insulin
therapy can be initiated under close medical supervision.
Gliclazide MR tablets should be prescribed according to the same therapeutic regimen used in
subjects under 65.
The therapeutic regimen used should be the same as for subjects with normal renal function but
with careful monitoring.
Mode of Administration
Oral
Contraindications
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In general, it is not advisable to combine this drug with phenylbutazone, danazol or alcohol.
Hypoglycaemia
Hypoglycaemia may occur during treatment with hypoglycaemic sulphonylureas. Some cases
may be severe and prolonged. Hospitalisation may be required and blood sugar levels should be
corrected for several days if necessary. Careful selection of the patient and the dosage, as well as
keeping the patient adequately informed are necessary to avoid episodes of hypoglycaemia.
Patients who are elderly, undernourished or with a change in their general state, and patients with
adrenal insufficiency or hypopituitarism are particularly sensitive to the hypoglycaemic effects
of anti-diabetic agents. Hypoglycaemia may be difficult to diagnose in elderly subjects and
patients treated with beta-blockers.
This treatment should only be prescribed if the patient is likely to eat regularly (including
breakfast). A regular intake of carbohydrates is important due to the increased risk of
hypoglycaemia if meals are taken late, in cases of inadequate diet or if the diet contains an
inadequate balance of carbohydrates. Hypoglycaemia is more likely to occur in subjects
following a low-calorie diet, after considerable or prolonged exertion, after the consumption of
alcohol or during the administration of a combination of hypoglycaemic agents.
Renal or hepatic insufficiency may alter the distribution of gliclazide and hepatic insufficiency
may also reduce the capacity for gluconeogenesis ; these two effects increase the risk of serious
hypoglycaemic reactions.
Glycaemic imbalance
Control of blood glucose levels by anti-diabetic agents may be reduced in patients with fever,
trauma or infection or in patients undergoing surgery. In these cases, it may be necessary to
discontinue the treatment and administer insulin.
The efficacy of all oral hypoglycaemic agents, including gliclazide, in lowering blood sugar to
the desired level decreases in the long term in many patients. This may be due to an increase in
the severity of the diabetes or to a reduced response to the treatment. This phenomenon is known
as secondary failure and should be distinguished from primary failure, in which the drug proves
to be ineffective when prescribed as first-line treatment for a given patient. Adequate dosage
adjustment and observation of the diet must be considered before classing the patient as a
secondary failure.
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Biological tests
Medicinal products of the sulphonylurea class can cause a haemolytic anaemia in patients who
are carriers of a G6PD enzyme deficiency. As gliclazide belongs to this class, precautions must
be taken in G6PD deficient patients and a treatment from another therapeutic class other than
sulphonylureas must be envisaged.
Patient information
The risks of hypoglycaemia, together with its symptoms, treatment, and conditions that
predispose to its development, should be explained to the patient and to family members.
The patient should be informed of the importance of following dietary advice, of taking regular
exercise, and of regular monitoring of blood glucose levels.
Contra-indicated association
Inadvisable associations
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Phenylbutazone (systemic route)
Increase in the hypoglycaemic effect of sulphonylureas (displacement of plasma protein binding
and/or decrease in their elimination). An alternative anti-inflammatory agent with less potential
for interaction should preferably be used, otherwise to warn the patient and emphasize the need
for self-monitoring; if necessary, adjust the dosage of gliclazide during treatment with the anti-
inflammatory agent and after it has been discontinued.
Alcohol
Increased hypoglycaemic reaction (inhibition of compensatory mechanisms), which may
increase the likelihood of hypoglycaemic coma. Avoid the consumption of alcoholic drinks and
medicines containing alcohol.
Beta-blockers
All beta-blockers mask certain symptoms of hypoglycaemia : palpitations and tachycardia. Most
non-cardioselective beta-blockers increase the incidence and severity of hypoglycaemia. Inform
the patient and encourage self-monitoring of blood glucose levels, particularly at the start of
treatment.
Fluconazole
Increase in the half-life of the sulphonylurea with the possible occurrence of hypoglycaemic
symptoms. Inform the patient, emphasise the need for self-monitoring of blood glucose levels
and, if necessary, adjust the dosage of the sulphonylurea during treatment with fluconazole.
Inadvisable association
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Combinations requiring special precautions
Chlorpromazine (neuroleptics)
At high doses (100 mg per day of chlorpromazine) blood sugar levels may be raised (decrease in
the release of insulin). Inform the patient and emphasise the need for self-monitoring of blood
glucose levels. If necessary, adjust the dosage of the anti-diabetic agent during treatment with the
neuroleptic and after it has been discontinued.
Glucocorticoids (systemic and local route: intra-articular, cutaneous and rectal preparations)
and tetracosactrin
Increase in blood glucose levels with possible ketosis (reduced tolerance to carbohydrates due to
glucocorticoids).
Pregnancy
Relevant clinical data is currently insufficient for an evaluation of the possible malformative or
foetotoxic effects of gliclazide when it is administered during pregnancy.
Course of action
Maintaining diabetic control allows pregnancy to progress normally in this category of patients.
Insulin treatment is essential, irrespective of the type of diabetes, I or II, gestational or
permanent. In this last case, a change from oral treatment to insulin is recommended from the
time that pregnancy is planned, or if a pregnancy is discovered accidentally in a patient exposed
to gliclazide; in this case it is not automatically necessary to recommend a termination of the
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pregnancy, but the pregnancy should be monitored with particular care with appropriate prenatal
screening. Neonatal monitoring of blood glucose levels is recommended.
Lactation
In the absence of data concerning the passage into breast milk, and taking into account the risk of
neonatal hypoglycaemia, breast-feeding is contraindicated during treatment with this drug.
Hypoglycaemia
As for other sulphonylureas, treatment with gliclazide tablets can cause hypoglycaemia, if
mealtimes are irregular and, in particular, if meals are skipped. Possible symptoms of
hypoglycaemia are: headache, intense hunger, nausea, vomiting, lassitude, sleep disorders,
agitation, aggression, poor concentration, reduced awareness and slowed reactions, depression,
confusion, visual and speech disorders, aphasia, tremor, paresis, sensory disorders, dizziness,
feeling of powerlessness, loss of self-control, delirium, convulsions, shallow respiration,
bradycardia, drowsiness and loss of consciousness, possibly resulting in coma and lethal
outcome.
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Hepato-biliary disorders
Raised hepatic enzyme levels (AST, ALT, alkaline phosphatase), hepatitis (isolated reports).
Discontinue treatment if cholestatic jaundice appears. These symptoms usually disappear after
discontinuation of treatment.
Eye disorders
Transient visual disturbances may occur especially on initiation of treatment, due to changes in
blood glucose levels.
Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders, are
possible and constitute a medical emergency requiring the immediate hospitalisation of the
patient.
Plasma clearance of gliclazide may be prolonged in patients suffering from a hepatic disorder.
Dialysis is of no value as gliclazide is highly protein-bound.
Storage Conditions
Store below ….C
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Dosage Forms and Packaging Available
[ Packaging type & pack size eg Alu-alu blister of 10s X 10/box, HDPE bottle of 30s/box etc ]
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