Diamicron/Diamicron MR 60

Diamicron/Diamicron MR 60 Dosage/Direction for Use

gliclazide

Manufacturer:

Servier

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
Diamicron: Restricted to adults.
As with any hypoglycemic agent, the dosages should be adjusted to the particular circumstances.
In the event of a transitory loss of blood glucose control in a patient where good control is usually achieved by diet, it may be sufficient to administer this product for a short period.
Patients under the age of 65: Initial dose: The recommended initial dose is one tablet per day.
Dosage steps: Adjustments in posology are usually made in steps of one tablet at a time, depending on the response in blood glucose. At least 14 days should separate successive steps in the dose.
Maintenance treatment: The posology can vary from 1 to 3, or rarely 4, tablets per day.
The usual posology is 2 tablets a day, as 2 daily doses.
Patients at particular risk: Patients over the age of 65: Begin the treatment with a half-tablet once a day.
The dose can be progressively increased until the patient's blood glucose is satisfactorily controlled, while keeping to steps of at least 14 days between successive levels, and with close monitoring of blood glucose.
Other patients at particular risk: In patients who are malnourished or showing markedly poor general state of health, or whose calorie intake is irregular, or whose kidney or liver function is impaired, treatment should be begun at the lowest dose. The stepwise increases in dosage must be scrupulously adhered to in order to avoid a hypoglycemic reaction.
Patients treated with other oral hypoglycemic agents: As with any sulfonylurea, this medicinal product can be used as follow-on from another antidiabetic drug, without any transitional period being needed. When patients change to this medication from a sulfonylurea with a longer half-life (such as chlorpropamide), they must be closely monitored (for several weeks). This is to avoid the possible occurrence of hypoglycemia due to an overlapping of effects from the two treatments.
Pediatric population: The safety and efficacy of Gliclazide (Diamicron) 80 mg in children and adolescents have not been established. No data are available.
Method of administration: Oral route.
Missed Dose: Take one tablet with the next meal. Do not take a double dose to compensate the single dose the patient has forgotten to take.
Diamicron MR 60: The daily dose of GLICLAZIDE (DIAMICRON MR) 60 mg may vary from one half to 2 tablets per day, i.e. from 30 to 120 mg taken orally in a single intake at breakfast time.
It is recommended to swallow the dose without crushing or chewing.
If a dose is forgotten, there must be no increase in the dose taken the next day.
As with any hypoglycemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbA1c).
Initial dose: The recommended starting dose is 30 mg daily [half a tablet of GLICLAZIDE (DIAMICRON MR) 60 mg. If blood glucose is effectively controlled, this dose may be used for maintenance treatment.
If blood glucose is not adequately controlled, the dose may be increased to 60, 90 or 120 mg daily, in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment.
The maximum recommended daily dose is 120 mg.
One GLICLAZIDE (DIAMICRON MR) 60 mg modified-release tablet is equivalent to two Gliclazide (Diamicron MR) 30 mg modified-release tablets. The breakability of the GLICLAZIDE (DIAMICRON MR) 60 mg modified-release tablet enables flexibility of dosing to be achieved.
Switching from Gliclazide (Diamicron) 80 mg tablets to GLICLAZIDE (DIAMICRON MR) 60 mg modified-release tablets: One tablet of Gliclazide (Diamicron) 80 mg tablet is comparable to 30 mg of the modified release formulation (i.e. half a tablet of DIAMICRON 60 mg.) Consequently, the switch can be performed with careful blood monitoring.
Switching from another oral antidiabetic agent to GLICLAZIDE (DIAMICRON MR) 60 mg: GLICLAZIDE (DIAMICRON MR) 60 mg can be used to replace other oral antidiabetic agents.
The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to GLICLAZIDE (DIAMICRON MR) 60 mg.
A transitional period is not generally necessary. A starting dose of 30 mg should be used and this should be adjusted to suit the patient's blood glucose response, as described previously.
When switching from a hypoglycemic sulfonylurea with a prolonged half-life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which might cause hypoglycemia. The procedure described for initiating treatment should also be used when switching to treatment with GLICLAZIDE (DIAMICRON MR) 60 mg, i.e. a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response.
Combination treatment with other antidiabetic agents: GLICLAZIDE (DIAMICRON MR) 60 mg can be given in combination with biguanides, alpha glucosidase inhibitors or insulin.
In patients not adequately controlled with GLICLAZIDE (DIAMICRON MR) 60 mg, concomitant insulin therapy can be initiated under close medical supervision.
Special Populations: Elderly: GLICLAZIDE (DIAMICRON MR) 60 mg should be prescribed using the same dosing regimen recommended for patients under 65 years of age.
Renal impairment: In patients with mild to moderate renal insufficiency, the same dosing regimen can be used as in patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials.
Patients at risk of hypoglycemia: Undernourished or malnourished; Severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency); Withdrawal of prolonged and/or high dose corticosteroid therapy; Severe vascular disease (severe coronary heart disease, severe carotid impairment, diffuse vascular disease).
It is recommended that the minimum daily starting dose of 30 mg is used.
Pediatric population: The safety and efficacy of GLICLAZIDE (DIAMICRON MR) 60 mg in children and adolescents have not been established. No data are available.
Missed Dose: It is important to take the medicine everyday as regular treatment works better.
However, if the patient forgets to take a dose of GLICLAZIDE (DIAMICRON MR) 60 mg, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
Discontinuation of Treatment: As the treatment for diabetes is usually life long, the patient should discuss with the doctor before stopping this medicinal product.
Stopping could cause high blood sugar (hyperglycemia) which increases the risk of developing complications of diabetes. If the patient has any further questions on the use of this product, ask the doctor or pharmacist.
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