Medicinal Products

DIAMICRON 30 mg

Generic drug of the therapeutic class: Metabolism and nutrition
active ingredients: Gliclazide
laboratory: Servier

Modified release tablet
Box of 180
All forms

Indication

Non-insulin-dependent diabetes (type 2) in adults, when diet, exercise and weight reduction alone are not sufficient to achieve glycemic control.

Dosage DIAMICRON 30 mg Modified release tablet Box of 180

Oral way.
Reserved for adults.
- The daily dose may vary from 1 to 4 tablets per day, or 30 to 120 mg in a single oral intake at breakfast.
- It is recommended to swallow the whole tablet (s). If you miss a dose, the next day dose should not be increased.
- As with any hypoglycemic agent, the dosage should be adjusted according to the individual metabolic response of each patient (glycemia, HbA1c).
- Initial dose:
The recommended starting dose is 30 mg daily.
. If the glycemic control is satisfactory, this dosage can be adopted as a maintenance treatment,
. if the glycemic control is unsatisfactory, the dosage may be increased to 60, 90 or 120 mg per day, in successive increments, with an interval of at least 1 month between each level, except in patients for whom blood glucose does not decrease after two weeks of treatment. In this case, it is possible to propose an increase of the dosage as of the end of the second week of treatment.
The maximum recommended dose is 120 mg daily.
- Diamicron 80 mg tablets, tablets by Diamicron 30 mg, modified release tablets:
1 tablet of Diamicron 80 mg is comparable to 1 tablet of Diamicron 30 mg. Therefore, the relay can be done provided you follow carefully the evolution of blood glucose.
- Relay of another oral antidiabetic by Diamicron 30 mg:
. Diamicron 30 mg may take over from another oral antidiabetic therapy.
. In this case, the dosage and half-life of the previous antidiabetic agent should be taken into account.
. The relay will generally be without a transition period, preferably starting with a dosage of 30 mg. The dosage will then be adjusted as indicated above, depending on the glycemic response of each patient.
. In the case of relays of a sulphonylurea with a prolonged half-life, a therapeutic window of a few days may be necessary in order to avoid an additive effect of the two products which may lead to hypoglycaemia.
. During this relay, it is recommended to follow the same procedure as when initiating a treatment with Diamicron 30 mg, that is to say to start at the dose of 30 mg per day, then to increase the dosage in successive steps, depending on the metabolic results.
- Association with other oral antidiabetic agents:
. Diamicron 30 mg may be combined with biguanides, alpha-glucosidase inhibitors or insulin.
. In patients not adequately equilibrated with Diamicron 30 mg, insulin-associated therapy may be initiated under strict medical supervision.
- In patients over 65 years old, Diamicron 30 mg will be prescribed according to the same regimen as in subjects under 65 years of age.
- In patients with mild to moderate renal impairment, the dosing regimen will be the same as in subjects with normal renal function but with careful monitoring.
. These data were confirmed in clinical trials.
- In patients at risk of hypoglycemia:
. states of undernutrition or malnutrition,
. severe or poorly compensated endocrine pathologies (ante-pituitary insufficiency, hypothyroidism, adrenal insufficiency),
. weaning from prolonged and / or high dose corticosteroid
. severe vascular disease (severe coronary artery disease, severe carotid artery disease, diffuse vascular disease);
It is recommended that treatment be started at the minimum dose of 30 mg / day.
- There are no data or clinical trials in children.

Against indications

CONTRAINDICATED:
- known hypersensitivity to gliclazide or to one of the constituents, to other sulfonylureas, to sulphonamides;
- type 1 diabetes;
- diabetic precoma and coma, diabetic ketoacidosis;
- severe renal or hepatic impairment: in these situations, insulin is recommended;
- Breastfeeding: There is no data on the passage of gliclazide or its metabolites in breast milk. Because of the risk of neonatal hypoglycaemia, gliclazide is contraindicated in breastfeeding women;
- treatment with miconazole (see section interactions).
NOT RECOMMENDED :
- There are no data or clinical trials in children.
- Drugs in the sulfonylurea class are likely to cause haemolytic anemia in subjects with G6PD (glucose-6-phosphate dehydrogenase) enzyme deficiency. Since gliclazide belongs to this class, caution should be exercised in patients with G6PD deficiency and treatment in another therapeutic class than sulfonylureas should be considered.
- Pregnancy: There are no clinical data on the administration of gliclazide in pregnant women; few data exist with other sulfonylureas. In animals, gliclazide is not teratogenic. Diabetes control should be obtained before conception to reduce the risk of birth defects due to poorly balanced diabetes. During pregnancy, oral antidiabetic agents are not appropriate and insulin is the treatment of choice for diabetes. It is recommended to relay oral antidiabetic therapy with insulin when a pregnancy is planned or when it is discovered.
- Associations advised against : phenylbutazone (general route); alcohol; danazol.

Adverse effects Diamicron

Based on clinical experience with gliclazide and other sulfonylureas, the following side effects should be mentioned:
- Hypoglycaemia :
As with other hypoglycaemic sulfonamides, treatment with Diamicron 30 mg may result in hypoglycaemia, particularly when meals are taken at irregular intervals and when a meal is skipped.
Possible symptoms are: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggression, decreased concentration, alertness and reactions, depression, confusion, visual disturbances and speech disorders, aphasia, tremors, paresis, sensory disturbances, dizziness, feeling of helplessness, loss of self-control, delirium, convulsions, shallow breathing, bradycardia, drowsiness, loss of consciousness or even coma and which can lead to a fatal outcome.
On the other hand, signs of adrenergic counter-regulation can be observed: hypersudation, moist skin, anxiety, tachycardia, hypertension, palpitations, angina and cardiac arrhythmia.
Symptoms usually disappear after taking carbohydrates (carbohydrates). On the other hand, artificial sweeteners have no effect. Experience with other sulphonylureas shows that despite initially effective measures, hypoglycaemia may re-offend.
In case of severe or prolonged hypoglycemia, even temporarily controlled by sugar absorption, immediate medical treatment or hospitalization may be required.
Gastrointestinal disorders such as abdominal pain, nausea, vomiting, dyspepsia, diarrhea, constipation have been reported; they can be avoided or decreased if treatment is taken during breakfast.
- The following side effects have been reported more rarely:
. Mucocutaneous rashes: rash, pruritus, urticaria, erythema, maculopapular rash, bullous reactions.
. Hematologic disorders: they are rare and include anemia, leukopenia, thrombocytopenia, granulocytopenia. These abnormalities are usually reversible when the treatment is stopped.
. Hepatobiliary disorders: hepatic enzyme elevation (ASAT, ALT, alkaline phosphatase), hepatitis (isolated cases). Discontinue treatment if cholestatic jaundice develops.
In general, these symptoms regress when treatment is stopped.
. Visual disturbances: Transient visual disturbances due to changes in blood glucose may occur especially during the initiation of treatment.
- Class effects :
. Rare cases of erythrocytopenia, agranulocytosis, haemolytic anemia, pancytopenia and allergic vasculitis have been reported with other hypoglycemic sulfonamides.
. Rare cases of increased levels of liver enzymes, hepatic failure (cholestasis and jaundice) or even hepatitis have been observed with other sulphonylureas and decreased after discontinuation of treatment; only a few cases have led to life-threatening liver failure.

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