Medicinal Products

DIAMICRON 80 mg

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

Tablet breackable
Box of 180
All forms

Indication

Noninsulin-dependent diabetes, in combination with the adapted diet, when this diet is not sufficient to restore the glycemic balance alone.

Dosage DIAMICRON 80 mg Breakable tablet Box of 180

RESERVED FOR THE ADULT.
As with any hypoglycemic agent, dosages should be tailored to each particular case.
In case of transient glucose imbalance, a short period of administration of the product may be sufficient, in a patient usually well balanced by the diet.
- Subject under 65:
. Initial dose :
The recommended starting dose is 1 tablet daily.
. Bearings :
Dose adjustments are usually made in increments of 1 tablet depending on the glycemic response. At least 14 days must separate each dose level.
. Maintenance treatment :
The dosage varies from 1 to 3 tablets per day, exceptionally 4.
The usual dosage is 2 tablets a day, taken twice a day.
- Subjects at risk:
. Subject aged over 65 :
Start treatment with 1/2 tablet once a day.
This dose may be gradually increased until satisfactory glycemic balance of the patient, respecting levels of 14 days minimum and under close glycemic monitoring.
. In other patients at risk :
In patients who are malnourished or have marked changes in general health, or whose caloric intake is irregular and in patients with renal or hepatic impairment, treatment should be initiated at the lowest dose and dosage levels should be scrupulously respected, so as to avoid hypoglycaemic reactions (see warnings and precautions for use).
. Patients receiving other oral hypoglycemic agents :
As with any hypoglycemic sulfonylurea, this medication may take over from an antidiabetic treatment without a transition period. When switching from a long-acting hypoglycemic sulfonylurea (such as chlorpropamide) to this medication, patients will be closely monitored (for several weeks) to avoid hypoglycemia due to the possibility of overlapping therapeutic effects.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in case:
- hypersensitivity to gliclazide, other sulfonylureas or sulfonamides or any of the excipients used,
- insulin-dependent diabetes, in particular juvenile diabetes, ketoacidosis diabetes, diabetic precoma,
- severe renal or hepatic insufficiency,
- breastfeeding: in the absence of data on the passage into breast milk and taking into account the risk of neonatal hypoglycaemia, breastfeeding is contraindicated in case of treatment with this drug,
- treatment with miconazole (general route, oral gel) (see interactions).
Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
NOT RECOMMENDED :
- This drug is generally not recommended in combination with phenylbutazone (systemic), danazol (see interactions) and alcohol.
Pregnancy: Diabetes (gestational or permanent), when not balanced, is responsible for an increase in congenital malformations and perinatal mortality. In periconceptional period, a balance as good as possible of diabetes must be achieved, to reduce the risk of malformation. Hypoglycemic sulphonamides are teratogenic in animals at high doses. In clinical practice, there are currently no relevant data or sufficient numbers to evaluate a possible malformative or foetotoxic effect of gliclazide when administered during pregnancy. The re-equilibration of diabetes helps normalize the course of pregnancy in this category of patients. It requires imperative insulin, and this regardless of the type of diabetes, I or II, gestational or permanent. In the latter case, it is recommended to carry out the relay of an oral treatment by insulin as soon as a pregnancy is envisaged or in case of fortuitous discovery of a pregnancy exposed to this drug: in this case this is not the systematic argument for counseling a termination of pregnancy but leads to an attitude of caution and oriented antenatal surveillance. Neonatal monitoring of blood glucose is recommended.

Adverse effects Diamicron

- Hypoglycemia (see precautions for use and overdose: severe hypoglycaemic reactions with coma, convulsions or other neurological disorders are possible and constitute a medical emergency requiring immediate hospitalization of the patient).
- Gastrointestinal disorders including nausea, dyspepsia, diarrhea, constipation, have been reported; they can be avoided or reduced if gliclazide is taken during a meal or by splitting doses.
- The following side effects have been reported more rarely:
. mucocutaneous rash: rash, pruritus, urticaria, maculopapular rash;
. haematological disorders: anemia, leukopenia, thrombocytopenia;
. elevations of ASAT, ALT, alkaline phosphatase, hepatitis (exceptional).
Discontinue treatment if cholestatic jaundice appears.
In general, these symptoms regress when treatment is stopped.

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