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Diamicron-mr

Diamicron-mr contains gliclazide, an oral hypoglycaemic agent classified among the medications used in diabetes care, and is registered in 21 countries across multiple regions. The brand has a moderately international footprint that puts it in front of travellers and expatriates in markets as diverse as Australia, Mexico, Egypt, China, and the Netherlands.

Gliclazide is prescribed in the management of type 2 diabetes mellitus, and the structured indication block on this page also references diabetes-related complications such as nephropathy and retinopathy, alongside cerebrovascular events that can occur in patients with long-standing diabetes. The medication is part of long-term metabolic management rather than a short-course therapy, which makes continuity across borders a practical concern for many readers of this page.

Because Diamicron-mr is registered across a mix of European, Asia-Pacific, Latin American, and Middle Eastern markets — including Canada, Greece, Lebanon, Malaysia, Peru, and Hong Kong — travellers and people relocating between these countries can often find the same brand in the destination pharmacy. Outside this footprint, gliclazide itself remains widely available under other brand names and as generic preparations, and a local pharmacist is generally the right person to identify the regional equivalent.

Other oral hypoglycaemic agents exist in parallel under different molecules, and diabetes regimens are typically built around an individual patient's profile rather than a single product. Anyone managing diabetes across borders should treat any change of medication, brand, or formulation as a clinical decision made together with a healthcare provider who knows the patient's history.

Overdose

An overdose of sulfonylureas may cause hypoglycaemia.

Moderate symptoms of hypoglycaemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment and/or change of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.

Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalisation.

If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection of 50 ml of concentrated glucose solution (20 to 30%). This should be followed by continuous infusion of a more dilute glucose solution (10%) at a rate that will maintain blood glucose levels above 1 g/l. Patients should be monitored closely and, depending on the patient's condition after this time, the doctor will decide if further monitoring is necessary.

Dialysis is of no benefit to patients due to the strong binding of Diamicron-MR to proteins.

Incompatibilities

Not applicable

Undesirable effects

Based on the experience with Diamicron-MR, the following undesirable effects have to be mentioned.

Hypoglycaemia

As for other sulfonylureas, treatment with Diamicron-MR 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.

In addition, signs of adrenergic counter-regulation may be observed: sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris and cardiac arrhythmia.

Usually, symptoms disappear after intake of carbohydrates (sugar). However, artificial sweeteners have no effect. Experience with other sulfonylureas shows that hypoglycaemia can recur even when measures prove effective initially.

If a hypoglycaemic episode is severe or prolonged, and even if it is temporarily controlled by intake of sugar, immediate medical treatment or even hospitalisation are required.

Gastrointestinal disturbances, including abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation have been reported: if these should occur they can be avoided or minimised if Diamicron-MR is taken with breakfast.

The following undesirable effects have been more rarely reported:

Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, angioedema, erythema, maculopapular rashes, bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis).

Blood and lymphatic system disorders: Changes in haematology are rare. They may include anaemia, leucopenia, thrombocytopenia, granulocytopenia. These are in general reversible upon discontinuation of Diamicron-MR.

Hepatobiliary disorders: Raised hepatic enzyme levels (ASAT, ALAT, 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.

Class attribution effects

As for other sulfonylureas, the following adverse events have been observed: cases of erythrocytopenia, agranulocytosis, haemolytic anaemia, pancytopenia, allergic vasculitis, hyponatremia, elevated liver enzyme levels and even impairment of liver function (e.g. with cholestasis and jaundice) and hepatitis which regressed after withdrawal of the sulfonylurea or led to life-threatening liver failure in isolated cases.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

Preclinical safety data

Preclinical data reveal no special hazards for humans based on conventional studies of repeated dose toxicity and genotoxicity. Long term carcinogenicity studies have not been done. No teratogenic changes have been shown in animal studies, but lower fetal body weight was observed in animals receiving doses 9.4 fold higher than the maximum recommended dose in humans.

Pharmacodynamic properties

Pharmacotherapeuticgroup: sulfonamides, urea derivatives.

ATC code: A10BB09

Diamicron-MR is a hypoglycaemic sulfonylurea antidiabetic active substance differing from other related compounds by an N-containing heterocyclic ring with an endocyclic bond.

Diamicron-MR reduces blood glucose levels by stimulating insulin secretion from the β-cells of the islets of Langerhans. Increase in postprandial insulin and C-peptide secretion persists after two years of treatment.

In addition to these metabolic properties, Diamicron-MR has haemovascular properties.

Effects on insulin release

In type 2 diabetics, Diamicron-MR restores the first peak of insulin secretion in response to glucose and increases the second phase of insulin secretion. A significant increase in insulin response is seen in response to stimulation induced by a meal or glucose.

Haemovascular properties:

Diamicron-MR decreases microthrombosis by two mechanisms which may be involved in complications of diabetes:

- a partial inhibition of platelet aggregation and adhesion, with a decrease in the markers of platelet activation (beta thromboglobulin, thromboxane B2),

- an action on the vascular endothelium fibrinolytic activity with an increase in tPA activity.

Pharmacokinetic properties

The drug is well absorbed and its half-life in man is approximately 10-12 hours. Diamicron-MR is metabolised in the liver; less that 5% of the dose is excreted unchanged in the urine.

Special warnings and precautions for use

Hypoglycaemia

This treatment should be prescribed only if the patient is likely to have a regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk of hypoglycaemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. Hypoglycaemia is more likely to occur during low-calorie diets, following prolonged or strenuous exercise, alcohol intake or if a combination of hypoglycaemic agents is being used.

Hypoglycaemia may occur following administration of sulfonylureas. Some cases may be severe and prolonged. Hospitalisation may be necessary and glucose administration may need to be continued for several days.

Careful selection of patients, of the dose used, and clear patient directions are necessary to reduce the risk of hypoglycaemic episodes.

Factors which increase the risk of hypoglycaemia:

- patient refuses or (particularly in elderly subjects) is unable to co-operate

- malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes

- imbalance between physical exercise and carbohydrate intake

- renal insufficiency

- severe hepatic insufficiency

- overdose of Diamicron-MR

- certain endocrine disorders: thyroid disorders, hypopituitarism and adrenal insufficiency

- concomitant administration of certain other medicines.

Renal and hepatic insufficiency

The pharmacokinetics and/or pharmacodynamics of Diamicron-MR may be altered in patients with hepatic insufficiency or severe renal failure. A hypoglycaemic episode occurring in these patients may be prolonged, so appropriate management should be initiated.

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.

Poor blood glucose control

Blood glucose control in a patient receiving antidiabetic treatment may be affected by any of the following: fever, trauma, infection or surgical intervention. In some cases, it may be necessary to administer insulin.

The hypoglycaemic efficacy of any oral antidiabetic agent, including Diamicron-MR, is attenuated over time in many patients. This may be due to progression in the severity of the diabetes, or to a reduced response to treatment. This phenomenon is known as secondary failure which is distinct from primary failure, when an active substance is ineffective as first-line treatment. Adequate dose adjustment and dietary compliance should be considered before classifying the patient as secondary failure.

Laboratory tests

Measurement of glycated haemoglobin levels (or fasting venous plasma glucose) is recommended in assessing blood glucose control. Blood glucose self-monitoring may also be useful.

Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia. Caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered.

Effects on ability to drive and use machines

Diamicron-MR has no known influence on the ability to drive and use machines. However, patients should be informed that their concentration may be affected if their diabetes is not satisfactorily controlled, especially at the beginning of treatment.

Special precautions for disposal and other handling

No special requirements.

Frequently asked questions

What is Diamicron-mr used for?

Diamicron-mr is prescribed in the management of type 2 diabetes mellitus and is also referenced in the context of diabetes-related complications such as nephropathy and retinopathy, as well as cerebrovascular events that can occur in patients with long-standing diabetes. As a hypoglycaemic agent, it forms part of broader diabetes care rather than a stand-alone solution. The structured indication section below this introduction lists each registered use.

Which active substance is in Diamicron-mr?

Diamicron-mr contains gliclazide, an oral hypoglycaemic agent used in the management of type 2 diabetes. Gliclazide is a well-established molecule that circulates internationally under several brand names and as generic preparations, particularly in markets where the original patent has expired and multiple manufacturers produce gliclazide-containing products in parallel.

In how many countries is Diamicron-mr available?

Diamicron-mr is registered in 21 countries spanning several continents. Representative markets include Australia, Canada, China, Mexico, Egypt, the Netherlands, and Malaysia. The footprint covers parts of Europe, the Asia-Pacific region, the Americas, and the Middle East. If your country is not on this list, a local pharmacist can usually confirm whether gliclazide is available there under a different brand name or as a generic.

Are there other medications with the same active ingredient as Diamicron-mr?

Gliclazide is sold under several brand names worldwide and is also widely available as a generic in markets where the original patent has expired. Other oral hypoglycaemic agents exist as well, although molecules within and across diabetes drug classes are not freely interchangeable — each has its own clinical positioning. To identify a local gliclazide-containing product, search the active ingredient on Pill2Trip or ask a pharmacist.

Should I consult a doctor before taking Diamicron-mr?

Yes. Diamicron-mr is a prescription medication, and diabetes therapy in particular is calibrated to a patient's individual profile, concurrent medications, kidney function, and broader treatment plan. This is especially relevant for travellers and people relocating between countries, since prescription rules, available brands, and generic equivalents differ across regulatory regimes. Any decision to start, stop, switch, or substitute gliclazide should involve a healthcare provider.

Diamicron-mr

Available in 21 countries