Claglid

Claglid is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It belongs to the sulfonylurea class of insulin secretagogues, which act by stimulating β cells of the pancreas to release insulin. Sulfonylureas increase both basal insulin secretion and meal-stimulated insulin release. Medications in this class differ in their dose, rate of absorption, duration of action, route of elimination and binding site on their target pancreatic β cell receptor. Sulfonylureas also increase peripheral glucose utilization, decrease hepatic gluconeogenesis and may increase the number and sensitivity of insulin receptors. Sulfonylureas are associated with weight gain, though less so than insulin. Due to their mechanism of action, sulfonylureas may cause hypoglycemia and require consistent food intake to decrease this risk. The risk of hypoglycemia is increased in elderly, debilitated and malnourished individuals. Claglid has been shown to decrease fasting plasma glucose, postprandial blood glucose and glycosolated hemoglobin (HbA1c) levels (reflective of the last 8-10 weeks of glucose control). Claglid is extensively metabolized by the liver; its metabolites are excreted in both urine (60-70%) and feces (10-20%).

30-mg: Non-insulin dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.

80-mg: Claglid is a sulphonylurea hypoglycemic agent which is given by mouth in the treatment of non-insulin dependent diabetes mellitus. It is used to supplement treatment by diet modification when such modification has not proved effective on its own. Its duration of action is 12 hours or more. Claglid may be used in place of chlorpropamide in elderly patients.

Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.

Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.

Polyethylene glycol electrolyte solution may also be used for purposes not listed in this medication guide.

The daily dose of Claglid may vary from ½-2 tablets daily (ie, from 30-120 mg) taken orally in a single intake at breakfast.

If a dose is missed, there must be no increase in the dose the following day.

As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbA1c).

Initial Dose: Recommended Starting Dose: 30 mg daily (½ Claglid tablet). 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 was not reduced after 2 weeks of treatment.

In such cases, the dose may be increased at the end of the 2nd week of treatment.

Maximum Recommended Daily Dose: 120 mg.

One Claglid modified-release tablet is equivalent to 2 Diamicron 30 mg modified-release tablet. The breakability of the Claglid modified-release tablet enables flexibility of dosing to be achieved.

Switching from Diamicron 80 mg Tablet to Claglid Modified-Release Tablet: 1 tablet of Diamicron 80 mg is comparable to 30 mg of the modified-release formulation (ie, ½ Claglid tablet). Consequently, the switch can be performed with careful blood monitoring.

Switching from Another

Oral Antidiabetic Agent to Claglid:

The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Claglid.

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, as previously described.

When switching from a hypoglycaemic sulfonylurea with a prolonged half-life, a treatment-free period of a few days may be necessary to avoid an additive effect of the 2 antidiabetic agents, which might cause hypoglycaemia. The procedure described for initiating treatment should also be used when switching to treatment with Claglid ie, a starting dose of 30 mg daily, followed by a stepwise increase in dose, depending on the metabolic response.

Combination Treatment with Other Antidiabetic Agents: Claglid can be given in combination with biguanides, α-glucosidase inhibitors or insulin.

In patients inadequately controlled with Claglid, concomitant insulin therapy can be initiated under close medical supervision.

Elderly (>65 years): Same dosing regimen as the one recommended for patients <65 years.

Patients with Renal Impairment: Same dosing regimen as the one recommended for patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials.

Patients at Risk of Hypoglycaemia: In undernourished or malnourished patients; patients with 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 starting dose of 30 mg is used.

Administration: For oral use. It is recommended to swallow the dose without crushing or chewing.

If a dose is missed, there must be no increase in the dose taken the following day.

See also:
What is the most important information I should know about Claglid?

Hypersensitivity to Claglid, other sulfonylureas, sulfonamides or to any of the excipients of Claglid.

Type I diabetes, diabetic ketoacidosis, diabetic pre-coma and coma; severe renal or hepatic insufficiency.

Treatment with miconazole.

Lactose Intolerance: Due to the presence of lactose in Claglid, patients with rare hereditary problems of galactose intolerance, glucose galactose malabsorption or Lapp lactase deficiency should not take this medicinal product.

Use in pregnancy: Category C: It is important to achieve strict normoglycaemia during pregnancy.

Oral hypoglycaemic agents should be replaced by insulin. The sulfonylureas may enter the fetal circulation and cause neonatal hypoglycaemia. In animal studies, embryotoxicity and/or birth defects have been demonstrated with some sulfonylureas.

Claglid should not be used in pregnant women although animal studies of Claglid have not shown any teratogenic effect. From a clinical point of view, there are no adequate data to allow evaluation of the possible malformative or foetotoxic effects of Claglid, when administered during pregnancy.

Use in lactation: In the absence of data on the transfer of Claglid into breast milk and given the risk of neonatal hypoglycaemia, breastfeeding is contraindicated during treatment with Claglid.

Claglid is used to lower the blood sugar levels in type 2 diabetes mellitus when diet, physical exercise and weight reduction alone are not adequate.

See also:
What other drugs will affect Claglid?

Claglid: Drugs which may increase the hypoglycemic effect of Claglid include phenylbutazone, salicylates, sulfonamides, coumarin derivatives, clofibrate, monoamine oxidase inhibitors (MAOIs), β-adrenergic blocking drugs, cimetidine, disopyramide, miconazole, tetracycline compounds and chloramphenicol.

Drugs which may reduce the effectiveness of Claglid include corticosteroids, oral contraceptives, thiazide diuretics, thyroid hormones, phenothiazine derivatives and abuse of laxatives.

Care should be taken with any other drugs which may affect the diabetic condition.

Claglid-OD: Hepatic enzyme inhibitors eg, sulfonamides, tuberculostatics, clarithromycin, phenylbutazone, clofibrate, coumarin derivatives, salicyclates, nonsteroidal anti-inflammatory agents (NSAIDs), probenecid, β-blockers (eg, propranolol), tetracycline compounds, chloramphenicol, azole antifungal agents (eg, miconazole, ketoconazole, itraconazole), H₂-receptor antagonists (eg, cimetidine), disopyramide and angiotensin-converting enzymes (ACE) inhibitors (eg, captopril and enalapril), and MAOIs may increase Claglid’s hypoglycemic effect.

Inducers of hepatic enzymes eg, rifampicin, barbiturates, thyroid hormones and phenytoin may lower Claglid’s plasma concentration.

Concomitant administration with anticoagulants (warfarin and other anticoagulants) may lead to potentiation of anticoagulation. Adjustment of anticoagulant dosage may be necessary.

Drugs that induce hyperglycemia leading to a loss of control of blood sugar: diuretics (thiazides, furosemide), corticosteroids and tetracosactrin, danazol, chlorpromazine, ritodrine/salbutamol/terbutaline (IV), oral contraceptives (estrogens plus progestogens, and nicotinic acid in pharmacologic doses.

Acute or chronic alcohol intake may unpredictably potentiate or reduce the activity of Claglid.

See also:
What are the possible side effects of Claglid?

Good clinical acceptability of Claglid, has been established in many studies as well as in medical practice.

The safety of a modified-release formulation of Claglid (30-120 mg) has been evaluated in controlled clinical trials in 955 patients, of which 728 patients were treated in long-term comparative trials, against a Claglid immediate-release formulation (80-320 mg), for up to 10 months. In these comparative trials, the overall incidence and type of adverse events were similar in both groups. Adverse events were generally mild and transient, not requiring discontinuation of therapy.

However, where patients did discontinue due to adverse events, the percentage was lower in the modified-release group (2.9%) than in the immediate-release group (4.5%).

Hypoglycaemia : As is the case with all sulfonylurea drugs, hypoglycaemic reactions have been reported following Claglid administration. However, a number of studies have shown that hypoglycaemia is less common with Claglid than with glibenclamide.

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 seIf-control, delirium, convulsions, shallow respiration, bradycardia, drowsiness and loss of consciousness, possibly resulting in coma and/or death.

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 carbohydrate eg, sugar (artificial sweeteners have no effect). Experience with other sulfonylureas shows that hypoglycaemia can recur even when these measures are initially effective. 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 is required.

In long-term comparative studies, the percentage of patients experiencing hypoglycaemic episodes was similar between patients treated with the modified-release formulation of Claglid (11.6%) and those treated with the immediate-release formulation of Claglid (11.1 %). However, the number of hypoglycaemic episodes/100 patient-months was lower in the modified-release group (3.5) than in the immediate-release group (4.8).

Analysis of elderly patients (>65 years old) showed less hypoglycaemia than in the general population, with a prevalence of hypoglycaemic episodes lower in the modified-release group (2.6 hypoglycaemic episodes for 100 patient-months) than in the immediate-release group (4.1).

The percentage of patients experiencing hypoglycaemic episodes in the sub-population with renal failure, was similar to that observed in the general population.

Other Adverse Events: Adverse events reported during controlled clinical trials with the modified-release formulation of Claglid were those expected in an ageing population with diabetes.

Adverse events that were reported in at least 2% of patients, in long-term controlled clinical studies, are presented in Table 2. The most frequent adverse events were not specifically related to the disease (eg, respiratory infections or back pain).

Analysis of adverse events in sub-populations showed a similar pattern to that seen in the general population. Gender, age and renal insufficiency had no significant influence on the safety profile of the modified-release formulation of Claglid.

Gastrointestinal disturbances (reported with Claglid), including nausea, dyspepsia, diarrhoea, abdominal pain, vomiting and constipation may be avoided or minimised if Claglid is taken with breakfast.

The following adverse events have been rarely reported: Skin and mucosae reactions: Pruritus, urticaria, maculopapular rashes, rash, erythema and bullous reactions.

Haematological Disorders (As with Other Sulfonylurea Drugs): A few rare cases of anaemia, leucopenia, thrombocytopenia and agranulocytosis.

Occasional elevations of serum creatinine, blood urea nitrogen, serum bilirubin and hepatic enzymes (AST, ALT, alkaline phosphatase) levels and exceptionally, hepatitis. Treatment should be discontinued if cholestatic jaundice appears.

These symptoms usually disappear after discontinuation of treatment.

As with any glucose-lowering medication, transient visual disturbances may occur on initiation of treatment due to changes in blood glucose levels.