BENDROFLUMETHIAZIDE

Posology It is recommended that the tablets should be taken in the morning to avoid nocturia. 5 -10 mg two or three times weekly. 5-5 mg once daily in the morning. When Bendroflumethiazide is used concurrently with other specific hypotensive agents, the dosage of such agents should be reduced and then adjusted as necessary.

Children under 12 years:

Initially the dosage may be up to 400 micrograms/kg bodyweight daily, reducing to the maintenance dose of 50-100 micrograms/kg bodyweight daily. A more appropriate dosage form may be required.

Elderly:

Particular caution is needed in the elderly. Their dosage may need to be reduced, particularly when renal function is impaired, because of their susceptibility to electrolyte imbalance.

Method of administration:

Oral.

The following undesirable effects have been divided into the following categories:

Very common: ≥1/10, Common: ≥1/100 to <1/10, Uncommon: ≥1/1,000 to<1/100 Rare: ≥1/10,000 to <1/1,000, Very rare: <1/10,000, Not known (cannot be estimated from the available data) Effects on blood Rare: Rarely, blood dyscrasias, including agranulocytosis, aplastic anaemia, thrombocytopenia and leucopenia, have been reported.

Hypersensitivity reactions Not known:

Rashes (including exfoliative dermatitis), photosensitivity, pneumonitis and pulmonary oedema have been reported occasionally.

Metabolic effects Not known:

Bendroflumethiazide may lower carbohydrate tolerance and the insulin dosage of some diabetic patients may require adjustment. Care is required when bendroflumethiazide is administered to patients with a known predisposition to diabetes.

Bendroflumethiazide may raise serum uric acid levels and exacerbate gout in susceptible individuals. Plasma lipids may be altered in patients taking bendroflumethiazide.

Effects on electrolytes Not known:

Bendroflumethiazide administration may cause hypokalaemia, hyponatraemia, hypomangnesaemia, hypercalcaemia and hypochloraemic alkalosis Hypokalaemia may result in polyuria, malaise, muscle weakness or cramp, dizziness, nausea, anorexia or vomiting.

Gastrointestinal effects Not known:

Nausea, vomiting, diarrhoea, constipation and gastric irritation have all been reported.

Other reactions Not known:

Bendroflumethiazide diuretics should be used with caution in patients with mild or moderate hepatic or renal impairment (avoid if severe). Renal function should be monitored during Bendroflumethiazide therapy. Thiazide diuretics may exacerbate or activate systemic lupus erythematosus (SLE) in susceptible patients.

All thiazide diuretics can produce a degree of electrolyte imbalance, especially in patients with hepatic and renal impairment or when dosage is high or prolonged. Serum electrolytes should be checked for abnormalities, particularly hypokalaemia, and the latter corrected by the addition of a potassium supplementto the regimen.

Aggravates diabetes and gout; increased risk of hypomagnesaemia in alcoholic cirrhosis. Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium. Marked hyperglycaemia may be evidence of hidden hyperparathyroidism.

Thiazides should be discontinued before carrying out tests for parathyroid function. Regular ongoing monitoring and blood tests are to be performed in elderly patients and patients who are on long term treatment with bendroflumethiazide.

Choroidal effusion, acute myopia and secondary angle-closure glaucoma:

Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.

Untreated acute angle-closure glaucoma can lead to permanent vision loss, the primary treatment is to discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.

1 • Severe renal or hepatic insufficiency. • Addison’s disease. • Refractory hypokalaemia, hyponatraemia, hypercalcaemia and symptomatic hyperuricaemia.