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BENDROFLUMETHIAZIDE is a brand name for Bendroflumethiazide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oedema: Bendroflumethiazide is indicated in the treatment of oedema associated with conditions such as congestive heart failure, nephrotic syndrome, cirrhosis of the liver and pre-menstrual oedema. In non-oedematous patients, there may be little noticeable diuretic effect. Essential hypertension: Bendroflumethiazide…
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration:
Oral ADULTS: Oedema: Initially: 5 - 10mg in the morning, once daily or on alternative days. Maintenance: 5mg-10mg one to three times a week. 5 mg in the morning, Higher doses are rarely necessary. alone or in conjunction with other antihypertensive agents in more severe hypertension.
the dosage of such agents should be reduced and then adjusted as necessary The dosage should be reduced in the elderly with impaired renal function. Suppression of lactation: 5mg in the morning and 5mg at midday for about five days.
5mg each morning for seven days before the period is due. 4 mg per kg of body-weight per day. 1 mg per kg of body-weight per day. A more appropriate dosage form may be required. 4 mg/kg body-weight per day as a single dose or in two divided daily doses, adjusted according to response ELDERLY: The dosage of thiazide diuretics may need to be reduced in the elderly, particularly when renal function is impaired, because of the possibility of electrolyte imbalance.
Serious adverse reactions include pancreatitis, hypersensitivity reactions, serious skin reactions and blood dyscrasias. Adverse reactions listed below are based on available data for bendroflumethiazide and classified according to frequency and system organ class (SOC).
Frequency categories are defined according to the following convention: 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), and not known (cannot be estimated from the available data).
g. hypokalaemia. Thiazide diuretics may raise the serum uric acid levels with subsequent exacerbation of gout in susceptible subjects. Thiazide diuretics sometimes lower carbohydrate tolerance and the insulin dosage of the diabetic patient may require adjustment.
Care is necessary when bendroflumethiazide is administered to those with a known predisposition to diabetes.
Immune system disorders:
Hypersensitivity reactions are not known.
Mild gastro-intestinal effects Investigations:
Increased triglyceride, total cholesterol, low-density and very-low density lipoprotein cholesterol concentrations, hypokalaemia, hypomagnesaemia, hyponatraemia, hypercalcaemia, hypochloraemic alkalosis, Hyperuricaemia with/without gout, hyperglycaemia, and altered plasma lipid concentration are not known.
Nervous system disorders:
Headache, Dizziness, Paraesthesia, Drowsiness are not known. Eye disorders: choroidal effusion* is not known. Vascular disorders like Postural hypotension and Vasculitis are not known. Gastrointestinal disorders like Nausea, vomiting, diarrhoea, constipation, dry mouth, thirst and gastric irritation are not known.
4 Special warnings and special precautions for use Hypokalaemia Electrolytes should be monitored during treatment as continued or intensive use of bendroflumethiazide may result in hypokalaemia. This effect may be enhanced with concomitant use of medicines that can also cause hypokalaemia such as other diuretics or beta-2 agonists.
5). Potassium replacement or conservation may be necessary in patients at risk from the cardiac effects of hypokalaemia, such as those with prolonged QT intervals, severe heart disease, those taking digitalis preparations or high doses of diuretics and in patients with severe liver disease.
4 mmol potassium) is detected, it must be corrected and it should be prevented in at-risk patients. Potassium supplements should not be given in renal insufficiency complicated by hyperkalaemia. Potassium supplementation alone may not be sufficient to correct hypokalaemia in patients who are also deficient in magnesium.
Hyponatraemia Some patients may be particularly susceptible to hyponatraemia, including the elderly and those with severe heart failure who are very oedematous, particularly with large doses of thiazides in conjunction with restricted salt in the diet.
The onset of hyponatraemia can be sudden and life-threatening. All patients, including the elderly who may be particularly susceptible, should be carefully observed for signs of fluid and electrolyte imbalance, especially in the presence of vomiting or during parenteral fluid therapy.
Regular serum electrolyte determinations should be performed in the elderly and in patients receiving long-term therapy. Hypomagnesaemia There is an increased risk of hypomagnesaemia in patients with alcoholic cirrhosis taking bendroflumethiazide.
Hypomagnesaemia has been implicated as a risk factor for arrhythmias. Electrolyte levels including magnesium should be monitored during treatment of patients with alcoholic cirrhosis. Hypercalcaemia Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium.
Hypersensitivity to Bendroflumethiazide or any of the excipients and other sulphonamide-derived drugs. Bendroflumethiazide is contra-indicated in patients with: • severe renal insufficiency or anuria • Addison's disease • refractory hypokalaemia • hyponatraemia • hypercalcaemia • serious hepatic disorders (risk of precipitation of encephalopathy) • symptomatic hyperuricaemia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Pancreatitis is rare.
Musculoskeletal and connective tissue disorders:
Systemic lupus erythematosus are not known.
Renal and urinary disorders:
Acute interstitial nephritis; non-opaque urate calculi and Oliguria are not known.
Skin and subcutaneous tissue disorders:
Rashes (including exfoliative dermatitis), photosensitivity; Skin eruptions resembling lichen planus and subacute cutaneous lupus erthyematosus; Erythema multiforme and Pseudoporphyria are not known.
Blood and lymphatic system disorders:
Blood dyscrasias, including agranulocytosis, including neutropenia, aplastic anaemia, thrombocytopenia and leucopenia are rare.
Respiratory thoracic and mediastinal disorders:
Pneumonitis and pulmonary oedema (as part of hypersensitivity reaction) are not known.
Endocrine disorders:
Thiazides may cause hyperglycaemia and aggregate or unmask diabetes mellitus are not known.
Hepatobiliary disorders:
Cholestasis and Cholecystitis are not known.
Reproductive system and breast disorders:
Impotence (reversible on discontinuing the drug) are not known. *see subsection below for additional information Description of selected adverse reactions Choroidal effusion: Cases of choroidal effusion with visual field defect have been reported after the use of thiazide and thiazide-like diuretics.
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. uk/yellowcard. or search for MHRA Yellow Card in the Google Play or Apple App Store.
Marked hypercalcaemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.
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.
Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. Regular ongoing monitoring and blood tests are to be performed in elderly patients and patients who are on long term treatment with bendroflumethiazide.
3). Renal function should be monitored during bendroflumethiazide therapy. Thiazides can cause electrolyte balance which is more severe in patients with hepatic and renal impairment and in those receiving higher or prolonged doses. 3).
In case of hepatic impairment, thiazide diuretics may precipitate hepatic encephalopathy, particularly in case of electrolyte imbalance. Administration of the diuretic must be stopped immediately if this occurs. Regular ongoing monitoring and blood tests are to be performed in elderly patients and patients who are on long term treatment with bendroflumethiazide.
Concomitant use with lithium Bendroflumethiazide inhibits the tubular elimination of lithium resulting in an elevated plasma lithium concentration and risk of toxicity. Both lithium and thiazide and related diuretics can cause hypokalaemia, increasing the risk of torsade de pointes.
Avoid concurrent use unless lithium levels and potassium concentrations can be closely monitored and the lithium dose adjusted as necessary. 5). 5). 8). If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
If re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA. Systemic lupus erythematosus Thiazide diuretics can induce a cutaneous lupus-like adverse reaction.
Thiazide diuretics may also exacerbate or activate systemic lupus erythematosus (SLE) in susceptible patients. Pancreatitis Pancreatitis has been reported during thiazide therapy. Thiazide therapy is associated with hypercalcaemia and hyperlipidaemia both of which are risk factors for pancreatitis.
Gout Thiazide use may aggravate gout. Serum uric acid levels may be raised with or without gout in some patients. Diabetes mellitus Bendroflumethiazide may precipitate diabetes mellitus and may impair glycaemic control in patients with diabetes.
Hyperlipidaemia […]