CO-AMILOZIDE is a brand name for Hydrochlorothiazide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Co-amilozide is indicated in patients with hypertension, congestive heart failure, or hepatic cirrhosis with ascites, in whom potassium depletion might be anticipated. Amiloride hydrochloride in co-amilozide minimises the possibility of excessive potassium loss during vigorous diuresis for long term therapy.…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The rate of loss of weight and the serum electrolyte levels should determine the dosage. 0 kg/day.
Hypertension:
Initially one tablet given once a day. The dosage may be increased if necessary to two tablets given once a day or in divided doses. Co-amilozide may be used alone or as an adjunct to other antihypertensive drugs, but since the antihypertensive effect of these agents may be enhanced, their dosage may need to be reduced in order to reduce the risk of an excessive drop in pressure.
Congestive heart failure:
Initially one tablet a day, subsequently adjusted if required, but not exceeding four tablets a day. Optimal dosage is determined by the diuretic response and the plasma potassium level. Once initial diuresis has been achieved, reduction in dosage may be attempted for maintenance therapy.
Maintenance therapy may be on an intermittent basis.
Hepatic cirrhosis with ascites:
Initiate therapy with a low dose. A single dose of two tablets may be increased gradually until there is an effective diuresis. Dosage should not exceed four tablets a day. A gradual weight reduction is especially desirable in cirrhotic patients to reduce the likelihood of untoward reactions associated with diuretic therapy.
Maintenance dosages may be lower than those required to initiate diuresis; dosage reduction should therefore be attempted when the patient's weight is stabilised.
Elderly:
Particular caution is needed in the elderly because of their susceptibility to electrolyte imbalance. The dosage should be carefully adjusted to renal function and clinical response. (See also Special Warnings & Precautions, subsections - Hyperkalaemia, Electrolyte imbalance).
3). Method of administration For oral use.
, Electrolyte Imbalance). Hypokalaemia may develop, especially as a result of brisk diuresis, after prolonged therapy or when severe cirrhosis is present. A potassium chloride supplement is recommended in these circumstances, however, neither potassium supplements nor a potassium-rich diet should be used with co-amilozide except under careful monitoring in severe and/or refractory cases of hypokalaemia.
Potassium conserving therapy should be initiated with caution in severely ill patients in whom metabolic or respiratory acidosis may occur, eg patients with decompensated diabetes or cardiopulmonary disease. Shifts in acid base balance alter the balance of extracellular/intracellular potassium.
The development of acidosis may be associated with rapid increases in serum potassium. Potassium replacement or conservation is also likely to be necessary in patients at risk from the cardiac effects of hypokalaemia such as those with severe heart disease, those taking cardiac glycosides preparations or high doses of diuretics and in patients with severe liver disease.
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. Magnesium depletion has also been implicated as a risk factor for arrhythmias.
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.
Diuretic-induced hyponatraemia is usually mild and asymptomatic. It may become severe and symptomatic in a few patients who will then require immediate attention and appropriate treatment. Thiazides may decrease urinary calcium excretion.
Hyperkalaemia:
Hyperkalaemia has been observed in patients receiving amiloride hydrochloride, either alone or with other diuretics, particularly in the aged and in diabetics. Hyperkalaemia has been reported in seriously ill hospital patients with congestive heart failure or hepatic cirrhosis who had renal impairment, or were undergoing vigorous diuretic therapy.
Such patients should be carefully observed for laboratory, clinical and ECG evidence of hyperkalaemia (which may not always be associated with an abnormal ECG). ] Treatment of hyperkalaemia: Should hyperkalaemia develop, co-amilozide should be discontinued immediately.
If necessary, active measures should be taken to reduce the serum potassium to normal.
Impaired renal function:
Due to the risk of developing hyperkalaemia, patients with impaired renal function should be monitored carefully for serum electrolytes and blood urea levels, as should seriously ill patients, such as those with hepatic cirrhosis with ascites and metabolic alkalosis or those with resistant oedema who are also taking diuretics.
Thiazide diuretics become ineffective when creatinine clearance falls below 30 ml/min.
Electrolyte imbalance and blood urea increases:
Although the likelihood of electrolyte imbalance is reduced by co-amilozide, careful check should be kept for such signs of fluid and electrolyte imbalance hyponatraemia, hypochloraemic alkalosis, hypokalaemia and hypomagnesaemia, [particularly in the elderly and in patients receiving long-term therapy and in the presence of excessive vomiting or during parenteral fluid therapy.
8 Undesirable Effects, Electrolyte Imbalance). Hypokalaemia may develop, especially as a result of brisk diuresis, after prolonged therapy or when severe cirrhosis is present. A potassium chloride supplement is recommended in these circumstances, however, neither potassium supplements nor a potassium-rich diet should be used with co-amilozide except under careful monitoring in severe and/or refractory cases of hypokalaemia.
1, or other sulphonamide derived drugs. 5 mmol/l); other potassium-conserving diuretics. ) • Hypercalcaemia • Severe renal impairment; severe progressive renal disease; acute renal failure; anuria; use of potassium conserving agents may result in rapid development of hyperkalaemia in patients with renal impairment; patients with blood urea over 10 mmol/l or those with serum creatinine over 130 μmol/l in whom serum electrolyte and blood urea levels cannot be monitored carefully and frequently • Severe hepatic failure; precoma associated with hepatic cirrhosis • Diabetic nephropathy; patients with diabetes mellitus • Addison's disease • Concomitant treatment with spironolactone or triamterene • Concurrent lithium therapy • The safety of amiloride hydrochloride for use in children under 18 years of age has not been established.
Co-amilozide is not recommended for children. 6 'Pregnancy and Lactation'.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Therapy should be discontinued before carrying out tests for parathyroid function. In seriously ill patients, reversible increases in blood urea have been reported accompanying vigorous diuresis, hepatic cirrhosis, ascites and metabolic alkalosis or those with resistant oedema.
Serum electrolyte and blood urea levels should be carefully monitored in these patients. Co-amilozide should be used with caution in patients with renal impairment. 3 Contraindications). Uraemia may be precipitated or increased by hydrochlorothiazide.
Co-amilozide should be discontinued if increasing oliguria and uraemia occurs during treatment.
Liver disease:
Use with caution in hepatic impairment or progressive liver disease. 8 Undesirable Effects). 3 Contraindications). 8 Undesirable Effects, Metabolic subsection). Thiazides may impair glucose tolerance. 3 'Contraindications'). Dosage adjustment of antidiabetic agents, including insulin, may be required.
Co-amilozide should be discontinued at least three days before glucose tolerance tests are performed in patients with diabetes or suspected diabetes mellitus, especially if there is renal insufficiency or diabetic nephropathy, because of the risks of provoking severe hyperkalaemia.
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Other:
Sensitivity reactions to thiazides may occur in patients with or without a history of allergy or bronchial asthma. Caution is required in patients with severe asthma, as hypokalaemia associated with beta2-agonist therapy can be potentiated by concurrent use of diuretics.
It has been reported that the thiazides may possibly activate or exacerbate systemic lupus erythematosus. Non-melanoma skin cancer An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC. Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions.
Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.
8). 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 […]
Potassium conserving therapy should be initiated with caution in severely ill patients in whom metabolic or respiratory acidosis may occur, eg patients with decompensated diabetes or cardiopulmonary disease. Shifts in acid base balance alter the balance of extracellular/intracellular potassium.
The development of acidosis may be associated with rapid increases in serum potassium. Potassium replacement or conservation is also likely to be necessary in patients at risk from the cardiac effects of hypokalaemia such as those with severe heart disease, those taking cardiac glycosides preparations or high doses of diuretics and in patients with severe liver disease.
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. Magnesium depletion has also been implicated as a risk factor for arrhythmias.
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.
Diuretic-induced hyponatraemia is usually mild and asymptomatic. It may become severe and symptomatic in a few patients who will then require immediate attention and appropriate treatment. Thiazides may decrease urinary calcium excretion.
Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Therapy should be discontinued before carrying out tests for parathyroid function. In seriously ill patients, reversible increases in blood urea have been reported accompanying vigorous diuresis, hepatic cirrhosis, ascites and metabolic alkalosis or those with resistant oedema.
Serum electrolyte and blood urea levels should be carefully monitored in these patients. Co-amilozide should be used with caution in patients with renal impairment. 3 Contraindications). Uraemia may be precipitated or increased by hydrochlorothiazide.
Co-amilozide should be discontinued if increasing oliguria and uraemia occurs during treatment.
Liver disease:
Use with caution in hepatic impairment or progressive liver disease. 8 Undesirable Effects). 3 Contraindications). 8 Undesirable Effects, Metabolic subsection). Thiazides may impair glucose tolerance. 3 'Contraindications'). Dosage adjustment of antidiabetic agents, including insulin, may be required.
Co-amilozide should be discontinued at least three days before glucose tolerance tests are performed in patients with diabetes or suspected diabetes mellitus, especially if there is renal insufficiency or diabetic nephropathy, because of the risks of provoking severe hyperkalaemia.
Increases in cholesterol and triglyceride levels may be associated with thiazide […]