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Hypertensives: Patients taking combination of Valsartan and Hydrochlorothiazide may develop hypokalemia, hyperkalemia, decrease in serum potassium. Thus, periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
Valsartan: Valsartan should be used with caution in patients with hepatic impairment, cirrhosis, or biliary obstruction. Valsartan is excreted in urine and in bile and in reduced doses may therefore be required in patients with renal impairment and should be considered in patients with hepatic impairment. Patients with volume depletion (for example those who have received high-dose diuretic therapy) may experience hypotension; volume depletion should be corrected before starting therapy, or a low initial dose should be used. Since hyperkalemia may occur, serum-potassium concentrations should be monitored, especially in the elderly and patients with renal impairment, and the concomitant use of potassium-sparing diuretics should generally be avoided.
Hydrochlorothiazide: All diuretics produce changes in fluid and electrolyte balance. They should be used with caution in patients with existing fluid and electrolyte disturbances or who are at risk from changes in fluid and electrolyte balance, such as the elderly. They should be avoided in patients with severe hepatic impairment, in whom encephalopathy may be precipitated. Patients with hepatic cirrhosis are also most likely to develop hypokalemia. Hyponatremia may occur in patients with severe heart failure who are very edematous, particularly with large doses of thiazides and restricted salt intake. Thiazides should not be given to patients with Addison's disease. Should also be given with caution in renal impairment since they can further reduce renal function. Most thiazides are not effective in patients with a creatinine clearance of less than 30 mL/minute. They should not be used in patients with severe renal impairment or anuria.
Thiazides may precipitate attacks of gout in susceptible patients. They may cause hyperglycemia and aggravate or unmask diabetes mellitus. Thiazides can reduce urinary excretion of calcium, sometimes resulting in mild hypercalcemia; they should not be given to patients with pre-existing hypercalcemia.
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 observe 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. The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC.
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