chlorothiazide
Hypokalaemia has been reported under treatment with thiazide diuretics including hydrochlorothiazide.
Treatment with thiazide diuretics, including hydrochlorothiazide, has been associated with hyponatraemia and hypochloroaemic alkalosis. Thiazides, including hydrochlorothiazide, increase the urinary excretion of magnesium, which may result in hypomagnesaemia. Calcium excretion is decreased by thiazide diuretics. This may result in hypercalcaemia.
Renal impairment
No dosage adjustment of Exforge HCT is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2). Periodic monitoring of serum potassium, creatinine and uric acid is recommended when Exforge HCT is used in patients with renal impairment.
Renal artery stenosis
No data are available on the use of Exforge HCT in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney.
Kidney transplantation
To date there is no experience of the safe use of Exforge HCT in patients who have had a recent kidney transplantation.
Hepatic impairment
Valsartan is mostly eliminated unchanged via the bile, whereas amlodipine is extensively metabolised by the liver. In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Exforge HCT is not suitable in this group of patients (see sections 4.2, 4.3 and 5.2).
Heart failure and coronary artery disease
As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death. Similar outcomes have been reported with valsartan.
In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Exforge HCT, 10 mg/320 mg/25 mg, since available data in these patient populations is limited.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy
As with all other vasodilators, special caution is indicated in patients with aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Pregnancy
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Primary hyperaldosteronism
Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-ang |
