Valsartan Teva Special Precautions

Hyperkalemia: Caution should be exercised during concurrent use of potassium supplements, potassium sparing diuretics, salt substitutes containing potassium or other medicinal products that may increase potassium levels (heparin, etc.) and frequent monitoring of potassium levels should be performed.
Sodium and/or volume depleted patients: In severely sodium depleted and/or volume depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with valsartan. Sodium and/ or volume depletion shall be corrected prior to initiation of treatment with valsartan, e.g. by diuretic dose reduction.
If hypotension occurs, the patient should be placed in the supine position and, if necessary, give an i.v. infusion of normal saline. Treatment can be continued once blood pressure had been stabilized.
Renal artery stenosis: Safety of valsartan use in patients with bilateral renal artery stenosis or stenosis to a solitary kidney has not been demonstrated.
Short-term use of valsartan in twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal hemodynamics, serum creatinine, or blood urea nitrogen (BUN). However, since other drugs that affect the renin-angiotensin-aldosterone system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, monitoring is recommended as a safety measure.
Kidney transplantation: No experience with respect to safety of the use of valsartan in patients after recent kidney transplantation is yet available.
Primary hyperaldosteronism: Valsartan should not be used in patients with primary hyperaldosteronism since the disease affects the renin-angiotensin-aldosterone system.
Aortic and mitral stenosis, obstructive hypertrophic cardiomyopathy: As with other vasodilators, special caution should be exercised in patients with aortic and mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Renal impairment: No dose adjustment is necessary in patients with impaired renal function with creatinine clearance >10 ml/min.
As a consequence of inhibiting the rennin angiotensin aldosterone system, increase of blood urea and serum creatinine and changes in renal function including renal failure (very rarely) have been reported particularly in patients with pre-existing renal dysfunction or those with severe cardiac insufficiency.
Hepatic impairment: Caution should be exercised when valsartan is used in patients with mild to moderate non-cholestatic hepatic impairment. The dose of valsartan should not exceed 80 mg.
Recent myocardial infarction: Increased clinical benefits of concurrent use of captopril and valsartan has not been confirmed, and instead the risk of adverse effects was increased compared to treatment with the products separately (see Pharmacology: Pharmacodynamics under Actions and Adverse Reactions). Concomitant use of these products is therefore not recommended.
Caution should be exercised when initiating treatment in post-myocardial infarction patients. Evaluation of post-myocardial infarction patients should always include evaluation of renal function (see Dosage & Administration).
Use of valsartan in post-myocardial infarction patients is commonly accompanied by some blood pressure reduction but usually treatment does not need to be discontinued due to continued symptomatic hypotension, provided that dose recommendations are being followed.
Heart failure: Clinical benefits of a triple combination with ACE-inhibitor, beta-blocker and valsartan have not been confirmed for patients with heart failure (see Pharmacology: Pharmacodynamics under Actions). This combination seems to increase the risk of adverse events and is therefore not recommended.
The use of valsartan in patients with heart failure commonly causes some blood pressure reduction, but usually treatment does not need to be discontinued due to continued symptomatic hypotension, provided that dose recommendations are being followed. Caution should be observed when initiating therapy in patients with heart failure.
In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure) treatment with ACE-inhibitors has been associated with oliguria and/or progressive azotemia and in rare cases acute renal failure. Since valsartan is an angiotensin II receptor antagonist it has an inhibitory effect on the renin-angiotensin-aldosterone system and therefore it cannot be excluded that the use of valsartan may be associated with impairment of the renal function.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. When driving and using machines it should be considered that orthostatic hypotension, dizziness or weariness may occur.
Use in Pregnancy: Angiotensin II Receptor Inhibitors (AIIRAs) should not be initiated during pregnancy. Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive 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 Contraindications and Use in Pregnancy & Lactation).