Valgen-AM Special Precautions

Patients with sodium- and/or volume depletion: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with VALGEN-AM in placebo-controlled studies. In patients with an activated renin- angiotensin system (such as volume- and/or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur. Correction of this condition prior to administration of VALGEN-AM or close medical supervision at the start of treatment is recommended.
If hypotension occurs with VALGEN-AM, the patient should be placed in the supine position and, if necessary, given an I.V. infusion of normal saline. Treatment can be continued once blood pressure has been stabilized.
Hyperkalemia: Concomitant use with potassium supplements, potassium sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium levels (heparin, etc.) should be used with caution and with frequent monitoring of potassium.
Patients with renal artery stenosis: VALGEN-AM should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Patients with renal impairment: No data is available for severe cases (creatinine clearance <10 mL/min) and caution is therefore advised. No dosage adjustment of VALGEN-AM is required for patients with mild to moderate renal impairment.
The use of ARBs - including valsartan - or of ACEIs with aliskiren should be avoided in patients with severe renal impairment (GFR <30 mL/min).
Patients with kidney transplantation: To date there is no experience of the safe use of VALGEN-AM in patients who have had recent kidney transplantation.
Patients with hepatic impairment: Valsartan is mostly eliminated unchanged via the bile whereas amlodipine is extensively metabolized by the liver. In patient with mild to moderate hepatic impairment without cholestasis, VALGEN-AM should be used with caution and careful monitoring of liver function tests should be performed. The daily dose of VALGEN-AM should not exceed 5/80 mg. Patients with severe hepatic impairment, biliary cirrhosis or cholestasis should not take VALGEN-AM.
Angioedema: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. VALGEN-AM should be immediately discontinued in patients who develop angioedema, and VALGEN-AM should not be re-administered.
Patients with heart failure/post-myocardial infarction: In general, calcium channel blockers including amlodipine should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV).
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 angiotensin converting enzyme inhibitors or angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia, and in rare cases with acute renal failure and/or death. Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function.
Patients with acute myocardial infarction: Worsening angina pectoris and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
Patients with aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: As with all other vasodilators, special caution is required when using amlodipine in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS): Caution is required while co-administering ARBs, including valsartan, with other agents blocking the RAAS such as ACEIs or aliskiren (see Valsartan: Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS) with ARBs, ACEIs or aliskiren under Interactions).
Effects on Ability to Drive and Use Machine: Patient taking VALGEN-AM and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur. Amlodipine can have a mild or moderate influence on the ability to drive and use machines. If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.