Viacoram Initio/Viacoram Special Precautions

Hypertensive crisis: The safety and efficacy of amlodipine in hypertensive crisis has not been established.
Use in patients with cardiac failure: Patients with heart failure should be treated with caution. Perindopril arginine + Amlodipine besilate (Viacoram Initio/Viacoram) should be used with caution in patients with congestive heart failure, as amlodipine may increase the risk of future cardiovascular events and mortality.
Hypotension: ACE inhibitors may cause a fall in blood pressure. Symptomatic hypotension is seen rarely in uncomplicated hypertensive patients and is more likely to occur in patients who have been volume-depleted e.g. by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting, or who have severe renin-dependent hypertension. In patients at high risk of symptomatic hypotension, blood pressure, renal function and serum potassium should be monitored closely during treatment with Perindopril arginine + Amlodipine besilate (Viacoram Initio/Viacoram).
Similar considerations apply to patients with ischemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of sodium chloride 9 mg/mL (0.9%) solution. A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.
Aortic and mitral valve stenosis/hypertrophic cardiomyopathy: ACE inhibitors should be given with caution to patients with mitral valve stenosis and obstruction in the outflow of the left ventricle such as aortic stenosis or hypertrophic cardiomyopathy.
Race: ACE inhibitors cause a higher rate of angioedema in black patients than in non-black patients.
ACE inhibitors may be less effective in lowering blood pressure in black people than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.
Cough: Cough has been reported with the use of Perindopril arginine + Amlodipine besilate (Viacoram Initio/Viacoram). Characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy. ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Surgery/Anesthesia: In patients undergoing major surgery or during anesthesia with agents that produce hypotension, perindopril may block angiotensin II formation secondary to compensatory renin release. Perindopril arginine + Amlodipine besilate (Viacoram Initio/Viacoram) should be discontinued one day prior to the surgery. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Hyperkalemia: Elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including perindopril. Risk factors for the development of hyperkalemia include those with renal insufficiency, worsening of renal function, age (> 70 years), diabetes mellitus, intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, and concomitant use of potassium-sparing diuretics (e.g. spironolactone, eplerenone, triamterene, or amiloride, alone or in combination), potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin, other ACE inhibitors, angiotensin-II antagonists, acetylsalicylic acid ≥ 3 g/day, COX-2 inhibitors and non-selective NSAIDs, immunosuppressant agents such as ciclosporin or tacrolimus, trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole). The use of potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes particularly in patients with impaired renal function may lead to a significant increase in serum potassium. Hyperkalemia can cause serious, sometimes fatal arrhythmias. If concomitant use of Perindopril arginine + Amlodipine besilate (Viacoram Initio/Viacoram) and any of the previously mentioned agents is deemed appropriate, they should be used with caution and with frequent monitoring of serum potassium.
Diabetic patients: In diabetic patients treated with oral antidiabetic agents or insulin, glycemic control should be closely monitored during the first month of treatment with Perindopril arginine + Amlodipine besilate (Viacoram Initio/Viacoram).
Potassium-sparing drugs, potassium supplements or potassium-containing salt substitutes: The combination of Perindopril arginine + Amlodipine besilate (Viacoram Initio/Viacoram) and potassium-sparing drugs, potassium supplements or potassium-containing salt substitutes is not recommended.
Excipients: This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Driving and Using Machines: No studies on the effects of Perindopril arginine + Amlodipine besilate (Viacoram Initio/Viacoram) on the ability to drive and use machines have been performed.
Perindopril and amlodipine can have minor or moderate influence on the ability to drive and use machines. If patients suffer from dizziness, headache, fatigue, weariness or nausea, the ability to react may be impaired.
Caution is recommended with Perindopril arginine + Amlodipine besilate (Viacoram Initio/Viacoram) especially at the start of treatment.