Volteri Special Precautions

Careful Administration: (Volteri Tablets should be administered with care in the following patients): Patients with bilateral or unilateral renal artery stenosis (Candesartan cilexetil may aggravate renal function.) (See Important Precautions in the following text.)
Patients with renal dysfunction (Renal function may be aggravated by excessive decrease in blood pressure).
Patients with hyperkalemia (Candesartan cilexetil may aggravate hyperkalemia) (see Important Precautions in the following text).
Patients with hepatic dysfunction: Candesartan cilexetil may aggravate hepatic function, and decrease in clearance of candesartan active metabolite is anticipated. (See Pharmacology: Pharmacokinetics under Actions.)
Since amlodipine besilate is mainly metabolized in the liver, blood concentration half life may prolong and area under the blood concentration - time curve (AUC) may increase in the patients with hepatic dysfunction.
Patients with a history of drug hypersensitivity.
Elderly patients (see Use in the Elderly in the following text).
Important Precautions: This drug is a combination of candesartan cilexetil 8 mg and amlodipine 5 mg. Since adverse reactions by both candesartan cilexetil and amlodipine besilate may occur, the use of this drug should be considered appropriately.
Since candesartan cilexetil may rapidly deteriorate renal function in patients with bilateral or unilateral artery stenosis due to a decrease in renal blood flow and/or glomerular filtration pressure, administration of this drug should be avoided unless it is considered therapeutically essential.
Since candesartan cilexetil may aggravate hyperkalemia in patients with hyperkalemia, administration of this drug should be avoided unless it is considered therapeutically essential.
Additionally, since hyperkalemia may occur in patients whose serum potassium level is liable to increase due to renal dysfunction or uncontrolled diabetes mellitus, etc., caution should be paid to serum potassium levels.
In patients receiving concomitant administration of aliskiren fumarate, since renal dysfunction, hyperkalemia or hypotension may occur, Volteri Tablets should be administered carefully while closely observing the patient’s condition. In patients with renal dysfunction (eGFR <60mL/min/1.73 m²), concomitant administration of aliskiren fumarate should be avoided unless it is considered therapeutically essential.
Candesartan cilexetil may rarely cause a sudden fall in blood pressure, resulting in shock, syncope, transient unconsciousness, or renal hypofunction. Therefore, blood pressure, renal function and the patient's condition should be closely observed while administration of this drug especially to the following patients (see Adverse Reactions.): Patients on hemodialysis; Patients on strict dietary salt restriction; Patients under diuretic therapy (especially patients who have recently started diuretic therapy); Patients with hyponatremia; Patients with renal dysfunction; Patients with heart failure.
Since dizziness and lightheadedness may occur due to antihypertensive action of this drug, patients should be cautioned against engaging operation of machinery involving risk, such as working at a height, operating machinery or driving motor vehicles.
It is recommended not to administer this drug within 24 hours before surgery. (Patients on angiotensin II receptor antagonists may develop a severe fall in blood pressure during anesthesia and surgery due to inhibitory action on renin-angiotensin system).
Mild hypotensive effect remains after the termination of the administration of amlodipine besilate due to its long blood concentration half life. Therefore, when using other antihypertensive after termination of the administration of this drug, patient's condition should be closely observed, such as paying attention to dosage and intervals of administration etc.
Precautions concerning Use: When dispensing the drug: The patient must be instructed to remove the tablets from the alufoil package before they are ingested.
Other Precautions: Although the causal relationship has not been established, myocardial infarction and arrhythmia (including ventricular tachycardia) were reported during the administration of amlodipine besilate.
Use in Children: The safety of Volteri Tablets in low birth weight infants, neonates, nursing infants, infants and children has not been established (no clinical experience).
Use in the Elderly: Volteri Tablets should be administered carefully while closely observing the patient’s condition with attention to following points: It is generally acknowledged that an excessive fall of blood pressure should be avoided in the elderly (cerebral infarction, etc., may occur).
In the pharmacokinetics study of amlodipine besilate in the elderly, tendency of higher blood concentration and longer half life were observed. Therefore, Volteri Tablets should be administered carefully, taking such measures as starting with a lower dose.