Source: Health Products Regulatory Authority (IE) Revision Year: 2015 Publisher: Astellas Pharma Co. Ltd, 5 Waterside, Citywest Business Campus, Naas Road, Dublin 24, Ireland
Nivadil is indicated for the treatment of essential hypertension.
For oral administration.
The prolonged release capsule should be swallowed whole, with a little liquid, in the morning. It may be taken after breakfast.
The recommended dose is 1 Nivadil 8 mg prolonged release capsule per day in the morning as a starting dose. If after 2-4 weeks of therapy an adequate anti-hypertensive effect is not achieved, a daily dose of 16 mg nilvadipine (2 × 8 mg Nivadil prolonged release capsules, or 1 × 16 mg Nivadil prolonged release capsule, in the morning) may improve the blood pressure response.
No dosage adjustment is required in mild to moderate renal insufficiency. Nivadil should not however be used in patients with severe renal insufficiency.
In patients with cirrhosis of the liver, due to diminished first-pass effect, the bioavailability is increased by a factor of 2 to 3. The currently available data lead to the recommendation that a daily dose of 1 × 8 mg nilvadipine (equivalent to 1 Nivadil 8 mg prolonged release capsule) may only be exceeded under close monitoring in such patients.
Plasma levels in elderly patients may be higher than in younger patients and increasing the dose in elderly patients should therefore be done cautiously.
Not recommended.
The duration of use is at the discretion of the physician.
Nivadipine should not be taken with grapefruit juice (see interactions).
In general, clinical symptoms following an overdose of calcium antagonists develop within 30 to 60 minutes after administration of a dose five to ten times higher than the therapeutic dose.
There has been no clinical experience with acute overdoses of Nivadil. Flush, headache, hypotension, electrophysiological effects (sinus bradycardia, prolonged AV conduction, second and third degree AV block, reflex tachycardia may also be experienced), effects on the central nervous system (drowsiness, confusion and, rarely, convulsions), gastrointestinal symptoms (nausea and vomiting) and metabolic effects (hyperglycaemia) can theoretically be expected to occur with overdose.
Hospital treatment is necessary in the event of intoxication. Symptomatic treatment and continuous ECG monitoring are indicated.
Since there is no known specific antidote, the therapy of cases of intoxication should be directed by clinical symptoms. The immediate administration of activated charcoal and intensive gastric lavage are recommended measures when the intoxication is recognised early. An intravenous (dosage 0.2 ml/kg body weight) injection of calcium (preferably 10 ml of a calcium chloride solution of 10%) should be given over a period of 5 minutes, up to a total dose of 10 ml 10%. Contractility of the myocardium, sinus rhythm and atrioventricular conduction will thus be improved. The treatment can be repeated every 15 to 20 minutes (up to a total of 4 doses) based on the patient’s response. Calcium levels should be checked.
However, when administering laxatives, attention should be paid to the possible inhibition of the intestinal musculature (atony) that may occur with calcium antagonists. Hemodialysis is not indicated since Nilvadipine is not removed by dialysis. Plasmapheresis (high plasma protein binding, relatively small distribution volume) on the other hand, is recommended.
Bradycardias are treated symptomatically with atropine and/or beta-sympathomimetic agents; in cases of lifethreatening bradycardia, the temporary implantation of a pacemaker device is indicated.
Hypotension as a consequence of cardiogenic shock and arterial vasodilatation is treated with calcium (1-2 g calcium gluconate intravenously), dopamine (up to 25 µg/kg/bw per minute) dobutamine (up to 15 µg/kg/bw per minute) or epinephrine/norepinepherine. The dose levels of these drugs are determined by the response of the patient.
The serum calcium concentration should be maintained at normal or slightly raised levels. Due to risk of cardiac overload, fluid or volume should be substituted cautiously with careful monitoring of haemodynamic parameters.
Shelf life: 5 years.
This medicinal product does not require any special storage conditions.
Nature: Blister made of PVC/PVDC Film on aluminium foil (250 mm coated with 40 g/m PVDC; 20 mm Al).
Package sizes: Original packages containing: 28 prolonged release capsules
No special requirements.
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