Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2019 Publisher: Bayer New Zealand Limited, 3 Argus Place, Hillcrest, North Shore, Auckland 0627 Free Phone 0800 233 988 www.bayer.co.nz
As far as possible the treatment must be tailored to the needs of the individual according to the severity of the disease and the patient’s response.
Depending on the clinical picture in each case, the basic dose must be introduced gradually. In patients with mild, moderate or severe impaired liver function, careful monitoring and a dose reduction may be necessary. The pharmacokinetics of nifedipine has not been investigated in patients with severe hepatic impairment (see Special warnings and precautions for use and Pharmacokinetic properties).
ADALAT 10 is particularly suitable for dose titration. Dose titration is recommended for hypertensives with severe cerebrovascular disease and for patients who, because of low body weight or multiple therapies with other antihypertensive drugs, are likely to have an excessive reaction to nifedipine. In addition, for patients who experience adverse effects in response to the nifedipine treatment, a finer dose adjustment is desirable and should be individually stabilised with ADALAT 10.
Unless otherwise prescribed, the following dosage guidelines apply for adults:
| In Coronary Heart Disease: | |
| Chronic stable angina pectoris | One ADALAT 10 tablet twice daily |
| (angina of effort) | (2 × 10 mg/day) |
| One ADALAT 20 tablet twice daily | |
| (2 × 20 mg/day) | |
| If higher dosages are necessary, the dose can be increased in stages up to maximum 60 mg daily. | |
| In Hypertension: | One ADALAT 10 tablet twice daily |
| (2 × 10 mg/day) | |
| One ADALAT 20 tablet twice daily | |
| (2 × 20 mg/day) | |
If higher dosages are necessary the dose can be increased in stages up to maximum 60 mg daily.
Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all (see Interaction with other medicines and other forms of interaction.
The attending doctor will determine the duration of use.
Because ADALAT has a pronounced antiischemic and antihypertensive action, it should be discontinued gradually, particularly when high doses are used.
Tablets are generally swallowed whole with a little liquid, irrespective of meal times. Simultaneous food intake leads to delayed but not reduced absorption.
Grapefruit juice is to be avoided (see Interaction with other medicines and other forms of interaction).
Do not chew or halve tablet.
The recommended dosage interval for ADALAT 10 or ADALAT 20 is about 12 hours and should not be less than 4 hours.
The safety and efficacy of ADALAT in children below 18 years has not been established.
The pharmacokinetics of ADALAT are altered in the elderly so that lower maintenance doses of ADALAT may be required compared to younger patients.
In patients with mild, moderate or severe impaired liver function, careful monitoring and a dose reduction may be necessary. The pharmacokinetics of nifedipine has not been investigated in patients with severe hepatic impairment (see Special warnings and precautions for use and Pharmacokinetic properties).
Based on pharmacokinetic data, no dosage adjustment is required in patients with renal impairment (see Pharmacokinetic properties).
The following symptoms are observed in cases of severe nifedipine intoxication:
Disturbances of consciousness to the point of coma, a drop in blood pressure, tachycardiac/bradycardiac heart rhythm disturbances, hyperglycaemia, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary oedema.
As far as treatment is concerned, elimination of the active substance and the restoration of stable cardiovascular conditions have priority.
After oral ingestion, thorough gastric lavage is indicated, if necessary in combination with irrigation of the small intestine.
Particularly in cases of intoxication with slow-release nifedipine formulations such as ADALAT, elimination must be as complete as possible, including the small intestine, to prevent the otherwise inevitable subsequent absorption of the active substance.
Haemodialysis serves no purpose, as nifedipine is not dialysable, but plasmapheresis is advisable (high plasma protein binding, relatively low volume of distribution).
Bradycardiac heart rhythm disturbances may be treated symptomatically with β-sympathomimetics, and in life-threatening bradycardiac disturbances of heart rhythm, temporary pacemaker therapy can be advisable.
Hypotension as a result of cardiogenic shock and arterial vasodilation can be treated with calcium (10 to 20 mL of a 10% calcium gluconate solution administered slowly intravenously and repeated if necessary). As a result, the serum calcium can reach the upper normal range to slightly elevated levels. If an insufficient increase in blood pressure is achieved with calcium, vasoconstricting sympathomimetics such as dopamine or noradrenaline are additionally administered. The dosage of these drugs is determined solely by the effect obtained.
Additional liquid or volume must be administered with caution because of the danger of overloading the heart.
For advice on the management of overdose, please contact the National Poisons Centre on 0800 POISON (0800 764766)
48 months.
Store below25°C.
The active substance nifedipine is highly light-sensitive. Therefore, the film-coated tablets must not be broken, as the protection against light due to the pigment film-coating is no longer guaranteed.
The light-sensitive active substance contained in the film-coated tablets is protected from light inside and outside its packaging. Nevertheless, tablets must only be removed from the packaging immediately before use.
PP/Alu blister strips of 10 tablets in boxes containing 60 tablets.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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