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Indications/Uses
Capsule: Treatment and prophylaxis of angina pectoris and treatment of hypertension. Also for mild to moderate hypertension.
SR Tablet: Treatment of coronary heart disease, chronic stable angina pectoris (angina of effort). Treatment of hypertension. Coronary spasm. Raynaud's syndrome.
SR Tablet: Treatment of coronary heart disease, chronic stable angina pectoris (angina of effort). Treatment of hypertension. Coronary spasm. Raynaud's syndrome.
Dosage/Direction for Use
Capsule: 5-10 mg 2-3 times a day taken during or after meals. This may be increased, if necessary. Elderly patients or those on concomitant medication may require less dosage, or as prescribed by the physician.
SR Tablet: Adults: 1 SR tab twice daily. If a higher dose is necessary, the dose could be slowly increased to 2 SR tablets twice daily.
Administration: Nelapine SR tablets are generally swallowed whole with a little liquid, independently of meals. Simultaneous food intake leads to delay but not reduced absorption.
SR Tablet: Adults: 1 SR tab twice daily. If a higher dose is necessary, the dose could be slowly increased to 2 SR tablets twice daily.
Administration: Nelapine SR tablets are generally swallowed whole with a little liquid, independently of meals. Simultaneous food intake leads to delay but not reduced absorption.
Overdosage
Overdosage with nifedipine may be associated with tachycardia and hypotension.
Treatment: 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.
Hemodialysis serves no purpose, as nifedipine is not dialyzable, but plasmapheresis is advisable.
Treatment: 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.
Hemodialysis serves no purpose, as nifedipine is not dialyzable, but plasmapheresis is advisable.
Administration
May be taken with or without food: Swallow whole, do not chew/crush. Avoid grapefruit juice.
Contraindications
Patients hypersensitive to nifedipine.
Nifedipine must not be used in combination with rifampicin because no efficient plasma levels of nifedipine may be obtained due to enzyme induction.
Use in pregnancy & lactation: Nifedipine is contraindicated throughout pregnancy, as administration in animals was associated with embryotoxic, fetotoxic and teratogenic effects.
Nifedipine passes into the breast milk. As there is no experience of possible effects on infants, breastfeeding should first be stopped if nifedipine treatment becomes necessary during breastfeeding period.
Nifedipine must not be used in combination with rifampicin because no efficient plasma levels of nifedipine may be obtained due to enzyme induction.
Use in pregnancy & lactation: Nifedipine is contraindicated throughout pregnancy, as administration in animals was associated with embryotoxic, fetotoxic and teratogenic effects.
Nifedipine passes into the breast milk. As there is no experience of possible effects on infants, breastfeeding should first be stopped if nifedipine treatment becomes necessary during breastfeeding period.
Warnings
Doses exceeding 180 mg/day are not recommended.
Special Precautions
Nifedipine should be used with caution in patients whose cardiac reserve is poor.
Nifedipine should be discontinued immediately if hypersensitivity reaction occurs.
In patients with impaired liver function, careful monitoring and, in severe cases, a dose reduction may be necessary.
Impairment of Fertility: In single cases of in vitro fertilization, calcium antagonists eg, nifedipine, have been associated with reversible biochemical changes in the spermatozoa's head section that may result in impaired sperm function.
Nifedipine should be discontinued immediately if hypersensitivity reaction occurs.
In patients with impaired liver function, careful monitoring and, in severe cases, a dose reduction may be necessary.
Impairment of Fertility: In single cases of in vitro fertilization, calcium antagonists eg, nifedipine, have been associated with reversible biochemical changes in the spermatozoa's head section that may result in impaired sperm function.
Use In Pregnancy & Lactation
Nifedipine is contraindicated throughout pregnancy, as administration in animals was associated with embryotoxic, fetotoxic and teratogenic effects.
Nifedipine passes into the breast milk. As there is no experience of possible effects on infants, breastfeeding should first be stopped if nifedipine treatment becomes necessary during breastfeeding period.
Nifedipine passes into the breast milk. As there is no experience of possible effects on infants, breastfeeding should first be stopped if nifedipine treatment becomes necessary during breastfeeding period.
Adverse Reactions
The most common adverse reactions after nifedipine intake are associated with vasodilatory actions eg, dizziness, flushing, headache, hypotension and peripheral edema. A paradoxical increase in ischemic chest pain may occur at the start of treatment. Rarely, abnormalities in liver function have been reported. Chest pain has also been reported.
Drug Interactions
The blood pressure-lowering effect of nifedipine may be potentiated upon co-administration of other antihypertensive drugs.
Nifedipine may potentiate the effect of reserpine, methyldopa and cimetidine.
Cimetidine: Due to its inhibition of cytochrome P-450 3A4, cimetidine elevates the plasma concentrations of nifedipine and may potentiate the antihypertensive effect.
Rifampicin: Strongly induces the cytochrome P-450 3A4 system. Upon co-administration with rifampicin, the bioavailability of nifedipine is distinctly reduced and thus, its efficacy weakened. The use of nifedipine in combination with rifampicin is therefore contraindicated.
Grapefruit juice inhibits the cytochrome P-450 3A4 system. Administration of nifedipine together with grapefruit juice thus results in elevated plasma concentrations of nifedipine due to an increase of drug bioavailability. As a consequence, the blood pressure-lowering effect may be increased.
Cisapride: Simultaneous administration of cisapride and nifedipine may lead to increased plasma concentrations of nifedipine.
Nifedipine may potentiate the effect of reserpine, methyldopa and cimetidine.
Cimetidine: Due to its inhibition of cytochrome P-450 3A4, cimetidine elevates the plasma concentrations of nifedipine and may potentiate the antihypertensive effect.
Rifampicin: Strongly induces the cytochrome P-450 3A4 system. Upon co-administration with rifampicin, the bioavailability of nifedipine is distinctly reduced and thus, its efficacy weakened. The use of nifedipine in combination with rifampicin is therefore contraindicated.
Grapefruit juice inhibits the cytochrome P-450 3A4 system. Administration of nifedipine together with grapefruit juice thus results in elevated plasma concentrations of nifedipine due to an increase of drug bioavailability. As a consequence, the blood pressure-lowering effect may be increased.
Cisapride: Simultaneous administration of cisapride and nifedipine may lead to increased plasma concentrations of nifedipine.
Caution For Usage
Nifedipine is highly light sensitive. Therefore, the film-coated tablets must not be broken, as otherwise, the protection against light due to the pigment film-coating is no longer ensured.
Storage
Store at a temperature not exceeding 30°C.
Action
Pharmacology: Calcium-channel blocker.
Nifedipine is a calcium antagonist of the 14-dihydropyridine type. Calcium antagonists reduce the transmembranal influx of calcium ions through the slow calcium channel into the cell. Nifedipine acts particularly on the cells of the myocardium and the smooth muscle cells of the coronary arteries and the peripheral resistance vessels. Parallel to this, nifedipine reduces the oxygen requirement by lowering peripheral resistance (afterload). With long-term use, nifedipine can also prevent the development of new atherosclerotic lesions in the coronary arteries.
At the beginning of the nifedipine treatment, there may be a transient reflex increase in heart rate and thus in the cardiac output. However, this increase is not enough to compensate for the vasodilation, thereby causing lowering of blood pressure. Nifedipine increases sodium and water excretion both in short-term and long-term use.
In Raynaud's syndrome, nifedipine can prevent or reduce the occurring digital vasospasm.
The t½ of nifedipine is 4-6 hrs.
Nifedipine is a calcium antagonist of the 14-dihydropyridine type. Calcium antagonists reduce the transmembranal influx of calcium ions through the slow calcium channel into the cell. Nifedipine acts particularly on the cells of the myocardium and the smooth muscle cells of the coronary arteries and the peripheral resistance vessels. Parallel to this, nifedipine reduces the oxygen requirement by lowering peripheral resistance (afterload). With long-term use, nifedipine can also prevent the development of new atherosclerotic lesions in the coronary arteries.
At the beginning of the nifedipine treatment, there may be a transient reflex increase in heart rate and thus in the cardiac output. However, this increase is not enough to compensate for the vasodilation, thereby causing lowering of blood pressure. Nifedipine increases sodium and water excretion both in short-term and long-term use.
In Raynaud's syndrome, nifedipine can prevent or reduce the occurring digital vasospasm.
The t½ of nifedipine is 4-6 hrs.
MedsGo Class
Calcium Antagonists
Features
Brand
Nelapine
Full Details
Dosage Strength
20 mg
Drug Ingredients
- Nifedipine
Drug Packaging
Sustained Release Tablet 100's
Generic Name
Nifedipine
Dosage Form
Sustained Release Tablet
Registration Number
DRP-3769-01
Drug Classification
Prescription Drug (RX)