Adalat

$ 119.48$ 245.26

Category: Blood Pressure
Commercial name: Adalat
Active ingredient: Nifedipine
Production form: Pills
Available dosage: 10 mg, 20 mg

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Description

Adalat (Nifedipine). Dosage, Side Effects, Interactions

Adalat (Nifedipine) is a dihydropyridine derivative that is primarily used to treat hypertensive emergencies, vasospastic angina, Raynaud’s syndrome and angina pectoris. The drug acts as an L-type calcium channel antagonist, vasodilating and hypotensive.

Adalat (Nifedipine) is used to treat:

  • Vasospastic angina (Prinzmetal’s angina, variant angina)
  • Hypertensive emergency
  • Chronic stable angina pectoris (stress angina)
  • Essential hypertension
  • Raynaud’s syndrome

Note:
There is evidence that Adalat (Nifedipine) in immediate-release dosage forms in patients with essential hypertension or chronic angina leads to dose-dependent complications of the cardiovascular system (e.g. myocardial infarction ) and to an increase in mortality. Therefore, immediate-release formulations should only be used in these two conditions when other drugs are not indicated.

Application type

Nifedipine is available on the market in the form of soft capsules, hard capsules, as an infusion solution, sustained-release tablets, sustained-release capsules and drops.

Nifedipine is taken whole after meals with sufficient liquid (no grapefruit juice!), preferably in the morning, at noon and in the evening, if possible at the same time. Simultaneous food intake can lead to delayed but not reduced absorption. Discontinuation of nifedipine should be done gradually, especially at high doses.

How Adalat (Nifedipine) works

Nifedipine is a 1,4-dihydropyridine derivative which, as a so-called calcium channel antagonist, blocks the influx of calcium ions through the slow calcium channel in the cell, resulting in vasodilatation in the vessels. Nifedipine acts primarily on the smooth muscle cells of the coronary arteries and on the peripheral resistance vessels. In therapeutic doses, nifedipine has practically no direct effect on the myocardium.

Effects of Nifedipine:

  • blood flow in the large coronary arteries of the heart is improved by reducing muscle tone.
  • peripheral resistance is reduced.
  • at the beginning of treatment, there may be a reflex increase in heart rate and cardiac output.
  • with long-term treatment with nifedipine, the initially increased cardiac output returns to baseline.
  • A particularly marked drop in blood pressure after nifedipine can be observed in hypertensive patients.

Pharmacokinetics

After oral administration on an empty stomach, nifedipine is rapidly and almost completely absorbed with a systemic availability of 50 to 70 percent. When taking a solution containing nifedipine, maximum plasma or serum concentrations are reached after about 15 minutes, when other preparations with non-delayed release are administered after 30 to 85 minutes. The plasma protein binding of nifedipine is 95 to 98 percent and the mean volume of distribution Vss is 0.77 to 1.12 l/kg. Nifedipine is almost completely metabolized in the liver (high first-pass effect), primarily via oxidative processes. The metabolites do not show any pharmacodynamic activities. Neither the unchanged substance nor the metabolite M-1 are eliminated renally to any significant extent (<0.1% of the dose). The polar metabolites M-2 and M-3 are eliminated renally to about 50 percent of the dose (partly in conjugated form), with the major part being excreted within 24 hours. The rest is excreted in the faeces. The elimination half-life is between 1.7 and 3.4 hours (prolonged-release preparation). No accumulation of the substance was observed during long-term therapy at the usual dosage. Impaired liver function leads to a marked increase in the elimination half-life and a reduction in total clearance, which may necessitate a dose reduction. The elimination half-life is between 1.7 and 3.4 hours (prolonged-release preparation). No accumulation of the substance was observed during long-term therapy at the usual dosage. Impaired liver function leads to a marked increase in the elimination half-life and a reduction in total clearance, which may necessitate a dose reduction. The elimination half-life is between 1.7 and 3.4 hours (prolonged-release preparation). No accumulation of the substance was observed during long-term therapy at the usual dosage. Impaired liver function leads to a marked increase in the elimination half-life and a reduction in total clearance, which may necessitate a dose reduction.

Dosage of Adalat (Nifedipine)

Hypertension:

Drug forms with delayed active ingredient release:
initial dose: 30 to 60 mg per day
maintenance dose: 30 to 90 mg per day
maximum dose: up to 120 mg per day

Angina pectoris:

Immediate-release dosage forms:
Loading dose: 5 to 10 mg 3 times a day
Maintenance dose: 10 to 30 mg 3 to 4 times a day
Maximum dose: 180 mg per day

Drug forms with delayed active ingredient release:
initial dose: 30 to 60 mg per day
maintenance dose: 30 to 90 mg per day
maximum dose: up to 120 mg per day

Raynaud’s Syndrome:

Immediate-release dosage forms:
Initial dose: 10 to 20 mg three times a day per day
Maximum dose: 60 mg per day

Hypertensive emergency:

Immediate release dosage forms:
10 mg orally (bite open capsule and swallow contents immediately).
At the earliest after about 30 minutes, if the effect is absent or insufficient, another dose of 10 mg nifedipine can be given.

Side effects of Adalat (Nifedipine)

Very common (≥ 1/10) side effects with nifedipine include:

  • Headache, especially at the beginning of treatment
  • Edema (including peripheral edema)

Common (≥1/100 to <1/10) side effects are:

  • Dizziness, lightheadedness, weakness
  • palpitations
  • Vasodilation (e.g. flush)
  • nausea, constipation
  • Erythema, erythromelalgia especially at the beginning of treatment
  • general malaise

interactions

Nifedipine is metabolised via the cytochrome P450 3A4 system . Drugs that affect this enzyme system may alter the first-pass metabolism or elimination of nifedipine.

The plasma levels of nifedipine can be increased, for example, by the following drugs, which are known to be inhibitors of this enzyme system:

  • Macrolide antibiotics (e.g. erythromycin )
  • Anti-HIV protease inhibitors (e.g. ritonavir )
  • Azole-type antifungals ( e.g. ketoconazole )
  • Antidepressants : nefazodone and fluoxetine
  • Quinupristin / Dalfopristin
  • valproic acid
  • cimetidine
  • tricyclic antidepressants, vasodilators
  • cisapride
  • diltiazem

Medicinal products that induce the cytochrome P450 3A4 system can lead to reduced nifedipine plasma levels or decreased bioavailability:

  • rifampicin
  •  Antiepileptic drugs (e.g. phenytoin , carbamazepine , phenobarbital )

Other interactions:

  • Antihypertensive drugs ► Nifedipine may potentiate the blood pressure-lowering effect of concomitantly administered antihypertensive drugs
  • Theophylline ► Nifedipine can cause an increase in theophylline plasma levels
  • Vincristine ► Nifedipine decreases the elimination of vincristine
  • Cephalosporins (e.g. cefixime ) ► Elevated cephalosporin plasma levels possible
  • Quinidine ► In individual cases, nifedipine causes a drop in the quinidine plasma level or stopping nifedipine causes a significant increase in the quinidine plasma level
  • Tacrolimus ► Elevated tacrolimus plasma levels possible

Interactions with food and drink

  • Grapefruit Juice ► Grapefruit juice inhibits the cytochrome P450 3A4 system. As a result, the blood level of nifedipine can be increased and the duration of action prolonged. After regular consumption of grapefruit juice, this effect can last for at least 3 days after the last ingestion of grapefruit juice.

Other types of interactions

  • Spectrophotometric determination of vanillinmandelic acid in urine can lead to falsely elevated values ​​under nifedipine; the determination by HPLC remains unaffected.

contraindication

Nifedipine must not be used in:

  • Hypersensitivity to the active substance
  • cardiovascular shock
  • high grade aortic stenosis
  • unstable angina pectoris
  • acute myocardial infarction (within the first 4 weeks)
  • concomitant use of rifampicin, since effective plasma levels of nifedipine are not achieved due to enzyme induction
  • Pregnancy unless use is absolutely necessary
  • lactation

Pregnancy/breastfeeding

pregnancy

Nifedipine should not be used during pregnancy unless the clinical condition of the woman requires nifedipine treatment.

lactation

Nifedipine passes into breast milk and must not be used during breastfeeding. The nifedipine concentration in the milk is almost comparable to the maternal serum concentration.

Driving ability

The ability to drive, use machines, or work without a secure footing may be affected by taking nifedipine. This applies to a greater extent at the start of treatment, when the dose is increased and when the drug is changed, as well as in combination with alcohol.

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Additional information

Dosage

10 mg, 20 mg

Quantity

30, 60, 90, 120, 180

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