pharmacopeia
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/api/v1/drug/isradipine

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Calcium Channel Antagonists; L-Calcium Channel Receptor Antagonists.

Calcium ChannelL-Calcium Channel Receptor

Indications

Sourced from openFDA
  • Hypertension Isradipine capsules are indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.ICD-10: I10

Contraindications

Sourced from openFDA
  • Isradipine is contraindicated in individuals who have shown hypersensitivity to any of the ingredients in the formulation.contraindicated

Dosage & administration

Sourced from openFDA

The dosage of isradipine should be individualized. The recommended initial dose of isradipine is 2.5 mg b.i.d. alone or in combination with a thiazide diuretic. An antihypertensive response usually occurs within 2 to 3 hours. Maximal response may require 2 to 4 weeks. If a satisfactory reduction in blood pressure does not occur after this period, the dose may be adjusted in increments of 5 mg/day at 2 to 4 week intervals up to a maximum of 20 mg/day. Most patients, however, show no additional response to doses above 10 mg/day, and adverse effects are increased in frequency above 10 mg/day. The bioavailability of isradipine (increased AUC) is increased in elderly patients (above 65 years of age), patients with hepatic functional impairment, and patients with mild renal impairment. Ordinarily, the starting dose should still be 2.5 mg b.i.d. in these patients.

Warnings & precautions

Sourced from openFDA

None

Adverse reactions

Sourced from openFDA

In multiple dose U.S. studies in hypertension, 1228 patients received isradipine alone or in combination with other agents, principally a thiazide diuretic, 934 of them in controlled comparisons with placebo or active agents. An additional 652 patients (which includes 374 normal volunteers) received isradipine in U.S. studies of conditions other than hypertension, and 1321 patients received isradipine in non-U.S. studies. About 500 patients received isradipine in long-term hypertension studies, 410 of them for at least 6 months. The adverse reaction rates given below are principally based on controlled hypertension studies, but rarer serious events are derived from all exposures to isradipine, including foreign marketing experience. Most adverse reactions were mild and related to the vasodilatory effects of isradipine (dizziness, edema, palpitations, flushing, tachycardia), and many were transient. About 5% of isradipine patients left studies prematurely because of adverse reactions (vs. 3% of placebo patients and 6% of active control patients), principally due to headache, edema, dizziness, palpitations, and gastrointestinal disturbances. The following table shows the most common adverse reactions, volunteered or elicited, considered by the investigator to be at least possibly drug related.

Use in specific populations

Sourced from openFDA

Pregnancy Pregnancy Category C: Isradipine was administered orally to rats and rabbits during organogenesis. Treatment of pregnant rats with doses of 6, 20, or 60 mg/kg/day produced a significant reduction in maternal weight gain during treatment with the highest dose (150 times the maximum recommended human daily dose) but with no lasting effects on the mother or the offspring. Treatment of pregnant rabbits with doses of 1, 3, or 10 mg/kg/day (2.5, 7.5, and 25 times the maximum recommended human daily dose) produced decrements in maternal body weight gain and increased fetal resorption at the two higher doses. There was no evidence of embryotoxicity at doses which were not maternotoxic and no evidence of teratogenicity at any dose tested. In a peri/postnatal administration study in rats, reduced maternal body weight gain during late pregnancy at oral doses of 20 and 60 mg/kg/day isradipine was associated with reduced birth weights and decreased peri and postnatal pup survival. There are no adequate and well controlled studies in pregnant women. The use of isradipine during pregnancy should only be considered if the potential benefit outweighs potential risks.

Overdosage

Sourced from openFDA

Minimal empirical data are available on isradipine overdosage. Three individual suicide attempts with dosages of isradipine reported to be from 20 mg up to 100 mg resulted in lethargy, sinus tachycardia and, in the case of the person ingesting 100 mg, transient hypotension which responded to fluid therapy. A foreign report of the ingestion of 200 mg of isradipine with ethanol resulted only in flushing, tachycardia with ST depression on ECG, and hypotension, all of which were reversible. The ingestion of 5 mg of isradipine by a 22-month old child and the accidental ingestion of 100 mg of isradipine by a 58-year old female did not result in any sequelae. Available data suggest that, as with other dihydropyridines, overdosage with isradipine might result in excessive peripheral vasodilatation with subsequent marked and probably prolonged systemic hypotension, and tachycardia. Emesis, gastric lavage, administration of activated charcoal followed in 30 minutes by a saline cathartic would be reasonable therapy. Isradipine is highly protein-bound and not removed by hemodialysis.

Approval history

Sourced from openFDA
  • Jan 5, 2006ANDAANDA077317Watson Labs Teva
  • Apr 24, 2006ANDAANDA077169Elite Labs Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
543 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective356.4%
  2. 2Drug Interaction315.7%
  3. 3Dyspnoea315.7%
  4. 4Off Label Use305.5%
  5. 5Hypertension295.3%
  6. 6Acute Kidney Injury264.8%
  7. 7Nausea264.8%
  8. 8Diarrhoea213.9%
  9. 9Asthenia203.7%
  10. 10Renal Failure203.7%
  11. 11Chronic Kidney Disease193.5%
  12. 12Hypotension193.5%
  13. 13Tubulointerstitial Nephritis193.5%
  14. 14Oedema Peripheral183.3%
  15. 15Pyrexia183.3%

Literature

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Recent PubMed references pinned to Isradipine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Isradipine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Isradipine work?
Mechanism-of-action classes: Calcium Channel Antagonists; L-Calcium Channel Receptor Antagonists.
What is Isradipine used for?
According to FDA labeling, Isradipine carries indications including: Hypertension Isradipine capsules are indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Isradipine?
Isradipine is classified as Dihydropyridine derivatives, Dihydropyridine Calcium Channel Blocker, Calcium Channel Antagonists, L-Calcium Channel Receptor Antagonists, Coronary Arterial Vasodilation, Decreased Blood Pressure.
What are the contraindications for Isradipine?
Isradipine labeling lists contraindications including: Isradipine is contraindicated in individuals who have shown hypersensitivity to any of the ingredients in the formulation.. Always consult the full prescribing information and a clinician.
Note. Data for isradipine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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