Isradipine 5 mg/1
Isradipine · CAPSULE · Elite Laboratories, Inc.
Isradipine is a capsule containing isradipine at 5 mg/1, taken oral. Manufactured by Elite Laboratories, Inc..
Key Facts
- Brand Name
- Isradipine
- Generic Name
- Isradipine
- NDC Code (Product)
64850-911- Manufacturer
- Elite Laboratories, Inc.
- Strength
- 5 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077169
- Drug Class
- Dihydropyridine Calcium Channel Blocker [EPC]
- Marketing Start
- 12/28/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Hypertension Isradipine capsules are indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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
WARNINGS None
Contraindications
CONTRAINDICATIONS Isradipine is contraindicated in individuals who have shown hypersensitivity to any of the ingredients in the formulation.
Drug Interactions
Drug Interactions Nitroglycerin: Isradipine has been safely coadministered with nitroglycerin. Hydrochlorothiazide: A study in normal healthy volunteers has shown that concomitant administration of isradipine and hydrochlorothiazide does not result in altered pharmacokinetics of either drug. In a study in hypertensive patients, addition of isradipine to existing hydrochlorothiazide therapy did not result in any unexpected adverse effects, and isradipine had an additional antihypertensive effect. Propranolol: In a single dose study in normal volunteers, co-administration of propranolol had a small effect on the rate but no effect on the extent of isradipine bioavailability. Significant increases in AUC (27%) and C max (58%) and decreases in t max (23%) of propranolol were noted in this study. However, concomitant administration of 5 mg b.i.d. isradipine and 40 mg b.i.d. propranolol to healthy volunteers under steady-state conditions had no relevant effect on either drug's bioavailability. AUC and C max differences were <20% between isradipine given singly and in combination with propranolol, and between propranolol given singly and in combination with isradipine. Cimetidine: In a st…
Adverse Reactions
ADVERSE REACTIONS 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 show…
Frequently Asked Questions
What is Isradipine used for?
Isradipine contains Isradipine. It is a capsule taken oral. Consult your doctor for specific uses.
Is Isradipine a controlled substance?
Isradipine is not classified as a controlled substance by the DEA.
What is the generic name for Isradipine?
The generic name for Isradipine is Isradipine. There are no other listed brand versions of Isradipine.
What is the NDC code for Isradipine 5 mg/1?
The NDC (National Drug Code) for Isradipine 5 mg/1 is 64850-911, listed by Elite Laboratories, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)