Isradipine (Page 3 of 3)

OVERDOSAGE

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. Overdosage characterized by clinically significant hypotension should be treated with active cardiovascular support including monitoring of cardiac and respiratory function, elevation of lower extremities, and attention to circulating fluid volume and urine output. A vasoconstrictor (such as epinephrine, norepinephrine, or levarterenol) may be helpful in restoring a normotensive state, provided that there is no contraindication to its use.

Refractory hypotension or AV conduction disturbances may be treated with intravenous calcium salts, or glucagon. Cimetidine should be withheld in such instances due to the risk of further increasing plasma isradipine levels.

Significant lethality was observed in mice given oral doses of over 200 mg/kg and rabbits given about 50 mg/kg of isradipine. Rats tolerated doses of over 2000 mg/kg without effects on survival.

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.

HOW SUPPLIED

Isradipine Capsules, USP

2.5 mg
Brown opaque, imprinted with “Cobalt symbol” IS 2.5.
Bottles of 100 capsules (NDC 16252-539-01)

5 mg
Caramel opaque, imprinted with “Cobalt symbol” IS 5.
Bottles of 100 capsules (NDC 16252-540-01)

Store and Dispense
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and dispense in a tight, light-resistant container.

Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054

Rev. A 11/2023

PRINCIPAL DISPLAY PANEL

NDC 16252-539-01

Isradipine
Capsules, USP
2.5 mg Rx only

100 Capsules

2_5 mg
(click image for full-size original)

2_5 mg

PRINCIPAL DISPLAY PANEL

NDC 16252-540-01

Isradipine
Capsules, USP 5 mg

Rx only

100 Capsules

5mg
(click image for full-size original)
ISRADIPINE isradipine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16252-539
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISRADIPINE (ISRADIPINE) ISRADIPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
GELATIN
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
SHELLAC
POTASSIUM HYDROXIDE
Product Characteristics
Color brown Score no score
Shape CAPSULE Size 6mm
Flavor Imprint Code IS;2;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16252-539-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077317 01/05/2004
ISRADIPINE isradipine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16252-540
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISRADIPINE (ISRADIPINE) ISRADIPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FERRIC OXIDE YELLOW
GELATIN
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
SHELLAC
POTASSIUM HYDROXIDE
Product Characteristics
Color brown (caramel) Score no score
Shape CAPSULE Size 6mm
Flavor Imprint Code IS;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16252-540-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077317 01/05/2006
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 11/2023 Actavis Pharma, Inc.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.