Isradipine
Generic Name: isradipine
Brand Names:
Isradipine
DESCRIPTION Isradipine is a calcium antagonist available for oral administration in capsules containing 2.5 mg or 5 mg. The structural formula of isradipine is: Chemically, isradipine is 3,5-Pyridinedicarboxylic acid, 4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl-, methyl 1-methylethyl ester. Isradipine is a yellow, fine crystalline powder which is odorless or has a faint characteristic odor.
Overview
DESCRIPTION Isradipine is a calcium antagonist available for oral administration in capsules containing 2.5 mg or 5 mg. The structural formula of isradipine is: Chemically, isradipine is 3,5-Pyridinedicarboxylic acid, 4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl-, methyl 1-methylethyl ester. Isradipine is a yellow, fine crystalline powder which is odorless or has a faint characteristic odor.
Uses
INDICATIONS AND USAGE Hypertension Isradipine is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.
Dosage
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 2-3 hours. Maximal response may require 2-4 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 2-4 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.
Side Effects
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.
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.
Warnings
WARNINGS None CONTRAINDICATIONS Isradipine is contraindicated in individuals who have shown hypersensitivity to any of the ingredients in the formulation.
Pregnancy
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.
Storage
HOW SUPPLIED Isradipine Capsules, USP 2.5 mg Brown opaque, imprinted with “ ” IS 2.5. Bottles of 100 capsules (NDC 42291-062-01) 5 mg Caramel opaque, imprinted with “ ” IS 5. Store and Dispense Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature] and dispense in a tight, light-resistant container Rx Only Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev.
Frequently Asked Questions
What is Isradipine used for?▼
INDICATIONS AND USAGE Hypertension Isradipine is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.
What are the side effects of Isradipine?▼
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.
Can I take Isradipine during pregnancy?▼
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.
What are the important warnings for Isradipine?▼
WARNINGS None CONTRAINDICATIONS Isradipine is contraindicated in individuals who have shown hypersensitivity to any of the ingredients in the formulation.
Related Medications
Carduus Marianus, Ascorbicum Acidum, Cysteinum, Natrum Oxalaceticum, Nicotinamidum, Pulsatilla (pratensis), Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Alpha-ketoglutaricum Acidum, Alpha-lipoicum Acidum, Cerium Oxalicum, Citricum Acidum, Fumaricum Acidum, Magnesium Oroticum Dihydricum, Malicum Acidum, Nadidum, Natrum Pyruvicum, Pantothenic Acid, Succinicum Acidum, Adrenalinum, Adenosinum Triphosphoricum Dinatrum, Hepar Sulphuris Calcareum, Sulphur, Aconiticum Acidum, Cis-,
carduus marianus, ascorbicum acidum, cysteinum, natrum oxalaceticum, nicotinamidum, pulsatilla (pratensis), pyridoxinum hydrochloricum, riboflavinum, thiaminum hydrochloricum, alpha-ketoglutaricum acidum, alpha-lipoicum acidum, cerium oxalicum, citricum acidum, fumaricum acidum, magnesium oroticum dihydricum, malicum acidum, nadidum, natrum pyruvicum, pantothenic acid, succinicum acidum, adrenalinum, adenosinum triphosphoricum dinatrum, hepar sulphuris calcareum, sulphur, aconiticum acidum, cis-,
Calculi Dissolution Agent [EPC]
PURPOSE: Aconiticum Acidum, Cis - Fatigue, Adenosinum Triphosphoricum Dinatrum - Weakness, Adrenalinum - Exhaustion, Alpha-Ketoglutaricum Acidum - Weakness, Alpha-Lipoicum Acidum - Fatigue, Ascorbicum Acidum - Exhaustion, Barium Oxalsuccinicum - Fatigue, Carduus Marianus - Exhaustion, Cerium Oxalicum - Fatigue, Citricum Acidum - Weakness, Cysteinum - Exhaustion, Fumaricum Acidum - Fatigue, Hepar Sulphuris Calcareum - Fatigue, Magnesium Oroticum Dihydricum - Weakness, Malicum Acidum - Exhaustion,
Aralia Quinquefolia, Hydrocotyle Asiatica, Polygonum Multiflorum, Hypophysis Suis, Hypothalamus Suis, Germanium Sesquioxide, Pineal Gland (suis)
aralia quinquefolia, hydrocotyle asiatica, polygonum multiflorum, hypophysis suis, hypothalamus suis, germanium sesquioxide, pineal gland (suis)
INDICATIONS: For temporary relief of weakness, exhaustion, vertigo, and difficult mental concentration.
Ferumoxsil
ferumoxsil
Manufactured by AMAG PHARMS INC. Dosage form: SUSPENSION. Route: ORAL. Active ingredients: FERUMOXSIL (EQ 0.175MG IRON/ML). Application: NDA020410.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.