IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Nimodipine Compounded Oral Suspension: A True Documented Medical Need

Author(s):  McElhiney Linda F

Issue:  Mar/Apr 2019 - Volume 23, Number 2
View All Articles in Issue

Abstract:  What happens when there is an entire patient population, not just a specific patient, which cannot take a commercial product due to significant adverse effects, although the commercial product has a U.S. Food and Drug Administration-approved indication for the medical problem? What should or can be done in this situation? This article discusses this dilemma using a subarachnoid hemorrhage as an example of a true documented medical need, and discusses the option and circumstances surrounding the compounding of a nimodipine oral solution, a U.S. Food and Drug Administration–approved indication for the treatment of subarachnoid hemorrhages.

Related Keywords: Linda F. McElhiney, PharmD, RPh, MSP, FIACP, FASHP, FACA, DPLA, nimodipine, dihydropyridine calcium channel blocker, formulations, US Food and Drug Administration, FDA, DQSA, subarachnoid hemorrhage, bleeding in brain, drug safety, dosage forms, adverse effects

Related Categories: FORMULATIONS, LEGAL, ADVERSE DRUG EVENTS, HEMOSTASIS, BLEEDING, ANTICOAGULATION, NEUROLOGY

Printer-Friendly Version




Download in electronic PDF format for $35

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Nimodipine Compounded Oral Suspension: A True Documented Medical Need McElhiney Linda F Mar/Apr 2019 106-111 Buy
PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs Allen Loyd V Jr Sep/Oct 2017 356 Buy
Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines Allen Loyd V Jr Jul/Aug 2016 351 View Sample
U.S. Food and Drug Administration Proposed Guidance Document: Compounding Animal Drugs from Bulk Substances Miller David G Jul/Aug 2015 303-305 Buy
Preventing Medication Errors with Nimodipine by Compounding Proper Dosage Forms McElhiney Linda F Sep/Oct 2013 364-368 Buy
U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs Allen Loyd V Jr Nov/Dec 2015 487-488 Buy
Basics of Compounding: Providing Pharmacy Services to Bariatric Surgery Patients McElhiney Linda F Jan/Feb 2018 30-39 Buy
U.S. Food and Drug Administration Inspection Authority: How to Know Whether U.S. Food and Drug Administration Inspectors Are Crossing the Line Snow Stephen T, Stannard Robert W, Bellis Jennifer, Moss Carrie A Jan/Feb 2019 32-33 Buy
Basics of Sterile Compounding: Biopharmaceutics of Injectable Dosage Forms Akers Michael J Jan/Feb 2017 47-56 Buy
U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies Yoch Doug Mar/Apr 2017 95-102 Buy