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Nimodipine Compounded Oral Suspension: A True Documented Medical Need

Author(s):  McElhiney Linda F

Issue:  Mar/Apr 2019 - Volume 23, Number 2
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Page(s):  106-111

Nimodipine Compounded Oral Suspension: A True Documented Medical Need Page 1
Nimodipine Compounded Oral Suspension: A True Documented Medical Need Page 2
Nimodipine Compounded Oral Suspension: A True Documented Medical Need Page 3
Nimodipine Compounded Oral Suspension: A True Documented Medical Need Page 4
Nimodipine Compounded Oral Suspension: A True Documented Medical Need Page 5
Nimodipine Compounded Oral Suspension: A True Documented Medical Need Page 6

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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

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