"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
(remifentanil hydrochloride) for Injection
ULTIVA (remifentanil hydrochloride) for Injection is a μ-opioid agonist chemically designated as a 3-[4-methoxycarbonyl-4- [(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt, C20H28N2O5•HCl, with a molecular weight of 412.91. It has the following chemical structure:
ULTIVA (remifentanil) is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1, 2, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of ULTIVA are clear and colorless and contain remifentanil hydrochloride (HCI) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of ULTIVA ranges from 2.5 to 3.5. Remifentanil HCI has a pKa of 7.07. Remifentanil HCI has an n-octanol:water partition coefficient of 17.9 at pH 7.3.
What are the possible side effects of remifentanil (Ultiva)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Your caregivers will monitor you for any of these serious side effects, which may clear up within minutes after stopping the remifentanil infusion or decreasing the dose:
- weak, shallow breathing, or breathing that stops;
- fast or slow heart rate;
- stiff muscles; or
- severe weakness, feeling light-headed or fainting.
Less serious side effects may include:
Last reviewed on RxList: 5/8/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Ultiva Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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