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Remifentanil Hydrochloride

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Overview

What is Ultiva?

ULTIVA (remifentanil hydrochloride) for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is CHNO•HCl, and it has the following chemical structure.

ULTIVA is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, 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 (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of ULTIVA ranges from 2.5 to 3.5. Remifentanil hydrochloride has a pKa of 7.07. Remifentanil hydrochloride has an n-octanol:water partition coefficient of 17.9 at pH 7.3.



What does Ultiva look like?



What are the available doses of Ultiva?

For injection: 1 mg, 2 mg, and 5 mg for intravenous administration after reconstitution and dilution ()

What should I talk to my health care provider before I take Ultiva?

How should I use Ultiva?

ULTIVA is indicated for intravenous (IV) administration:

Monitor patients closely for respiratory depression when initiating therapy and following dosage increases with ULTIVA and adjust the dosage accordingly

ULTIVA is for IV use only.

ULTIVA should not be administered without dilution.

Consider an alternative to ULTIVA for patients taking mixed agonist/antagonist and partial agonist opioid analgesics due to reduced analgesic effect or potential withdrawal symptoms. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue ULTIVA if patient is not responding appropriately to treatment.

Discard unused portion.


What interacts with Ultiva?

Sorry No Records found


What are the warnings of Ultiva?

Sorry No Records found


What are the precautions of Ultiva?

Sorry No Records found


What are the side effects of Ultiva?

Sorry No records found


What should I look out for while using Ultiva?

ULTIVA is contraindicated:


What might happen if I take too much Ultiva?

Clinical Presentation

Acute overdose with ULTIVA can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations .

Treatment of Overdose

In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.

The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to remifentanil overdose, stop the infusion or administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to remifentanil overdose.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.


How should I store and handle Ultiva?

Storage and StabilitySTELARA vials and prefilled syringes must be refrigerated at 2°C to 8°C (36°F to 46°F). Store STELARA vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.Storage and StabilitySTELARA vials and prefilled syringes must be refrigerated at 2°C to 8°C (36°F to 46°F). Store STELARA vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is supplied as follows:ULTIVA should be stored at 2° to 25°C (36° to 77°F).Discard unused portion.ULTIVA is a registered trademark of Glaxo Group Limited.Diprivan is a registered trademark of Fresenius Kabi USA, LLC.U.S. Patent No. 5,866,591Manufactured for: Rockford, IL 61103 U.S.A.Manufactured by: Lake Forest, IL 60045 U.S.A.Revised: 12/2017MI:ULTIIJ:R4ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is supplied as follows:ULTIVA should be stored at 2° to 25°C (36° to 77°F).Discard unused portion.ULTIVA is a registered trademark of Glaxo Group Limited.Diprivan is a registered trademark of Fresenius Kabi USA, LLC.U.S. Patent No. 5,866,591Manufactured for: Rockford, IL 61103 U.S.A.Manufactured by: Lake Forest, IL 60045 U.S.A.Revised: 12/2017MI:ULTIIJ:R4ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is supplied as follows:ULTIVA should be stored at 2° to 25°C (36° to 77°F).Discard unused portion.ULTIVA is a registered trademark of Glaxo Group Limited.Diprivan is a registered trademark of Fresenius Kabi USA, LLC.U.S. Patent No. 5,866,591Manufactured for: Rockford, IL 61103 U.S.A.Manufactured by: Lake Forest, IL 60045 U.S.A.Revised: 12/2017MI:ULTIIJ:R4ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is supplied as follows:ULTIVA should be stored at 2° to 25°C (36° to 77°F).Discard unused portion.ULTIVA is a registered trademark of Glaxo Group Limited.Diprivan is a registered trademark of Fresenius Kabi USA, LLC.U.S. Patent No. 5,866,591Manufactured for: Rockford, IL 61103 U.S.A.Manufactured by: Lake Forest, IL 60045 U.S.A.Revised: 12/2017MI:ULTIIJ:R4ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is supplied as follows:ULTIVA should be stored at 2° to 25°C (36° to 77°F).Discard unused portion.ULTIVA is a registered trademark of Glaxo Group Limited.Diprivan is a registered trademark of Fresenius Kabi USA, LLC.U.S. Patent No. 5,866,591Manufactured for: Rockford, IL 61103 U.S.A.Manufactured by: Lake Forest, IL 60045 U.S.A.Revised: 12/2017MI:ULTIIJ:R4ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is supplied as follows:ULTIVA should be stored at 2° to 25°C (36° to 77°F).Discard unused portion.ULTIVA is a registered trademark of Glaxo Group Limited.Diprivan is a registered trademark of Fresenius Kabi USA, LLC.U.S. Patent No. 5,866,591Manufactured for: Rockford, IL 61103 U.S.A.Manufactured by: Lake Forest, IL 60045 U.S.A.Revised: 12/2017MI:ULTIIJ:R4ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is supplied as follows:ULTIVA should be stored at 2° to 25°C (36° to 77°F).Discard unused portion.ULTIVA is a registered trademark of Glaxo Group Limited.Diprivan is a registered trademark of Fresenius Kabi USA, LLC.U.S. Patent No. 5,866,591Manufactured for: Rockford, IL 61103 U.S.A.Manufactured by: Lake Forest, IL 60045 U.S.A.Revised: 12/2017MI:ULTIIJ:R4


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Clinical Information

Chemical Structure

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Clinical Pharmacology

ULTIVA is a µ-opioid agonist with rapid onset and peak effect, and short duration of action. The µ-opioid activity of ULTIVA is antagonized by opioid antagonists such as naloxone.

Unlike other opioids, ULTIVA is rapidly metabolized by hydrolysis of the propanoic acid-methyl ester linkage by nonspecific blood and tissue esterases. ULTIVA is not a substrate for plasma cholinesterase (pseudocholinesterase) and, therefore, patients with atypical cholinesterase are expected to have a normal duration of action.

Non-Clinical Toxicology
ULTIVA is contraindicated:

Drug Interactions

Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary,

ULTIVA contains remifentanil, a Schedule II controlled substance. As an opioid, ULTIVA exposes users to the risks of addiction, abuse, and misuse

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when handling ULTIVA. Strategies to reduce these risks include proper product storage and control practices for a C-II drug. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

The following serious adverse reactions are described, or described in greater detail, in other sections:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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