Remifentanil Hydrochloride

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Overview

What is Remifentanil Hydrochloride?

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.

Remifentanil hydrochloride for injection 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 remifentanil HCl are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of remifentanil HCl ranges from 2.5 to 3.5. Remifentanil HCl has a pKa of 7.07. Remifentanil HCl has an n-octanol:water partition coefficient of 17.9 at pH 7.3.

What does Remifentanil Hydrochloride look like?

What are the available doses of Remifentanil Hydrochloride?

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 Remifentanil Hydrochloride?

How should I use Remifentanil Hydrochloride?

Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration:

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

Remifentanil HCl is for intravenous use only.

Remifentanil HCl should not be administered without dilution.

Consider an alternative to remifentanil HCl 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 remifentanil HCl if patient is not responding appropriately to treatment.

What interacts with Remifentanil Hydrochloride?

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What are the warnings of Remifentanil Hydrochloride?

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What are the precautions of Remifentanil Hydrochloride?

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What are the side effects of Remifentanil Hydrochloride?

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What should I look out for while using Remifentanil Hydrochloride?

Remifentanil HCl is contraindicated:

Addiction, Abuse, and Misuse

Remifentanil hydrochloride for injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Remifentanil hydrochloride for injection

[see Warnings and Precautions ()]

What might happen if I take too much Remifentanil Hydrochloride?

How should I store and handle Remifentanil Hydrochloride?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Remifentanil HCl for injection should be stored at 2° to 25°C (36° to 77°F). Remifentanil HCl for IV use is supplied as follows: The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451363Issued: September 2017 Remifentanil HCl for injection should be stored at 2° to 25°C (36° to 77°F). Remifentanil HCl for IV use is supplied as follows: The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451363Issued: September 2017 Remifentanil HCl for injection should be stored at 2° to 25°C (36° to 77°F). Remifentanil HCl for IV use is supplied as follows: The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451363Issued: September 2017 Remifentanil HCl for injection should be stored at 2° to 25°C (36° to 77°F). Remifentanil HCl for IV use is supplied as follows: The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451363Issued: September 2017 Remifentanil HCl for injection should be stored at 2° to 25°C (36° to 77°F). Remifentanil HCl for IV use is supplied as follows: The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451363Issued: September 2017 Remifentanil HCl for injection should be stored at 2° to 25°C (36° to 77°F). Remifentanil HCl for IV use is supplied as follows: The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451363Issued: September 2017

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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

Unlike other opioids, remifentanil HCl is rapidly metabolized by hydrolysis of the propanoic acid-methyl ester linkage by nonspecific blood and tissue esterases. Remifentanil HCl 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

Remifentanil HCl is contraindicated:

Addiction, Abuse, and Misuse

Remifentanil hydrochloride for injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Remifentanil hydrochloride for injection

[see Warnings and Precautions ()]

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine and possibly with griseofulvin, ampicillin, and tetracyclines (72).

Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation:

Do not co-administer Bekyree with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations .

Consult the labeling of the concurrently-used drug to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Remifentanil HCl contains remifentanil, a Schedule II controlled substance. As an opioid, remifentanil HCl 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 remifentanil HCl. 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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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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