OXYMORPHONE HYDROCHLORIDE

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Overview

What is OXYMORPHONE HYDROCHLORIDE?

Oxymorphone hydrochloride USP is a semi-synthetic opioid analgesic supplied in 5 mg and 10 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, and pregelatinized maize (corn) starch. In addition, the 5 mg tablets contain FD&C Blue No. 2 Lake. The 10 mg tablets contain D&C Red No. 27 Aluminum Lake.

Chemically, oxymorphone hydrochloride is 4,5α-epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The pK1 and pK2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98.

The structural formula for oxymorphone hydrochloride is as follows:

What does OXYMORPHONE HYDROCHLORIDE look like?

What are the available doses of OXYMORPHONE HYDROCHLORIDE?

Tablets: 5 mg and 10 mg. ()

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

How should I use OXYMORPHONE HYDROCHLORIDE?

Oxymorphone hydrochloride tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses , reserve oxymorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals .

Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse .

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with oxymorphone hydrochloride tablets and adjust the dosage accordingly .

Oxymorphone hydrochloride tablets should be administered on an empty stomach, at least one hour prior to or two hours after eating .

To avoid medication errors, prescribers and pharmacists must be aware that oxymorphone is available as both immediate-release 5 mg and 10 mg tablets and extended-release 5 mg and 10 mg tablets .

What interacts with OXYMORPHONE HYDROCHLORIDE?

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What are the warnings of OXYMORPHONE HYDROCHLORIDE?

Sorry No Records found

What are the precautions of OXYMORPHONE HYDROCHLORIDE?

Sorry No Records found

What are the side effects of OXYMORPHONE HYDROCHLORIDE?

Sorry No records found

What should I look out for while using OXYMORPHONE HYDROCHLORIDE?

Oxymorphone hydrochloride tablets are contraindicated in patients with:

What might happen if I take too much OXYMORPHONE HYDROCHLORIDE?

Clinical Presentation

[see Clinical Pharmacology ()].

Treatment of Overdose

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 oxymorphone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxymorphone overdose.

Because the duration of opioid reversal is expected to be less than the duration of action of oxymorphone in oxymorphone hydrochloride tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.

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 initiated with care and by titration with smaller than usual doses of the antagonist.

How should I store and handle OXYMORPHONE HYDROCHLORIDE?

Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Oxymorphone hydrochloride tablets are supplied as follows:5 mg Tablet:Light blue, round tablets debossed with “1009” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1009-0110 mg Tablet: Pink, round tablets debossed with “1010” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1010-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Oxymorphone hydrochloride tablets are supplied as follows:5 mg Tablet:Light blue, round tablets debossed with “1009” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1009-0110 mg Tablet: Pink, round tablets debossed with “1010” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1010-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Oxymorphone hydrochloride tablets are supplied as follows:5 mg Tablet:Light blue, round tablets debossed with “1009” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1009-0110 mg Tablet: Pink, round tablets debossed with “1010” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1010-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Oxymorphone hydrochloride tablets are supplied as follows:5 mg Tablet:Light blue, round tablets debossed with “1009” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1009-0110 mg Tablet: Pink, round tablets debossed with “1010” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1010-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Oxymorphone hydrochloride tablets are supplied as follows:5 mg Tablet:Light blue, round tablets debossed with “1009” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1009-0110 mg Tablet: Pink, round tablets debossed with “1010” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1010-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Oxymorphone hydrochloride tablets are supplied as follows:5 mg Tablet:Light blue, round tablets debossed with “1009” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1009-0110 mg Tablet: Pink, round tablets debossed with “1010” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1010-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Oxymorphone hydrochloride tablets are supplied as follows:5 mg Tablet:Light blue, round tablets debossed with “1009” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1009-0110 mg Tablet: Pink, round tablets debossed with “1010” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1010-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Oxymorphone hydrochloride tablets are supplied as follows:5 mg Tablet:Light blue, round tablets debossed with “1009” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1009-0110 mg Tablet: Pink, round tablets debossed with “1010” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1010-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Oxymorphone hydrochloride tablets are supplied as follows:5 mg Tablet:Light blue, round tablets debossed with “1009” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1009-0110 mg Tablet: Pink, round tablets debossed with “1010” on one side and “M” in a box on the other side.Bottles of 100 tablets…………………NDC 0406-1010-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Oxymorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxymorphone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxymorphone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Non-Clinical Toxicology

Oxymorphone hydrochloride tablets are contraindicated in patients with:

CYP3A4 Interactions

Lovastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4. Potent inhibitors of CYP3A4 (below) increase the risk of myopathy by reducing the elimination of lovastatin.

See and .

Itraconazole

Ketoconazole

Erythromycin

Clarithromycin

Telithromycin

HIV protease inhibitors

Nefazodone

Large quantities of grapefruit juice (>1 quart daily)

Interactions With Lipid-lowering Drugs That Can Cause Myopathy When Given Alone

The risk of myopathy is also increased by the following lipid-lowering drugs that are not potent CYP3A4 inhibitors, but which can cause myopathy when given alone.

See .

Gemfibrozil

Other fibrates

Niacin (nicotinic acid) (≥ 1 g/day)

Oxymorphone hydrochloride tablets contain oxymorphone, a Schedule II controlled substance. As an opioid, oxymorphone hydrochloride tablets expose users to the risks of addiction, abuse, and misuse .

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed oxymorphone hydrochloride tablets. Addiction can occur at recommended dosages and if the drug is misused or abused.

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing oxymorphone hydrochloride tablets, and monitor all patients receiving oxymorphone hydrochloride tablets for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as oxymorphone hydrochloride tablets, but use in such patients necessitates intensive counseling about the risks and proper use of oxymorphone hydrochloride tablets along with intensive monitoring for signs 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 prescribing or dispensing oxymorphone hydrochloride tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused 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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