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Roxybond
Overview
What is Roxybond?
ROXYBOND (oxycodone hydrochloride) tablets for oral administration are available in 5 mg, 15 mg, and 30 mg strengths, each containing an equivalent of 4.5 mg, 13.5 mg, and 27 mg of oxycodone free base, respectively.
Oxycodone hydrochloride is an opioid agonist. It is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).
Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula:
Each ROXYBONDtablet contains the following inactive ingredients common to all strengths: alginic acid, ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, dimethylaminoethyl methacrylate copolymer, ethyl acrylate and methyl methacrylate copolymer dispersion, ethylcellulose, hypromellose, iron oxide black, isopropyl alcohol, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, n-butyl alcohol, polyethylene glycol, polysorbate 80, polyvinyl alcohol, propylene glycol, shellac in ethanol, sodium alginate, talc, titanium dioxide, and xanthan gum.
The 15 mg ROXYBOND tablets also contain: FD&C Blue No. 2 and iron oxide yellow.
The 30 mg ROXYBONDtablets also contain: FD&C Blue No. 2.
What does Roxybond look like?
What are the available doses of Roxybond?
Tablets: 5 mg, 15 mg, 30 mg ()
What should I talk to my health care provider before I take Roxybond?
How should I use Roxybond?
ROXYBOND is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
[see Warnings and Precautions (
)]
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 ROXYBOND and adjust the dosage accordingly
.
What interacts with Roxybond?
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What are the warnings of Roxybond?
Sorry No Records found
What are the precautions of Roxybond?
Sorry No Records found
What are the side effects of Roxybond?
Sorry No records found
What should I look out for while using Roxybond?
ROXYBOND is contraindicated in patients with:
Addiction, Abuse, and Misuse
ROXYBOND 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 ROXYBOND, and monitor all patients regularly for the development of these behaviors and conditions
[see Warnings and Precautions (
)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of ROXYBOND. Monitor for respiratory depression, especially during initiation of ROXYBOND or following a dose increase
[see Warnings and Precautions (
)].
Accidental Ingestion
Accidental ingestion of even one dose of ROXYBOND, especially by children, can result in a fatal overdose of oxycodone
[see Warnings and Precautions (
)].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of ROXYBOND during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
[see Warnings and Precautions (
)].
Cytochrome P450 3A4 Interaction
The concomitant use of ROXYBOND with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving ROXYBOND and any CYP3A4 inhibitor or inducer
[see Warnings and Precautions (
), Drug Interactions (
), Clinical Pharmacology (
)].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
[see Warnings and Precautions (
), Drug Interactions (
)].
What might happen if I take too much Roxybond?
Clinical Presentation
Acute overdose with ROXYBOND 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 re-establishment 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 advance life-support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from for opioid overdose. For clinically significant respiratory or circulatory depression secondary to oxycodone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in ROXYBOND, 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 Roxybond?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].ROXYBOND (oxycodone hydrochloride) tablets are supplied as 5 mg, 15 mg, and 30 mg strength round and color coated tablets with ink-prints on one side. The tablets are packaged in 100 tablet opaque HDPE bottles.Dispense in a tight, light-resistant container, with a child-resistant closure. Protect from moisture.Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions to 15°C to 30°C (59°F to 86°F).ROXYBOND (oxycodone hydrochloride) tablets are supplied as 5 mg, 15 mg, and 30 mg strength round and color coated tablets with ink-prints on one side. The tablets are packaged in 100 tablet opaque HDPE bottles.Dispense in a tight, light-resistant container, with a child-resistant closure. Protect from moisture.Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions to 15°C to 30°C (59°F to 86°F).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
ROXYBOND is contraindicated in patients with:Addiction, Abuse, and Misuse
ROXYBOND 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 ROXYBOND, and monitor all patients regularly for the development of these behaviors and conditions
[see Warnings and Precautions (
)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of ROXYBOND. Monitor for respiratory depression, especially during initiation of ROXYBOND or following a dose increase
[see Warnings and Precautions (
)].
Accidental Ingestion
Accidental ingestion of even one dose of ROXYBOND, especially by children, can result in a fatal overdose of oxycodone
[see Warnings and Precautions (
)].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of ROXYBOND during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
[see Warnings and Precautions (
)].
Cytochrome P450 3A4 Interaction
The concomitant use of ROXYBOND with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving ROXYBOND and any CYP3A4 inhibitor or inducer
[see Warnings and Precautions (
), Drug Interactions (
), Clinical Pharmacology (
)].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
[see Warnings and Precautions (
), Drug Interactions (
)].
The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects.
Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index.
Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when oxybutynin chloride was administered with ketoconazole, a potent CYP3A4 inhibitor.
Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered.
ROXYBOND contains oxycodone, a Schedule II controlled substance. As an opioid, ROXYBOND exposes 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 ROXYBOND. Addiction can occur at recommended dosages, when taken as directed, and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing ROXYBOND, and monitor all patients receiving ROXYBOND 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 ROXYBOND, but use in such patients necessitates intensive counseling about the risks and proper use of ROXYBOND 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 ROXYBOND. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drugs . 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 are described in greater detail, in other sections:
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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