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OXAYDO
Overview
What is OXAYDO?
OXAYDO (oxycodone HCl) 5 mg and 7.5 mg tablets are an immediate-release opioid agonist intended for oral administration only.
Chemically, oxycodone HCl is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one HCl, a white, odorless crystalline powder. Oxycodone HCl is soluble in water (1 g in 6 to 7 mL). The molecular weight of oxycodone HCl is 351.82. The molecular formula for oxycodone HCl is CHNO•HCl, and the structure is:
The inactive ingredients in OXAYDO include: colloidal silicon dioxide NF; crospovidone NF; magnesium stearate NF; microcrystalline cellulose NF; polyethylene oxide NF; and sodium lauryl sulfate NF.
The tablets are round, convex, white and debossed with the strength (5 or 7.5) on one side and the letter “O” on the other side.
What does OXAYDO look like?
What are the available doses of OXAYDO?
Tablets: 5 mg and 7.5 mg oxycodone HCl ()
What should I talk to my health care provider before I take OXAYDO?
How should I use OXAYDO?
OXAYDO is indicated for the management of acute and chronic 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 OXAYDO 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 24-72 hours of initiating therapy and following dosage increases with OXAYDO and adjust the dosage accordingly
OXAYDO must be swallowed whole. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth ]. OXAYDO is not amenable to crushing and dissolution. Do not administer OXAYDO via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.
What interacts with OXAYDO?
Sorry No Records found
What are the warnings of OXAYDO?
Sorry No Records found
What are the precautions of OXAYDO?
Sorry No Records found
What are the side effects of OXAYDO?
Sorry No records found
What should I look out for while using OXAYDO?
OXAYDO is contraindicated in patients with:
Addiction, Abuse, and Misuse
OXAYDO 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 OXAYDO, and monitor all patients regularly for the development of these behaviors and conditions .
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of OXAYDO. Monitor for respiratory depression, especially during initiation of OXAYDO or following a dose increase .
Accidental Ingestion
Accidental ingestion of even one dose of OXAYDO, especially by children, can result in a fatal overdose of oxycodone .
Neonatal Opioid Withdrawal Syndrome
Prolonged use of OXAYDO 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 .
Cytochrome P450 3A4 Interaction
The concomitant use of OXAYDO 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 OXAYDO and any CYP3A4 inhibitor or inducer .
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 .
What might happen if I take too much OXAYDO?
Clinical Presentation
Acute overdose with OXAYDO 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 may 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 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 OXAYDO, 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 OXAYDO?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.OXAYDO (oxycodone HCl) 5 mg tablets are round, convex, white tablets debossed with the strength “5” on one side and the letter “O” on the other side and supplied as:NDCOXAYDO 7.5 mg tablets are round, convex, white tablets debossed with the strength “7.5” on one side and the letter “O” on the other side and supplied as:NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Protect from moisture.OXAYDO (oxycodone HCl) 5 mg tablets are round, convex, white tablets debossed with the strength “5” on one side and the letter “O” on the other side and supplied as:NDCOXAYDO 7.5 mg tablets are round, convex, white tablets debossed with the strength “7.5” on one side and the letter “O” on the other side and supplied as:NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Protect from moisture.OXAYDO (oxycodone HCl) 5 mg tablets are round, convex, white tablets debossed with the strength “5” on one side and the letter “O” on the other side and supplied as:NDCOXAYDO 7.5 mg tablets are round, convex, white tablets debossed with the strength “7.5” on one side and the letter “O” on the other side and supplied as:NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Protect from moisture.OXAYDO (oxycodone HCl) 5 mg tablets are round, convex, white tablets debossed with the strength “5” on one side and the letter “O” on the other side and supplied as:NDCOXAYDO 7.5 mg tablets are round, convex, white tablets debossed with the strength “7.5” on one side and the letter “O” on the other side and supplied as:NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Protect from moisture.OXAYDO (oxycodone HCl) 5 mg tablets are round, convex, white tablets debossed with the strength “5” on one side and the letter “O” on the other side and supplied as:NDCOXAYDO 7.5 mg tablets are round, convex, white tablets debossed with the strength “7.5” on one side and the letter “O” on the other side and supplied as:NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Protect from moisture.OXAYDO (oxycodone HCl) 5 mg tablets are round, convex, white tablets debossed with the strength “5” on one side and the letter “O” on the other side and supplied as:NDCOXAYDO 7.5 mg tablets are round, convex, white tablets debossed with the strength “7.5” on one side and the letter “O” on the other side and supplied as:NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Protect from moisture.OXAYDO (oxycodone HCl) 5 mg tablets are round, convex, white tablets debossed with the strength “5” on one side and the letter “O” on the other side and supplied as:NDCOXAYDO 7.5 mg tablets are round, convex, white tablets debossed with the strength “7.5” on one side and the letter “O” on the other side and supplied as:NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Protect from moisture.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Oxycodone 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 oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. 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
OXAYDO is contraindicated in patients with:Addiction, Abuse, and Misuse
OXAYDO 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 OXAYDO, and monitor all patients regularly for the development of these behaviors and conditions .
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of OXAYDO. Monitor for respiratory depression, especially during initiation of OXAYDO or following a dose increase .
Accidental Ingestion
Accidental ingestion of even one dose of OXAYDO, especially by children, can result in a fatal overdose of oxycodone .
Neonatal Opioid Withdrawal Syndrome
Prolonged use of OXAYDO 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 .
Cytochrome P450 3A4 Interaction
The concomitant use of OXAYDO 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 OXAYDO and any CYP3A4 inhibitor or inducer .
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 .
Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with atenolol tablets plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension.
Calcium channel blockers may also have an additive effect when given with atenolol tablets (see ).
Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta blockers.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers.
Beta blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta blockers should be delayed for several days after clonidine administration has stopped.
Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects of beta blockers.
Information on concurrent usage of atenolol and aspirin is limited. Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta blockers in the acute myocardial infarction setting.
While taking beta blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
OXAYDO contains oxycodone, a Schedule II controlled substance. As an opioid, OXAYDO 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 OXAYDO. 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 OXAYDO, and monitor all patients receiving OXAYDO 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 OXAYDO, but use in such patients necessitates intensive counseling about the risks and proper use of OXAYDO 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 OXAYDO. 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 the 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:
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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