oxyCODONE HCl 15 MG Oral Tablet
WARNINGS
Respiratory Depression: Respiratory depression is the chief hazard from all opioid agonist preparations.
Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.
Oxycodone hydrochloride tablets should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.
In such patients, even usual therapeutic doses of oxycodone hydrochloride tablets may decrease respiratory drive to the point of apnea.
In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
Hypotensive Effect: Oxycodone hydrochloride tablets, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone.
Oxycodone hydrochloride tablets may produce orthostatic hypotension in ambulatory patients.
Oxycodone hydrochloride tablets, like all opioid analgesics, should be administered with caution to patients in circulatory shock since vasodilatation produced by the drug may further reduce cardiac output and blood pressure.
Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure.
Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
DRUG INTERACTIONS
Drug Interactions Oxycodone is metabolized in part to oxymorphone via the cytochrome p450 isoenzyme CYP2D6.
While this pathway may be blocked by a variety of drugs (e.g., certain cardiovascular drugs and antidepressants), such blockade has not yet been shown to be of clinical significance with this agent.
However, clinicians should be aware of this possible interaction.
Neuromuscular Blocking Agents: Oxycodone, as well as other opioid analgesics, may enhance the neuromuscular, blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
CNS Depressants: Patients receiving narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with oxycodone hydrochloride tablets may exhibit an additive CNS depression.
Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual dosage of oxycodone hydrochloride tablets.
When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Mixed Agonist/Antagonist Opioid Analgesics: Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone hydrochloride tablets.
In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone hydrochloride tablets and/or may precipitate withdrawal symptoms in these patients.
Monoamine Oxidase Inhibitors (MAOIs): MAOIs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma.
The use of oxycodone hydrochloride tablets is not recommended for patients taking MAOIs, or within 14 days of stopping such treatment.
DESCRIPTION
Oxycodone hydrochloride tablet USP is an opioid analgesic.
Each tablet for oral administration contains 15 mg or 30 mg of oxycodone hydrochloride USP.
Oxycodone hydrochloride, 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-methyl-morphinan-6-one hydrochloride and has the following structural formula: The tablets contain the following inactive ingredients: Corn starch, D&C Yellow #10 Aluminum Lake (15 mg tablet), FD&C Blue #2 Aluminum Lake (15 mg and 30 mg tablets), lactose monohydrate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, and stearic acid.
The 15 mg and 30 mg tablets contain the equivalent of 13.5 mg and 27.0 mg, respectively, of oxycodone free base.
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HOW SUPPLIED
Oxycodone hydrochloride tablets, USP 15 mg are available as green colored, round tablets, debossed “A214” on the bisected side.
Supplied in bottles of 60, 90, 120 and 180.
Dispense in a tight, light-resistant, container.
Protect from moisture.
Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].
Do not take this product if the safety seal under the cap is broken or missing.
DEA Order Form Required.
GERIATRIC USE
Geriatric Use Of the total number of subjects in clinical studies of oxycodone hydrochloride tablets, 20.8% (112/538) were 65 and over, while 7.2% (39/538) were 75 and over.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Hepatic Impairment: Since oxycodone is extensively metabolized, its clearance may decrease in hepatic failure patients.
Dose initiation in patients with hepatic impairment should follow a conservative approach.
Dosages should be adjusted according to the clinical situation.
Renal Impairment: Published data reported that elimination of oxycodone was impaired in end-stage renal failure: Mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance.
Dose initiation should follow a conservative approach.
Dosages should be adjusted according to the clinical situation.
Ambulatory Patients: Oxycodone hydrochloride tablets may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
The patient using this drug should be cautioned accordingly.
INDICATIONS AND USAGE
Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
PEDIATRIC USE
Pediatric Use The safety and efficacy of oxycodone in pediatric patients have not been evaluated.
PREGNANCY
Pregnancy Teratogenic Effects: Category B: Reproduction studies in Sprague-Dawley rats and New Zealand rabbits revealed that when oxycodone was administered orally at doses up to 16 mg/kg (approximately 2 times the daily oral dose of 90 mg for adults on a mg/m 2 basis) and 25 mg/kg (approximately 5 times the daily oral dose of 90 mg on a mg/m 2 basis), respectively was not teratogenic or embryo-fetal toxic.
There are no adequate and well controlled studies of oxycodone in pregnant women.
Because animal reproductive studies are not always predictive of human responses, oxycodone hydrochloride tablets should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects Neonates whose mothers have taken oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery.
NUSRING MOTHERS
Nursing Mothers Oxycodone has been detected in breast milk.
Withdrawal symptoms can occur in breast-feeding infants when maternal administration of an opioid analgesic is stopped.
Ordinarily, nursing should not be undertaken while a patient is receiving oxycodone hydrochloride tablets since oxycodone may be excreted in milk.
INFORMATION FOR PATIENTS
Information for Patients/Caregivers: If clinically advisable, patients (or their caregivers) receiving oxycodone hydrochloride tablets should be given the following information by the physician, nurse, pharmacist or caregiver: 1.
Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy.
Individualization of dosage is essential to make optimal use of this medication.
2.
Patients should be advised not to adjust the dose of oxycodone hydrochloride tablets without consulting the prescribing professional.
3.
Patients should be advised that oxycodone hydrochloride tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g.
driving, operating heavy machinery).
4.
Patients should not combine oxycodone hydrochloride tablets with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.
5.
Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
6.
Patients should be advised that oxycodone hydrochloride tablets is a potential drug of abuse.
They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
7.
Patients should be advised that if they have been receiving treatment with oxycodone hydrochloride tablets for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the oxycodone hydrochloride tablets dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms.
Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.
DOSAGE AND ADMINISTRATION
Oxycodone hydrochloride tablets are intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic.
The dose should be individually adjusted according to severity of pain, patient response and patient size.
If the pain increases in severity, if analgesia is not adequate, or if tolerance occurs, a gradual increase in dosage may be required.
Patients who have not been receiving opioid analgesics should be started on oxycodone hydrochloride tablets in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain.
The dose should be titrated based upon the individual patient’s response to their initial dose of oxycodone hydrochloride tablets.
Patients with chronic pain should have their dosage given on an around-the-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred.
This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient.
For control of severe chronic pain, oxycodone hydrochloride tablets should be administered on a regularly scheduled basis, every 4 to 6 hours, at the lowest dosage level that will achieve adequate analgesia.
As with any potent opioid, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience.
Although it is not possible to list every condition that is important to the selection of the initial dose of oxycodone hydrochloride tablets, attention should be given to: 1) the daily dose, potency, and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously, 2) the reliability of the relative potency estimate to calculate the dose of oxycodone needed, 3) the degree of opioid tolerance, 4) the general condition and medical status of the patient, and 5) the balance between pain control and adverse experiences.
Conversion From Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs: When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made whether or not to continue the non-opioid analgesic.
If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of oxycodone hydrochloride tablets in response to the level of analgesia and adverse effects afforded by the dosing regimen.
If the non-opioid regimen is continued as a separate single entity agent, the starting dose of oxycodone hydrochloride tablets should be based upon the most recent dose of opioid as a baseline for further titration of oxycodone.
Incremental increases should be gauged according to side effects to an acceptable level of analgesia.
Patients Currently on Opioid Therapy: If a patient has been receiving opioid-containing medications prior to taking oxycodone hydrochloride tablets, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.
In converting patients from other opioids to oxycodone hydrochloride tablets close observation and adjustment of dosage based upon the patient’s response to oxycodone hydrochloride tablets is imperative.
Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of oxycodone hydrochloride tablets may be necessary, especially in patients who have disease states that are changing rapidly.
Maintenance of Therapy: Continual re-evaluation of the patient receiving oxycodone hydrochloride tablets is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy.
If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain.
During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be re-assessed as appropriate.
Cessation of Therapy: When a patient no longer requires therapy with oxycodone hydrochloride tablets or other opioid analgesics for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal).
In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see Drug Abuse and Dependence section for description of the signs and symptoms of withdrawal).
If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.
It is not known at what dose of oxycodone hydrochloride tablets that treatment may be discontinued without risk of the opioid abstinence syndrome.