oxyCODONE HCl 10 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 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 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, 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 may produce orthostatic hypotension in ambulatory patients.
Oxycodone hydrochloride, 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.
OVERDOSAGE
Signs and Symptoms: Acute overdose with oxycodone hydrochloride can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension, and death.
Treatment: To treat oxycodone hydrochloride overdose, primary attention should be given to the reestablishment of a patent airway and institution of assisted or controlled ventilation.
Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated.
Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
The narcotic antagonists, naloxone or nalmefene, are specific antidotes for opioid overdose.
Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone hydrochloride overdose.
If needed the appropriate dose of naloxone hydrochloride or nalmefene should be administered simultaneously with efforts at respiratory resuscitation (see package insert for each drug for the details).
Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.
Gastric emptying may be useful in removing unabsorbed drug.
Opioid antagonists should be administered cautiously to persons who are suspected to be physically dependent on any opioid agonist, including oxycodone (see Opioid-Tolerant Individuals).
Opioid-Tolerant Individuals: In an individual physically dependent on opioids, administration of a usual dose of antagonist will precipitate an acute withdrawal.
The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered.
Use of an opioid antagonist should be reserved for cases where such treatment is clearly needed.
If it is necessary to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses.
DESCRIPTION
Oxycodone hydrochloride tablets, USP is an opioid analgesic.
Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 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-methylmorphinan-6-one hydrochloride and has the following structural formula: Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid.
The 10 mg tablet also contains D&C Red No.
27.
The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No.
10 and FD&C Blue No.
2.
The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No.
2, FD&C Red No.
40 and FD&C Yellow No.
6.
The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No.
10 and FD&C Blue No.
2.
The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg and 27 mg, respectively, of oxycodone free base.
a02fe6bf-figure-01
HOW SUPPLIED
Oxycodone hydrochloride tablets, USP 5 mg are supplied as white, round, biconvex tablets debossed with “A” on the left and “04” on the right of the score on one side and plain on the other side.
They are available as follows: Bottles of 30: NDC 65162-047-03 Bottles of 100: NDC 65162-047-10 Bottles of 250: NDC 65162-047-25 Bottles of 500: NDC 65162-047-50 Oxycodone hydrochloride tablets, USP 10 mg are supplied as pink, round, biconvex tablets debossed with “A” on the left and “48” on the right of the score on one side and plain on the other side.
They are available as follows: Bottles of 30: NDC 65162-048-03 Bottles of 100: NDC 65162-048-10 Bottles of 250: NDC 65162-048-25 Oxycodone hydrochloride tablets, USP 15 mg are supplied as green, round, biconvex tablets debossed with “A” on the left and “49” on the right of the score on one side and plain on the other side.
They are available as follows: Bottles of 30: NDC 65162-049-03 Bottles of 100: NDC 65162-049-10 Bottles of 250: NDC 65162-049-25 Bottles of 500: NDC 65162-049-50 Oxycodone hydrochloride tablets, USP 20 mg are supplied as gray, round, biconvex tablets debossed with “A” on the left and “50” on the right of the score on one side and plain on the other side.
They are available as follows: Bottles of 30: NDC 65162-050-03 Bottles of 100: NDC 65162-050-10 Bottles of 250: NDC 65162-050-25 Oxycodone hydrochloride tablets, USP 30 mg are supplied as blue, round, biconvex tablets debossed with “A” on the left and “51” on the right of the score on one side and plain on the other side.
They are available as follows: Bottles of 30: NDC 65162-051-03 Bottles of 100: NDC 65162-051-10 Bottles of 250: NDC 65162-051-25 Bottles of 500: NDC 65162-051-50 DEA Order Form Required Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
Protect from moisture.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
To request medical information or to report suspected adverse reactions, contact Amneal Pharmaceuticals at 1-877-835-5472.
Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Rev.
12-2015-02
INDICATIONS AND USAGE
Oxycodone hydrochloride tablets, USP 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.
DOSAGE AND ADMINISTRATION
Oxycodone hydrochloride tablets, USP 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, USP 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, USP.
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, USP 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, USP, 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 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 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, 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, close observation and adjustment of dosage based upon the patient’s response to oxycodone hydrochloride is imperative.
Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of oxycodone hydrochloride 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 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 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 that treatment may be discontinued without risk of the opioid abstinence syndrome.