Oxycodone Hcl Controlled-release

Oxycodone Hcl Controlled-release Manufacturers

• Ranbaxy Pharmaceuticals Inc
  

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  Oxycodone Hcl Controlled-release | Ranbaxy Pharmaceuticals Inc

  

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  General Principles

  OXYCODONE HCl CONTROLLED-RELEASE TABLETS ARE AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

  OXYCODONE HCl CONTROLLED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCODONE HCl CONTROLLED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

  One Oxycodone HCl controlled-release 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).

  Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION; Initiation of Therapy).

  In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.

  Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows Oxycodone HCl Controlled-Release Tablets to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

  Initiation of Therapy

  It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:

  the general condition and medical status of the patient; the daily dose, potency, and kind of the analgesic(s) the patient has been taking; the reliability of the conversion estimate used to calculate the dose of oxycodone; the patient's opioid exposure and opioid tolerance (if any); the Special Instructions for Oxycodone HCl Controlled-Release 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and the balance between pain control and adverse experiences.

  Care should be taken to use low initial doses of Oxycodone HCl Controlled-Release Tablets in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).

  For initiation of Oxycodone HCl Controlled-Release Tablets therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

  Experience indicates a reasonable starting dose of Oxycodone HCl Controlled-Release Tablets for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. Oxycodone HCl Controlled-Release Tablets should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone. When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of Oxycodone HCl Controlled-Release Tablets. Round down to a dose which is appropriate for the tablet strengths available (10 mg,20 mg, 40 mg, and 80 mg tablets). Discontinue all other around-the-clock opioid drugs when Oxycodone HCl Controlled-Release Tablet therapy is initiated. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 4.

  * To be used only for conversion to oral oxycodone. For patients receiveing high-dose parenteral opiods, a more conservative conversion is warranted. For example, for high-dose parenteral morphone, use 1.5 instead of 3 as a multiplication factor.

  Multiplication Factors for Converting the Daily Dose of Prior Opiods to the Daily Dose of Oral Oxycodone* (Mg/Day Prior Opiod x Factor = Mg/Day Oral Oxycodone) Oral Prior Opiod Parenteral Prior Opiod Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3

  In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

  Oxycodone HCl Controlled-Release Tablets can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

  Conversion from Transdermal Fentanyl to Oxycodone HCl Controlled-Release Tablets

  Eighteen hours following the removal of the transdermal fentanyl patch, Oxycodone HCl Controlled-Release Tablet treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of Oxycodone HCl Controlled-Release Tablets, should be initially substituted for each 25-µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

  Managing Expected Opioid Adverse Experiences

  Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from Oxycodone HCl Controlled-Release Tablets are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.

  Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

  Patients receiving Oxycodone HCl Controlled-Release Tablets may pass an intact matrix “ghost” in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

  Individualization of Dosage

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

  If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

  Special Instructions for Oxycodone HCl Controlled-Release 80 mg Tablets, or a single dose greater than 40 mg (for use in opioid-tolerant patients only.)

  Oxycodone HCl Controlled-Release 80 mg Tablets, or a single dose greater than 40 mg, are for use in opioid-tolerant patients only. A single daily dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

  One Oxycodone HCl Controlled-Release 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

  Maintenance of Therapy

  The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

  During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with Oxycodone HCl Controlled-Release Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from Oxycodone HCl Controlled-Release Tablets to Parenteral Opioids

  To avoid overdose, conservative dose conversion ratios should be followed.

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