Oxycodone Hcl

Oxycodone Hcl Manufacturers

• Ranbaxy Pharmaceuticals Inc.
  

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  Oxycodone Hcl | Ranbaxy Pharmaceuticals Inc.

  

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  2.1 Initial Dosing

  OXYCODONE HCL EXTENDED-RELEASE TABLETS should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  OXYCODONE HCL EXTENDED-RELEASE TABLETS 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established.  Patients considered opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OXYCODONE HCL EXTENDED-RELEASE TABLETS [see Warnings and Precautions (5.2)].

  OXYCODONE HCL EXTENDED-RELEASE TABLETS must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)]. Crushing, chewing, or dissolving OXYCODONE HCL EXTENDED-RELEASE TABLETS tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Use of OXYCODONE HCL EXTENDED-RELEASE TABLETS as the First Opioid Analgesic
  
  Initiate treatment with OXYCODONE HCL EXTENDED-RELEASE TABLETS with one 10 mg tablet orally every 12 hours.
  
  Use of OXYCODONE HCL EXTENDED-RELEASE TABLETS in Patients who are not Opioid Tolerant
  
  The starting dose for patients who are not opioid tolerant is OXYCODONE HCL EXTENDED-RELEASE TABLETS 10 mg orally every 12 hours. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.
  
  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from other Oral Oxycodone Formulations to OXYCODONE HCL EXTENDED-RELEASE TABLETS

  Patients receiving other oral oxycodone formulations may be converted to OXYCODONE HCL EXTENDED-RELEASE TABLETS by administering one-half of the patient's total daily oral oxycodone dose as OXYCODONE HCL EXTENDED-RELEASE TABLETS every 12 hours.

  Conversion from other Opioids to OXYCODONE HCL EXTENDED-RELEASE TABLETS
  
  Discontinue all other around-the-clock opioid drugs when OXYCODONE HCL EXTENDED-RELEASE TABLETS therapy is initiated.
  
  There are no established conversion ratios for conversion from other opioids to OXYCODONE HCL EXTENDED-RELEASE TABLETS defined by clinical trials. Discontinue all other around-the-clock opioid drugs when OXYCODONE HCL EXTENDED-RELEASE TABLETS therapy is initiated and initiate dosing using OXYCODONE HCL EXTENDED-RELEASE TABLETS 10 mg orally every 12 hours.
  
  It is safer to underestimate a patient’s 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone requirements which could result in adverse reactions. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.
  
  Conversion from Methadone to OXYCODONE HCL EXTENDED-RELEASE TABLETS
  
  Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  Conversion from Transdermal Fentanyl to OXYCODONE HCL EXTENDED-RELEASE TABLETS

  Eighteen hours following the removal of the transdermal fentanyl patch, OXYCODONE HCL EXTENDED-RELEASE TABLETS treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OXYCODONE HCL EXTENDED-RELEASE TABLETS, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OXYCODONE HCL EXTENDED-RELEASE TABLETS, as there is limited documented experience with this conversion.

  2.2 Titration and Maintenance of Therapy

  Individually titrate OXYCODONE HCL EXTENDED-RELEASE TABLETS to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OXYCODONE HCL EXTENDED-RELEASE TABLETS to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse and misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.
  
  Patients who experience breakthrough pain may require a dose increase of OXYCODONE HCL EXTENDED-RELEASE TABLETS or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the OXYCODONE HCL EXTENDED-RELEASE TABLETS dose. Because steady-state plasma concentrations are approximated in 1 day, OXYCODONE HCL EXTENDED-RELEASE TABLETS dosage may be adjusted every 1 to 2 days. If unacceptable opioid-related adverse reactions are observed, the subsequent dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  2.3 Patients with Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.4 Discontinuation of OXYCODONE HCL EXTENDED-RELEASE TABLETS

  When the patient no longer requires therapy with OXYCODONE HCL EXTENDED-RELEASE TABLETS tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically dependent patient. Do not abruptly discontinue OXYCODONE HCL EXTENDED-RELEASE TABLETS.

  2.5 Administration of OXYCODONE HCL EXTENDED-RELEASE TABLETS

  Instruct patients to swallow OXYCODONE HCL EXTENDED-RELEASE TABLETS tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.1)].

  Instruct patients to take OXYCODONE HCL EXTENDED-RELEASE TABLETS one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see Warnings and Precautions (5.9) and Patient Counseling Information (17)].

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