Opana . OPANA (oxymorphone hydrochloride) tablet is an opioid agonist available in 5 mg and 10 mg tablet strengths for oral administration. The chemical name for oxymorphone hydrochloride is 4, 5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 337.80. The molecular formula is C17H19NO4. HCl and it has the following chemical structure. Opana is used to treat moderate to severe pain. The extended-release form of this medicine is for around-the-clock treatment of severe pain. ER is not for use on an as-needed basis for pain. Opana may also be used for purposes not listed in this medication guide.
You should not use if you have severe asthma or breathing problems, a blockage in your stomach or intestines, or moderate to severe liver disease.
Oxymorphone can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
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 [see WARNINGS AND PRECAUTIONS].
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS].
should be administered on an empty stomach, at least one hour prior to or two hours after eating [see CLINICAL PHARMACOLOGY].
To avoid medication errors, prescribers and pharmacists must be aware that oxymorphone is available as both immediate-release 5 mg and 10 mg tablets and extended-release 5 mg and 10 mg tablets [see Dosage Forms and Strengths].
Use Of As The First Opioid Analgesic
Initiate treatment with OPANA in a dosing range of 10 to 20 mg every 4 to 6 hours as needed for pain.
Do not initiate treatment with doses higher than 20 mg because of the potential serious adverse reactions [see Clinical Studies].
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of OPANA. It is safer to underestimate a patient’s 24-hour OPANA dosage than to overestimate the 24-hour OPANA dosage and manage an adverse reaction due to overdose.
For conversion from other opioids to OPANA, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start OPANA therapy by administering half of the calculated total daily dose of OPANA in 4 to 6 equally divided doses, every 4-6 hours. The initial dose of OPANA can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.