Oxynorm 20mg is an opioid agonist indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate.
Dosage and Administration
Selection of patients for treatment with Oxynorm should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.
OxyNorm Capsule, 5 mg: 5 mg to 15 mg every 4 to 6 hours as needed.
Side effects Oxynorm 20mg
The safety of Oxynorm 20mg prolonged-release tablets (Oxynorm) was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received Oxynorm prolonged-release tablets (Oxynorm) in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day.
Serious adverse reactions which may be associated with Oxynorm prolonged-release tablet (Oxynorm 20mg) therapy in clinical use are those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and (to an even lesser degree) circulatory depression, hypotension, or shock.
The non-serious adverse events seen on initiation of therapy with Oxynorm prolonged-release tablets (Oxynorm) are typical opioid side effects. These events are dose-dependent, and their frequency depends upon the dose, the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid analgesia. The most frequent (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and asthenia. In many cases the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large swings in the plasma concentrations of the opioid.
Many of these adverse events will cease or decrease in intensity as Oxynorm prolonged-release tablets (Oxynorm) therapy is continued and some degree of tolerance is developed. Clinical trials comparing Oxynorm prolonged-release tablets (Oxynorm 20mg) with immediate-release Oxynorm and placebo revealed a similar adverse event profile between Oxynorm prolonged-release tablets (Oxynorm) and immediate-release Oxynorm. The most common adverse events (>5%) reported by patients at least once during therapy were: See Table 5.
The following adverse experiences were reported in Oxynorm prolonged-release tablets (Oxynorm) treated patients with an incidence between 1% and 5%. In descending order of frequency they were anorexia, nervousness, insomnia, fever, confusion, diarrhea, abdominal pain, dyspepsia, rash, anxiety, euphoria, dyspnea, postural hypotension, chills, twitching, gastritis, abnormal dreams, thought abnormalities, and hiccups. The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in post marketing experience:
General: Accidental injury, chest pain, facial edema, malaise, neck pain, pain, allergic reactions, anaphylaxis, anaphylactoid reactions, drug dependence.
Cardiovascular: Migraine, syncope, vasodilation, ST depression.
Digestive: Dysphagia, eructation, flatulence, gastrointestinal disorder, increased appetite, nausea and vomiting, stomatitis, ileus.
Hemic and Lymphatic: Lymphadenopathy.
Metabolic and Nutritional: Dehydration, edema, hyponatremia, peripheral edema, syndrome of inappropriate antidiuretic hormone secretion, thirst.
Nervous: Abnormal gait, agitation, amnesia, depersonalization, depression, emotional lability, hallucination, hyperkinesia, hypesthesia, hypotonia, malaise, paresthesia, unvoluntary muscle contraction seizures, speech disorder, stupor, tinnitus, tremor, vertigo, withdrawal syndrome with or without seizures, hypertonia.
Respiratory: Cough increased, pharyngitis, voice alteration.
Skin: Dry skin, exfoliative dermatitis, urticaria.
Special Senses: Abnormal vision, miosis, taste perversion.
Urogenital: Amenorrhea, decreased libido, dysuria, hematuria, impotence, polyuria, urinary retention, impaired urination.
Important Dosage And Administration Instructions
Oxynorm 20mg should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Oxynorm single doses greater than 36 mg (equivalent to 40 mg Oxynorm [HCl]) or a total daily dose greater than 72 mg (equivalent to 80 mg Oxynorm HCl) are to be administered only to 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 per day, 25 mcg transdermal fentanyl per hour, 30 mg oral Oxynorm HCl per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
Oxynorm 20mg is administered, twice daily, every 12 hours, and must be taken with food. Instruct patients to take Oxynorm capsules with approximately the same amount of food for every dose in order to ensure consistent plasma levels are achieved..
Patients who are unable to swallow Oxynorm should be instructed to sprinkle the capsule contents on soft foods or into a cup and then administer directly into the mouth and immediately swallow. Oxynorm may also be administered through a gastrostomy or nasogastric feeding tube.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
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.
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with Oxynorm and adjust the dosage accordingly.
The maximum daily dose of Oxynorm is 288 mg per day (eight 36 mg capsules, equivalent to 320 mg Oxynorm HCl per day) as the safety of the excipients in Oxynorm for doses over 288 mg/day has not been established.
Oxynorm is formulated with Oxynorm base. The following table describes the equivalent amount of Oxynorm HCl present in other Oxynorm products. You may need Oxycodone 30mg also.