Opana

Opana is a narcotic analgesic used for the relief of pain by acting in the central nervous system. Opana extended-release tablets are used to relieve moderate to severe pain in patients requiring continuous, around-the-clock treatment for a long period of time, and should not be used if you need pain drugs for just a short time, such as when recovering from surgery.

This drug must not be used to relieve mild pain, or in situations when non-narcotic drugs are effective. Prolonged use of this drug can cause mental or physical dependence. When narcotics are used for clinical purposes, mental dependence is not likely to occur.

Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly and can be prevented by tapering the dose gradually over a period of time before treatment is stopped completely. This drug requires a prescription.

Before using Opana, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies in children regarding the correlation of age to the effects of oxymorphone have not been performed while safety and efficacy have not been established.

Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of oxymorphone. Adjustments in the dose of the elderly may be required since they are more likely to have age-related kidney, liver, or heart problems.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

• Alcohol, Anticholinergics, Cimetidine, Muscle Relaxants, CNS Depressants, Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics.

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

• Addison's disease
• Alcohol abuse
• Brain tumor
• Breathing or lung problems
• Central nervous system depression
• Chronic obstructive pulmonary disease
• Cor pulmonale
• Drug dependence
• Enlarged prostate
• Head injuries
• Hypothyroidism
• Kyphoscoliosis
• Mental illness
• Obesity
• Problems with passing urine
• Weakened physical condition
• Asthma
• Hypercarbia
• Liver disease
• Respiratory depression
• Gallbladder disease
• Hypotension
• Hypovolemia
• Pancreatitis
• Seizures
• Stomach or bowel blockage
• Kidney disease
• Liver disease
• Paralytic ileus
• or shock

To use Opana properly, you must follow all instructions given by your doctor. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional.

Prolonged use of increased doses of this drug may cause mental or physical dependence. It is recommended to take this drug on an empty stomach, at least 1 hour before or 2 hours after a meal.

The extended-release tablets must be swallowed whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth.

Crushing, breaking, cutting, dissolving, licking, or chewing the drug is not recommended. It is normal to pass part of the tablet into your stools while taking this drug.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults not taking narcotic drugs with moderate to severe pain are initially given 5 milligrams every 12 hours. Your healthcare professional may adjust your dose if necessary. Use and dose in children must be determined by your healthcare professional.

The initial dose for adults switching from OpanaВ® to OpanaВ® ER is half of the total oral OpanaВ® that you are taking per day, every 12 hours. Your healthcare professional may adjust your dose if necessary. Use and dose in children must be determined by your healthcare professional.

The initial dose for patients switching from oxymorphone injection to OpanaВ® ER is 10 times the total oxymorphone injection dose that you are receiving per day divided into two equal doses. Your healthcare professional may adjust your dose if necessary. Use and dose in children must be determined by your healthcare professional.

The initial dose for adults switching from oral opioids to OpanaВ® ER is half of the total daily dose that you are taking per day, every 12 hours. Your healthcare professional may adjust your dose if necessary. Use and dose in children must be determined by your healthcare professional.

Adults with pain are initially given 5 milligrams every 4 to 6 hours. Your healthcare professional may adjust your dose if needed. Use and dose in children must be determined by your healthcare professional. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

Before using Opana, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

This drug will potentiate the effects of alcohol and other CNS depressants such as:

• Antihistamines or drugs for allergies or colds
• sedatives
• tranquilizers or sleeping drugs
• other prescription pain drugs or narcotics
• drugs for seizures or barbiturates
• muscle relaxants or anesthetics
• including some dental anesthetics

Check with your healthcare professional before taking any of the drugs listed above while you are using this drug. Using more than your prescribed dose is not recommended even if you feel that the drug is not working as well to prevent any development of dependence.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This drug may cause dizziness, drowsiness, confusion, or disorientation. Be careful in taking this drug before you drive, use machines, or do anything else that could be dangerous. Using narcotics for a long time can cause severe constipation. To prevent this, your healthcare professional may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet.

Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems. Check with your healthcare professional before changing your dose or suddenly stop taking this drug if you have been using this drug regularly for several weeks or longer.

Your healthcare professional may slowly taper the amount you are using before stopping it completely to reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Consult with your healthcare professional before you take any other prescription or nonprescription drugs, and herbal or vitamin supplements.

As with many medications, there are several potential side effects associated with Opana. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

• Blurred vision
• Chest pain or discomfort
• Confusion
• Constricted, pinpoint, or small pupils
• Difficult or painful urination
• Difficult or troubled breathing
• Difficulty sleeping
• Disorientation
• Double vision
• Drowsiness or sleepiness
• Fast, pounding, or irregular heartbeat or pulse
• Frequent urge to urinate
• Hallucinations
• Irregular, fast or slow, or shallow breathing
• Noisy breathing
• Pale or blue lips, fingernails, or skin
• Slow or irregular heartbeat
• Seeing double
• Seeing, hearing, or feeling things that are not there
• Shortness of breath
• Tightness in chest
• Trouble breathing
• Unconsciousness
• Unusual tiredness or weakness
• Very slow breathing
• Wheezing
• Symptoms of overdose such as bigger, dilated
• Enlarged pupils cold, clammy skin
• Increased sensitivity of eyes to light
• Low blood pressure or pulse
• No muscle tone or movement
• Unconsciousness
• Or very slow heartbeat

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.