Opana ER

DRUG DESCRIPTION

OPANA ER (oxymorphone hydrochloride) extended-release tablet is a semi-synthetic opioid analgesic supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: hypromellose, polyethylene oxide, polyethylene glycol, ?-tocopherol, citric acid, polyvinyl alcohol, titanium dioxide, macrogol and talc. In addition, the 5 mg, 7.5 mg and 30 mg tablets contain iron oxide red. The 7.5 mg tablets contain iron oxide black, and iron oxide yellow. The 10 mg tablets contain FD&C yellow No. 6. The 20 mg tablets contain FD&C blue No. 1, FD&C yellow No. 6, and D&C yellow No. 10. The 40 mg tablets contain FD&C yellow No. 6, and D&C yellow No. 10.

Chemically, oxymorphone hydrochloride is 4, 5?-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and very slightly soluble in ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98.

The structural formula for oxymorphone hydrochloride is as follows:

OPANAź ER (oxymorphone hydrochloride) Structural Formula Illustration

What are the possible side effects of oxymorphone (Opana, Opana ER)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such...

Read All Potential Side Effects and See Pictures of Opana ER »

What are the precautions when taking oxymorphone hydrochloride extended release (Opana ER)?

Before taking oxymorphone, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g., codeine, morphine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercarbia, severe asthma), certain bowel diseases (e.g., paralytic ileus, infectious diarrhea), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives),...

Read All Potential Precautions of Opana ER »


Opana ER Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, headache, constipation, dry mouth, mild itching, lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, shortness of breath, mental/mood changes, fainting, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: slow/fast heartbeat, difficulty urinating, severe stomach/abdominal pain, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking oxymorphone, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g., codeine, morphine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercarbia, severe asthma), certain bowel diseases (e.g., paralytic ileus, infectious diarrhea), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives), moderate/severe liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat), lung diseases (e.g., chronic obstructive pulmonary disease-COPD, mild asthma, hypoxia, hypercapnia), disease of the pancreas (e.g., pancreatitis), mental/mood disorders (e.g., toxic psychosis), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, kidney disease, mild liver disease, adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), severe obesity, underactive thyroid (hypothyroidism), intestinal diseases (e.g., colitis), recent bowel/abdominal surgery.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing and drowsiness.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Opana ER Patient Information Including Side Effects

Brand Names: Opana, Opana ER

Generic Name: oxymorphone (Pronunciation: ox ee MOR fone)

  • What is oxymorphone (Opana ER)?
  • What are the possible side effects of oxymorphone (Opana ER)?
  • What is the most important information I should know about oxymorphone (Opana ER)?
  • What should I discuss with my healthcare provider before using oxymorphone (Opana ER)?
  • How should I use oxymorphone (Opana ER)?
  • What happens if I miss a dose (Opana ER)?
  • What happens if I overdose (Opana ER)?
  • What should I avoid while using oxymorphone (Opana ER)?
  • What other drugs will affect oxymorphone (Opana ER)?
  • Where can I get more information?

What is oxymorphone (Opana ER)?

Oxymorphone is in a group of drugs called narcotic pain relievers. It is similar to morphine.

Oxymorphone is used to treat moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain.

Oxymorphone is not for treating pain just after surgery unless you were already taking oxymorphone before the surgery.

Oxymorphone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of oxymorphone (Opana ER)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

  • nausea, vomiting, constipation;
  • dizziness, headache;
  • dry mouth;
  • sweating; or
  • itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about oxymorphone (Opana ER)?

Oxymorphone may be habit-forming and should be used only by the person it was prescribed for. Oxymorphone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are taking oxymorphone. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take more than your prescribed dose of oxymorphone. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Oxymorphone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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