Duramorph

Duramorph is a prescription medication used to treat pain that is not relieved by non narcotic pain relievers.

It belongs to a group of drugs called opioid narcotics. These work by changing the way the brain and nervous system respond to pain.

Duramorph is available as an injectable to be administered epidurally (into the epidural space) or intrathecally (within the spinal canal) and is given by a healthcare professional.

Common side effects of Duramorph include constipation, nausea, itchiness, and sleepiness. Do not drink alcohol or any foods or medications containing alcohol while receiving Duramorph as alcohol increases the risk that you will experience breathing problems or other serious, life-threatening side effects.

Duramorph is a prescription medication used to treat pain that is not relieved by non narcotic pain relievers.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

• Baxter Anesthesia & Critical Care

• Baxter Healthcare Corporation

• Elkins-Sinn, Inc.

• West-Ward Pharmaceutical Corp.

This medication may cause serious side effects. See "Drug Precautions".

Common side effects include:

• itching
• injection site pain
• dizziness
• drowsiness
• nausea
• vomiting
• constipation
• diarrhea
• loss of appetite
• weight loss
• dry mouth
• sweating
• weakness
• headache
• agitation
• nervousness
• mood changes
• confusion
• small pupils (black circles in the middle of the eyes)
• flu symptoms
• difficulty urinating or pain when urinating

Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• trouble breathing
• shortness of breath
• fast heartbeat
• chest pain
• swelling of your face
• tongue or throat
• extreme drowsiness, or you are feeling faint

These are not all the possible side effects of Duramorph. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. 

Tell your doctor about all the medications you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• antihistamines (found in cold and allergy medications)
• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• buprenorphine (Butrans, Subutex, in Suboxone)
• butorphanol (Stadol)
• cimetidine (Tagamet)
• diuretics ('water pills')
• medications for anxiety, seizures, depression, mental illness, or nausea
• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), procarbazine (Matulane), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• muscle relaxants
• nalbuphine (Nubain)
• other narcotic pain medications
• pentazocine (Talwin)
• quinidine  
• sedatives, sleeping pills, or tranquilizers

This is not a complete list of Duramorph drug interactions. Ask your doctor or pharmacist for more information.

Duramorph may be habit-forming.There is a greater risk that you will overuse Duramorph if you have or have ever had depression or another mental illness, or if you have abused alcohol, used street drugs, or overused prescription medications.

Duramorph may cause slowed or stopped breathing, especially when you begin your treatment and any time your dose is increased. Tell your doctor if you have slowed breathing and if you have or have ever had lung disease such as asthma, chronic obstructive pulmonary disease (COPD; a group of diseases including chronic bronchitis and emphysema that cause difficulty breathing), or other breathing problems. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking certain other medications during your treatment with Duramorph may increase the risk that you will experience breathing problems or other serious, life-threatening side effects.

Do not receive Duramorph if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

While receiving Duramorph do not:

• Drive or operate heavy machinery, until you know how Duramorph affects you. Duramorph can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Duramorph there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving this medication, tell your doctor if you:

• have severe asthma, trouble breathing, or other lung problems.
• have a bowel blockage or have narrowing of the stomach or intestines.
• have a history of head injury, seizures.
• have liver, kidney, thyroid, pancreas, or gallbladder problems.
• have problems urinating.
• are pregnant or planning to become pregnant. 
• are breastfeeding. 
• are taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
• have a history of abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Duramorph falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, Duramorph may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your healthcare provider if you are breastfeeding. Duramorph passes into human breast milk and may harm your baby.

Duramorph is available as an injectable to be administered epidurally (into the epidural space) or intrathecally (within the spinal canal) and is given by a healthcare professional.

If you feel that your pain is not controlled, tell your doctor. 

Take Duramorph exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

The dose your doctor recommends may be based on the following:

• the type and severity of the pain you have
• other medical conditions you have
• how you respond to this medication
• your weight

Duramorph is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Do not miss your follow-up appointment with your doctor.

Duramorph may be habit forming. Overdoses may cause respiratory depression, coma and death.

Duramorph administration should be limited to use by those familiar with the management of respiratory depression. Rapid intravenous administration may result in chest wall rigidity.

Prior to any epidural or intrathecal drug administration, the physician should be familiar with patient conditions (such as infection at the injection site, bleeding diathesis, anticoagulant therapy, etc.) which call for special evaluation of the benefit versus risk potential.

SEVERE RESPIRATORY DEPRESSION UP TO 24 HOURS FOLLOWING EPIDURAL OR INTRATHECAL ADMINISTRATION HAS BEEN REPORTED.

In the case of epidural or intrathecal administration, Duramorph should be administered by or under the direction of a physician experienced in the techniques and familiar with the patient management problems associated with epidural or intrathecal drug administration. Because epidural administration has been associated with less potential for immediate or late adverse effects than intrathecal administration, the epidural route should be used whenever possible. 

BECAUSE OF THE RISK OF SEVERE ADVERSE EFFECTS WHEN THE EPIDURAL OR INTRATHECAL ROUTE OF ADMINISTRATION IS EMPLOYED, PATIENTS MUST BE OBSERVED IN A FULLY EQUIPPED AND STAFFED ENVIRONMENT FOR AT LEAST 24 HOURS AFTER THE INITIAL DOSE.

THE FACILITY MUST BE EQUIPPED TO RESUSCITATE PATIENTS WITH SEVERE OPIATE OVERDOSAGE, AND THE PERSONNEL MUST BE FAMILIAR WITH THE USE AND LIMITATIONS OF SPECIFIC NARCOTIC ANTAGONISTS (NALOXONE, NALTREXONE) IN SUCH CASES.