Duramorph

Duramorph is part of the drug class:

• Natural opium alkaloids

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. 

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.

The most serious adverse experience encountered during administration of DURAMORPH (morphine injection) is respiratory depression and/or respiratory arrest. This depression and/or respiratory arrest may be severe and could require intervention. (See WARNINGS and OVERDOSAGE.) Because of delay in maximum CNS effect with intravenously administered drug (30 min), rapid administration may result in overdosing. Single-dose neuraxial administration may result in acute or delayed respiratory depression for periods at least as long as 24 hours.

Tolerance and Myoclonus

See WARNINGS for discussion of these and related hazards.

While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulating catecholamines. Excitation of the central nervous system, resulting in convulsions, may accompany high doses of morphine given intravenously. Dysphoric reactions may occur after any size dose and toxic psychoses have been reported.

Pruritus

Single-dose epidural or intrathecal administration is accompanied by a high incidence of pruritus that is dose-related but not confined to the site of administration. Pruritus, following continuous infusion of epidural or intrathecal morphine, is occasionally reported in the literature; these reactions are poorly understood as to their cause.

Urinary Retention

Urinary retention, which may persist 10 to 20 hours following single epidural or intrathecal administration, is a frequent side effect and must be anticipated primarily in male patients, with a somewhat lower incidence in females. Also frequently reported in the literature is the occurrence of urinary retention during the first several days of hospitalization for the initiation of continuous intrathecal or epidural morphine therapy. Patients who develop urinary retention have responded to cholinomimetic treatment and/or judicious use of catheters (see PRECAUTIONS).

Constipation

Constipation is frequently encountered during continuous infusion of morphine; this can usually be managed by conventional therapy.

Headache

Lumbar puncture-type headache is encountered in a significant minority of cases for several days following intrathecal catheter implantation; this, generally, responds to bed rest and/or other conventional therapy.

Other

Other adverse experiences reported following morphine therapy include-Dizziness, euphoria, anxiety, hypotension, confusion, reduced male potency, decreased libido in men and women, and menstrual irregularities including amenorrhea, depression of cough reflex, interference with thermal regulation and oliguria. Evidence of histamine release such as urticaria, wheals and/or local tissue irritation may occur. Nausea and vomiting are frequently seen in patients following morphine administration.

Pruritus, nausea/vomiting and urinary retention, if associated with continuous infusion therapy, may respond to intravenous administration of a low dose of naloxone (0.2 mg). The risks of using narcotic antagonists in patients chronically receiving narcotic therapy should be considered.

In general, side effects are amenable to reversal by narcotic antagonists.

NALOXONE INJECTION AND RESUSCITATIVE EQUIPMENT SHOULD BE IMMEDIATELY AVAILABLE FOR ADMINISTRATION IN CASE OF LIFE-THREATENING OR INTOLERABLE SIDE EFFECTS AND WHENEVER DURAMORPH (morphine injection) THERAPY IS BEING INITIATED.

Drug Abuse And Dependence

Morphine sulfate is a Schedule II narcotic under the United States Controlled Substance Act (21 U.S.C. 801-886).

Morphine is the most commonly cited prototype for narcotic substances that possess an addiction-forming or addiction-sustaining liability. A patient may be at risk for developing a dependence to morphine if used improperly or for overly long periods of time. As with all potent opioids which are µ-agonists, tolerance as well as psychological and physical dependence to morphine may develop irrespective of the route of administration (intravenous, intramuscular, intrathecal, epidural or oral). Individuals with a prior history of opioid or other substance abuse or dependence, being more apt to respond to the euphorogenic and reinforcing properties of morphine, would be considered to be at greater risk.

Care must be taken to avert withdrawal in patients who have been maintained on parenteral/oral narcotics when epidural or intrathecal administration is considered. Withdrawal symptoms may occur when morphine is discontinued abruptly or upon administration of a narcotic antagonist.

Read the entire FDA prescribing information for Duramorph (Morphine Injection)

Morphine injection is used to relieve moderate to severe pain. It may also be used before or during surgery with an anesthetic (medicine that puts you to sleep). Morphine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check the progress or you or your child while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before you or your child take any of the medicines listed above while you are using this medicine.

This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink a lot of fluids, or increase the amount of fiber in the diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Dizziness, lightheadedness, or fainting may occur when you or your child 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 medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you or your child are using this medicine. Serious unwanted effects can occur if certain medicines are given together with morphine injection.

If you or your child have been using this medicine regularly for several weeks or longer, do not suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Injection: 5 mg per10 mL (0.5 mg/mL) Preservative-free amber glass ampuls
Injection: 10 mg per10 mL (1 mg/mL) Preservative-free amber glass ampuls

Table 1 includes clinically significant drug interactions with Duramorph.

Table 1 Clinically Significant Drug Interactions with Duramorph

Duramorph (morphine sulfate injection) is an opioid agonist, available as a sterile, nonpyrogenic isobaric solution of morphine sulfate in strengths of 0.5 mg or 1 mg morphine sulfate per mL, free of antioxidants, preservatives or other potentially neurotoxic additives, and is intended for intravenous, epidural, or intrathecal administration. Morphine is the most important alkaloid of opium and is a phenanthrene derivative. It is available as the sulfate salt, chemically identified as 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2:1) (salt), pentahydrate, with the following structural formula:

 (C17H19NO3)2 • H2SO4 • 5H2O                                         Molecular Weight is 758.83

Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol,, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4).

Each mL of Duramorph contains morphine sulfate, USP 0.5 mg (5 mg/10 mL) or 1 mg (10 mg/ 10 mL) and sodium chloride 9 mg in Water for Injection. The pH range is 2.5 – 6.5. Contains no preservative. Each 10 mL ampul of Duramorph is intended for SINGLE USE ONLY.

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop.  Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications [see Drug Interactions (7)].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions (6)].

Manufactured by:

WEST-WARD
A HIKMA COMPANY
Eatontown, NJ 07724 USA

Revised: December 2016

462-212-04