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Morphine Sulfate Suspension for injection

It is used as a one time only dose to treat the pain of a major surgery or cesarean section

Generic Name: morphine  |  Brand Name: M-Eslon

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 01/10/2011] ISSUE: Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100 mg/5mL product. In most of these cases, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. The approval of this product is part of FDA’s unapproved drugs initiative. Prior to the recent approval, Roxane marketed a morphine sulfate oral solution with the strength expressed as 20 mg/mL, using a container label and carton labeling that had brown lettering on a white background. The newly approved product labeling and packaging feature revisions intended to reduce the risk of medication errors.

BACKGROUND: Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients.

RECOMMENDATION: See Roxane’s “Dear Healthcare Professional Letter” for a complete description and photos of labeling and product packaging changes. Changes include:

  • A warning stating “ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT” is displayed in a box to highlight that the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant patients only. The 100 mg per 5 mL concentration of morphine sulfate may cause fatal respiratory depression when administered to patients not previously exposed to opioids.
  • The strength is presented as 100 mg per 5 mL followed by a less prominently displayed concentration of (20 mg/mL). The intent of this designation is to help differentiate this product from the 20 mg/5 mL morphine sulfate product.
  • A bright yellow background is used on multiple sides of this product to differentiate the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) from other morphine sulfate oral solutions marketed by Roxane with a white background.
  • The drug name, strength and concentration are displayed in white lettering on a red background as an additional means of differentiating this product from other concentrations of morphine sulfate oral solutions.
  • A reminder is presented to the pharmacist to dispense the product to each patient with the enclosed Medication Guide.
  • Both the 30 mL and 120 mL bottles of morphine sulfate 100 mg per 5 mL (20 mg/mL) oral solution are packaged with a calibrated oral syringe to provide accurate dose measurements. Healthcare providers should read the instructions in the Medication Guide that describe the correct use of the oral syringe in order to help prevent medication errors from occurring.
  • Healthcare providers should discuss the correct use of the oral syringe with their patients.
For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for morphine to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of morphine and consists of the following: medication guide and communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

MORPHINE (MOR feen) is a pain reliever. It is used as a one time only dose to treat the pain of a major surgery or cesarean section.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • brain tumor
  • drug abuse or addiction
  • head injury
  • heart disease
  • frequently drink alcohol containing drinks
  • intestinal disease
  • kidney disease
  • liver disease
  • lung or breathing disease, like asthma
  • problems going to the bathroom
  • recent spinal cord injury or spinal puncture
  • seizures
  • taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days
  • an unusual or allergic reaction to morphine, other pain medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for injection as an epidural. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

  • alcohol
  • antihistamines
  • barbiturates like phenobarbital
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for sleep
  • muscle relaxants
  • naltrexone, naloxone
  • narcotic medicines (opiates) for pain
  • other medicines given by epidural
  • rifampin
  • tramadol

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • confusion
  • fever, chills
  • feeling faint or lightheaded
  • low blood pressure
  • red or sore at the injection site
  • seizures
  • slow or fast heartbeat
  • trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • back pain
  • constipation
  • dizzy, drowsy
  • headache
  • nausea, vomiting
  • pinpoint pupils
  • sweating


Last Updated: August 24, 2012
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