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Morphine Sulfate Oral capsule, extended release

It is used to treat moderate to severe pain that lasts for more than a few days

Generic Name: morphine  |  Brand Name: MS/S

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 to treat moderate to severe pain that lasts for more than a few days. It is used by people who have been taking an opioid or narcotic pain medicine.

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
  • if you drink alcohol containing drinks
  • intestinal disease
  • kidney disease or problems urinating
  • kyphoscoliosis
  • liver disease
  • lung disease, asthma, or breathing problems
  • seizures
  • taken isocarboxazid, phenelzine, tranylcypromine, or selegiline in the past 2 weeks
  • an unusual or allergic reaction to morphine, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not break, crush, or chew the capsules. Do not take a capsule that is not whole. A broken or crushed capsule can be very dangerous. You may get too much medicine. If the medicine upsets your stomach, take it with food or milk. If you have problems swallowing the capsule, you may carefully open it and sprinkle the contents on a small amount of cold applesauce. Immediately swallow all of the applesauce. Do not save it for later. Do not chew the applesauce. Do not let the medicine dissolve in the applesauce. Rinse your mouth with a sip of water. None of the medicine should stay in your mouth. Swallow all of the medicine. Follow the directions on the prescription label. Take the medicine at the same time each day. Do not take more than you are told to take.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

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

This medicine may also interact with the following medications:

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


Last Updated: August 24, 2012
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