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Morphine, Anhydrous Oral solution

However, this medicine is used to decrease the number and frequency of bowel movements

Generic Name: morphine  |  Brand Name: Alti-Morphine

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?

OPIUM TINCTURE (OH-pee-uhm) belongs to the same class of medicines as the narcotic pain relievers. However, this medicine is used to decrease the number and frequency of bowel movements. It is used to treat diarrhea.

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

They need to know if you have any of the following conditions:
  • brain tumor
  • drug abuse or addiction
  • head injury
  • heart disease
  • if you frequently drink alcohol-containing drinks
  • intestinal disease
  • kidney disease
  • liver disease
  • lung disease, asthma, or breathing problems
  • seizures
  • an unusual or allergic reaction to opium, morphine or other opiates, 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. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Use a specially marked spoon or container to measure each dose. You may also use the marked dropper provided with the medicine. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

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

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

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?

  • alcohol
  • antihistamines for allergy, cough and cold
  • certain medicines for depression, anxiety, or psychotic disturbances
  • certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
  • certain medicines for sleep
  • certain medicines used for nausea like dronabinol, droperidol, nabilone
  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
  • medicines for anesthesia
  • muscle relaxants
  • naltrexone
  • narcotic medicines for pain

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

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.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.


Last Updated: August 11, 2012
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