March 21, 2017

Levomethadyl oral solution

What is levomethadyl oral solution?

LEVOMETHADYL (ORLAAM®) is used in detoxification and maintenance programs to help prevent withdrawal symptoms in persons addicted to drugs such as heroin or other opiate-type drugs. Federal law only allows levomethadyl to be given at a specified treatment center. You will not be allowed to take levomethadyl at home. Generic levomethadyl oral solution is not available.

NOTE: This drug is discontinued in the United States.

What should my health care professional know before I take levomethadyl?

They need to know if you have any of these conditions:

  • biliary tract disease

  • diarrhea or constipation

  • heart disease

  • If you frequently drink alcohol-containing beverages

  • intestinal disease

  • kidney disease

  • liver disease

  • lung disease or breathing difficulties

  • seizures

  • an unusual or allergic reaction to levomethadyl, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I take this medicine?

Levomethadyl solution is given diluted in another liquid. You will receive levomethadyl at authorized treatment centers only. Levomethadyl is not to be taken on a daily basis. Usually, levomethadyl is given 3-times weekly (every other day).

Levomethadyl is not indicated for the treatment of children.

What if I miss a dose?

If you miss a dose or appointment, contact your health care provider at your treatment center.

What drug(s) may interact with levomethadyl?

Do not take levomethadyl with any of the following medicines:

  • cisapride

  • clarithromycin

  • dolasetron

  • erythromycin

  • haloperidol

  • medicines to regulate your heart rate

  • medicines for mental illness such as mesoridazine, thioridazine or ziprasidone

  • pimozide

  • probucol

  • rifampin

  • risperidone

  • some antidepressants such as amitriptyline, desipramine or imipramine

  • sparfloxacin

Other medicines that may interact with levomethadyl include:

  • antiviral medicines such as protease inhibitors, delavirdine, efavirenz, or nevirapine

  • bosentan

  • butorphanol

  • certain medicines for fungal infections taken by mouth

  • dronabinol, THC

  • fluoxetine

  • fluvoxamine

  • medicines for seizures

  • nalbuphine

  • naltrexone

  • nefazodone

  • pentazocine

  • rifabutin

  • rifampin

  • St. John's wort or any herbal products containing St. John's wort

Because levomethadyl can cause drowsiness, other medicines that also cause drowsiness may increase this effect of levomethadyl. Some medicines that cause drowsiness are:

  • alcohol and alcohol-containing medicines

  • barbiturates such as phenobarbital

  • certain antidepressants or tranquilizers

  • muscle relaxants

  • certain antihistamines used in cold medicines

  • tramadol

Ask your prescriber or health care professional about other medicines that may increase the effect of levomethadyl.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking levomethadyl?

Follow the treatment program closely. Report any side effects or withdrawal symptoms to your health care provider. Levomethadyl has a slow onset of action and may take several hours to see the first effect and a several days to determine your exact dose. Since it takes 7—10 days for you to feel the full effects of levomethadyl, do not take other drugs that have similar effects to levomethadyl, especially alcohol, antidepressants, or other opiate drugs. Do not suddenly stop taking levomethadyl.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how levomethadyl affects you. Alcohol can increase possible drowsiness, dizziness, confusion, and can affect your breathing. Avoid alcohol while taking levomethadyl.

Levomethadyl will cause constipation. Make sure to take a laxative and/or stool softener while taking levomethadyl. Try to have a bowel movement every 2—3 days, at least. If you do not have a bowel movement for 3 days or more, call your prescriber or health care professional. They may recommend using an enema or suppository to help you move your bowels.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Visit the dentist regularly.

If you are going to have surgery or dental work, or will be hospitalized, tell your prescriber or health care professional that you are taking levomethadyl and give them the name of your treatment center.

What side effects may I notice from taking levomethadyl?

Most side effects reported with levomethadyl are related to the withdrawal symptoms and improve once your appropriate dose has been achieved.

Side effects that you should report to your prescriber or health care professional as soon as possible:

  • breathing difficulties

  • confusion or unable to concentrate

  • dizziness, lightheadedness or fainting spells, especially on standing

  • fast heartbeat or palpitations

  • feeling "wired" or restless

  • rash

  • seizures

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

  • abnormal dreams

  • anxiety

  • blurred vision

  • bone and/or muscle pain

  • constipation

  • diarrhea

  • dizziness, drowsiness

  • dry mouth

  • flu-like symptoms

  • headache

  • hot flashes (especially in men)

  • impotence

  • inability to sleep (insomnia)

  • nausea/vomiting

  • pinpoint pupils

  • stomach pain

  • sweating

  • weakness

Where can I keep my medicine?

This medicine is only obtained through approved clinics. According to Federal regulations, patients are not able to receive this medicine to take at home.


March 21, 2017


U.S. FDA-approved Package Insert