Levomethadyl (patient information)

IMPORTANT WARNING

Levomethadyl is no longer available in the United States. If you are currently taking levomethadyl, you should call your doctor to discuss switching to another treatment.

Levomethadyl can cause irregular heartbeat, which can be life-threatening. If you experience any of the following symptoms, call your doctor immediately: irregular heartbeat, dizziness, lightheadedness, seizures. Before you start taking levomethadyl and maybe during treatments, your doctor will do an electrocardiogram to see if you are at risk for having irregular heartbeat.

Before taking erythromycin (E.E.S., Erythrocin, others), ketoconazole (Nizoral), phenobarbital (Barbital, Luminal, Solfoton), phenytoin (Dilantin, Diphenylan Sodium), rifampin (Rifadin, Rimactane), or saquinavir (Fortovase, Invirase), tell your doctor that you are taking levomethadyl.

Talk to your doctor about the risk of taking levomethadyl.

Levomethadyl should only be used in treatment programs for people addicted to narcotics.

Why this medication is prescribed

Levomethadyl is used in treatment programs for people addicted to narcotics.

How this medication should be used

Levomethadyl comes as a liquid to take by mouth. It is usually taken every 2 or 3 days. You must go to an approved clinic to obtain and take levomethadyl. Your doctor will tell you about the proper procedures for enrolling in this kind of treatment program.

Other uses for this medicine

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before taking levomethadyl:

• tell your doctor and pharmacist if you are allergic to codeine, methadone, levomethadyl, or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially those listed in the IMPORTANT WARNING section; other pain relievers; antidepressants; antipsychotics; diuretics ('water pills'); heart medications; laxatives; medications for cough, cold, or allergies; medications for malaria; sedatives; sleeping pills; tranquilizers; and vitamins.
• before taking any narcotics such as butorphanol (Stadol) or pentazocine (Talwin), tell your doctor that you are taking levomethadyl.
• tell your doctor if you have or have ever had liver, heart, or kidney disease; a history of alcoholism or seizures; lung, ulcer, or thyroid disease; electrolyte imbalance; prostatic hypertrophy; or urinary problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking levomethadyl, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking levomethadyl.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug.

What to do if you forget a dose

It is important that you receive all doses of levomethadyl as scheduled. If you miss a dose, call your doctor to establish a new dosing schedule. Do not use other mood-altering drugs, including alcohol, while your doctor is starting a new dosing schedule. Taking these drugs instead of levomethadyl treatment can be fatal. Levomethadyl should never be taken every day.

Side effects

Minor side effects

Levomethadyl may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• upset stomach
• vomiting
• constipation
• stomach pain
• sweating
• rash
• difficulty urinating

Severe side effects

If you experience either of the following symptoms or any of hose listed in the IMPORTANT WARNING section, call your doctor immediately:

• difficulty breathing
• fainting

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

If you are given doses of levomethadyl to take home, keep the medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Other information

Keep all appointments with your doctor, laboratory, and clinic. Your doctor will want to check your response to levomethadyl.

Brand names

• ORLAAM®