levomethadyl-oral liquid, Orlaam (cont.)

USES: This medication is used in the treatment of narcotic addiction as part of an approved program. This medication has been withdrawn from the U.S. market due to safety or effectiveness problems.

HOW TO USE: Take this medication exactly as prescribed, usually three times a week. It may take several days before the full effect of this medication are felt. Do not increase the dose, skip doses, take it more often than directed or continue taking this for longer than prescribed. Be sure to follow dosing instructions closely.

SIDE EFFECTS: Stomach pain, constipation, diarrhea, dry mouth, trouble sleeping, and headache may occur. If any of these effects persist or worsen, contact your doctor promptly. Notify your doctor immediately if you develop: dizziness, drowsiness, rash, mood changes (e.g., depression), breathing problems, anxiety, hallucinations, mental confusion, irritability, tremors, seizures, sweating. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: fainting, irregular heartbeat. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: heart problems, irregular heartbeat, low potassium or magnesium levels. This medication is not recommended for use if you have the following medical conditions: heart disease (QTc prolongation). Avoid the use of alcohol while taking this medication. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor. Because this medication may appear in breast milk, consult your doctor before breast-feeding.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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