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Levomethadyl acetate HCl oral
LEVOMETHADYL - ORAL LIQUID

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

LEVOMETHADYL - ORAL LIQUID

(lee-voh-METH-uh-dill)

COMMON BRAND NAME(S): Orlaam

WARNING: Taking levamethadyl more often than prescribed can lead to drug accumulation and a fatal overdose. Do not take this medication daily unless your doctor is monitoring you very carefully. This medication does not take effect immediately. If combined with mind-altering substances (including alcohol), a fatal overdose may occur even after this medication is stopped. Serious, even fatal heart problems (QTc interval prolongation) have occurred in patients taking this medication. This medicine should be used only when treatment with other drugs have failed. A heart test (EKG) should be performed before and periodically during treatment to check for abnormalities (QTc interval prolongation).

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 This medication has been withdrawn from the U.S. market due to safety or effectiveness problems.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.

Drug Interactions

Tell your doctor of any over-the-counter or prescription medication you use, including: antidepressants, anti- seizure drugs, narcotic pain relievers, sleeping pills, sedatives, rifamycins (e.g., rifampin, rifabutin), macrolide antibiotics (e.g., erythromycin), cimetidine, azole antifungals (e.g., ketoconazole, itraconazole), "water pills" (diuretics such as furosemide), laxatives (causing loss of potassium and magnesium), certain corticosteroids (those with potassium-wasting effects such as fludrocortisone), saquinavir. Report other drugs which affect the heart rhythm (QTc prolongation, such as: dofetilide, sotalol, quinidine, pimozide, moxifloxacin, sparfloxacin. Ask your doctor or pharmacist for more details. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately.

Notes

This medication is only used as part of a comprehensive treatment program approved by federal and state authorities and the Drug Enforcement Agency. This medication is not permitted by regulation for take-home use. Laboratory and/or medical tests (e.g., EKG) may be performed periodically to monitor your progress.

Missed Dose

It is important that each dose be taken on schedule. If you miss a dose, contact your doctor who will establish a new dosing schedule. Do not "double-up" the dose to catch up.

Storage

Store at room temperature protected from sunlight.