Mallinckrodt Pharmaceuticals Addiction Treatment Products

Mallinckrodt is a leading supplier of therapeutic products for treating opioid addiction. From manufacture of the raw material to production of the final dosage form, Mallinckrodt Pharmaceuticals serves the need for this important therapeutic modality. Our Methadose® brand of methadone hydrochloride is available in liquid, tablet, and powder forms to meet all prescribing needs. Our Depade® brand of naltrexone hydrochloride tablets, USP is available in a 50mg strength and in new 25 mg and 100 mg strengths.

Our Depade® brand of naltrexone continues to show promise as an adjunct in the treatment of other addictive disorders, particularly alcoholism.

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses. Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects. The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. Naltrexone does not appear to be a hepatotoxin at the recommended doses. Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatisis.

METHADOSE® is for oral administration only. This preparation must not be injected. It is recommended that METHADOSE®, if dispensed, be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion.

Abuse and dependence: Methadone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of methadone, and it should be prescribed and administered with the same degree of caution appropriated to the use of morphine.