"A joint US Food and Drug Administration (FDA) advisory committee has recommended that a new immediate-release (IR) opioid analgesic be approved and that labeling describe the product as deterring abuse via intranasal (IN) and intravenous (IV) rou"...
(methadone hydrochloride) Tablet, for Oral Use
ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and TREATMENT FOR OPIOID ADDICTION
Addiction, Abuse, and Misuse
Methadone hydrochloride tablets, USP exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing methadone hydrochloride tablets, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS AND PRECAUTIONS].
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of methadone hydrochloride tablets . Monitor for respiratory depression, especially during initiation of methadone hydrochloride tablets or following a dose increase [see WARNINGS AND PRECAUTIONS].
Accidental ingestion of even one dose of methadone hydrochloride tablets, especially by children, can result in a fatal overdose of methadone [see WARNINGS AND PRECAUTIONS].
Life-threatening QT Prolongation
QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients for changes in cardiac rhythm during initiation and titration of methadone hydrochloride tablets [see WARNINGS AND PRECAUTIONS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of methadone hydrochloride tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS AND PRECAUTIONS ].
Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction
For detoxification and maintenance of opioid dependence, methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8, including limitations on unsupervised administration [see INDICATIONS AND USAGE].
Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Its molecular formula is C21H27NO•HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula:
Each methadone hydrochloride tablet contains 10 mg of methadone hydrochloride, USP and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, and starch.
What are the possible side effects of methadone (Diskets, Dolophine, Methadose)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing;
- hallucinations or confusion;
- chest pain, dizziness, fainting, fast or pounding heartbeat; or
- trouble breathing, feeling light-headed, or fainting.
Less serious side effects may include:
- feeling anxious, nervous, or restless;
- sleep problems...
Last reviewed on RxList: 11/2/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Dolophine Information
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