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Dolophine

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Dolophine

DOLOPHINE®
(methadone hydrochloride) Tablets

WARNING

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

DOLOPHINE 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 DOLOPHINE, 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 DOLOPHINE. Monitor for respiratory depression, especially during initiation of DOLOPHINE or following a dose increase [see WARNINGS AND PRECAUTIONS].

Accidental Ingestion

Accidental ingestion of even one dose of DOLOPHINE, 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 DOLOPHINE [see WARNINGS AND PRECAUTIONS].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of DOLOPHINE 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].

DRUG DESCRIPTION

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:

DOLOPHINE® (methadone hydrochloride ) Structural Formula Illustration

Each DOLOPHINE tablet contains 5 or 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...

Read All Potential Side Effects and See Pictures of Dolophine »

What are the precautions when taking methadone (Dolophine)?

Before taking methadone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus),...

Read All Potential Precautions of Dolophine »

Last reviewed on RxList: 10/30/2014
This monograph has been modified to include the generic and brand name in many instances.

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Dolophine - User Reviews

Dolophine User Reviews

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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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