Dolophine

Generic Name: methadone (METH-a-done)
Brand Name: Examples include Dolophine and Methadose

Dolophine is a narcotic medicine that may become habit-forming. Misuse or abuse can lead to overdose and death. Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.

Dolophine may cause severe and sometimes fatal breathing problems. This effect may occur at any time after you take a dose. The risk may be greater when you first start this drug or with any increase in dose. Contact your doctor right away if you experience slow, shallow, or difficult breathing.

Accidental swallowing of Dolophine may be fatal, especially in children. Keep Dolophine out of the reach of children. Seek emergency medical care right away if another person swallows Dolophine.

Certain types of severe and sometimes fatal irregular heartbeat (QT prolongation, torsades de pointes) have occurred in patients taking Dolophine. Tell your doctor right away if you develop an irregular heartbeat.

Long-term use of Dolophine during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening. Discuss any questions or concerns with your doctor.

If Dolophine is used to treat narcotic (opioid) addiction, it can only be dispensed through a special program. Contact your doctor for instructions.


Dolophine is used for:

Managing moderate to severe pain when continuous (around-the-clock) treatment is needed for an extended period of time. Dolophine is not for use right after surgery, if only occasional or as-needed pain relief is needed, or if the pain is mild or is not expected to last for an extended period of time. Dolophine is also used in treating narcotic (opioid) addiction as part of a treatment program. It may also be used for other conditions as determined by your doctor.

Dolophine is a narcotic (opioid) medicine. It works by acting in the brain and nervous system.

Do NOT use Dolophine if:

  • you are allergic to any ingredient in Dolophine
  • you have slow, shallow, or difficult breathing
  • you have severe lung problems (eg, severe asthma), or you are having an asthma attack
  • you have narrowing of the stomach or bowels, or known or suspected stomach or bowel blockage (eg, paralytic ileus)
  • you are taking asenapine, mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine), nilotinib, tetrabenazine, or sodium oxybate (GHB)
  • you are taking a monamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline), or you have taken one within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Prescription Drug Addiction - Are You at Risk?

Before using Dolophine:

Some medical conditions may interact with Dolophine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, especially any narcotic pain medicines (eg, codeine, hydromorphone); foods; or other substances
  • if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, bronchitis, emphysema), sleep apnea, curvature of the spine (scoliosis), high levels of the carbon dioxide in the blood (hypercapnia or hypercarbia), or low levels of oxygen in the blood (hypoxia)
  • if you have severe drowsiness, increased pressure in the brain, a recent head injury, or growths in the brain (eg, tumors, lesions), or a history of seizures (eg, epilepsy)
  • if you have a history of liver or kidney problems, thyroid problems, stomach or bowel problems (eg, blockage, inflammation), gallbladder problems, pancreas problems (eg, pancreatitis), heart problems (eg, cor pulmonale; enlarged heart; fast, slow, or irregular heartbeat), or urinary blockage or trouble urinating, or an enlarged prostate
  • if you have low blood pressure, dehydration, low blood volume, constipation, stomach pain, low blood potassium or magnesium levels, or poor health
  • if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
  • if you or a family member have a history of mental or mood problems (eg, anxiety, depression), or alcohol or other substance abuse or dependence
  • if you are very overweight or have recently had or will be having surgery (eg, stomach or bowel surgery)
  • if you are taking a benzodiazepine (eg, alprazolam) or a laxative
  • if you have never taken a narcotic pain medicine before
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Dolophine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for alcohol or other substance abuse or dependence, cancer, depression or other mental or mood problems, hepatitis C, high blood pressure, HIV, Huntington disease, infections, immune system suppression, irregular heartbeat or other heart problems, nausea or vomiting, pain, Parkinson disease, reflux or other stomach problems, seizures, sleeping problems, Tourette syndrome), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Dolophine. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Dolophine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dolophine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dolophine:

Use Dolophine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Dolophine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dolophine refilled.
  • Take Dolophine by mouth with or without food. Dolophine is for oral use only and must not be injected.
  • Dolophine must be administered under close medical supervision.
  • Do not suddenly stop taking Dolophine. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop Dolophine, your doctor will gradually lower your dose.
  • Dolophine works best if it is taken at the same time(s) each day. Do not miss any doses.
  • If you miss a dose of Dolophine and:
    • You are taking it for pain, take it as soon as possible then take your next dose as directed by your doctor. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than your prescribed dose in 24 hours.
    • You are taking it for narcotic (opioid) addiction, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than your prescribed dose in 24 hours.

Ask your health care provider any questions you may have about how to use Dolophine.

Important safety information:

  • Dolophine may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Dolophine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or take medicines (prescription or nonprescription) that have alcohol in them while you are taking Dolophine. Ask your pharmacist if you have questions about whether any of your medicines have alcohol in them.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Dolophine; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects.
  • Dolophine may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Dolophine may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Dolophine, talk with your doctor or pharmacist.
  • Do NOT take more than the recommended dose, take Dolophine for longer than prescribed, or take more often than prescribed without talking with your doctor.
  • If you have side effects that concern you, contact your doctor. If you are taking Dolophine for pain, contact your doctor if your pain continues or becomes worse.
  • Tell your doctor or dentist that you take Dolophine before you receive any medical or dental care, emergency care, or surgery.
  • Seek emergency medical care right away if another person swallows Dolophine. Accidental swallowing of Dolophine may be fatal, especially in children.
  • Use Dolophine with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
  • Dolophine should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dolophine while you are pregnant. Long-term use of Dolophine during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Dolophine is found in breast milk. If you are or will be breast-feeding while you use Dolophine, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Dolophine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Dolophine stops working well. Do not take more than prescribed.

Some people who use Dolophine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Dolophine, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Dolophine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; light-headedness; nausea; sweating; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); abnormal sighing; chest pain; confusion; decreased sexual desire or ability; fainting; fast, slow, or irregular heartbeat; hallucinations; menstrual changes; mental or mood changes (eg, agitation, depression); muscle pain, weakness, or cramping; seizures; severe or persistent constipation or stomach pain; severe or persistent dizziness, drowsiness, headache, or light-headedness; shortness of breath; slow, difficult, or shallow breathing; sudden, unexplained weight gain; swelling of the arms, feet, or legs; trouble sleeping; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin or nails; cold and clammy skin; coma; fainting; limp muscles; pinpoint or enlarged pupils; severe dizziness, drowsiness, or light-headedness; shortness of breath; slow or irregular heartbeat; slow, shallow, or difficult breathing.

Proper storage of Dolophine:

Sometimes, Dolophine is stored in a hospital, clinic, or doctor's office. If you are storing Dolophine at home, store it at room temperature, 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dolophine out of the reach of children and away from pets.

General information:

  • If you have any questions about Dolophine, please talk with your doctor, pharmacist, or other health care provider.
  • Dolophine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Dolophine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Dolophine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Dolophine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Dolophine.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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