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Methadone Hydrochloride

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Methadone Hydrochloride

PATIENT INFORMATION

METHADONE HYDROCHLORIDE TABLETS USP (methadone)
5 mg, 10 mg

WARNINGS:

Keep methadone hydrochloride (methadone) tablets out of the reach of children. Accidental overdose by a child is a medical emergency and can result in death. If a child accidentally takes methadone hydrochloride (methadone) tablets, get emergency help right away.

Do not take a higher dose of methadone hydrochloride (methadone) tablets or take it more often than prescribed. This can lead to an overdose and possible death.

Read the Patient Information that comes with methadone hydrochloride (methadone) tablets before you take it and each time you get a new prescription. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. Share the important information in this leaflet with members of your household.

What is the Most Important Information I Should Know About Methadone Hydrochloride Tablets?

  • Methadone hydrochloride (methadone) tablets can cause life-threatening breathing problems which can lead to death. These problems are more likely to happen when methadone hydrochloride (methadone) tablets are first started or in someone who is not already taking other narcotic (opioid) pain medicines.
  • Breathing problems from methadone hydrochloride (methadone) tablets may not happen right away after taking a dose. Sometimes breathing problems will happen a while after you take a dose, even after pain has returned. It is very important that you take methadone hydrochloride (methadone) tablets exactly as your doctor has prescribed. Talk to your doctor about your pain. Your doctor can decide if your methadone hydrochloride tablets dose needs to be changed.
  • Methadone hydrochloride (methadone) tablets can cause life-threatening heartbeat problems that can lead to death. Most heartbeat problems have happened in people using large doses of methadone hydrochloride (methadone) tablets for pain treatment. Some heartbeat problems have happened in people using smaller doses of methadone hydrochloride tablets for treatment of narcotic drug addiction.

What are Methadone Hydrochloride Tablets?

Methadone hydrochloride (methadone) tablets are a prescription medicine that contains methadone, which is a narcotic pain medicine similar to morphine. Methadone hydrochloride (methadone) tablets are a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs.

  • Prevent theft and misuse. Keep your methadone hydrochloride (methadone) tablets in a safe place to protect them from theft. Never give methadone hydrochloride (methadone) tablets to anyone else even if they have the same symptoms you have. It may harm them and even cause death. Selling or giving away this medicine is dangerous and against the law.

Methadone hydrochloride (methadone) tablets are used:

  1. to treat moderate to severe pain in people that do not respond to non-narcotic pain medicines;
  2. to control withdrawal symptoms in patients being treated for narcotic drug addiction;
  3. for maintenance treatment of narcotic drug addiction along with other social and medical services. Stopping maintenance treatment of narcotic drug addiction with methadone hydrochloride (methadone) tablets may result in a return to narcotic drug use.

Who Should Not Take Methadone Hydrochloride Tablets?

Do not take methadone hydrochloride (methadone) tablets if you:

  • have severe asthma or severe lung problems.
  • have a blockage or obstruction in your intestines.
  • are allergic to methadone or anything else in methadone hydrochloride (methadone) tablets. See the end of this leaflet for a complete list of ingredients.

What Should I Tell my Doctor Before I Start Taking Methadone Hydrochloride Tablets?

Methadone hydrochloride (methadone) tablets may not be right for you. Before starting methadone hydrochloride (methadone) tablets, tell your doctor about all your medical and mental conditions including a history of drug or alcohol abuse or addiction.

Tell your doctor if you:

  • are pregnant or plan to become pregnant. Methadone hydrochloride (methadone) tablets may harm your unborn baby.
  • are breast-feeding. Methadone hydrochloride (methadone) tablets pass through your breast milk and may harm your baby. You should choose to use methadone hydrochloride tablets or breastfeed, but not both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with methadone hydrochloride tablets. Be especially careful about other medicines that may make you sleepy, such as other pain medicines, anti-depressant medicines, sleeping pills, anxiety medicines, antihistamines, or tranquilizers. Sometimes, the doses of certain medicines (including methadone hydrochloride (methadone) tablets) may need to be changed if they are used together.

Do not take any medicine while using methadone hydrochloride (methadone) tablets until you have first talked to your doctor or pharmacist. They will be able to tell you if it is safe to take other medicines while you are using methadone hydrochloride (methadone) tablets.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist each time you get a new medicine.

How Should I Take Methadone Hydrochloride Tablets?

  • Take methadone hydrochloride (methadone) tablets exactly as prescribed. Follow your doctor's directions exactly. Your doctor may change your dose based on your reactions to the medicine. Do not change your dose unless your doctor tells you to change it. Do not take a higher dose of methadone hydrochloride (methadone) tablets or take it more often than prescribed. This can lead to an overdose and possibly death.
  • If you take too much methadone hydrochloride (methadone) tablets or overdose, call 911 or your local emergency number right away.
  • Review your medical conditions regularly with your doctor to determine if you still need methadone hydrochloride (methadone) tablets, or if the dose needs to be adjusted.
  • When starting treatment with methadone hydrochloride (methadone) tablets for narcotic drug dependence, you should be aware that your dose of methadone will “hold” for longer periods of time as treatment goes on.
  • Stopping methadone hydrochloride (methadone) tablets. Ask your doctor for instructions on how to stop this medicine slowly to avoid uncomfortable symptoms. You should not stop taking methadone hydrochloride (methadone) tablets all at once if you have been taking it for more than a few days.
  • Tell all health professionals that treat you that you take methadone hydrochloride (methadone) tablets.
  • After stopping treatment with methadone hydrochloride (methadone) tablets, flush the unused tablets down the toilet.

What Should I Avoid While Taking Methadone Hydrochloride (methadone) Tablets?

  • Do not drive, operate heavy machinery, or do other possible dangerous activities until you know how methadone hydrochloride tablets affect you. Methadone hydrochloride (methadone) tablets can make you sleepy. Ask your doctor when it is okay to do these activities.
  • Do not drink alcohol while using methadone hydrochloride (methadone) tablets. It may increase the chance of having dangerous side effects.
  • Do not take other medicines with methadone hydrochloride (methadone) tablets without first talking with your doctor.

What are the Possible Side Effects of Methadone Hydrochloride Tablets?

  • Methadone hydrochloride (methadone) tablets can cause life-threatening breathing and heart problems which can lead to death. See “What is the Most Important Information I Should Know About Methadone Hydrochloride (methadone) Tablets?”.
  • Call your doctor or get medical help right away if you:
    • have trouble breathing.
    • have extreme drowsiness and breathing slows down.
    • have slow shallow breathing (little chest movement with breathing).
    • fast or slowed heartbeat.
    • feel faint, very dizzy, confused, have palpitations (irregular heartbeat) or any other unusual symptoms.
  • These can be symptoms that you have taken too much (overdose of) methadone hydrochloride tablets, or the dose is too high for you. They can also be symptoms of a serious heart reaction. These symptoms can lead to serious problems or death if not treated right away.
  • Methadone hydrochloride (methadone) tablets can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down.
  • Methadone hydrochloride (methadone) tablets can cause physical dependence. Do not stop taking methadone hydrochloride (methadone) tablets or any other opioid without first talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Talk to your doctor about slowly stopping methadone hydrochloride (methadone) tablets to avoid getting sick with withdrawal symptoms. Physical dependency is not the same as drug addiction.
  • For patients using methadone hydrochloride (methadone) tablets for pain treatment, there is a chance of abuse or addiction with methadone hydrochloride (methadone) tablets. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.

Some common side effects of methadone hydrochloride (methadone) tablets are lightheadedness, dizziness, drowsiness, nausea, vomiting and sweating. Other side effects include weakness, headache, constipation, itching, and dry mouth.

Talk to your doctor about any side effects that bother you or that do not go away.

These are not all the possible side effects of methadone hydrochloride (methadone) tablets. For a complete list, ask your doctor or pharmacist.

How Should I Store Methadone Hydrochloride Tablets?

  • Keep methadone hydrochloride (methadone) tablets in a safe place away from children. Accidental use by a child is a medical emergency that can result in death. If a child accidentally takes methadone hydrochloride (methadone) tablets, get emergency help right away.
  • Keep methadone hydrochloride (methadone) tablets at room temperature, 68° to 77°F (20° to 25°C).
  • Always keep methadone hydrochloride (methadone) tablets in a secure place to protect from theft.
  • Dispose of any unused methadone hydrochloride (methadone) tablets remaining from a prescription as soon as they are no longer needed. Unused tablets should be flushed down the toilet.

General Information About Methadone Hydrochloride (methadone) Tablets

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflet. Do not use methadone hydrochloride (methadone) tablets for a condition for which it was not prescribed. Do not give methadone hydrochloride (methadone) tablets to other people, even if they have the same symptoms you have. Methadone hydrochloride tablets can harm other people and even cause death. Sharing methadone hydrochloride tablets is against the law.

This leaflet summarizes the most important information about methadone hydrochloride (methadone) tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about methadone hydrochloride (methadone) tablets that was written for healthcare professionals, or you can visit www.Mallinckrodt.com or call 1-800-778-7898.

What are the Ingredients in Methadone Hydrochloride Tablets?

Active Ingredient: methadone hydrochloride (methadone) USP

Inactive Ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Last reviewed on RxList: 12/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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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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