Dolophine

Dolophine is a prescription medication that contains a long-acting opioid (narcotic) pain medication. It is used to treat moderate to severe pain in people that do not respond to non-narcotic pain medicines, and to control withdrawal symptoms in people being treated for narcotic drug addiction. Although Dolophine belongs to the same group of drugs as heroin and morphine, it acts differently in the body and is helpful in treating addiction because it helps eliminate the cravings addicts experience during withdrawal.

This medication comes in the form of tablets and injections. It is usually taken one to three times daily.

Common side effects include dizziness, drowsiness, nausea, and constipation. Do not drive or operate heavy machinery until you know how Dolophine affects you.

Methadone is a prescription medicine that contains methadone, which is a narcotic pain medicine similar to morphine. 

Methadone is 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 may result in a return to narcotic drug use.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• PD-Rx Pharmaceuticals, Inc.

• Roxane Laboratories, Inc.

• Methadone can cause life-threatening breathing and heart problems which can lead to death.
• 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)
  • have 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, 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 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 can cause physical dependence. Do not stop taking methadone 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 to avoid getting sick with withdrawal symptoms. Physical dependency is not the same as drug addiction.
• For patients using methadone for pain treatment, there is a chance of abuse or addiction with methadone. 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 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. For a complete list, ask your doctor or pharmacist.

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. 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) may need to be changed if they are used together.

Do not take any medicine while using methadone 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.

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.

• Methadone can cause life-threatening breathing problems which can lead to death. These problems are more likely to happen when methadone is first started or in someone who is not already taking other narcotic (opioid) pain medicines.
• Breathing problems from methadone 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 exactly as your doctor has prescribed. Talk to your doctor about your pain. Your doctor can decide if your methadone dose needs to be changed.
• Methadone can cause life-threatening heartbeat problems that can lead to death. Most heartbeat problems have happened in people using large doses of methadone for pain treatment. Some heartbeat problems have happened in people using smaller doses of methadone for treatment of narcotic drug addiction.
• Keep methadone 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, get emergency help right away.
• Do not drive, operate heavy machinery, or do other possible dangerous activities until you know how methadone affects you. methadone can make you sleepy. Ask your doctor when it is okay to do these activities.
• Do not drink alcohol while using methadone. It may increase the chance of having dangerous side effects.
• Do not take other medicines with methadone without first talking with your doctor.

Do not take methadone if you:

• have severe asthma or severe lung problems.
• have a blockage or obstruction in your intestines.
• are allergic to methadone or any ingredient in it.

Grapefruit and grapefruit juice may interact with methadone and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
 

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 may harm your unborn baby.
• are breastfeeding. Methadone passes through your breast milk and may harm your baby. You should choose to use methadone 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. 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) may need to be changed if they are used together.

Do not take any medicine while using methadone 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Methadone falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. Methadone passes through your breast milk and may harm your baby. You should choose to use methadone or breastfeed, but not both.

• Take methadone 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 or take it more often than prescribed. This can lead to an overdose and possibly death.
• If you take too much methadone 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, or if the dose needs to be adjusted.
• When starting treatment with methadone 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. Ask your doctor for instructions on how to stop this medicine slowly to avoid uncomfortable symptoms. You should not stop taking methadone 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.
• After stopping treatment with methadone, flush the unused tablets down the toilet.

Take methadone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

Your doctor may change your dose of methadone during your treatment. Do not stop taking methadone without talking to your doctor. Your dose may be decreased gradually to avoid withdrawal symptoms (restlessness, sweating, chills, muscle pain, tearing eyes, runny nose, widened pupils).

If you take too much methadone or overdose, call 911 or your local emergency number right away.

• Keep methadone 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, get emergency help right away.
• Keep methadone at room temperature, 68° to 77°F (20° to 25°C).
• Always keep methadone in a secure place to protect from theft.
• Dispose of any unused methadone remaining from a prescription as soon as they are no longer needed. Unused tablets should be flushed down the toilet.

Methadone is 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 tablets in a safe place to protect them from theft. Never give methadone 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.

Deaths, cardiac and respiratory, have been reported during initiation and conversion of pain patients to methadone treatment from treatment with other opioid agonists. It is critical to understand the pharmacokinetics of methadone when converting patients from other opioids. Particular vigilance is necessary during treatment initiation, during conversion from one opioid to another, and during dose titration.

Respiratory depression is the chief hazard associated with methadone hydrochloride administration. Methadone's peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects, particularly in the early dosing period. These characteristics can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration.

In addition, cases of QT interval prolongation and serious arrhythmia (torsades de pointes) have been observed 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.

Methadone treatment for analgesic therapy in patients with acute or chronic pain should only be initiated if the potential analgesic or palliative care benefit of treatment with methadone is considered and outweighs the risks.

Conditions for Distribution and Use of Methadone Products for the Treatment of Opioid Addiction

Code of Federal Regulations, Title 42, Sec 8

Methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8.12). See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment.

Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program.

Regulatory Exceptions to the General Requirement for Certification to Provide Opioid Agonist Treatment:

1. During inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21 CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis.
2. During an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility (pursuant to 21 CFR 1306.07(b)).