Generic Name: methadone (METH-a-done)
Brand Name: Methadose
Methadose concentrate 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.
Methadose concentrate 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 even 1 dose of Methadose concentrate may be fatal, especially in children. Keep Methadose concentrate out of the reach of children. Seek emergency medical care right away if another person swallows Methadose concentrate.
Certain types of severe and sometimes fatal irregular heartbeat (QT prolongation, torsades de pointes) have occurred in patients taking Methadose concentrate. Tell your doctor right away if you develop an irregular heartbeat.
Long-term use of Methadose concentrate 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.
Methadose concentrate can only be dispensed through a special program. Discuss any questions or concerns with your doctor.
Methadose concentrate is used for:
Treating narcotic (opioid) addiction as part of a treatment program. It may also be used for other conditions as determined by your doctor.
Methadose concentrate is a narcotic (opioid) medicine. It works by acting in the brain and nervous system.
Do NOT use Methadose concentrate if:
- you are allergic to any ingredient in Methadose concentrate
- you have slow, shallow, or difficult breathing
- you have severe lung problems (eg, severe asthma) or high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or if 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, buprenorphine, a mixed agonist/antagonist pain medicine (eg, butorphanol, nalbuphine, pentazocine), nilotinib, tetrabenazine, or sodium oxybate (GHB)
- you are taking a monamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline) or have taken one within the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Methadose concentrate:
Some medical conditions may interact with Methadose concentrate. 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 carbon dioxide in the blood, or low levels of oxygen in the blood (hypoxia)
- if you have severe drowsiness, increased pressure in the brain, a recent head injury, 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), adrenal gland problems (eg, Addison disease), an enlarged prostate, or urinary blockage or trouble urinating
- 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). Deaths have happened when Methadose concentrate was abused by people taking a benzodiazepine.
- 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 Methadose concentrate. 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, constipation, 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) because they may interact with Methadose concentrate. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Methadose concentrate
This may not be a complete list of all interactions that may occur. Ask your health care provider if Methadose concentrate 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 Methadose concentrate:
Use Methadose concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Methadose concentrate by mouth with or without food. Methadose concentrate is for oral use only and must not be injected or snorted.
- Methadose concentrate must be administered under close medical supervision.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Methadose concentrate must be mixed with water or other liquid before you use it. Follow your doctor's instructions on how to mix Methadose concentrate.
- Do not suddenly stop taking Methadose concentrate. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop Methadose concentrate, your doctor will gradually lower your dose.
- Methadose concentrate works best if it is taken at the same time(s) each day. Do not miss any doses.
- If you miss a dose of Methadose concentrate, 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 Methadose concentrate.
Important safety information:
- Tell your doctor or dentist that you take Methadose concentrate before you receive any medical or dental care, emergency care, or surgery.
- Methadose concentrate may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Methadose concentrate 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 Methadose concentrate. Ask your pharmacist if you have questions about if 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 using Methadose concentrate; 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.
- Methadose concentrate 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.
- Methadose concentrate 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 Methadose concentrate, talk with your doctor or pharmacist.
- Do NOT take more than the recommended dose, take Methadose concentrate 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.
- Seek emergency medical care right away if another person swallows Methadose concentrate. Accidental swallowing of Methadose concentrate may be fatal, especially in children.
- Use Methadose concentrate with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Methadose concentrate while you are pregnant. Long-term use of Methadose concentrate during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Methadose concentrate is found in breast milk. If you are or will be breast-feeding while you use Methadose concentrate, check with your doctor. Discuss any possible risks to your baby.
When used for long periods of time or at high doses, Methadose concentrate 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 Methadose concentrate stops working well. Do not take more than prescribed.
Some people who use Methadose concentrate 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 stop taking Methadose concentrate suddenly, you may have WITHDRAWAL symptoms. These may include 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 Methadose concentrate:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; dizziness; drowsiness; headache; light-headedness; nausea; sweating; tiredness; vomiting.
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.Proper storage of Methadose concentrate:
Sometimes, Methadose concentrate is stored in a hospital, clinic, or doctor's office. If you are storing Methadose concentrate at home, store it at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Methadose concentrate out of the reach of children and away from pets.
- If you have any questions about Methadose concentrate, please talk with your doctor, pharmacist, or other health care provider.
- Methadose concentrate 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 Methadose concentrate 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 Methadose concentrate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Methadose concentrate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Methadose concentrate.
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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