Methadose

Methadose is used for:

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Treating moderate to severe pain that is not relieved by other pain medicines. It is also used in treating narcotic addiction as part of a treatment program. It may also be used for other conditions as determined by your doctor.

Methadose is a narcotic analgesic. It works by acting on opiate pain receptors in the brain and on smooth muscle to provide pain relief.

Do NOT use Methadose if:

• you are allergic to any ingredient in Methadose
• you have slowed breathing or severe asthma, or if you are having an asthma attack
• you have a stomach or bowel blockage or certain severe bowel problems (eg, paralytic ileus)
• you have diarrhea caused by food poisoning or antibiotic use
• you are taking sodium oxybate (GHB)
• if you have taken a monamine oxidase inhibitor type B (MAOI-B) (eg, rasagiline, selegiline) within the last 14 days

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

Before using Methadose :

Some medical conditions may interact with Methadose . 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, foods, or other substances
• if you have lung or breathing problems (eg, asthma), chronic obstructive pulmonary disease (COPD), sleep apnea, stomach or bowel problems (eg, bowel inflammation), stomach pain or constipation, liver or kidney problems, thyroid problems, or Addison disease
• if you have an abnormal curvature of the spine; narrowing of the urethra, trouble urinating, or an enlarged prostate; low blood volume, blood pressure, or blood oxygen levels; low potassium or magnesium blood levels; increased pressure, tumors, or lesions in your head; a recent head injury; or seizures
• if you have a history of heart problems (eg, enlarged heart) or irregular heartbeat
• if you or a family member have a history of mental or mood problems (eg, anxiety, depression), suicidal thoughts or attempts, or alcohol or substance abuse
• if you are elderly, very ill, or very overweight, or if you have recently had stomach or intestine surgery

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

• Barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, midazolam), cimetidine, MAOI-B (eg, rasagiline, selegiline), other narcotic analgesics (eg, morphine), phenothiazines (eg, promethazine), or sodium oxybate (GHB) because side effects such as sedation and slowed breathing may occur
• Antiarrhythmics (eg, amiodarone, dofetilide, flecainide, propafenone), antipsychotics (eg, haloperidol, paliperidone, ziprasidone), calcium channel blockers (eg, nifedipine), certain antiemetics (eg, dolasetron, droperidol), chloroquine, cisapride, diuretics (eg, furosemide), H₁ antagonists (eg, astemizole), kinase inhibitors (eg, lapatinib, nilotinib), lithium, macrolide antibiotics (eg, clarithromycin), phenothiazines (eg, chlorpromazine), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin), tacrolimus, or tricyclic antidepressants (eg, desipramine) because the risk of QT prolongation may be increased
• Azole antifungals (eg, fluconazole, ketoconazole, voriconazole) or certain selective serotonin reuptake inhibitors (SSRIs) (eg, fluvoxamine, sertraline) because they may increase the risk of Methadose 's side effects
• Abacavir, carbamazepine, efavirenz, HIV protease inhibitors (eg, amprenavir, lopinavir, nelfinavir, ritonavir), narcotic agonists/antagonists (eg, butorphanol, nalbuphine, pentazocine), narcotic antagonists (eg, naloxone, naltrexone), nevirapine, phenobarbital, phenytoin, rifampin, or St. John's wort because they may decrease Methadose 's effectiveness
• Zidovudine because the risk of its side effects may be increased by Methadose
• Nucleoside reverse transcriptase inhibitors (NRTIs) (eg, abacavir, didanosine, stavudine) because their effectiveness may be decreased by Methadose

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methadose 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 :

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

• An extra patient leaflet is available with Methadose . Talk to your pharmacist if you have questions about this information.
• Take Methadose by mouth with or without food. Methadose is for oral use only and must not be injected.
• Methadose must be administered under close medical supervision.
• Take Methadose on a regular schedule to get the most benefit from it. It is more effective in preventing pain than in treating pain after it occurs.
• If Methadose is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Methadose properly.
• Always keep Methadose in a secure place to protect from theft.
• If you miss a dose of Methadose , take it as soon as possible. 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. If you miss your doses of Methadose for more than 2 days, contact your doctor before you start taking Methadose again.

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

Important safety information:

• Methadose may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Methadose with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Methadose ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Methadose may cause dizziness, lightheadedness, 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.
• Breathing problems may occur some time after you take a dose of Methadose . Tell your doctor or seek medical care immediately if you notice trouble breathing (eg, slowed or shallow breathing) while you take Methadose
• Methadose may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative.
• The risk of Methadose becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the recommended dose or use Methadose for longer than prescribed without talking with your doctor.
• Tell your doctor or dentist that you take Methadose before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including liver function, lung function, and heart function, may be performed while you use Methadose . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Methadose with caution in the ELDERLY; they may be more sensitive to its effects.
• Methadose should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Methadose may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Methadose while you are pregnant. Methadose is found in breast milk. If you are or will be breast-feeding while you use Methadose , check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Methadose 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 stops working well. Do not take more than prescribed.

Some people who use Methadose 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 Methadose , 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 Methadose :

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; dry mouth; headache; increased sweating; itching; lightheadedness; nausea; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; decreased sexual desire or ability; excessive drowsiness; fainting; fast, slow, or irregular heartbeat; hallucinations; loss of appetite; menstrual changes; mental or mood changes (eg, agitation, disorientation, exaggerated sense of well-being); seizures; severe or persistent dizziness or lightheadedness; shortness of breath; slow or shallow breathing; swelling of the arms, feet, or legs; trouble sleeping; trouble urinating; unusual bruising or bleeding.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include cold and clammy skin; coma; fainting; fast, slow, or irregular heartbeat; muscle weakness; pinpoint pupils; severe dizziness, drowsiness, or lightheadedness; slow, shallow, or difficult breathing.

Store Methadose between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Methadose out of the reach of children and away from pets.

General information:

• If you have any questions about Methadose , please talk with your doctor, pharmacist, or other health care provider.
• Methadose 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.

This information is a summary only. It does not contain all information about Methadose . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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