Consumer Drug Information

Methadose

Generic Name: Methadone Tablets for Oral Suspension (METH-a-done)
Brand Name: Methadone Diskets

Methadose may cause severe and sometimes fatal heart and breathing problems. These problems may occur some time after you take a dose. Tell your doctor right away if you develop any new or worsening symptoms such as slowed or shallow breathing or irregular heartbeat. Your doctor will perform heart and lung function tests to check for side effects while you take Methadose . Keep all doctor and laboratory appointments. Talk with your doctor and be sure to understand the risks and benefits of using Methadose .

Do not exceed the recommended dose or take Methadose more often than prescribed. This can lead to overdose and possible death.

Methadose is used for:

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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 receptors in the brain.

Do NOT use Methadose if:

you are allergic to any ingredient in Methadose
you have slowed breathing, 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 due to food poisoning or antibiotic use
you are taking sodium oxybate (GHB)
you have taken a monoamine oxidase type B (MAO-B) inhibitor (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 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 have a history of heart problems (eg, enlarged heart), or irregular heartbeat
if you have lung problems, chronic obstructive pulmonary disease (COPD), breathing problems (eg, asthma), sleep apnea, stomach or bowel problems (eg, bowel inflammation), liver problems, kidney problems, thyroid problems, Addison disease, seizures, curvature of the spine, narrowing of the urethra, trouble urinating, enlarged prostate, low blood volume, low blood pressure, low blood oxygen levels, or low potassium or magnesium blood levels
if you have increased pressure or tumors or lesions in your head or a recent head injury, or if you have recently had surgery
if you are elderly or very ill, or if you are very overweight

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

Carbamazepine, efavirenz, HIV protease inhibitors (eg, ritonavir, nelfinavir), lopinavir, naltrexone, narcotic antagonists (eg, naloxone), nevirapine, narcotic agonists/antagonists (eg, pentazocine), phenobarbital, phenytoin, rifampin, or St. John's wort because they may decrease Methadose 's effectiveness
Barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, midazolam), cimetidine, MAO-B inhibitors (eg, rasagiline, selegiline), or sodium oxybate (GHB) because side effects such as sedation, confusion, and slowed breathing may occur
Calcium channel blockers (eg, nifedipine), cisapride, diuretics (eg, furosemide), dofetilide, H₁ antagonists (eg, astemizole), neuroleptics (eg, haloperidol), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin), or tricyclic antidepressants (eg, desipramine) because the risk of QT prolongation may be increased
Zidovudine because the risk of its side effects may be increased by Methadose
Efavirenz or HIV protease inhibitors (eg, abacavir) because their effectiveness may be decreased by Methadose
Fluconazole, fluvoxamine, ketoconazole, macrolide antibiotics (eg, clarithromycin), sertraline, or voriconazole because they may increase the risk of Methadose 's side effects

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.

Take Methadose by mouth with or without food.
Do not chew or swallow the tablet. Place the tablet in a glass and add about 4 oz/120 mL of cold water, orange juice, or other acidic fruit beverage before taking. Allow the tablet to dissolve completely, the drink all of the liquid. Rinse the container with an additional small amount of fluid and drink the contents to ensure the entire dose is taken. Methadose is for oral use only and must not be injected.
The initial dose of Methadose must be administered under close medical supervision.
Take this medicine on a regular schedule to get the most benefit from it.
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.

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.
This medicine 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.
Do NOT take more than the recommended dose or use for longer than prescribed without checking 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. Do not breast-feed while taking Methadose .

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 this medicine stops working well. Do not take more than prescribed.

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; increased sweating; lightheadedness; nausea; vomiting; weakness.

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, or tongue); confusion; excessive drowsiness; fainting; fast, slow, or irregular heartbeat; loss of appetite; mental or mood changes; seizures; severe or persistent dizziness or lightheadedness; shortness of breath; slow heartbeat; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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 / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include cold and clammy skin; coma; difficult or slowed breathing; muscle weakness; pinpoint pupils, severe dizziness, drowsiness, or lightheadedness; slow heartbeat.

Proper storage of Methadose :

Store Methadose at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. 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.

Issue Date: August 6, 2008

Database Edition 08.3.1.002