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Methadone Solution is used for:

Relieving moderate to severe pain and temporarily treating a narcotic addiction as part of a treatment program. It is used in patients who are unable to take medicine by mouth. It may also be used for other conditions as determined by your doctor.

Methadone Solution is a synthetic narcotic analgesic with multiple actions similar to those of morphine, including pain relief. It also provides sedation and temporary maintenance treatment of narcotic addiction.

Do NOT use Methadone Solution if:

• you are allergic to any ingredient in Methadone Solution
• you have diarrhea due to poisoning, pseudomembranous colitis, or hypercapnia (abnormally increased carbon dioxide tension in your arteries), or are taking sodium oxybate (GHB)
• you drink alcohol
• you are having an asthma attack or have slowed breathing

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

Before using Methadone Solution:

Some medical conditions may interact with Methadone Solution. 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 prostate problems, a brain tumor, heart problems, liver disease, breathing problems, seizures, bowel problems, urination problems, a lesion or increased pressure on the brain, low blood levels of potassium or magnesium, underactive thyroid, anxiety, low blood volume, kidney problems, Addison disease, or suicidal thoughts
• if you are at risk for developing irregular heartbeat, are severely overweight, have problems breathing while sleeping (eg, sleep apnea), difficult or slowed breathing, or a history of drowsiness leading to unresponsiveness or coma
• if you have ever abused substances, have head trauma, or have had GI tract surgery

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

• Efavirenz, HIV protease inhibitors (eg, ritonavir), naltrexone, narcotic antagonists (eg, naloxone), nevirapine, narcotic agonists/antagonists (eg, pentazocine), risperidone, or St. John's wort because they may decrease Methadone Solution's effectiveness
• Barbiturate anesthetics (eg, thiopental), cimetidine, ethanol, fluconazole, fluvoxamine, ketorolac, quinolones (eg, ciprofloxacin), or sodium oxybate (GHB) because side effects such as sedation, confusion, and slowed breathing may occur
• Barbiturate anesthetics (eg, thiopental), desipramine, sodium oxybate (GHB), or zidovudine because their actions and the risk of their side effects may be increased by Methadone Solution
• Mexiletine or nucleoside reverse transcriptase inhibitors (eg, lamivudine) because their effectiveness may be decreased by Methadone Solution

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

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

• Methadone Solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Methadone Solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Methadone Solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Methadone Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Methadone Solution must be administered under close medical supervision.
• Take Methadone Solution 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 you miss a dose of Methadone Solution and you are using it regularly, use 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 use 2 doses at once.

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

Important safety information:

• Methadone Solution may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Methadone Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Methadone Solution may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative.
• Tell your doctor or dentist that you take Methadone Solution before you receive any medical or dental care, emergency care, or surgery.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Methadone Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Use Methadone Solution with caution in the ELDERLY; they may be more sensitive to its effects.
• Methadone Solution should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Methadone Solution while you are pregnant. Methadone Solution is found in breast milk. If you are or will be breast-feeding while you use Methadone Solution, check with your doctor. Discuss any possible risks to your baby.

Some people who use Methadone Solution 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 Methadone Solution suddenly, you may have WITHDRAWAL symptoms. These may include convulsions, tremor, stomach and muscle cramps, vomiting, and sweating. Do not stop therapy suddenly or change the dosage without asking your doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Methadone Solution:

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; lightheadedness; nausea; pain or irritation at the injection site; sweating.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; excessive drowsiness; fainting; itching; pounding in the chest; seizures; shortness of breath; slow heartbeat; sweating; vomiting.

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/findyour.htm), or emergency room immediately. Symptoms may include cold and clammy skin; deep sleep; difficulty breathing, dizziness; drowsiness leading to unresponsiveness or coma; lightheadedness; loss of consciousness; low body temperature; pinpoint pupils; shock; slow breathing; slow heartbeat.

Store Methadone Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Methadone Solution out of the reach of children and away from pets.

General information:

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