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|Methadose Concentrate

Methadose Concentrate

Methadose Concentrate is used for:

Temporarily treating a narcotic addiction as part of a treatment program. It may also be used for other conditions as determined by your doctor.

Methadose Concentrate 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 Methadose Concentrate if:

• you are allergic to any ingredient in Methadose Concentrate
• 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 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, 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 have ever abused substances, have head trauma, or have had GI tract surgery

Some MEDICINES MAY INTERACT with Methadose Concentrate. 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 Methadose Concentrate"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 Methadose Concentrate
• Mexiletine or nucleoside reverse transcriptase inhibitors (eg, lamivudine) because their effectiveness may be decreased by 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 this medicine 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 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.
• Take Methadose Concentrate 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.
• Methadose Concentrate is for oral use only and must not be injected.
• 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.
• If you miss a dose of Methadose Concentrate and you are using it regularly, 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 Concentrate.

Important safety information:

• Methadose Concentrate may cause drowsiness, dizziness, blurred vision, or lightheadedness. 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.
• Methadose Concentrate may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative.
• Tell your doctor or dentist that you take Methadose Concentrate 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 Methadose Concentrate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Use Methadose Concentrate with caution in the ELDERLY; they may be more sensitive to its effects.
• Methadose Concentrate 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 Methadose Concentrate while you are pregnant. 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.

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 convulsions, tremor, stomach and muscle cramps, vomiting, and sweating. 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. Do not stop therapy suddenly or change the dosage without asking your doctor. Discuss overuse with your doctor or pharmacist.

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:

Constipation; dizziness; drowsiness; headache; lightheadedness; nausea; vomiting.

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; difficult or slow breathing, especially when lying down; dizziness; drowsiness; lightheadedness; loss of consciousness; low body temperature; pinpoint pupils; shock; slow heartbeat.

Store Methadose Concentrate 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 Methadose Concentrate out of the reach of children and away from pets.

General information:

• 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.

This information is a summary only. It does not contain all information about Methadose Concentrate. 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.