METHADONE - ORAL CONCENTRATE

Warnings  
Serious (rarely fatal) breathing problems and certain heart problems (QT prolongation in the EKG, torsades de pointes) can occur with the use of methadone. These problems are more likely when you first start taking methadone, and may also occur if you take more of this drug and/or take it more often than prescribed. Breathing problems may occur some time after your dose, even after the pain has returned. To reduce the risk, follow your doctor's directions exactly. Even if your pain is not well controlled, do not take more of this medication or use it more often without first consulting your doctor. Seek immediate medical attention if you experience slow/shallow breathing, fast/irregular heartbeat, severe dizziness, or fainting.

Serious (rarely fatal) breathing problems and certain heart problems (QT prolongation in the EKG, torsades de pointes) can occur with the use of methadone. These problems are more likely when you first start taking methadone, and may also occur if you take more of this drug and/or take it more often than prescribed. Breathing problems may occur some time after your dose, even after the pain has returned. To reduce the risk, follow your doctor's directions exactly. Even if your pain is not well controlled, do not take more of this medication or use it more often without first consulting your doctor. Seek immediate medical attention if you experience slow/shallow breathing, fast/irregular heartbeat, severe dizziness, or fainting.

Uses 
This medication is used to treat narcotic (e.g., heroin) addiction as a part of an approved program. Methadone is a man-made (synthetic) opiate-type narcotic that is long-acting. It acts on certain centers in the brain.

How to use Methadone Oral

Read the Patient Information Leaflet that may be provided by your pharmacist before you start using methadone and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Dilute this medication with water or other liquid, and take by mouth, with or without food, as directed by your doctor. If you are not sure how to dilute your dose, ask your doctor or pharmacist. If you have nausea, consult your doctor or pharmacist about ways to reduce it (e.g., antihistamines, lying down for 1-2 hours with as little head movement as possible). Do not inject this medication.

The dosage is based on your medical condition and response to treatment.

If you are taking this medication for pain, remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has significantly worsened, the medication may not work as well.

Use this medication exactly as prescribed. Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for an extended period of time, do not suddenly stop using this drug without your doctor's approval.

This medication may cause dependence, especially if it has been used regularly for an extended period of time, or if it has been used in high doses. In such cases, if you suddenly stop this drug, withdrawal reactions may occur. When stopping extended, regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Such reactions can include weakness, anxiety, loss of appetite, headaches, diarrhea, restlessness, widened pupils, watering eyes, body aches, cold sweats, and hot/cold flashes. Withdrawal symptoms may take three to four days to develop, may worsen over the first week, and may last for two weeks. Report any such reactions to your doctor immediately.

If you are taking this drug for narcotic addiction, your doctor will gradually reduce your dose. Be sure to follow your doctor's dosing instructions closely. People who are physically dependent on narcotics will experience withdrawal symptoms if given the usual dose of a narcotic blocker (e.g., naloxone). The seriousness of withdrawal symptoms is related to the level of dependence and dose of the narcotic blocker. If possible, these people should not receive narcotic blockers.

Withdrawal symptoms may also be caused by using certain narcotics (e.g., pentazocine, butorphanol, nalbuphine) after using methadone. If you are using any of these medications, tell your doctor immediately if you develop withdrawal symptoms.

Although it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercapnia), diarrhea due to infection (e.g., Clostridium difficile colitis), paralyzed gut (paralytic ileus), stomach/abdominal problems of unknown cause.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, difficulty urinating (e.g., enlarged prostate, urethral stricture), alcohol use, drug dependency, lung disease (e.g., asthma, chronic obstructive pulmonary disease), head injury, low blood pressure (hypotension), dehydration, seizures, heart problems (e.g., QT prolongation in the EKG, slow heartbeat, heart failure, recent heart attack), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death), mental/mood disorders (e.g., depression), gallbladder disease, mineral imbalance (low magnesium or potassium blood levels), overactive or underactive thyroid, a certain endocrine disease (Addison's disease), severe headaches or changes in vision.

This drug may make you dizzy or drowsy; use caution while engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially the decreased breathing and drowsiness effects.

During pregnancy, this medication should be used only when clearly needed. Pregnant women in a methadone maintenance program should inform all their doctors that they are taking this medication. Infants born to mothers who take this medication regularly may have breathing problems or withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, loss of consciousness, pinpoint pupils, cold/clammy/blue skin, muscle spasms/weakness, low body temperature, deep sleep.

NOTES:

Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (e.g., EKG-QT interval) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type) and stool softener.

MISSED DOSE:

If you are prescribed this drug on a regular schedule and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep this medication in a childproof container out of the reach of children and pets to prevent accidental poisoning.

Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

See also Warning section.

Nausea, vomiting, constipation, lightheadedness, dizziness, dry mouth, drowsiness, stomach upset, blurred vision, flushing, increased sweating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., unusual elevated mood, agitation, depression), hallucinations, difficulty urinating, shaking (tremor), confusion.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: naltrexone, drugs which may affect the heart rhythm (QT prolonging drugs such as bepridil, droperidol, halofantrine, mesoridazine, pimozide, sertindole, sparfloxacin).

If you are currently using any of these medications, tell your doctor or pharmacist before starting methadone.

Other drugs besides methadone which may affect the heart rhythm (QT prolongation in the EKG) include amiodarone, dofetilide, erythromycin, moxifloxacin, procainamide, quinidine, and sotalol, among others. Before using methadone, report all medications you are currently using to your doctor or pharmacist. QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (e.g., severe dizziness, fainting) that require immediate medical attention. Ask your doctor or pharmacist for more details and for instructions on how you may reduce the risk of this effect.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: amphetamines, blood thinners (e.g., warfarin), drugs affecting liver enzymes that remove methadone from your body (such as azole antifungals-including itraconazole, cimetidine, efavirenz, fluvoxamine, macrolide antibiotics-including erythromycin, nevirapine, protease inhibitors-including ritonavir, rifamycins-including rifampin, St. Johns wort, certain anti-seizure medicines including phenytoin), MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), certain nucleoside analogues (e.g., didanosine, stavudine, zidovudine), pentazocine, certain "water pills" (potassium-wasting diuretics such as hydrochlorothiazide, furosemide).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: anesthesia drugs, certain antihistamines (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., sedatives), muscle relaxants, other narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline and desipramine), tranquilizers.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.