Methadone dispersible tablets for oral suspension

What is this medicine?

METHADONE (METH a done) is a pain reliever. It is used to treat severe pain. The medicine is also used to prevent withdrawal symptoms in people addicted to other drugs.

How should I use this medicine?

Take the medicine by mouth. Follow the directions on the prescription label. Determine the number of tablets you need for your dose. Dissolve the tablets in a glass of water, orange juice, citrus Tang, or citrus flavors of Kool-Aid. Stir well for one minute. You will see some of the tablet in the glass. The tablet will not completely melt. Drink all of the liquid in the glass. Do not chew or swallow whole tablets. The tablets must be dissolved. You can take this medicine with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of adrenal insufficiency like nausea; vomiting; loss of appetite; fatigue; weakness; dizziness; low blood pressure

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• signs and symptoms of serotonin syndrome like agitation; confusion; diarrhea; fast or irregular heartbeat; muscle twitching; stiff muscles; trouble walking; increased sweating; high fever; seizures; shivering; vomiting

• trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• dry mouth

• nausea, vomiting

• tiredness

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines for fungal infections like itraconazole, ketoconazole, posaconazole, voriconazole

• certain medicines for irregular heart beat like bepridil, bretylium, dronedarone, quinidine

• cisapride

• halofantrine

• mesoridazine

• pimozide

• rasagiline

• selegiline

• thioridazine

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• antiviral medicines for HIV or AIDS

• arsenic trioxide

• atropine

• certain antibiotics like clarithromycin, erythromycin, gemifloxacin, levofloxacin, moxifloxacin, ofloxacin, pentamidine, telithromycin, rifampin, rifapentine

• certain medicines for anxiety or sleep

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for cancer like dasatinib, lapatinib, sunitinib, vorinostat

• certain medicines for depression like amitriptyline, desipramine, fluoxetine, sertraline

• certain medicines for irregular heart beat like amiodarone, disopyramide, flecainide, procainamide, propafenone, sotalol

• certain medicines for malaria like chloroquine, mefloquine

• certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

• certain medicines for nausea or vomiting like dolasetron, droperidol, granisetron, ondansetron

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin, primidone

• certain medicines for stomach problems like dicyclomine, hyoscyamine

• certain medicines for travel sickness like scopolamine

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• fluconazole

• general anesthetics like halothane, isoflurane, methoxyflurane, propofol

• haloperidol

• ipratropium

• linezolid

• local anesthetics like lidocaine, pramoxine, tetracaine

• MAOIs like Marplan, Nardil, and Parnate

• medicines that relax muscles for surgery

• methylene blue

• octreotide

• other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone

• other narcotic medicines for pain or cough

• peginterferon alfa-2b

• phenothiazines like chlorpromazine, prochlorperazine

• ranolazine

• tacrolimus

• vardenafil

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and is against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed.

This medicine may cause harm and death if it is taken by other adults, children, or pets. Return medicine that has not been used to an official disposal site. Contact the DEA at 1-800-882-9539 or your city/county government to find a site. If you cannot return the medicine, flush it down the toilet. Do not use the medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• Addison's disease

• brain tumor

• drug abuse or addiction

• gallbladder disease

• head injury

• history of irregular heartbeat

• if you often drink alcohol

• kidney disease

• liver disease

• low blood pressure

• lung or breathing disease, like asthma

• mental illness

• problems urinating

• seizures

• stomach or intestine problems

• thyroid disease

• an unusual or allergic reaction to methadone, other opioid analgesics, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your health care provider if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this drug. Tolerance means that you will need a higher dose of the drug for pain relief. Tolerance is normal and is expected if you take this drug for a long time.

There are different types of narcotic drugs (opioids) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all drugs you use. He or she will tell you how much drug to take. Do not take more drug than directed. Get emergency help right away if you have problems breathing.

Do not suddenly stop taking your drug because you may develop a severe reaction. Your body becomes used to the drug. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a nonmedical reason. If you have pain, you have a medical reason to take pain drug. Your health care provider will tell you how much drug to take. If your health care provider wants you to stop the drug, the dose will be slowly lowered over time to avoid any side effects.

Talk to your health care provider about naloxone and how to get it. Naloxone is an emergency drug used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other drugs or substances, like alcohol. Know the symptoms of an overdose, like trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this drug. Avoid alcoholic drinks.

This drug will cause constipation. If you do not have a bowel movement for 3 days, call your health care provider.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care provider if the problem does not go away or is severe.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your doctor about the benefits and risks of breast-feeding while using this drug. This drug does pass into breast milk. Talk to your doctor if you plan to begin or stop using this drug while breast-feeding or if you plan to stop breast-feeding.