Methadone oral solution

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 this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate You can take this medicine with or without food. If it upsets your stomach, take it with food. You may mix the medicine with food or juice if you will immediately eat or drink it. Do not store food or drink with medicine added. 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, dofetilide, dronedarone, quinidine

• cisapride

• halofantrine

• mesoridazine

• pimozide

• rasagiline

• selegiline

• thioridazine

• ziprasidone

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)

• 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 against the law.

Store Methadose at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Protect from light. Keep container tightly closed.

Store methadone hydrochloride oral solution and oral concentrate (Methadone Intensol) at room temperature between 15 and 30 degrees C (59 and 86 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 doctor or health care professional 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 the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.

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

There are different types of narcotic medicines (opiates). If you take more than one type at the same time or if you are taking another medicine that also causes drowsiness, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing or unusual sleepiness.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand 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 medicine. Avoid alcoholic drinks.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor 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 medicine. This medicine does pass into breast milk. Talk to your doctor if you plan to begin or stop using this medicine while breast-feeding or if you plan to stop breast-feeding.