Methadone Dispersible Tablets

What is this medication?

METHADONE (METH a done) treats opioid use disorder. It works by reducing withdrawal symptoms and cravings to use opioids. It is most effective when used in combination with counseling and behavior therapy. It belongs to a group of medications called opioids.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Methadose

What should I tell my care team before I take this medication?

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

• Brain tumor
• Drug abuse or addiction
• Head injury
• Heart disease
• If you often drink alcohol
• Kidney disease
• Liver disease
• Low adrenal gland function
• Low blood pressure
• Lung, asthma, or breathing problems
• Mental health disease
• Seizures
• Stomach or intestine problems
• Taken an MAOI such as Marplan, Nardil, or Parnate in the last 14 days
• Thyroid disease
• An unusual or allergic reaction to methadone, other opioid analgesics, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take the medication 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 medication with or without food. If it upsets your stomach, take it with food. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team'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 care team regarding the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medication?

Do not take this medication with any of the following:

• Certain medications for fungal infections like itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for irregular heart beat like bepridil, bretylium, dronedarone, quinidine
• Cisapride
• Halofantrine
• Mesoridazine
• Pimozide
• Rasagiline
• Selegiline
• Thioridazine

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Antiviral medications for HIV or AIDS
• Arsenic trioxide
• Atropine
• Certain antibiotics like clarithromycin, erythromycin, gemifloxacin, levofloxacin, moxifloxacin, ofloxacin, pentamidine, telithromycin, rifampin, rifapentine
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for cancer like dasatinib, lapatinib, sunitinib, vorinostat
• Certain medications for depression like amitriptyline, desipramine, fluoxetine, sertraline
• Certain medications for irregular heart beat like amiodarone, disopyramide, flecainide, procainamide, propafenone, sotalol
• Certain medications for malaria like chloroquine, mefloquine
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for nausea or vomiting like dolasetron, droperidol, granisetron, ondansetron
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin, primidone
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Certain medications 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
• Medications that relax muscles for surgery
• Methylene blue
• Octreotide
• Other medications that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone
• Other narcotic medications for pain or cough
• Peginterferon alfa-2b
• Phenothiazines like chlorpromazine, prochlorperazine
• Ranolazine
• Tacrolimus
• Vardenafil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team regularly. If you are using this medication for pain, tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. If you are using this medication for opioid use disorder, attend counseling or support groups that your care team recommends. Do not try to overcome the effects of the medication by taking large amounts of narcotics. This can cause severe problems including death. Also, you may be more sensitive to lower doses of narcotics after you stop taking this medication.

Do not suddenly stop taking your medication because you may develop a severe reaction. Your body becomes used to the medication. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

If you take other medications that also cause drowsiness like other narcotic pain medications, benzodiazepines, or other medications for sleep, you may have more side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Get emergency help right away if you have trouble breathing or are unusually tired or sleepy.

Talk to your care team about naloxone and how to get it. Naloxone is an emergency medication 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 medications 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 medication 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 medication. Avoid alcoholic drinks.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medication and dosage regimens.

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

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

Women should inform their care team 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 care team about the benefits and risks of breast-feeding while using this medication. This medication does pass into breast milk. Talk to your care team if you plan to begin or stop using this medication while breast-feeding or if you plan to stop breast-feeding.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

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

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication 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 medication may cause harm and death if it is taken by other adults, children, or pets. Return medication 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 medication, flush it down the toilet. Do not use the medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.