Arymo ER is a prescription medication used to relieve severe pain in adults who require around-the-clock, long-term treatment.

Arymo ER belongs to a group of drugs called opioid analgesics. These drugs work by changing the way the brain and nervous system respond to pain.

This medication comes in extended-release tablet form and is typically taken two to three times daily with a full glass of water. Do not chew, divide, or break Arymo ER tablets. Swallow Arymo ER tablets whole.

Common side effects include constipation, nausea, and abdominal pain. Arymo ER can make you dizzy or sleepy. Do not drive or operate heavy machinery until you know how it affects you.

Arymo ER is a prescription medication for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Arymo ER. See the “Arymo ER Precautions” section.

Common side effects of Arymo ER include:

• constipation
• nausea
• sleepiness
• vomiting
• tiredness
• headache
• dizziness
• abdominal pain

This is not a complete list of Arymo ER side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Benzodiazepines and other Central Nervous System (CNS) Depressants

• Medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)

• Monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)

• Muscle relaxants such as Carisoprodol (Soma), cyclobenzapril (Flexeril), methocarbamol (Robaxin), metaxalone (Skelaxin)
• Mixed agonists/antagonists such as butorphanol, nalbuphine, pentazocine, buprenorphine
• Diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
• Anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), dicyclomine (Bentyl), propantheline (Pro-Banthine), and atropine (Atropen, Sal-Tropine)

• Medications that block the p-glycoprotein transporter such as amiodarone (Cordarone, Pacerone), azithromycin (Zithromax, Zmax), captopril (Capoten), carvedilol (Coreg), clarithromycin (Biaxin), conivaptan (Vaprisol), cyclosporine (Neoral, Sandimmune, Gengraf), diltiazem (Cardizem), dronedarone (Multaq), erythromycin (EES, Ery-Tab), felodipine (Plendil),  itraconazole (Sporanox, Onmel), ketoconazole (Nizoral), lopinavir and ritonavir (Kaletra), quinidine (Cardioquine, Quinact, Duraquin), ranolazine (Ranexa), verapamil (Calan, Isoptin, Covera, Verelan)

• Cimetedine

This is not a complete list of Arymo ER drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Arymo ER including the following:

• Arymo ER may be habit-forming. Take this medication as prescribed. Do not take more of it, or take it more often than as directed by your doctor. There is a greater risk that you will overuse Arymo ER if you have or have ever had depression or another mental illness, or if you have abused alcohol, used street drugs, or overused prescription medications.
• Do not allow anyone else to take your medication. Keep this medication out of the reach of children and in a safe place so that no one else can take it as Arymo ER may harm or cause death to other people who take your medication, especially children. 
• Arymo ER may cause slowed or stopped breathing, especially when you begin your treatment and any time your dose is increased. Tell your doctor if you have slowed breathing and if you have or have ever had lung disease such as asthma, chronic obstructive pulmonary disease (COPD; a group of diseases including chronic bronchitis and emphysema that cause difficulty breathing), or other breathing problems. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.
• Arymo ER may cause adrenal insufficiency. Call your doctor immediately if you have signs and symptoms of nausea, vomiting, loss of appetite, weakness, dizziness, and low blood pressure.
• Taking certain other medications during your treatment with Arymo ER may increase the risk that you will experience breathing problems or other serious, life-threatening side effects.

Important information about Arymo ER:

• Get emergency help right away if you take too much Arymo ER (overdose). Arymo ER overdose can cause life-threatening breathing problems that can lead to death.
• Never give anyone else your Arymo ER. They could die from taking it. Store Arymo ER away from children and in a safe place to prevent stealing or abuse.
• Selling or giving away Arymo ER is against the law. Arymo ER is a federally controlled substance (CII) because it can be abused or lead to dependence.
• While taking Arymo ER do not:
  • Drive or operate heavy machinery, until you know how morphine affects you. morphine can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

Do not take Arymo ER if you have:

• used an MAO inhibitor in the last 14 days
• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or narrowing of the stomach or intestines

Do not take Arymo ER if you are allergic to Arymo ER or to its active ingredient morphine

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Arymo ER there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Arymo ER, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Arymo ER or to its active ingredient morphine.
• have low blood pressure.
• have a bowel blockage or narrowing of the stomach or intestines.
• have severe asthma, trouble breathing, or other lung problems.
• have a history of head injury, seizures.
• have liver, kidney, thyroid, pancreas, or gallbladder problems.
• have problems urinating.
• are pregnant or planning to become pregnant. 
• are breastfeeding. 
• are taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
• have a history of abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. Prolonged use of Arymo ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Prolonged use of Arymo ER during pregnancy can cause neonatal opioid withdrawal syndrome. Signs and symptoms may include acting irritable or jittery, feeding problems, diarrhea, and decreased weight.

Arymo ER can prolong labor.

Tell your healthcare provider if you are breastfeeding. Arymo ER passes into human breast milk and may harm your baby.

Follow the directions on your prescription label carefully. Take this medication as prescribed by your healthcare provider. Do not change your dose.

Do not chew, divide, or break Arymo ER tablets. Swallow Arymo ER tablets whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Arymo ER at the same time.

Arymo ER comes in a long-acting tablet form and is taken as 15mg two to three times daily for moderate to severe pain. Dose adjustments may be done every 1 to 2 days.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Initial Arymo ER dose should be lowered and slowly increased if you have kidney or liver problems. Watch for signs of breathing problems, sedation, and low blood pressure.

If you feel that your pain is not controlled, call your doctor. Do not change the dose of your medication without talking to your doctor.

Do not stop taking Arymo ER without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop taking Arymo ER, you may experience withdrawal symptoms such as restlessness; teary eyes; runny nose; yawning; irritability; anxiety; sweating; difficulty falling asleep or staying asleep; chills; back, muscle. or joint pain; nausea; vomiting; loss of appetite; diarrhea; stomach cramps; weakness; fast heartbeat; or fast breathing.

If you take too much Arymo ER, call your local Poison Control Center or seek emergency medical attention right away.

• Store  Arymo ER at room temperature. 
• Keep this and all medicines out of the reach of children.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

• Addiction, Abuse, and Misuse
  • ARYMO™ ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. 
• Life-Threatening Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur with use of ARYMO ER. Swallow ARYMO ER tablets whole; crushing, chewing, or dissolving ARYMO ER tablets can cause rapid release and absorption of a potentially fatal dose of morphine. 
• Accidental Ingestion
  • Accidental ingestion of even one dose of ARYMO ER, especially by children, can result in a fatal overdose of morphine.
• Neonatal Opioid Withdrawal Syndrome
  • Prolonged use of ARYMO ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 
• Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
  • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.