Hysingla ER

Hysingla ER is a prescription medication used to relieve severe pain. Hysingla ER belongs to a group of drugs called narcotic analgesics. These work by changing the way that the brain and nervous system respond to pain.

This medication comes in an extended release tablet form and is taken once a day.

Do not chew, divide, crush, dissolve, or break Hysingla ER tablets. Swallow tablets whole.

Common side effects of Hysingla ER include nausea, vomiting, constipation, lightheadedness, anxiety, mood changes, rash, and itching.

Hysingla ER can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Hysingla ER affects you.

Hysingla ER is a prescription medication used to relieve severe pain in patients who require daily, around-the-clock, long-term treatment with opioid analgesics.

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

• Purdue Pharma LP

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

Common side effects of Hysingla ER include the following:

• Nausea
• Vomiting
• Constipation
• Drowsiness
• Dizziness
• Lightheadedness
• Headache
• Fuzzy thinking
• Anxiety
• Abnormally happy or abnormally sad mood
• Dry throat
• Difficulty urinating
• Rash
• Itching
• Narrowing of the pupils
• Upper respiratory tract infection

This is not a complete list of Hysingla 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:

• Antidepressants
• Antihistamines
• Antipsychotics (medications for mental illness)
• Ipratropium (Atrovent)
• Medications for irritable bowel disease, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• Monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• Sedatives
• Sleeping pills
• Tranquilizers

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

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

• Life-threatening respiratory depression. Tell your healthcare provider right away if you have some or all of the following symptoms of respiratory depression:
  • Slowed or irregular breathing
  • Chest tightness

Hysingla ER can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Hysingla ER affects you.

Do not take Hysingla ER if you:

• are allergic to Hysingla ER or to any of its ingredients
• are taking any other products containing Hysingla ER or other narcotic medications, such as morphine or codeine

Medications 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 Hysingla ER, there are no specific foods that you must exclude from your diet when receiving this medication.

Do not drink alcohol or take products containing alcohol while taking Hysingla ER.

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

• are allergic to Hysingla ER or to any of its ingredients
• have or have had lung disease
• had recent surgery
• have croup
• have a head injury
• have any conditions that increases pressure in your brain
• have an enlarged prostate
• have a narrowing of the urethra
• have Addison’s disease
• have glaucoma
• have liver problems
• have kidney problems
• have thyroid disease
• have intestinal disease
• are pregnant or breastfeeding

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.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Hysingla ER falls into category C. 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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Hysingla ER has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Hysingla ER, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Hysingla ER exactly as prescribed.

Hysingla ER comes in a extended release tablet and is taken once a day. This formulation is difficult to crush, break or dissolve to reduce abuse.

Do not chew, divide, dissolve, or break Hysingla ER tablets. Swallow the tablets whole.

If you miss a dose, take your next dose at your usual time the next day. Do not take two doses of Hysingla ER at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

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

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Hysingla ER tablets for the treatment of severe pain is 20 mg every 24 hours in patients who are not yet tolerant to opiate medications. As you become tolerant to this medication, your dose may be increased by your physician.

Total daily doses greater than 80 mg are only for use if you have been receiving opiate medications to the point where you become tolerant and require higher doses.

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

If Hysingla ER is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Hysingla 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; INTERACTION WITH ALCOHOL; and CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse
Hysingla ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Hysingla ER and monitor all patients regularly for the development of these behaviors or conditions.

Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of Hysingla ER. Monitor for respiratory depression, especially during initiation of Hysingla ER or following a dose increase. Instruct patients to swallow Hysingla ER tablets whole; crushing, chewing, or dissolving Hysingla ER tablets can cause rapid release and absorption of a potentially fatal dose of Hysingla ER.

Accidental Ingestion
Accidental ingestion of even one dose of Hysingla ER, especially by children, can result in a fatal overdose of Hysingla ER.

Neonatal Opioid Withdrawal Syndrome
Prolonged use of Hysingla 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. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

The concomitant use of Hysingla ER with all cytochrome P450 3A4 inhibitors may result in an increase in Hysingla ER plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in Hysingla ER plasma concentration. Monitor patients receiving Hysingla ER and any CYP3A4 inhibitor or inducer.