Hysingla ER

Hysingla ER is a long-acting, extended-release (ER) opioid used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine, when other non-opioid pain medicines do not treat your pain well enough, or you cannot tolerate them.

Long-acting opioid pain medicines can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Hysingla ER should not be taken on an "as needed" basis.

Hysingla ER (hydrocodone extended-release) first received FDA-approval on November 20, 2014. Generic hydrocodone bitartrate ER tablets are available.

Hysingla ER should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing it in your mouth to avoid choking on the tablet.

• Swallow Hysingla ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject Hysingla ER because this may cause you to overdose and die.

When taking Hysingla ER:

• Do not change your dose. Take Hysingla ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 24 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time the next day.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking Hysingla ER without talking to your healthcare provider.

Dispose of expired, unwanted, or unused Hysingla ER by promptly flushing it down the toilet if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking Hysingla ER, DO NOT:

• Drive or operate heavy machinery until you know how Hysingla ER affects you. Hysingla ER can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Hysingla ER may cause you to overdose and die.

Get emergency help or call 911 right away if you take too much Hysingla ER (overdose). When you first start taking Hysingla ER, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.

Taking Hysingla ER with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Never give anyone else your Hysingla ER. They could die from taking it. Selling or giving away Hysingla ER is against the law.

Store Hysingla ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take Hysingla ER if you have:

• Severe asthma, trouble breathing, or other lung problems
• A bowel blockage or a narrowing of the stomach or intestines.

Before taking Hysingla ER, tell your healthcare provider if you have a history of:

• Head injury, seizures
• Liver, kidney, thyroid problems
• Problems urinating
• Pancreas or gallbladder problems
• Heart rhythm problems (long QT syndrome)
• A history of abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

• Noticing your pain getting worse. If your pain gets worse after you take Hysingla ER, do not take more of Hysingla ER without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Hysingla ER.
• Pregnant or planning to become pregnant. Use of Hysingla ER for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• Breastfeeding. Not recommended during treatment with Hysingla ER. It may harm your baby.
• Living in a household where there are small children or someone who has abused street or prescription drugs.
• Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Hysingla ER with certain other medicines can cause serious side effects and could lead to death.

The possible side effects of Hysingla ER are constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

• Trouble breathing or shortness of breath
• Fast heartbeat or chest pain
• Swelling of your face, tongue, or throat
• Extreme drowsiness
• Light-headedness when changing positions or feeling faint
• Agitation
• High body temperature
• Trouble walking
• Stiff muscles
• Mental changes such as confusion.

These are not all the possible side effects of Hysingla ER. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is safer to underestimate a patient's 24-hour oral hydrocodone dosage and provide rescue medication (such as an immediate-release opioid) than to overestimate the 24-hour oral hydrocodone dosage and manage an adverse reaction due to an overdose.

Adult Dose Of Hysingla ER for Chronic Pain In Patients who are not Opioid Tolerant

• Initial dose: 20 mg orally every 24 hours

Adult Dose of Hysingla ER When Converting From Other Opioids

While useful tables of opioid equivalents are readily available, there is inter-patient variability in the potency of opioid drugs and opioid formulations. Frequently reevaluate patients for signs and symptoms of opioid withdrawal and for signs of oversedation/toxicity after converting patients to Hysingla ER.

• See the Hysingla ER Prescribing Information for Conversion Dosage Information.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydrocodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend that you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids - opioid pain medicine or prescription cough medicine;
• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with hydrocodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Active ingredient: Hydrocodone bitartrate

Inactive Ingredients: Polyethylene glycol 3350, microcrystalline cellulose, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, ferric oxide yellow, magnesium stearate, butylated hydroxytoluene, hydroxypropyl cellulose, and polyethylene glycol.

Hysingla ER is manufactured by Purdue Pharma L.P., Stamford, CT 06901-3431, www.purduepharma.com, or call 1-888-726-7535.