Hydrocodone extended-release (ER) is a long-acting opioid medication. It's used for severe chronic pain that non-opioid options can't relieve. Once-daily tablets are available as brand name Hysingla ER and generics. Capsules are only available as generics and are taken every 12 hours. The dosage depends on the severity of your pain and your previous pain medications. Side effects include constipation, nausea, and sleepiness. Hydrocodone ER (Hysingla ER) is a controlled substance because it has a high risk for misuse and dependence.
Severe chronic pain that isn't relieved by non-opioid pain medications
Hydrocodone ER (Hysingla ER) is an opioid. It attaches to certain opioid receptors (signaling proteins) in the brain. This changes how you react to pain and helps lower how much pain you feel.
Hydrocodone ER (Hysingla ER) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Personal or family history of alcohol or substance use disorder | Personal or family history of depression or other mental health condition
Hydrocodone ER (Hysingla ER) is a controlled substance with a risk of addiction and misuse. Misusing the medication can lead to serious, life-threatening side effects, like dangerously slow breathing and overdose.
To stay safe, take hydrocodone ER (Hysingla ER) exactly as prescribed. You'll get prescribed the lowest dose for the shortest amount of time needed to manage your pain. Don't change how much or how often you take it without talking to your pain specialist first.
Because of the risk of addiction and misuse, hydrocodone ER (Hysingla ER) is only available through a special Risk Evaluation and Mitigation Strategy (REMS) program. This program is called the Opioid Analgesic REMS program. Your prescriber and pharmacy must register with the program and get trained on safe medication use. They'll talk to you about how to safely take hydrocodone ER (Hysingla ER).
Risk factors: Conditions that cause breathing problems (e.g., COPD, asthma, head injury) | Older age | Being frail | Taking medications that can cause slow breathing or slow the body down | Drinking alcohol | Taking too much hydrocodone ER (Hysingla ER)
Hydrocodone ER (Hysingla ER) can cause dangerously slow breathing, which can be life-threatening. This can happen to anyone and at recommended doses of the medication. But the risk is highest when you first start the medication and when your dose goes up.
Don't drink alcohol while you're taking hydrocodone ER (Hysingla ER). Also, don't take it with medications that slow your body down, like benzodiazepines, other opioids, and muscle relaxants. This can raise the risk of dangerously slow breathing.
Your pain specialist will recommend keeping naloxone (Narcan) with you at all times. Naloxone can quickly reverse slowed breathing from opioids. Make sure you and your loved ones know how to use naloxone (Narcan) in case of an emergency. Give naloxone (Narcan) and call 911 right away if you have trouble breathing or notice bluish-colored lips, fingers, or toes.
Risk factors: History of opioid use disorder | Previous opioid overdose | Taking high doses of hydrocodone ER (Hysingla ER) | Taking more opioids than prescribed | Alcohol use
Take hydrocodone ER (Hysingla ER) exactly as prescribed. Taking too much or taking it more often than prescribed can lead to an overdose. Keep it out of reach from children, visitors, and pets to prevent an accidental exposure or overdose.
Symptoms of an opioid overdose include not responding to sound or touch, very slowed breathing, slow heartbeat, extreme sleepiness, and cold or clammy skin. Be sure you and your loved ones know how to spot an overdose. Your pain specialist will recommend getting naloxone (Narcan), which can quickly treat an opioid overdose. Always carry naloxone and use it right away if an overdose happens. Call 911 right away after giving naloxone (Narcan).
Risk factors: Taking high doses of hydrocodone ER (Hysingla ER) | Drinking alcohol | Taking other medications that can cause sleepiness
Hydrocodone ER (Hysingla ER) can cause extreme sleepiness. It can also make it hard to think, react, and focus. Don't mix alcohol with hydrocodone ER (Hysingla ER). Also don't take it with other medications that can cause sleepiness or "brain fog." These include benzodiazepines, muscle relaxants, and sleep aids. Taking these medications together can make you even sleepier and slow your thinking.
Make sure you know how hydrocodone ER (Hysingla ER) affects you before driving a car or doing activities that need your full attention. Talk to your prescriber right away if the medication makes you too sleepy.
Hydrocodone ER (Hysingla ER) interacts with many medications. Tell your care team about all the medications you take to make sure they're safe together. Also, talk to them before making any changes to your medications because sudden adjustments can be harmful.
Some interactions can raise hydrocodone levels in the body. This can raise your risk of serious side effects, like dangerously slowed breathing and overdose. Examples include taking the opioid with erythromycin, ketoconazole, or ritonavir (Norvir).
Other interactions can lower hydrocodone levels in the body. This can make the opioid work less well for pain and possibly cause withdrawal symptoms. Examples include taking the opioid with rifampin (Rifadin) or carbamazepine (Tegretol).
Long-term use of hydrocodone ER (Hysingla ER) during pregnancy can make your unborn baby dependent on the medication. This happens because the opioid can pass through the placenta to your baby. Your baby can have withdrawal symptoms after they're born.
Signs of withdrawal in newborns include high-pitched crying, poor feeding, poor sucking, and trembling. In severe cases, it can lead to seizures.
Withdrawal can be life-threatening if not recognized and treated in time. Tell your care team if you've taken hydrocodone ER (Hysingla ER) during pregnancy. Specialized healthcare professionals will make sure your baby gets the care they need.
Risk factors: Long-term use of hydrocodone ER (Hysingla ER)
Taking hydrocodone ER (Hysingla ER) regularly for a long time can cause physical dependence. This means that your body relies on the medication to function. You might have withdrawal if you lower your dose or stop taking the medication too suddenly.
Withdrawal can make your pain come back. It can also cause unpleasant symptoms like anxiety, irritability, body aches, stomach upset, and chills.
Don't lower your dose or stop taking hydrocodone ER (Hysingla ER) suddenly without talking to your prescriber. If needed, they'll slowly lower your dose over time to prevent withdrawal. Talk to your prescriber if you're worried about dependence and withdrawal with hydrocodone ER (Hysingla ER).
Risk factors: Medical conditions that make it hard to have a stable blood pressure | Taking medications that can drop blood pressure
Hydrocodone ER (Hysingla ER) can sometimes cause extremely low blood pressure. This can include a drop in blood pressure when you stand from a sitting or lying down position. Low blood pressure can lead to dizziness and fainting.
To avoid falling, get up slowly if you've been sitting or lying down. Talk to your prescriber if dizziness or lightheadedness doesn't go away.
Risk factors: Taking hydrocodone ER (Hysingla ER) for longer than 1 month
Some people taking opioids like hydrocodone ER (Hysingla ER) have had low adrenal hormone levels. This is more likely if you've taken opioids for a month or longer. Tell your prescriber if you have symptoms of low adrenal hormone levels. These can include long-lasting tiredness, muscle weakness, low appetite, and nausea. If your adrenal hormone levels are too low, you might need to stop hydrocodone ER (Hysingla ER) and take corticosteroids for treatment.
Risk factors: Taking other medications that cause QT prolongation | Personal or family history of long QT syndrome | History of heart failure | History of abnormal heart rhythms (arrhythmias) | Slow heart rate | Abnormal electrolyte levels
Although rare, hydrocodone ER (Hysingla ER) can cause QT prolongation. This is when your heart takes longer to recharge between beats. It can affect your heart rhythm, which can be serious and life-threatening.
Before starting hydrocodone ER (Hysingla ER), tell your prescriber about your full medical history. Also let them know about all your medications. Your risk for QT prolongation is higher if you already have heart rhythm problems or abnormal electrolyte levels. The risk is also higher if you take medications that can affect heart rhythm, like amiodarone (Pacerone) or ciprofloxacin (Cipro).
Call your prescriber if you have a pounding heartbeat, trouble breathing, chest pain, or lightheadedness while taking hydrocodone ER (Hysingla ER). These could be signs of heart rhythm problems. Your prescriber might lower your dose or switch you to a different pain medication if needed.
Risk factors: History of seizures | Taking other medications or having health conditions that raise your risk of seizures
If you've had a seizure before, opioids like hydrocodone ER (Hysingla ER) can raise the risk of having seizures more often. Opioids can also put you at risk of seizures in some situations. Get medical help right away if you have a seizure while you're taking hydrocodone ER (Hysingla ER).
Source:Â Dailymed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
Bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
body aches or pain
chills
difficult or labored breathing
difficult, burning, or painful urination
ear congestion
fear or nervousness
frequent urge to urinate
headache
loss of voice
lower back or side pain
rapid weight gain
tightness in the chest
tingling of the hands or feet
unusual tiredness or weakness
unusual weight gain or loss
Incidence not known
Agitation
darkening of the skin
difficulty swallowing
fast heartbeat
loss of appetite
mental depression
overactive reflexes
poor coordination
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
restlessness
shivering
talking or acting with excitement you cannot control
trembling or shaking
twitching
vomiting
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Blue lips and fingernails
blurred vision
change in consciousness
chest pain or discomfort
cold and clammy skin
confusion
constricted pupil (black part of the eye)
coughing that sometimes produces a pink frothy sputum
decreased awareness or responsiveness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
increased sweating
irregular, fast or slow, or shallow breathing
lightheadedness, dizziness, or fainting
pale skin
sleepiness or unusual drowsiness
slow or irregular heartbeat
weak muscle tone
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Difficulty having a bowel movement
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
An option if non-opioid pain relievers aren't enough for managing severe chronic pain
Provides long-lasting pain relief throughout the day
Can take with or without food
Not for treating sudden pain
Has many serious risks, like very slow breathing, misuse, and being habit-forming
Must slowly lower the dose to stop the medication after long-term use to avoid withdrawal symptoms
Take hydrocodone ER (Hysingla ER) exactly as prescribed. Don't change your dose or stop taking it suddenly without talking to your prescriber first. Sudden changes in your treatment plan can lead to an accidental overdose or uncomfortable withdrawal symptoms.
For the hydrocodone ER tablets (Hysingla ER): Take the tablet once per day. Don't take extra tablets to treat sudden pain. This can make you have very slowed breathing and raise your risk of overdose.
For the hydrocodone ER capsules: Take the capsule every 12 hours. Don't take the capsules to treat any breakthrough pain. This can raise your risk of serious side effects like very slowed breathing and overdose.
Swallow the pill whole, one at a time, with a glass of water. Don't pre-soak, lick, or wet the pill before you take it because it could get stuck in your throat and cause choking. Also don't chew, break, crush, or tamper with it. Too much medication can get released all at once into your body and lead to a life-threatening overdose.
Take hydrocodone ER (Hysingla ER) with or without food. If you get an upset stomach from the medication, you can try taking it with food next time. This might help lessen the risk of stomach upset.
A common side effect of opioids is constipation. Drink plenty of water each day and add more fiber-rich foods to your diet. Talk to a healthcare professional if constipation is bothering you. They can recommend medications for relief or a change in your pain treatment.
Don't drink alcohol while you're taking hydrocodone ER (Hysingla ER). Mixing them together can make you very sleepy or dizzy. It can also make it harder to think clearly. This can possibly cause accidents if you're not careful.
Always have naloxone (Narcan) with you. It can quickly reverse the effects of hydrocodone ER (Hysingla ER) in an emergency like an accidental overdose. Teach your loved ones how to use naloxone (Narcan) in case you can't do it yourself. Call 911 after giving naloxone (Narcan) because its effects are temporary.
Tell your care team about all the medications you take or plan to take. They can check if they're safe to take together. This is because many medications can interact with hydrocodone ER (Hysingla ER), which can be harmful. For example, taking hydrocodone ER (Hysingla ER) with sedatives, like benzodiazepines, can raise the risk of overdose.
Let your prescriber know if you're pregnant or breastfeeding. Hydrocodone ER (Hysingla ER) isn't recommended during pregnancy or while breastfeeding. This is because there are serious risks to the baby. Talk to them about safer options to relieve your pain.
Keep hydrocodone ER (Hysingla ER) out of reach from visitors, children, and pets. There are a few drug take-back options to get rid of the medication safely if you don't need it anymore. This lessens the risk for accidental overdose and medication misuse.
Your prescriber will work with you to find the right dose for your individual needs. It's recommended to take the lowest dose possible for the shortest amount of time to manage your pain.
Extended-release tablet: The typical starting dose is 20 mg by mouth once per day.
Extended-release capsule: The typical starting dose is 10 mg by mouth every 12 hours.
Your starting dose might differ if you have liver problems or kidney problems. It also depends on what opioid pain medications you were taking before hydrocodone ER (Hysingla ER).
Your prescriber will then adjust your dose depending on how well it's helping your pain.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Severely slowed breathing (respiratory depression)
Severe asthma
Medical conditions that cause blockage of the stomach passageway
Allergy to hydrocodone
Severe chronic pain that isn't relieved by non-opioid pain medications
Pain that isn't relieved by non-opioid medications
Long-term pain that isn't relieved by non-opioid pain medications alone
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