Brand Name
US Brand Name
Hysingla ER
Vantrela ER
Zohydro ER
Canadian Brand Name
Hycodan
pdp-HYDROcodone
Robidone
Description
Hydrocodone is used to relieve pain in opioid-tolerant patients severe enough to require around-the-clock pain relief for a long period of time. It should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain. This medicine should not be used to treat pain that you only have once in a while or "as needed". It is also used to manage severe and persistent pain that requires an extended opioid treatment and when other pain medicines did not work well or cannot be tolerated.
Hydrocodone belongs to the group of medicines called opioid analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.
When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using opioids to relieve their pain. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms if treatment is stopped suddenly. However, severe withdrawal symptoms can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
This medicine is available only with your doctor's prescription. Hysingla® and Zohydro® are available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.
This product is available in the following dosage forms:
- Tablet, Extended Release
- Capsule, Extended Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone in the elderly. However, elderly patients are more likely to have confusion and severe drowsiness and age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving hydrocodone.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
- Naltrexone
- Safinamide
- Samidorphan
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.
- Abametapir
- Acepromazine
- Aclidinium
- Alfentanil
- Almotriptan
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anileridine
- Apalutamide
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asenapine
- Atazanavir
- Atropine
- Avacopan
- Baclofen
- Belladonna
- Belzutifan
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
- Benzphetamine
- Benzthiazide
- Benztropine
- Berotralstat
- Biperiden
- Boceprevir
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison disease (adrenal gland problem) or
- Alcohol use disorder or
- Brain tumor, history of or
- Breathing or lung problems (eg, apnea, low oxygen levels) or
- Chronic obstructive pulmonary disease (COPD) or
- Congestive heart failure or
- Cor pulmonale (serious heart condition) or
- Depression, history of or
- Drug dependence, especially with opioid use disorder or dependence, history of or
- Electrolyte imbalance or
- Gallbladder problems or
- Head injury, history of or
- Heart rhythm problems (eg, congenital long QT syndrome, slow heartbeat) or
- Increased pressure in the head or
- Mental health problems, history of or
- Stomach or bowel problems or
- Trouble swallowing or
- Weakened immune system—Use with caution. May increase risk for more serious side effects.
- Asthma, acute or severe or
- Lung or breathing problems (eg, respiratory depression), severe or
- Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.
- Hypotension (low blood pressure) or
- Pancreatitis (swelling of the pancreas) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.
It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of hydrocodone. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.
If you are using the extended-release capsules or extended-release tablets:
- Hydrocodone extended-release capsules or extended-release tablets are for use in opioid-tolerant patients only. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.
- Take this medicine at the same time each day, with or without food.
- Swallow the extended-release tablet whole. Do not crush, break, chew, or dissolve it. Do not pre-soak, lick, or wet the tablet before placing it in the mouth. Take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth.
Take this medicine at the same time each day.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For severe pain:
- For oral dosage form (extended-release capsules):
- Patients who are not taking opioid medicines:
- Adults—At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Patients switching from other opioid medicines:
- Adults—The capsule is given every 12 hours. Your doctor will determine your dose and adjust the dose as needed.
- Children—Use and dose must be determined by your doctor.
- Patients who are not taking opioid medicines:
- For oral dosage form (extended-release tablets):
- Patients who are not taking opioid medicines:
- Adults—
- Hysingla® ER: At first, 20 milligrams (mg) every 24 hours. Your doctor may adjust your dose as needed.
- Vantrela™: At first, 15 mg every 12 hours. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Adults—
- Patients switching from other opioid medicines:
- Adults—
- Hysingla® ER: The tablet is given every 24 hours. Your doctor will determine your dose and adjust the dose as needed.
- Vantrela™: The tablet is given every 12 hours. Your doctor will determine your dose and adjust the dose as needed.
- Children—Use and dose must be determined by your doctor.
- Adults—
- Patients who are not taking opioid medicines:
- For oral dosage form (extended-release capsules):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose of Hysingla® ER, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Hydrocodone can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong opioid pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.
Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions
It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or opioids, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of these medicines while you are using this medicine.
This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Using too much hydrocodone may cause an overdose, which can be life-threatening. Signs of an overdose include: change in consciousness, cold, clammy skin, dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, loss of consciousness, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, sleepiness or unusual drowsiness, or yellow eyes or skin. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary.
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.
Using opioids for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem including QT prolongation.
Do not suddenly stop or change your dose without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely, or to take another opioid for a while, to lessen the chance of withdrawal symptoms (eg, anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
For nursing mothers:
- Talk to your doctor if you have any questions about taking hydrocodone or about how this medicine may affect your baby. This medicine may be present in your breast milk and passed to your baby.
- Call your doctor if you become extremely tired and have difficulty caring for your baby.
- Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
- Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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
- chest tightness
- chills
- cough
- depression
- difficult or labored breathing
- difficult, burning, or painful urination
- ear congestion
- fear or nervousness
- fever
- frequent urge to urinate
- headache
- loss of voice
- lower back or side pain
- rapid weight gain
- runny or stuffy nose
- sneezing
- sore throat
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Agitation
- darkening of the skin
- diarrhea
- difficulty swallowing
- fast heartbeat
- hives, itching, skin rash
- increased sensitivity to pain
- loss of appetite
- mental depression
- nausea
- 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
- worsening of pain
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
- loss of consciousness
- 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
Less common
- Back pain
- dry mouth
- heartburn
- muscle spasms
- stomach pain or discomfort
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.
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