What is the most important information I should know about hydrocodone?
MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
What is hydrocodone?
Hydrocodone is an opioid pain medication.
Zohydro ER and Hysingla ER are extended-release forms of hydrocodone that are used for around-the-clock treatment of severe pain. Extended-release hydrocodone is not for use on an as-needed basis for pain.
Hydrocodone may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking hydrocodone?
You should not use hydrocodone if you are allergic to it, or if you have:
- severe asthma or breathing problems; or
- a blockage in your stomach or intestines.
Tell your doctor if you have ever had:
- breathing problems, sleep apnea;
- a head injury, brain tumor, or seizures;
- drug or alcohol addiction, or mental illness;
- urination problems;
- liver or kidney disease;
- problems with your gallbladder, pancreas, or thyroid; or
- a heart rhythm disorder called long QT syndrome.
If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.
Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.
How should I take hydrocodone?
Follow the directions on your prescription label and read all medication guides. Never use hydrocodone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.
Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.
Your dose needs may be different if you have recently used a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.
Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose. Never crush or break a hydrocodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause death.
Do not stop using this medicine suddenly after long-term use, or you could have serious withdrawal symptoms. Ask your doctor how to safely stop using hydrocodone.
Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
What happens if I miss a dose?
Since hydrocodone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid 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 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.
What should I avoid while taking hydrocodone?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
What are the possible side effects of hydrocodone?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Stop using hydrocodone and call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
- a slow heart rate or weak pulse;
- pain or burning when you urinate;
- confusion, tremors, severe drowsiness;
- a light-headed feeling, like you might pass out;
- low cortisol levels --nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
- high levels of serotonin in the body --agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.
Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.
Common side effects may include:
- constipation, nausea, vomiting;
- dizziness, drowsiness, feeling tired;
- headache; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect hydrocodone?
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 affect hydrocodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Where can I get more information?
Your doctor or pharmacist can provide more information about hydrocodone.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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