Hydrocodone

Hydrocodone is used to relieve severe and persistent pain in people who are expected to need an opioid pain medication around the clock for a long time and who cannot be treated with other pain medications. Hydrocodone extended-release (long-acting) capsules or extended-release tablets should not be used to treat pain that can be controlled by medication that is taken as needed. Hydrocodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

This monograph only includes information about the use of hydrocodone alone. If you are taking a hydrocodone combination product, be sure to read information about all the ingredients in the hydrocodone-combination monograph and ask your doctor or pharmacist for more information.

Hydrocodone comes as an extended-release (long-acting) capsule and an extended-release (long-acting) tablet to take by mouth. The extended-release capsule is usually taken once every 12 hours. The extended-release tablet is usually taken once daily. Take hydrocodone at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take hydrocodone exactly as directed by your doctor.

Swallow the extended-release capsules or extended-release tablets one at a time with plenty of water. Swallow each capsule or tablet as soon as you put it in your mouth. Do not presoak, wet, or lick the extended-release tablets before you put them in your mouth.

Your doctor may adjust your dose of hydrocodone during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling during your treatment with hydrocodone. Tell your doctor if you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with hydrocodone. Do not take more of it or take it more often than prescribed by your doctor.

Do not stop taking hydrocodone without talking to your doctor. If you suddenly stop taking hydrocodone, you may experience withdrawal symptoms such as restlessness, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle pain, widened pupils (black circles in the middle of the eyes), irritability, anxiety, back or joint pain, weakness, stomach cramps, difficulty falling asleep or staying asleep, nausea, loss of appetite, vomiting, diarrhea, fast breathing, or fast heartbeat. Your doctor will probably decrease your dose gradually.

Off-label uses refer to situations where a medication is prescribed for conditions other than those approved by regulatory bodies, like the FDA. While hydrocodone is primarily approved for treating pain and cough, it may sometimes be used off-label for other purposes. Here are some of the off-label uses of hydrocodone:

1. Management of Chronic, Non-Cancer Pain

Hydrocodone is typically prescribed for acute pain (such as post-surgical pain or injury-related pain), but it may be used off-label for the long-term management of chronic pain not related to cancer, such as:

• Osteoarthritis
• Fibromyalgia
• Chronic lower back pain
• Neuropathic pain This use is generally approached cautiously due to the risk of tolerance, dependence, and addiction.

2. Restless Legs Syndrome (RLS)

Some healthcare providers may prescribe hydrocodone off-label to help patients with restless legs syndrome, especially when other medications do not provide relief. Opioids like hydrocodone may reduce the discomfort caused by RLS, though this use is less common.

3. Severe Anxiety or Emotional Distress

In certain cases, hydrocodone may be used off-label to treat severe anxiety or emotional distress when standard treatments are ineffective. The calming and sedative effects of hydrocodone could provide temporary relief, though this is highly discouraged due to the potential for dependence and misuse.

4. Diabetic Neuropathy

In certain instances, hydrocodone is used off-label to manage the pain associated with diabetic neuropathy. While other medications like gabapentin or pregabalin are typically preferred, opioids, including hydrocodone, may be prescribed for patients who do not respond to first-line treatments.

5. Migraine and Severe Headaches

Although it’s not typically recommended for migraine treatment, hydrocodone may be prescribed off-label for patients with severe migraines or cluster headaches who do not respond to more standard treatments, such as triptans or NSAIDs. However, this is a controversial use due to the risk of rebound headaches and dependency.

6. Cough Suppression in Conditions Not Related to Respiratory Illness

In rare cases, hydrocodone may be used off-label to suppress coughing caused by conditions that are not primarily respiratory, such as GERD (gastroesophageal reflux disease) or post-nasal drip, when other treatments fail.

7. End-of-Life Care (Palliative Care)

Hydrocodone may be used in palliative care to provide comfort for patients experiencing intractable pain or dyspnea (shortness of breath) in conditions like advanced heart failure or chronic obstructive pulmonary disease (COPD). This is done to improve quality of life rather than cure or manage a specific condition.

Risks and Considerations

• Tolerance and Dependence: Long-term use of hydrocodone, even for off-label conditions, can lead to physical dependence and tolerance, requiring higher doses for the same effect.
• Opioid-Induced Hyperalgesia: In some cases, prolonged opioid use can lead to increased sensitivity to pain.
• Legal and Ethical Concerns: Off-label use of opioids like hydrocodone is controversial due to the potential for misuse, addiction, and legal implications.

Alternatives for Off-Label Uses

When considering off-label hydrocodone use, physicians often weigh the risks and explore alternative treatments, such as anticonvulsants, antidepressants, or non-opioid pain relievers, to minimize the risk of dependence and side effects.

Before taking hydrocodone,

• tell your doctor and pharmacist if you are allergic to hydrocodone, any other medications, or any of the ingredients in hydrocodone extended-release capsules or extended-release tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate).
• The following nonprescription or herbal products may interact with hydrocodone: St. John’s wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking hydrocodone. Do not start these medications while taking hydrocodone without discussing it with your healthcare provider.
• tell your doctor if you have any of the conditions mentioned in the IMPORTANT WARNING section, a blockage or narrowing of your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take hydrocodone.
• tell your doctor if you have or have ever had low blood pressure; difficulty urinating; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); diabetes; seizures; or thyroid, gall bladder, pancreas, liver, or kidney disease.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking hydrocodone. Hydrocodone can cause shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness in breastfed infants.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking hydrocodone.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking hydrocodone.
• you should know that hydrocodone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that hydrocodone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking hydrocodone. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that hydrocodone may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.

What Side Effects can Hydrocodone Cause?

Hydrocodone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• stomach pain
• dry mouth
• tiredness
• headache
• back pain
• muscle tightening
• ringing in the ears
• difficulty falling asleep or staying asleep
• foot, leg, or ankle swelling
• uncontrollable shaking of a part of the body
• increased sweating

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• chest pain
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• inability to get or keep an erection
• irregular menstruation
• decreased sexual desire
• changes in heartbeat
• rash; hives; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue or throat
• difficult, frequent, or painful urination

Hydrocodone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children, and in a location that is not easily accessible by others, including visitors to the home. Store it at room temperature and away from excess heat and moisture (not in the bathroom). You must immediately dispose of any medication that is outdated or no longer needed through a medicine take-back program.. If you do not have a take-back program nearby or one that you can access promptly, flush any hydrocodone tablets or capsules that are outdated or no longer needed down the toilet. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

While taking hydrocodone, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer’s website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include the following:

• slow or shallow breathing
• difficulty breathing
• sleepiness
• muscle weakness
• cold, clammy skin
• narrowed or widened pupils (dark circles in the middle of the eyes)
• slowed heartbeat
• unable to respond or wake up
• unusual snoring

Keep all appointments with your doctor and laboratory. Your doctor will order certain lab tests to check your body’s response to hydrocodone.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking hydrocodone.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of hydrocodone if your doctor wants you to continue taking this medication. If you continue to have pain after you finish your hydrocodone prescription, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand Names of Hydrocodone