Hydrocodone Combination Products

Hydrocodone combination products may be habit forming. Take your hydrocodone combination product exactly as directed. Do not take more or less of it, take it more often, stop taking it suddenly, or take it in a different way than directed by your doctor. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness.

Hydrocodone may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Hydrocodone combination products may harm or cause death to other people who take your medication, especially children. Keep hydrocodone combination products in a safe place so that no one else can take it accidentally or on purpose.

Taking certain medications, drinking alcohol, or using street drugs with a hydrocodone combination product may increase the risk of serious or life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully.

Tell your doctor if you are pregnant or plan to become pregnant. If you take a hydrocodone combination product regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with a hydrocodone combination product and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of taking a hydrocodone combination product.

Hydrocodone is available in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone combination products are used to relieve severe pain. Other hydrocodone combination products are used to relieve cough. Hydrocodone is in a class of medications called opiate (narcotic) analgesics and in a class of medications called antitussives. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing.

You will take hydrocodone in combination with at least one other medication, but this monograph only provides information about hydrocodone. Be sure to read information about the other ingredients in the hydrocodone product you are taking. Ask your doctor or pharmacist if you have any questions.

Hydrocodone combination products come as a tablet, a syrup, a solution (clear liquid), and an extended-release (long-acting) suspension (liquid) to take by mouth. Take the tablet, syrup, and solution every 4 to 6 hours as needed. Take the extended-release suspension every 12 hours as needed.

Shake the extended-release suspension well before each use to mix the medication evenly. Do not mix the extended-release suspension with other medications or with other liquids such as water.

When taking hydrocodone combination solution, syrup, or extended-release suspension, do not use a household teaspoon to measure your dose. Use a properly marked measuring device such as a dropper, medicine spoon, or oral syringe. Ask your pharmacist if you need help getting or using a measuring device.

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 a hydrocodone combination product. 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 a hydrocodone combination product. Do not take more of it or take it more often than prescribed by your doctor.

Talk to your doctor or pharmacist about access to rescue medicines, naloxone or nalmefene, while taking hydrocodone combination product. Rescue medications can reverse the life-threatening effects of an opioid overdose and are available over the counter or with a prescription. Make sure that you and your family members and people usually around you know how to recognize an overdose, how to use naloxone or nalmefene, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and others how to use it. If symptoms of an overdose occur, they should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. If your symptoms return, the person should give you another dose of the rescue medication. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Do not stop taking a hydrocodone combination product without talking to your doctor. If you suddenly stop taking a hydrocodone combination product, you may experience withdrawal symptoms such as restlessness, teary eyes, runny nose, yawning, sweating, chills, 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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking a hydrocodone combination product,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with hydrocodone combination products. Make sure you have discussed any medications you are currently taking or plan to take before starting a hydrocodone combination product with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking a hydrocodone combination product, please get the advice of your doctor or pharmacist.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, or tranylcypromine.
• the following nonprescription or herbal products may interact with hydrocodone combination products: 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 a hydrocodone combination product. Do not start these medications while taking a hydrocodone combination product without discussing it with your healthcare provider.
• tell your doctor if you have slowed breathing, asthma, chronic pulmonary disease (COPD), or other lung problems; 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 a hydrocodone combination product.
• tell your doctor if you have or have ever had a brain tumor, or any condition that increases the amount of pressure in your brain; seizures; or thyroid, liver, pancreas, gallbladder, heart, or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking a hydrocodone combination product, call your doctor.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking a hydrocodone combination product.
• you should know to not drink alcoholic beverages while you are taking hydrocodone. Alcohol can make the side effects from hydrocodone worse.
• you should know that hydrocodone combination products 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 combination products 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 a hydrocodone combination product. 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 combination products may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.

Unless your doctor tells you otherwise, continue your normal diet.

This medication is usually taken as needed. If your doctor has told you to take a hydrocodone combination product regularly, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Hydrocodone combination products may cause side effects. Tell your doctor if any of these symptoms or those in the SPECIAL PRECAUTIONS section are severe or do not go away:

• nausea, vomiting, stomach pain
• increased sweating
• decreased sexual desire, inability to get or keep an erection

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

• 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
• chest pain, changes in heartbeat
• rash; hives; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue or throat
• seizures
• extreme drowsiness
• new pain or pain from touch or doing ordinary tasks such as combing your hair
• difficulty swallowing, regurgitation (bringing up swallowed food into throat and mouth), pain in the chest area
• unusual snoring or long pauses during breaths during sleep

Hydrocodone combination products 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).

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 combination products that are outdated or no longer needed down the toilet so that others will not take it. Talk to your pharmacist about the proper disposal of your medication.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. 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.

Symptoms of overdose may include the following:

• narrowed or widened pupils (dark circles in the middle of the eyes)
• slow, shallow, or stopped breathing; difficulty breathing
• slowed heartbeat
• cold, clammy, or blue skin
• excessive sleepiness
• unable to respond or wake up

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking a hydrocodone combination product.

This prescription is not refillable. If you continue to have pain or a cough after you finish taking your medication, call your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Allay^® (containing Acetaminophen, Hydrocodone)^¶
• Anexsia^® (containing Acetaminophen, Hydrocodone)^¶
• Azdone^® (containing Aspirin, Hydrocodone)^¶
• Bancap HC^® (containing Acetaminophen, Hydrocodone)^¶
• Co-Gesic^® (containing Acetaminophen, Hydrocodone)^¶
• Hycodan^® (containing Homatropine, Hydrocodone)
• Hy-Phen^® (containing Acetaminophen, Hydrocodone)^¶
• Lorcet^® (containing Acetaminophen, Hydrocodone)^¶
• Lorcet Plus^® (containing Acetaminophen, Hydrocodone)^¶
• Lortab^® (containing Acetaminophen, Hydrocodone)^¶
• Norco^® (containing Acetaminophen, Hydrocodone)^¶
• Reprexain^® (containing Hydrocodone, Ibuprofen)^¶
• Rezira^® (containing Hydrocodone, Pseudoephedrine)^¶
• TussiCaps^® (containing Chlorpheniramine, Hydrocodone)^¶
• Tussionex^® (containing Chlorpheniramine, Hydrocodone)^¶
• Vicodin^® (containing Acetaminophen, Hydrocodone)^¶
• Vicodin ES^® (containing Acetaminophen, Hydrocodone)^¶
• Vicodin HP^® (containing Acetaminophen, Hydrocodone)^¶
• Vicoprofen^® (containing Hydrocodone, Ibuprofen)^¶
• Vituz^® (containing Chlorpheniramine, Hydrocodone)^¶
• Zutripro^® (containing Chlorpheniramine, Hydrocodone, Pseudoephedrine)^¶
• Zydone^® (containing Acetaminophen, Hydrocodone)^¶

• dihydrocodeinone