Hydrocodone Combination Products

IMPORTANT WARNING:

Hydrocodone combination products may be habit forming. Take your hydrocodone combination product exactly as directed. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. While taking hydrocodone combination products, discuss with your healthcare provider your pain treatment goals, length of treatment, and other ways to manage your pain. 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. There is a greater risk that you will overuse a hydrocodone combination product if you have or have ever had any of these conditions. Talk to your healthcare provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

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. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to take a hydrocodone combination product. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury, a brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. 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.

When a hydrocodone combination product was used in children, serious and life-threatening breathing problems such as slow or difficulty breathing and deaths were reported. Hydrocodone should never be used to treat pain or a cough in children younger than 18 years of age. If your child is currently prescribed a cough and cold medicine containing hydrocodone, talk to your child's doctor about other treatments.

Do not allow anyone else to take your medication. 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. Be especially careful to keep hydrocodone out of the reach of children. Keep track of how much hydrocodone combination product is left so you will know if any medication is missing.ª

Taking certain medications 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. If you take a hydrocodone combination product with other medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with a hydrocodone combination product increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.

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. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

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 (http://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.

WHY is this medicine prescribed?

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 (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in people who are expected to need an opioid pain medication and whose symptoms cannot be controlled by the use of alternative pain medications. Other hydrocodone combination products are used to relieve cough in adults. 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

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. The tablet, syrup, and solution are usually taken every 4 to 6 hours as needed. The extended-release suspension is usually taken every 12 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

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.

If you will be using hydrocodone combination solution, syrup, or extended-release suspension, do not use a household teaspoon to measure your dose. Household teaspoons are not accurate measuring devices, and you may receive too much medication or not enough medication if you measure your dose with a household teaspoon. Instead, use a properly marked measuring device such as a dropper, medicine spoon, or oral syringe. Ask your doctor or 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. You may receive a dangerous overdose if you take more medication or take your medication more often than prescribed by your doctor.

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.

What SPECIAL PRECAUTIONS should I follow?

Before taking a hydrocodone combination product,

• tell your doctor and pharmacist if you are allergic to hydrocodone, the other medication in the hydrocodone combination product you are taking, any other medications, or any of the ingredients in the hydrocodone combination product you are taking. Ask your pharmacist or check the manufacturer's information for the patient 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 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 or have ever had 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 a hydrocodone combination product.

• tell your doctor if you have or have ever had 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, intestinal, liver, pancreas, gallbladder, or kidney disease.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking a hydrocodone combination product. Hydrocodone combination products 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 a hydrocodone combination product.

• 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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

• stomach pain
• headache
• drowsiness
• lightheadedness
• fuzzy thinking
• anxiety
• abnormally happy or abnormally sad mood
• dry mouth

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:

• slowed or irregular breathing
• 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
• chest pain
• fast heartbeat
• rash; hives; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue or throat
• difficulty urinating

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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 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.

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. http://www.upandaway.org

What should I do in case of OVERDOSE?

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 a hydrocodone combination product, 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:

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

What OTHER INFORMATION should I know?

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

Before having any laboratory test (especially those that involve methylene blue), 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.

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.

^¶ This branded product is no longer on the market. Generic alternatives may be available.