Anexsia (Acetaminophen / Hydrocodone Bitartrate)

(hye droe koe' done)

[Posted 01/11/2018] AUDIENCE: Family Practice, Pediatrics ISSUE: FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone. Some codeine cough medicines are available OTC in a few states, and FDA is also considering regulatory action for these products. FDA is taking this action after conducting an extensive review and convening a panel of outside experts, available at: http://bit.ly/2D5011o. Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18. See the FDA Drug Safety Communication, available at: http://bit.ly/2EBSDHU, for a list of prescription cough and cold medicines containing codeine or hydrocodone BACKGROUND: Codeine and hydrocodone are available in combination with other medicines, such as antihistamines and decongestants, in prescription medicines to treat coughs and symptoms associated with allergies or the common cold. Other non-opioid prescription and OTC medicines are available to treat these symptoms. RECOMMENDATION: Health care professionals should be aware that FDA is changing the age range for which prescription opioid cough and cold medicines are indicated. These products will no longer be indicated for use in children, and their use in this age group is not recommended. Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated. For those children in whom cough treatment is necessary, alternative medicines are available. These include over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products. Parents and caregivers should be aware that prescription opioid cough and cold medicines that include codeine or hydrocodone should not be used in children. Codeine and hydrocodone are narcotic medicines called opioids and may carry serious risks when used in children. It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment. If a cough medicine is prescribed, ask your child's health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone. Always read the labels on prescription bottles. If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine, or if you have any questions or concerns. 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, 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. 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 if you are taking, plan to take or plan to stop taking any of the following medications: certain antifungal medications including itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion); erythromycin (Erytab, Erythrocin); certain medications for human immunodeficiency virus (HIV) including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); medications for mental illness or nausea; other medications for pain; phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate); muscle relaxants; sedatives; sleeping pills; or tranquilizers. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take a hydrocodone combination product with any of these 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. Hydrocodone combination products may be habit-forming. Do not take more of it, take it more often, 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 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. Do not allow anyone else to take your medication. Hydrocodone may harm or cause death to other people who take your medication, especially children. 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. 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 moderate-to-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. Hydrocodone must be used with caution in children. Extended-release products containing hydrocodone should not be given to children younger than 6 years of age and should be used with caution in children 6 to 12 years of age. Talk to your doctor about the risks of giving hydrocodone to your child. 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 capsule, a syrup, a solution (clear liquid), an extended-release (long-acting) capsule, and an extended-release (long-acting) suspension (liquid) to take by mouth. The tablet, capsule, syrup, and solution are usually taken every 4 to 6 hours as needed. The extended-release capsule and the extended-release suspension are usually taken every 12 hours as needed. If you are taking hydrocodone on a regular schedule, take it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Swallow the extended-release capsules whole; do not split, chew, or crush them. 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. Call your doctor if your symptoms are not controlled by the hydrocodone combination product you are taking. Do not increase your dose of medication on your own. You may receive a dangerous overdose if you take more medication or take your medication more often than prescribed by your doctor. If you have taken a hydrocodone combination product for several weeks or longer, do not stop taking the medication without talking to your doctor. If you suddenly stop taking a hydrocodone combination product, you may experience withdrawal symptoms. Your doctor will probably decrease your dose gradually. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient, available for certain hydrocodone combination products.

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, other opiate (narcotic) medications such as morphine or codeine, 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 and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; antihistamines; antipsychotics (medications for mental illness) cyclobenzaprine (Amrix); dextromethorphan (found in many cough medications; in Nuedexta); ipratropium (Atrovent); lithium (Lithobid); medications for irritable bowel disease, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), milnacipran (Savella), and venlafaxine (Effexor); tramadol, trazodone (Oleptro); and tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Also tell your doctor or pharmacist if you are taking or receiving monoamine oxidase (MAO) inhibitors or have stopped taking them within the past 2 weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Many other medications may also interact with hydrocodone combination products, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John's wort and tryptophan.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section 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; seizures; or thyroid, intestinal, liver, pancreas, gallbladder, or kidney disease.
• tell your doctor if you are breastfeeding.
• 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.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are 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.

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, take the missed dose as soon as you remember it. Then wait at least 4 hours before taking your next dose of the tablets, syrup, capsule, or solution, or at least 12 hours before taking your next dose of the extended-release capsules or extended-release solution. If it is almost time for your next dose, 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 are severe or do not go away:

• constipation
• drowsiness
• lightheadedness
• fuzzy thinking
• anxiety
• abnormally happy or abnormally sad mood
• dry throat
• difficulty urinating
• rash
• itching
• narrowing of the pupils (black circles in the center of the eyes)

Some side effects can be serious. If you experience any of these symptoms, 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, nausea, vomiting, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• inability to get or keep an erection
• irregular menstruation
• decreased sexual desire
• chest tightness

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Flush any medication that is 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

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.

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 hydrocodone. 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.