URL of this page: https://medlineplus.gov/druginfo/meds/a601006.html

Hydrocodone Combination Products

pronounced as (hye droe koe' done)


[Posted 08/31/2016]

AUDIENCE: Pharmacy, Internal Medicine, Psychiatry, Neurology, Family Practice

ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings, our strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. See the Drug Safety Communication, available at: http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm, for a listing of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants.

FDA conducted and reviewed several studies showing that serious risks are associated with the combined use of opioids and benzodiazepines, other drugs that depress the CNS, or alcohol (see the FDA Drug Safety Communication, available at: http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm, for a Data Summary). Based on these data, FDA is requiring several changes to reflect these risks in the opioid and benzodiazepine labeling, and new or revised patient Medication Guides. These changes include the new Boxed Warnings and revisions to the Warnings and Precautions, Drug Interactions, and Patient Counseling Information sections of the labeling.

FDA is continuing to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy (MAT) drugs used to treat opioid addiction and dependence. FDA is also evaluating whether labeling changes are needed for other CNS depressants, and will update the public when more information is available.

BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. Benzodiazepines are a class of medicines that are widely used to treat conditions including anxiety, insomnia, and seizures.

RECOMMENDATION: Health care professionalsshould limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.

Patients taking opioids with benzodiazepines, other CNS depressant medicines, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

Why is this medication 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 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.

How should this medicine be used?

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.

Hydrocodone may be habit-forming. Take hydrocodone combination products exactly as directed. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor. Call your doctor if you develop a strong desire to take more medication than prescribed.

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.

Other uses for this medicine

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

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, 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 (Alsuma, Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); sedatives; 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); sleeping pills; tranquilizers; trazodone (Oleptro); and tricylic 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 two 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 recently had surgery and if you have or have ever had lung disease; breathing problems; croup (a barking cough that most often occurs at night); a head injury; any condition that causes increased pressure in your brain; prostatic hypertrophy (enlargement of a male reproductive gland); urethral stricture (narrowing of the tube that removes urine from the body); Addison's disease (condition in which the body does not make enough of certain natural substances); difficulty urinating; glaucoma; or thyroid, intestinal, liver, or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. 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.
  • 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.
  • ask your doctor about the safe use of alcoholic beverages while you are taking hydrocodone. Alcohol can make the side effects from hydrocodone worse.

What special dietary instructions should I follow?

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

What should I do if I forget a dose?

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.

What side effects can this medication cause?

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.

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. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

Store your hydrocodone combination product in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules or how much liquid is left so you will know if any medication is missing.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

  • narrowed or widened pupils
  • slow, shallow, or stopped breathing
  • slowed or stopped heartbeat
  • cold, clammy, or blue skin
  • excessive sleepiness
  • loss of consciousness
  • seizures
  • death

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 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.

Brand names of combination products

  • Allay® (containing Acetaminophen, Hydrocodone)
  • Alor® (containing Aspirin, Hydrocodone)
  • Anexsia® (containing Acetaminophen, Hydrocodone)
  • Anolor DH5® (containing Acetaminophen, Hydrocodone)
  • Atuss HD® (containing Chlorpheniramine, Hydrocodone, Phenylephrine)
  • Azdone® (containing Aspirin, Hydrocodone)
  • Baltussin HC® (containing Chlorpheniramine, Hydrocodone, Phenylephrine)
  • Bancap HC® (containing Acetaminophen, Hydrocodone)
  • Ceta Plus® (containing Acetaminophen, Hydrocodone)
  • Codiclear DH® (containing Guaifenesin, Hydrocodone)
  • Co-Gesic® (containing Acetaminophen, Hydrocodone)
  • Damason-P® (containing Aspirin, Hydrocodone)
  • Dolacet® (containing Acetaminophen, Hydrocodone)
  • Dolagesic® (containing Acetaminophen, Hydrocodone)
  • Dolorex Forte® (containing Acetaminophen, Hydrocodone)
  • Donatussin MAX® (containing Carbinoxamine, Hydrocodone, Phenylephrine)
  • DuoCet® (containing Acetaminophen, Hydrocodone)
  • EndaCof XP® (containing Guaifenesin, Hydrocodone)
  • EndaCof-Plus® (containing Dexchlorpheniramine, Hydrocodone, Phenylephrine)
  • Entuss® (containing Guaifenesin, Hydrocodone)
  • Histinex HC® (containing Chlorpheniramine, Hydrocodone, Phenylephrine)
  • Hycet® (containing Acetaminophen, Hydrocodone)
  • Hycodan® (containing Homatropine, Hydrocodone)
  • Hycomed® (containing Acetaminophen, Hydrocodone)
  • Hycomine Compound® (containing Acetaminophen, Caffeine, Chlorpheniramine, Hydrocodone, Phenylephrine)
  • Hycotuss® (containing Guaifenesin, Hydrocodone)
  • Hydrocet® (containing Acetaminophen, Hydrocodone)
  • Hydrogesic® (containing Acetaminophen, Hydrocodone)
  • Hydromet® (containing Homatropine, Hydrocodone)
  • Hy-Phen® (containing Acetaminophen, Hydrocodone)
  • Ibudone® (containing Hydrocodone, Ibuprofen)
  • Kwelcof® (containing Guaifenesin, Hydrocodone)
  • Liquicet® (containing Acetaminophen, Hydrocodone)
  • Lorcet® (containing Acetaminophen, Hydrocodone)
  • Lorcet Plus® (containing Acetaminophen, Hydrocodone)
  • Lortab® (containing Acetaminophen, Hydrocodone)
  • Lortuss HC® (containing Hydrocodone, Phenylephrine)
  • Margesic-H® (containing Acetaminophen, Hydrocodone)
  • Maxidone® (containing Acetaminophen, Hydrocodone)
  • Norco® (containing Acetaminophen, Hydrocodone)
  • Oncet® (containing Acetaminophen, Hydrocodone)
  • Panacet® (containing Acetaminophen, Hydrocodone)
  • Panasal® (containing Aspirin, Hydrocodone)
  • Panlor® (containing Acetaminophen, Hydrocodone)
  • Polygesic® (containing Acetaminophen, Hydrocodone)
  • Procet® (containing Acetaminophen, Hydrocodone)
  • Reprexain® (containing Hydrocodone, Ibuprofen)
  • Rezira® (containing Hydrocodone, Pseudoephedrine)
  • Stagesic® (containing Acetaminophen, Hydrocodone)
  • T-Gesic® (containing Acetaminophen, Hydrocodone)
  • TussiCaps® (containing Chlorpheniramine, Hydrocodone)
  • Tussionex® (containing Chlorpheniramine, Hydrocodone)
  • Ugesic® (containing Acetaminophen, Hydrocodone)
  • Vanacet® (containing Acetaminophen, Hydrocodone)
  • Vanex-HD® (containing Chlorpheniramine, Hydrocodone, Phenylephrine)
  • Vendone® (containing Acetaminophen, Hydrocodone)
  • Vicodin® (containing Acetaminophen, Hydrocodone)
  • Vicodin ES® (containing Acetaminophen, Hydrocodone)
  • Vicodin HP® (containing Acetaminophen, Hydrocodone)
  • Vicoprofen® (containing Hydrocodone, Ibuprofen)
  • Vidone® (containing Acetaminophen, Hydrocodone)
  • Vituz® (containing Chlorpheniramine, Hydrocodone)
  • Xodol® (containing Acetaminophen, Hydrocodone)
  • Zamicet® (containing Acetaminophen, Hydrocodone)
  • Zolvit® (containing Acetaminophen, Hydrocodone)
  • Zutripro® (containing Chlorpheniramine, Hydrocodone, Pseudoephedrine)
  • Zydone® (containing Acetaminophen, Hydrocodone)

Other names

  • dihydrocodeinone

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

Last Revised - 09/15/2016