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Hydrocodone and acetaminophen is a combination medicine used to relieve moderate to severe pain.

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What is hydrocodone and acetaminophen?

Hydrocodone and acetaminophen is a combination medicine used to relieve moderate to severe pain. Hydrocodone is an opioid pain reliever and cough suppressant that belongs to the group of medicines called narcotic analgesics, that work on the central nervous system. Acetaminophen is a non-opioid analgesic used for pain relief and to reduce fever. Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

Hydrocodone and acetaminophen tablets have been marketed under the brand names Norco (discontinued), Vicodin  (discontinued), Lortab (discontinued), Hycet (discontinued), Lorcet (discontinued), Verdrocet (discontinued), Xodol (discontinued), Zamicet (discontinued) and now generic hydrocodone and acetaminophen products are available.

Is hydrocodone with acetaminophen a controlled substance?

Yes, hydrocodone with acetaminophen is a controlled substance. Under the Controlled Substances Act (CSA) hydrocodone (which includes hydrocodone with acetaminophen) is a schedule 2 controlled substance.  This means hydrocodone has a high potential for abuse, it currently has an accepted medical use which may include severe restrictions. Abuse may lead to severe psychological or physical dependence.

What strength is hydrocodone and acetaminophen tablets available as?

Examples of hydrocodone and acetaminophen tablets are:

  • hydrocodone and acetaminophen 2.5mg/325mg tablets
  • hydrocodone and acetaminophen 5mg/325mg tablets
  • hydrocodone and acetaminophen 7.5mg/325mg tablets
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  • hydrocodone and acetaminophen 10mg/325mg tablets

Sometimes hydrocodone and acetaminophen strengths get abbreviated to hydrocodone acetaminophen 5-325 or hydrocodone acetaminophen 5 325, but is better to use the correct names and strengths (hydrocodone and acetaminophen 5mg/325mg tablets or hydrocodone 5mg and acetaminophen 325mg) to avoid confusion and dosing errors.

Before taking this medicine

You should not use this medicine if you are allergic to acetaminophen or hydrocodone, or if you have:

  • severe asthma or breathing problems; or
  • a blockage in your stomach or intestines.

To make sure acetaminophen and hydrocodone is safe for you, tell your doctor if you have ever had:

  • breathing problems, sleep apnea;
  • liver disease;
  • a drug or alcohol addiction;
  • kidney disease;
  • a head injury or seizures;
  • urination problems; or
  • problems with your thyroid, pancreas, or gallbladder.

Pregnancy

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Breastfeeding

Do not breastfeed. Acetaminophen and hydrocodone can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

How should I take hydrocodone and acetaminophen?

Take hydrocodone and acetaminophen exactly as it was prescribed for you. Follow all directions on your prescription label. Never take hydrocodone and acetaminophen in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away hydrocodone and acetaminophen is against the law.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine.

You should not stop using this medicine suddenly. Follow your doctor’s instructions about tapering your dose.

Store acetaminophen and hydrocodone at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Dosage

Use: For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

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Usual Adult Dose for Pain:

Hydrocodone 2.5 mg-acetaminophen 325 mg per tabletHydrocodone 5 mg-acetaminophen 325 mg per tablet

  • Initial dose: 1 to 2 tablets every 4 to 6 hours as needed for pain
  • Maximum dose: 8 tablets/24 hours

Hydrocodone 7.5 mg-acetaminophen 325 mg, Hydrocodone 10 mg-acetaminophen 325 mg per tablet:

  • Initial dose: 1 tablet every 4 to 6 hours as needed for pain
  • Maximum dose: 6 tablets/24 hours

Hydrocodone 7.5 mg-acetaminophen 325 mg per 15 mL oral solution:

  • Initial dose: 15 mL every 4 to 6 hours as needed for pain
  • Maximum dose: 90 mL/24 hours

Hydrocodone 10 mg-acetaminophen 300 mg per 15 mL oral solution:

  • Initial dose: 11.25 mL every 4 to 6 hours as needed for pain
  • Maximum dose: 67.5 mL/24 hours

Comments:

  • Doses should be individually titrated to provide adequate analgesia while minimizing adverse reactions.
  • Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
  • Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

For more information on hydocodone/acetminophen doses for adults or children, or dosage adjustments required for medical conditions click on the link below.

Side effects of hydrocodone and acetaminophen

Common side effects of hydrocodone acetaminophen include:

  • dizziness, drowsiness, feeling tired;
  • nausea, vomiting, stomach pain;
  • constipation; or headache.

Serious side effects of hydrocodone acetaminophen include:

Get emergency medical help if you have signs of an allergic reaction to acetaminophen and hydrocodone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • a light-headed feeling, like you might pass out;
  • liver problems – nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
  • high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Warnings

MISUSE OF HYDROCODONE AND ACETAMINOPHEN CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in secure a place where others cannot get to it.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and hydrocodone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. See interactions section below for more information on drug interactions.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Stop taking acetaminophen and hydrocodone and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

 

 

 

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