hydrocodone/acetaminophen

Hydrocodone is a narcotic pain-reliever and a cough suppressant, similar to codeine. Hydrocodone blocks the receptors on nerve cells in the brain that give rise to the sensation of pain.

Acetaminophen is a non-narcotic analgesic (pain reliever) and antipyretic (fever reducer). Acetaminophen works by elevating the threshold to pain, that is, in order for pain to be felt, greater stimulation of the nerves responsible for the sensation of pain is necessary. It reduces fever through its action on the temperature-regulating center of the brain.

• Frequently, hydrocodone and acetaminophen are combined to achieve pain relief, as in Vicodin and Lortab. The FDA approved Vicodin in January 1983.

• Get emergency help right away if you take too much hydrocodone/acetaminophen (overdose). When you first start taking hydrocodone/acetaminophen, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Taking hydrocodone/acetaminophen with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your hydrocodone/acetaminophen. They could die from taking it. Store hydrocodone/acetaminophen away from children and in a safe place to prevent stealing or abuse. Selling or giving away hydrocodone/acetaminophen is against the law.

Do not take hydrocodone/acetaminophen if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.
• known hypersensitivity to hydrocodone or acetaminophen, or any ingredient in hydrocodone/acetaminophen

Common side effects of hydrocodone/acetaminophen include:

• dizziness, 
• drowsiness, 
• tiredness, 
• nausea, 
• vomiting, 
• stomach pain, 
• constipation, and 
• headache

Serious side effects of hydrocodone/acetaminophen include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• breathing that slows with a long pause, 
• blue colored lips, 
• difficult to wake up, 
• skin redness or a rash that spreads and causes blistering and peeling, 
• noisy breathing, 
• sighing, 
• shallow breathing that stops, 
• lightheadedness, 
• nausea, 
• upper stomach pain, 
• tiredness, 
• loss of appetite, 
• dark urine, 
• clay-colored stools, 
• yellowing of the skin or eyes, 
• vomiting, 
• loss of appetite, 
• dizziness, 
• worsening tiredness, 
• weakness, 
• agitation, 
• hallucinations, 
• fever, 
• sweating, 
• shivering, 
• fast heart rate, 
• muscle stiffness, 
• twitching, 
• loss of coordination,
• diarrhea, and
• spasm of the ureter, which can lead to difficulty in urinating.

Hydrocodone can impair thinking and the physical abilities required for driving or operating machinery. Hydrocodone can depress breathing and should be used with caution in elderly, debilitated patients and in patients with serious lung disease.

Hydrocodone may be habit-forming. Mental and physical dependence can occur but are unlikely when used for short-term pain relief.

Acetaminophen can cause severe liver failure if excessive amounts are used and when combined with chronic alcohol use or other drugs that also impair liver function.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

• The usual dose for adults is 1 to 2 tablets or capsules (hydrocodone 2.5 to 10 mg; acetaminophen 300 to 750 mg) every 4 to 6 hours, or
• 15 mL of liquid every 4 to 6 hours as needed.

Hydrocodone

• Acute overdose with hydrocodone bitartrate and acetaminophen tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Acetaminophen

• Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdose. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur.
• Early symptoms following a potentially hepatotoxic overdose may include nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor's recommendation.

• Patients receiving other narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with NORCO may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
• The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
• Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first. Here are the drug interactions or adverse effects.

• Hydrocodone/Acetaminophen has severe interactions with the following other drugs:
  • alvimopan
• Hydrocodone/Acetaminophen has serious interactions with at least 94 other drugs. 
• Hydrocodone/Acetaminophen has moderate interactions with at least 156 other drugs.
• Hydrocodone/Acetaminophen has minor interactions with at least 51 other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication. 

• There are no adequate studies of hydrocodone and acetaminophen in pregnant women.
• Hydrocodone/acetaminophen is excreted in breast milk, and, therefore should be used cautiously by nursing mothers.

What preparations of hydrocodone/acetaminophen are available?

Tablets, capsules, and liquid. Among the many brands, the dose of acetaminophen ranges between 300 and 750 mg, and the dose of hydrocodone ranges between 2.5 and 10 mg.

Vicodin was recently reformulated, and the acetaminophen component was reduced to 300 mg in all preparations, however, generic formulations may still contain 500 and 750 mg of acetaminophen.

How should I keep hydrocodone/acetaminophen stored?

Hydrocodone/acetaminophen should be stored at room temperature, between 15 C to 30 C (59 F to 86 F).