Hydrocodone and Acetaminophen

Hydrocodone/acetaminophen is a prescription medication used to treat moderate to moderately severe pain.

It is a single product containing 2 medications: hydrocodone and acetaminophen. Hydrocodone belongs to a group of drugs called narcotic analgesics. These work by changing the way that the brain and nervous system respond to pain. Acetaminophen belongs to a group of drugs called analgesics and antipyretics. These work by changing the way the body feels pain and by cooling the body.

This medication comes in tablet and oral solution forms and is taken every 4 to 6 hours.

Common side effects of hydrocodone/acetaminophen include lightheadedness, sedation, nausea, and vomiting.

Hydrocodone/acetaminophen can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how hydrocodone/acetaminophen affects you.

Hydrocodone/acetaminophen is a prescription medication used to treat moderate to moderately severe pain.

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

Hydrocodone and Acetaminophen may be found in some form under the following brand names:

• Anexsia

• Hycet

• Lorcet

• Lortab

• Maxidone

• Norco

• Stagesic

• Vicodin

• Xodol

• Zamicet

• Zolvit

• Zydone

Serious side effects have been reported with hydrocodone/acetaminophen. See the “Hydrocodone and Acetaminophen Precautions” section.

Common side effects of hydrocodone/acetaminophen include the following:

• lightheadedness
• dizziness
• sedation
• nausea and vomiting

This is not a complete list of hydrocodone/acetaminophen side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other narcotic analgesics
• antihistamines such as diphenhydramine (Benadryl)
• antipsychotics such as paliperidone (Invega), lurasidone (Latuda), olanzapine (Zyprexa), aripiprazole (Abilify), asenapine (Saphris), iloperidone (Fanapt), haloperidol (Haldol), prochlorperazine (Compazine), chlorpromazine (Thorazine), clozapine (Clozaril), risperidone (Risperdal), quetiapine (Seroquel), and ziprasidone (Geodon)
• antianxiety agents such as alprazolam (Xanax), diazepam (Valium), and lorazepam (Ativan)
• CNS depressants (including alcohol)
• MAO inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)

This is not a complete list of hydrocodone/acetaminophen drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with hydrocodone/acetaminophen.

At high doses or in sensitive patients, hydrocodone may produce respiratory depression. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. The respiratory depressant effects of hydrocodone may be exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Hydrocodone may also produce adverse reactions that may obscure the clinical course of patients with head injuries.

Hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Hydrocodone suppresses the cough reflex; caution should be exercised when hydrocodone/acetaminophen is used postoperatively and in patients with pulmonary disease.

Hydrocodone/acetaminophen should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.

Hydrocodone/acetaminophen can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how hydrocodone/acetaminophen affects you.

Do not take hydrocodone/acetaminophen if you are allergic to hydrocodone/acetaminophen or to any of its ingredients or are allergic to any other opioid medication.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of hydrocodone/acetaminophen, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking hydrocodone/acetaminophen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to hydrocodone/acetaminophen or to any of its ingredients or are allergic to any other opioid medication
• have or have ever had low blood pressure
• have or have ever had difficulty urinating
• have or have ever had seizures
• have or have ever had thyroid disease
• have or have ever had gall bladder disease
• have or have ever had pancreas disease
• have or have ever had liver disease
• have or have ever had kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Hydrocodone/acetaminophen falls into category C. There are no well-controlled studies that have been done in pregnant women. Hydrocodone/acetaminophen should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Acetaminophen has been detected in human breast milk. It is not known if hydrocodone crosses into human milk. Because of the possibility for adverse reactions in nursing infants from hydrocodone/acetaminophen, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take hydrocodone/acetaminophen exactly as prescribed.

This medication comes in tablet and oral solution forms and is taken every 4 to 6 hours.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of hydrocodone/acetaminophen at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The dosage of hydrocodone/acetaminophen should be adjusted according to the severity of the pain and response of the patient. However, it is important to remember that tolerance to hydrocodone can develop with continued use and that the incidence of adverse effects is dose-related.

If you take too much hydrocodone/acetaminophen, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If hydrocodone/acetaminophen is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store hydrocodone/acetaminophen at room temperature.
• Protect from exposure to light.
• Keep this and all medicines out of the reach of children.

HEPATOTOXICITY

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product.