VICODIN® 5 mg/300 mg, VICODIN ES® 7.5 mg/300 mg, and VICODIN HP® 10 mg/300 mg (hydrocodone bitartrate and acetaminophen) tablets, USP are indicated for the relief of moderate to moderately severe pain.
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 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.
VICODIN, VICODIN ES, and VICODIN HP tablets are contraindicated in patients who have hypersensitivity to the drugs or their inactive ingredients. VICODIN formulations contain hydrocodone, which is an opioid agonist and a Schedule III controlled substance with an abuse liability and that can cause dependence. It may cause dose-related respiratory depression in sensitive patients and caution should be exercised when prescribing to elderly or debilitated patients. The concomitant use with other central nervous system (CNS) depressants and monoamine oxidase (MAO) inhibitors or tricyclic antidepressants may increase the effect of either drug. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent.
Frequently Asked Questions
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Is AbbVie's Vicodin a brand or generic product?
AbbVie's Vicodin, which contains 5 mg/300 mg, 7.5 mg/300 mg, or 10 mg/300 mg, is a generic product. This means patients will pay a generic co-pay at the pharmacy.
Why am I seeing prescriptions for “Vicodin,” “Vicodin ES,” and “Vicodin HP,” but I'm not seeing prescriptions for the 300 mg product?
When you receive a prescription that says “Vicodin,” “Vicodin ES,” or “Vicodin HP” on it and the product strength is not included, remember that this product is only available with 300 mg acetaminophen.
This means that a product with 300 mg of acetaminophen, together with the appropriate hydrocodone strength, should be dispensed.
What does AbbVie's Vicodin look like?
The formulations of Vicodin look like this1:
Risks Associated With Acetaminophen Content
What is the risk of liver toxicity and acetaminophen-related overdose?
Information about the risk of liver toxicity and overdose associated with acetaminophen can be found on the FDA website at http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm2 and by clicking on the link “Additional Information for Healthcare Professionals.” Additional information can be found in the Vicodin Prescribing Information.
How should I counsel my patients about the risks of liver toxicity and overdose associated with acetaminophen?
You can find information to help counsel patients about liver toxicity and overdose associated with acetaminophen on the FDA website at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm168830.htm.3
How can I get information on the risks associated with the opioid component of Vicodin?
What is the recommended maximum daily dose of acetaminophen?
Patients should not exceed the maximum dose of 4000 mg (4 g) of acetaminophen within a 24-hour period.1,4
How can I report negative side effects?
You can assist us with monitoring the safety of Vicodin by reporting negative side effects to AbbVie at 1-800-633-9110. You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Information Regarding Patients
What should I tell my patients about AbbVie's Vicodin?
You should tell your patients that versions of AbbVie's Vicodin have a lower acetaminophen content in accordance with the U.S. Food and Drug Administration's (FDA) request to drug companies to limit the amount of acetaminophen in prescription medications.2 You should also tell your patients that they should not exceed the maximum dose of 4000 mg (4 g) of acetaminophen within a 24-hour period. You can direct patients to the FDA website at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm239871.htm for more information.4
Does AbbVie provide co-pay assistance for my patients who take Vicodin?
AbbVie does not offer co-pay assistance for patients taking Vicodin. Vicodin is a generic product. This means patients will pay a generic co-pay at the pharmacy.
How should my patients properly dispose of their medications?
You may advise patients of the following steps to properly dispose of their medications5:
- Start by taking inventory of the prescription drugs in your home.
- Discard expired or unused prescription drugs when children or teens are not at home.
- The best disposal method is to mix medications with undesirable substances like coffee grounds or kitty litter.
- Do not flush medication down the toilet.
For more information, please visit http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm.