July 29, 2016
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Vicodin ES

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Vicodin ES

VICODIN®
VICODIN ES®
VICODIN HP®
(hydrocodone bitartrate and acetaminophen) Tablets, USP




WARNING

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.

DRUG DESCRIPTION

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.

WARNING: May be habit-forming (see PRECAUTIONS, PATIENT INFORMATION /Caregivers, and Drug Abuse And Dependence).

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17- methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

Hydrocodone bitartrate - Structural Formula Illustration

C18H21NO3 •C4H6O6 •2½H2O     M.W. = 494.490

Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Acetaminophen - Structural Formula Illustration

C8H9NO2      M.W. = 151.16

Hydrocodone Bitartrate and Acetaminophen Tablets, USP is available in the following strengths:

VICODIN® : Hydrocodone Bitartrate........................ 5 mg

WARNING: May be habit-forming.

Acetaminophen.................................... 300 mg

VICODIN ES®: Hydrocodone Bitartrate........................ 7.5 mg

WARNING: May be habit-forming.

Acetaminophen.................................... 300 mg

VICODIN HP®: Hydrocodone Bitartrate........................ 10 mg

WARNING: May be habit-forming.

Acetaminophen.................................... 300 mg

In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

This product complies with USP dissolution test 2.

What are the possible side effects of acetaminophen and hydrocodone?

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

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • feeling light-headed, fainting;
  • confusion, fear, unusual thoughts or behavior;
  • seizure (convulsions);
  • problems with urination; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Vicodin ES »

What are the precautions when taking hydrocodone bitartrate and acetaminophen (Vicodin ES)?

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (such as hydromorphone, morphine, codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol,...

Read All Potential Precautions of Vicodin ES »

Last reviewed on RxList: 7/18/2016
This monograph has been modified to include the generic and brand name in many instances.

Vicodin ES - User Reviews

Vicodin ES User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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