Vicodin Hydrocodone Bitartrate and Acetaminophen

Get an overview of VICODIN (hydrocodone bitartrate and acetaminophen tablet), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Vicodin can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Vicodin.

Drug Basics

Brand Name: Vicodin

Generic Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Data Current As Of: 2018-11-15

indications & usage

Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

  • have not been tolerated, or are not expected to be tolerated,
  • have not provided adequate analgesia, or are not expected to provide adequate analgesia

contraindications

Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with:

adverse reactions

The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting.

Other adverse reactions include:

Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes.

Gastrointestinal System: Constipation.

Genitourinary System: Ureteral spasm, spasm of vesical sphincters, and urinary retention.

Special Senses: Cases of hearing impairment or permanent loss have been reported predominately in patients with chronic overdose.

Dermatological: Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions.

Hematological: Thrombocytopenia, agranulocytosis.

  • Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
  • Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
  • Anaphylaxis: Anaphylaxis has been reported with ingredients contained in hydrocodone bitartrate and acetaminophen tablets.
  • Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY ].

medication guide

MEDICATION GUIDE

VICODIN (vye" koe din)

VICODIN ES

VICODIN HP

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, CII

Vicodin is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Vicodin:

  • Get emergency help right away if you take too much Vicodin (overdose). When you first start taking Vicodin, 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 Vicodin 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 Vicodin. They could die from taking it. Store Vicodin away from children and in a safe place to prevent stealing or abuse. Selling or giving away Vicodin is against the law.

Do not take Vicodinif 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 Vicodin

Before taking Vicodin, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of Vicodin during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Hydrocodone bitartrate and acetaminophen pass into breast milk and may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Vicodin with certain other medicines can cause serious side effects that could lead to death.

When takingVicodin:

  • Do not change your dose. Take Vicodin exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every four to six hours as needed for pain.
  • Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking Vicodin regularly, do not stop taking Vicodin without talking to your healthcare provider.
  • After you stop taking Vicodin, the unused tablets should be disposed of by flushing down the toilet.

While taking VicodinDO NOT:

  • Drive or operate heavy machinery, until you know how Vicodin affects you. Vicodin can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Vicodin may cause you to overdose and die.

The possible side effects of Vicodin:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of Vicodin. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Manufactured for:

AbbVie Inc.

North Chicago, IL 60064 U.S.A.

Manufactured by:

Mikart, Inc.

Atlanta, GA 30318

1122F00

Rev. 02/17

medication guide

NDC 0074–3054–13

Vicodin HP ® (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP

CII

10 mg / 300 mg

Dispense the accompanying Medication Guide to each patient.

100 Tablets

Rx only abbvie

1a30b1ca 6ada 45aa 9263 2aa1be89138b 03.jpg

NDC 0074–3043–13

Vicodin ES ® (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP

CII

7.5 mg / 300 mg

Dispense the accompanying Medication Guide to each patient.

100 Tablets

Rx only abbvie

1a30b1ca 6ada 45aa 9263 2aa1be89138b 04.jpg

NDC 0074–3041–13

Vicodin ® (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP

CII

5 mg / 300 mg

Dispense the accompanying Medication Guide to each patient.

100 Tablets

Rx only abbvie

1a30b1ca 6ada 45aa 9263 2aa1be89138b 05.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. 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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