Vicodin

Do not use this medication if you are allergic to acetaminophen (Tylenol) or hydrocodone.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

To make sure you can safely take acetaminophen and hydrocodone, tell your doctor if you have any of these other conditions:

• asthma, COPD, sleep apnea, or other breathing disorders;
• liver or kidney disease;
• a history of head injury or brain tumor;
• low blood pressure;
• a stomach or intestinal disorder;
• underactive thyroid;
• Addison's disease or other adrenal gland disorder;
• curvature of the spine;
• mental illness; or
• a history of drug or alcohol addiction.

Hydrocodone may be habit forming and should be used only by the person it was prescribed for. Never share acetaminophen and hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Serious side effects have been reported with Vicodin. See the "Vicodin Precautions" page.

Common side effects of Vicodin include:

• Nausea
• Vomiting
• Sedation
• Lightheadedness
• Dizziness

This is not a complete list of Vicodin 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.

Grapefruit and grapefruit juice may interact with Vicodin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Tell your doctor if you are breastfeeding or plan to breastfeed. Lactation studies with Vicodin therapy have not been done in humans. Acetaminophen is excreted in human milk in small amounts; however, it is unknown if hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse effects in nursing infants, a decision should be made to discontinue nursing or discontinue Vicodin.

• If you have an allergy to hydrocodone, acetaminophen, or any other part of Vicodin.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.

This is not a list of all drugs or health problems that interact with Vicodin.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.

Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone.

Controlled Substance

Hydrocone bitartrate and acetaminophen tablets is classified as a Schedule II controlled substance.

Abuse and Dependence

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets are used for a short time for the treatment of pain.

Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

PHARMACIST: Dispense in a tight, light-resistant container with a child-resistant closure.

A Schedule II Narcotic

© AbbVie Inc. 2014
Manufactured for
AbbVie Inc.
North Chicago, IL 60064 U.S.A.

Manufactured by:
Mikart, Inc.
Atlanta, GA 30318

1122F00 Rev. 08/14 August, 2014

NDC 0074–3054–53

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

CII

10 mg / 300 mg

500 Tablets

Rx only abbvie

NDC 0074–3043–13

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

CII

7.5 mg / 300 mg

100 Tablets

Rx only abbvie

NDC 0074–3041–13

Vicodin® (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP

CII

5 mg / 300 mg

100 Tablets

Rx only abbvie

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

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Vicodin and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Call your doctor at once if you have:

• shallow breathing, slow heartbeat;

• a light-headed feeling, like you might pass out;

• confusion, unusual thoughts or behavior;

• seizure (convulsions);

• easy bruising or bleeding;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex;

• liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Vicodin side effects include:

• drowsiness, headache;

• upset stomach, constipation;

• blurred vision; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• May be taken with or without food.
• Intended for short-term use only. Long-term use may lead to addiction and dependence. Vicodin may need to be discontinued slowly depending on the duration of use. Talk to your doctor about a tapering schedule.
• May cause drowsiness which may impair your reaction skills and affect your ability to drive or operate machinery (hydrocodone component). Avoid alcohol.
• Avoid alcohol while taking Vicodin. Alcohol can contribute to the sedative effects of hydrocodone and also increase the risk of respiratory depression.
• Different strengths of Vicodin are available. Make sure you take the correct tablet and do not exceed the recommended dosage.
• Vicodin may make you feel dizzy when getting up from a lying down or sitting position to standing. Always get up slowly, but talk with your doctor if this dizziness results in a fall.
• Vicodin may cause constipation which can be relieved with laxatives. Talk to your doctor if you experience any troublesome side effects.
• Seek urgent medical advice if you experience any excessive sedation, breathing difficulties, wheezing, rash, itching, or facial swelling. Call emergency services if you suspect somebody has overdosed on Vicodin (pinpoint pupils may be indicative of overdosage).
• Tell your doctor if you think you have become addicted to this combination drug or the usual dosage does not appear to be working.
• Avoid taking extra acetaminophen while taking Vicodin. Be especially cautious when taking cough and cold remedies in addition to Vicodin. Some of these may also contain acetaminophen. Always check with your doctor or pharmacist that products you buy over-the-counter are compatible with Vicodin
• Do not use during pregnancy and breastfeeding unless specifically recommended by your doctor.
• Keep this medicine in a safe place and out of the reach of children and pets. Accidental ingestion can result in a fatal overdose of Vicodin, especially in children, and acetaminophen is toxic to dogs and cats. Never give Vicodin to children without a doctor's advice.

• It takes approximately 1.3 hours for the hydrocodone component of Vicodin to reach peak concentrations. Hydrocodone is metabolized entirely by the CYP2D6 hepatic enzymes to hydromorphone. The pain and cough-relieving effects of hydrocodone last for three to four hours; however it may take a day or two for hydrocodone and its metabolite hydromorphone to be completely cleared by the body.
• The peak analgesic effects of acetaminophen are reached within 30 to 60 minutes of oral administration and last for three to four hours.
• Note that up to 10% of Caucasians, 6% of Mexican-Americans, and 5% of African-Americans are poor metabolizers at CYP2D6 and are unlikely to metabolize hydrocodone into hydromorphone, which may limit its effect. 30% of Ethiopians, 20% of Saudis, 10% of Portuguese and Greeks, and 4% of North Americans are ultra-rapid metabolizers at CYP 2D6 and may experience excessive side effects, such as extreme sleepiness, confusion, and shallow breathing, even with normal dosages of Vicodin.

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Hydrocodone is an opioid pain medication, sometimes called a narcotic.

Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

Acetaminophen and hydrocodone is a combination medicine used to relieve moderate to severe pain.

Acetaminophen and hydrocodone may also be used for purposes not listed in this medication guide.

This medicine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have pain in your upper stomach, loss of appetite, dark urine, or jaundice (yellowing of your skin or eyes).

Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.