Acetaminophen and hydrocodone

Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Hydrocodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away acetaminophen and hydrocodone is against the law.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using acetaminophen and hydrocodone.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor.

Since acetaminophen and hydrocodone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: 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 this medicine 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 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.

Hydrocodone is in a group of drugs called narcotic pain relievers.

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

The combination of acetaminophen and hydrocodone is used to relieve moderate to severe pain.

Acetaminophen and hydrocodone may also be used for purposes other than those listed in this medication guide.

Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing.

Dosage adjustments in patients with renal dysfunction should be done cautiously.

Some dosage units may contain up to 325 mg of acetaminophen per unit.

Usual acetaminophen maximum dosage is 4 g per day.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Drowsiness or dizziness which may impair reaction skills and affect a person's ability to drive or operate machinery (hydrocodone component). Avoid alcohol.
• Stomach upsets including nausea, vomiting, and constipation (laxatives may be required); shortness of breath; dizziness; and low blood pressure (hydrocodone component). Hydrocodone may be more likely to cause constipation than other opioids such as oxycodone.
• Excessive dosages of acetaminophen can lead to liver injury or death. Care must be taken not to take additional acetaminophen from other sources.
• Unlike NSAID pain relievers like ibuprofen, acetaminophen does not have any appreciable anti-inflammatory action.
• Hydrocodone is habit forming and potentially abusable. The combination of acetaminophen and hydrocodone should only be used short-term at the lowest effective dose when other nonopioid analgesics are not effective. Legitimate supplies of products containing hydrocodone may be sought out by drug seekers. Hydrocodone is one of the most abused opioids in the United States.
• Abrupt discontinuation of any hydrocodone-containing medication in a person who has become physically dependent on it may lead to a withdrawal syndrome and symptoms such as restlessness, pupil dilation, watery eyes and a runny nose, sweating, muscle aches, insomnia, irritability and gastrointestinal complaints. Babies born to mothers who are physically dependent on hydrocodone will also be physically dependent.
• Rarely, serious, life-threatening, breathing problems may occur attributable to the hydrocodone component. The risk is greater with higher dosages of acetaminophen/hydrocodone, in people with pre-existing respiratory disease, in seniors or the frail, or in those taking other medications that cause respiratory depression (such as benzodiazepines).
• Interaction or overdosage may also cause serotonin syndrome. Symptoms include mental status changes such as agitation, hallucinations, coma, or delirium; a fast heart rate; dizziness; flushing; muscle tremor or rigidity; and stomach symptoms (including nausea, vomiting, and diarrhea).
• May not be suitable for people with pre-existing respiratory depression or respiratory disease, with seizure disorders or a head injury, people with gastrointestinal obstruction, or recent use of monoamine oxidase inhibitors.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (acetaminophen and hydrocodone) Excreted into animal milk: Yes (acetaminophen and hydrocodone) There have been reports of rash, drowsiness, limpness, and lethargy in breastfed infants of mothers taking acetaminophen-hydrocodone.