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Generic Name: acetaminophen/hydrocodone (a-SEET-a-MIN-oh-fen/HYE-droe-KOE-done)
Brand Name: Examples include Dolacet and Stagesic
Dolacet contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.
Dolacet is used for:
Treating moderate to moderately severe pain. It may also be used for other conditions as determined by your doctor.
Dolacet is an analgesic combination. Acetaminophen works by lowering a chemical in the brain that stimulates pain nerves. Hydrocodone, an opioid (narcotic) analgesic, works by binding to receptors in the brain and nervous system used by the body's natural "pain relievers." The combination may provide better pain relief than either medicine alone.
Do NOT use Dolacet if:
- you are allergic to any ingredient in Dolacet
- you have diarrhea associated with poisoning, antibiotic use, or a bacterial infection (from eating or drinking contaminated food or water)
- you are taking sodium oxybate (GHB)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Dolacet:
Some medical conditions may interact with Dolacet. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are allergic to other narcotic medicines (eg, medicines that contain codeine, morphine, oxycodone)
- if you have or have ever had alcoholism, substance abuse, narcotic dependence, or if you consume more than 3 alcoholic drinks per day
- if you have a history of suicidal thoughts or behavior
- if you have a head injury, increased pressure in the head, a brain injury or tumor, epilepsy, or seizures
- if you are having an asthma attack
- if you have an acute stomach or intestinal problem, chronic inflammation and ulceration of the bowel, or you have had recent abdominal surgery
- if you have adrenal gland problems; enlargement of the prostate gland; heart failure or lung disease, including shortness of breath; liver or kidney problems; thyroid disease; urinary blockage; or viral hepatitis
Some MEDICINES MAY INTERACT with Dolacet. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Barbiturate anesthetics (eg, thiopental), cimetidine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because serious side effects, such as increased sleepiness and decreased ability to breathe, may occur
- Naltrexone because it may decrease the effectiveness of Dolacet and withdrawal symptoms may occur in patients who have become physically dependent on opioids
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dolacet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Dolacet:
Use Dolacet as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Dolacet by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- If you miss a dose of Dolacet, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Dolacet.
Important safety information:
- Dolacet may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Dolacet with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Dolacet; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Dolacet may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
- Dolacet has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Dolacet may harm your liver. Your risk may be greater if you drink alcohol while you are using Dolacet. Talk to your doctor before you take Dolacet or other fever reducers if you drink more than 3 drinks with alcohol per day.
- Use Dolacet with caution in the ELDERLY; they may be more sensitive to its effects, especially possible decreased breathing and drowsiness.
- Dolacet should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dolacet while you are pregnant. Dolacet is found in breast milk. Do not breast-feed while taking Dolacet.
When used for long periods of time or at high doses, Dolacet may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Dolacet stops working well. Do not take more than prescribed.
Some people who use Dolacet for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.
If you suddenly stop taking Dolacet, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
Possible side effects of Dolacet:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Blurred vision; constipation; dizziness; drowsiness; flushing; light-headedness; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; change in the amount of urine produced; fear; hearing change or loss; interrupted breathing; mental or mood changes; unusual tiredness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin; cold/clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizure; stomach or intestinal pain.Proper storage of Dolacet:
Store Dolacet at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not refrigerate. Do not freeze. Dispense in a tight, light-resistant container. Do not store in the bathroom. Keep Dolacet out of the reach of children and away from pets.
- If you have any questions about Dolacet, please talk with your doctor, pharmacist, or other health care provider.
- Dolacet is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Dolacet. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.