Acetaminophen and benzhydrocodone

Generic name: Acetaminophen And Benzhydrocodone
Brand names: Apadaz
Dosage form: oral tablet (325 mg-4.08 mg; 325 mg-6.12 mg; 325 mg-8.16 mg)
Drug class: Narcotic analgesic combinations

Usage of Acetaminophen and benzhydrocodone

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

Acetaminophen and benzhydrocodone contains an opioid cough medicine, and may be habit-forming.

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

Acetaminophen and benzhydrocodone side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

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 acetaminophen and benzhydrocodone and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Acetaminophen and benzhydrocodone may cause serious side effects. Call your doctor at once if you have:

noisy breathing, sighing, shallow breathing, breathing that stops;

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

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

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

high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects include:

dizziness, drowsiness, feeling tired;

nausea, vomiting, stomach pain;

constipation; or

headache.

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.

Before taking Acetaminophen and benzhydrocodone

You should not use acetaminophen and benzhydrocodone if you are allergic to acetaminophen or hydrocodone, or if you have:

severe asthma or breathing problems; or

a blockage in your stomach or intestines.

Tell your doctor if you have ever had:

breathing problems, sleep apnea (breathing stops during sleep);

liver disease;

a drug or alcohol addiction;

kidney disease;

a head injury or seizures;

urination problems; or

problems with your thyroid, pancreas, or gallbladder.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Relate drugs

How to use Acetaminophen and benzhydrocodone

Usual Adult Dose for Pain:

Individualize therapy taking into account severity of pain, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse: As First Opioid Analgesic: Initial dose: 1 or 2 tablets (acetaminophen 325 to 650 mg/benzhydrocodone 6.12 to 12.24 mg) orally every 4 to 6 hours as needed for pain-Titrate to a dose that provides adequate analgesia and minimizes adverse reactions Maximum dose: 12 tablets/24 hoursMaximum acetaminophen dose (including all acetaminophen-containing products): 4000 mg in a 24-hour periodDuration of therapy: 7 to 14 daysEquivalence to Hydrocodone Bitartrate: -Benzhydrocodone 4.08 mg equivalent to hydrocodone bitartrate 5 mg-Benzhydrocodone 6.12 mg equivalent to hydrocodone bitartrate 7.5 mg -Benzhydrocodone 8.16 mg equivalent to hydrocodone bitartrate 10 mgComments:-This drug should be reserved for patients for whom alternative treatment options (e.g. non-opoid analgesics) have not been tolerated or are not expected to be tolerated; OR have not provided adequate analgesia or are not expected to provide adequate analgesia. -Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. -Monitor closely for respiratory depression, especially in the first 24 to 72 hours of initiating therapy and following any increase in dose.-As with all opioid drugs and opioid formulations, inter-patient variability is possible; if converting from other opioids to this drug, it is safer to underestimate patient requirements than overestimate dose and manage an adverse reaction due to overdose. Use: For the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Warnings

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

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.

What other drugs will affect Acetaminophen and benzhydrocodone

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

other opioids--opioid pain medicine or prescription cough medicine;

a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;

drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect acetaminophen and benzhydrocodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Disclaimer

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