Benzhydrocodone and acetaminophen

Generic name: Benzhydrocodone And Acetaminophen
Drug class: Narcotic analgesic combinations

Usage of Benzhydrocodone and acetaminophen

Benzhydrocodone and acetaminophen combination is used to relieve short-term pain (no more than 14 days) in patients who have taken other pain treatments (eg, non-opioid pain medicines) that did not work well.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including serious liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.

Benzhydrocodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When benzhydrocodone is used for a long time, it may become habit-forming, causing mental or physical Dependence when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you suddenly stop taking the medicine. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

Benzhydrocodone and acetaminophen side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blurred vision

confusion

difficult or labored breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

excess air or gas in the stomach or bowels

feeling of warmth

full or bloated feeling

passing gas

pressure in the stomach

redness of the face, neck, arms, and occasionally, upper chest

shakiness in the legs, arms, hands, or feet

stomach pain

sweating

swelling of the stomach area

tightness in the chest

trembling or shaking of the hands or feet

unusual tiredness or weakness

Rare

Agitation

chest discomfort

fainting

false or unusual sense of well-being

heartburn

vomiting

vomiting of blood

Incidence not known

Cough

darkening of the skin

diarrhea

difficulty swallowing

discouragement

dizziness

fast heartbeat

feeling sad or empty

fever

hives, itching, skin rash

irritability

loss of appetite

loss of interest or pleasure

nausea

overactive reflexes

poor coordination

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

restlessness

shivering

talking or acting with excitement you cannot control

trembling or shaking

trouble concentrating

trouble sleeping

twitching

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Black, tarry stools

chills

cold, clammy skin

dark urine

decreased awareness or responsiveness

headache

pale or blue lips, fingernails, or skin

severe sleepiness

unpleasant breath odor

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

Less common

Lack or loss of strength

Rare

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

diarrhea

itching of the eye

nightmare

runny nose

sneezing

stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Benzhydrocodone and acetaminophen

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of benzhydrocodone and acetaminophen combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of benzhydrocodone and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving benzhydrocodone and acetaminophen combination.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Nalmefene

Naltrexone

Safinamide

Samidorphan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir

Acepromazine

Alfentanil

Almotriptan

Alprazolam

Amifampridine

Amineptine

Amiodarone

Amitriptyline

Amitriptylinoxide

Amobarbital

Amoxapine

Amphetamine

Amprenavir

Anileridine

Aprepitant

Aripiprazole

Armodafinil

Asenapine

Atazanavir

Baclofen

Benperidol

Benzphetamine

Boceprevir

Bosentan

Bromazepam

Bromopride

Brompheniramine

Buprenorphine

Bupropion

Buspirone

Butabarbital

Butorphanol

Calcium Oxybate

Cannabidiol

Cannabis

Carbamazepine

Carbinoxamine

Carisoprodol

Carphenazine

Ceritinib

Cetirizine

Chloral Hydrate

Chlordiazepoxide

Chlorpheniramine

Chlorpromazine

Chlorzoxazone

Ciprofloxacin

Citalopram

Clarithromycin

Clobazam

Clomipramine

Clonazepam

Clopidogrel

Clorazepate

Clozapine

Cobicistat

Cocaine

Codeine

Conivaptan

Crizotinib

Cyclobenzaprine

Cyclosporine

Daridorexant

Darunavir

Dasabuvir

Delavirdine

Dexmedetomidine

Dextroamphetamine

Dextromethorphan

Dezocine

Diazepam

Dibenzepin

Dichloralphenazone

Difenoxin

Dihydrocodeine

Diltiazem

Diphenhydramine

Diphenoxylate

Dolasetron

Donepezil

Doxepin

Doxylamine

Dronedarone

Droperidol

Duloxetine

Efavirenz

Eletriptan

Enflurane

Enzalutamide

Erythromycin

Escitalopram

Esketamine

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethchlorvynol

Ethopropazine

Ethylmorphine

Etravirine

Fedratinib

Fenfluramine

Fentanyl

Fexinidazole

Flibanserin

Fluconazole

Fluoxetine

Fluphenazine

Flurazepam

Fluspirilene

Fluvoxamine

Fosamprenavir

Fosaprepitant

Fosnetupitant

Fosphenytoin

Fospropofol

Frovatriptan

Furazolidone

Gabapentin

Gabapentin Enacarbil

Gepirone

Granisetron

Halazepam

Haloperidol

Halothane

Hexobarbital

Hydromorphone

Hydroxytryptophan

Hydroxyzine

Idelalisib

Imatinib

Imipramine

Indinavir

Iproniazid

Isocarboxazid

Isoflurane

Isoniazid

Itraconazole

Ivacaftor

Ketamine

Ketazolam

Ketobemidone

Ketoconazole

Lacosamide

Lasmiditan

Lemborexant

Lenacapavir

Levocetirizine

Levomilnacipran

Levorphanol

Linezolid

Lisdexamfetamine

Lithium

Lofepramine

Lofexidine

Lomitapide

Lopinavir

Lorazepam

Lorcaserin

Loxapine

Lumacaftor

Magnesium Oxybate

Mavacamten

Meclizine

Melitracen

Melperone

Meperidine

Mephobarbital

Meprobamate

Meptazinol

Mesoridazine

Metaxalone

Methadone

Methamphetamine

Methdilazine

Methocarbamol

Methohexital

Methotrimeprazine

Methylene Blue

Metoclopramide

Mibefradil

Midazolam

Mifepristone

Milnacipran

Mirtazapine

Mitotane

Moclobemide

Modafinil

Molindone

Moricizine

Morphine

Morphine Sulfate Liposome

Nafcillin

Nalbuphine

Naratriptan

Nefazodone

Nelfinavir

Netupitant

Nevirapine

Nialamide

Nicomorphine

Nilotinib

Nitrazepam

Nitrous Oxide

Nortriptyline

Olanzapine

Omaveloxolone

Ombitasvir

Ondansetron

Opipramol

Opium

Opium Alkaloids

Orphenadrine

Oxazepam

Oxcarbazepine

Oxycodone

Oxymorphone

Ozanimod

Palbociclib

Palonosetron

Papaveretum

Paregoric

Paritaprevir

Paroxetine

Pentazocine

Pentobarbital

Perampanel

Perazine

Periciazine

Perphenazine

Phenelzine

Phenobarbital

Phenytoin

Piperacetazine

Pipotiazine

Piritramide

Pixantrone

Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate

Posaconazole

Potassium Oxybate

Prazepam

Prednisone

Pregabalin

Primidone

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propofol

Protriptyline

Quazepam

Quetiapine

Ramelteon

Ranitidine

Ranolazine

Rasagiline

Remifentanil

Remimazolam

Remoxipride

Rifabutin

Rifampin

Rifapentine

Ritonavir

Rizatriptan

RoPeginterferon Alfa-2b-njft

Saquinavir

Scopolamine

Secobarbital

Selegiline

Sertindole

Sertraline

Sibutramine

Sodium Oxybate

St John's Wort

Sufentanil

Sulpiride

Sumatriptan

Suvorexant

Tapentadol

Telaprevir

Telithromycin

Temazepam

Thiethylperazine

Thiopental

Thiopropazate

Thioridazine

Tianeptine

Tilidine

Tizanidine

Tolonium Chloride

Topiramate

Tramadol

Tranylcypromine

Trazodone

Triazolam

Trifluoperazine

Trifluperidol

Triflupromazine

Trimeprazine

Trimipramine

Tryptophan

Venlafaxine

Verapamil

Vilazodone

Voriconazole

Vortioxetine

Zaleplon

Ziprasidone

Zolmitriptan

Zolpidem

Zopiclone

Zotepine

Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Carbamazepine

Fosphenytoin

Lixisenatide

Phenytoin

Warfarin

Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage

Relate drugs

How to use Benzhydrocodone and acetaminophen

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of benzhydrocodone and acetaminophen combination. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours), as this may increase the risk for serious liver problems.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For acute pain:

For oral dosage form (tablets):

Adults—1 to 2 tablets every 4 to 6 hours as needed. However, the dose should not be more than 12 tablets per day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm .

Warnings

It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone and other medicines to treat an overdose.Signs of an overdose include: dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

For nursing mothers taking this medicine:

Talk to your doctor if you have any questions about taking benzhydrocodone or about how this medicine may affect your baby.

Call your doctor if you become extremely tired and have difficulty caring for your baby.

Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.

Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

This medicine may cause serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a cough, dizziness, fast heartbeat, hives, rash, itching, puffiness or swelling of the eyelids, or around the eyes, face, lips, or tongue, tightness in the chest, trouble breathing or swallowing, or unusual tiredness or weakness while you are using this medicine.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink 3 or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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