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APADAZ (benzhydrocodone HCl/acetaminophen)
- Acute pain
benzhydrocodone 4.08 mg-acetaminophen 325 mg tablet
- 1 tablet by oral route every 4-6 hours as needed
benzhydrocodone 6.12 mg-acetaminophen 325 mg tablet
- 1 tablet by oral route every 4-6 hours as needed
benzhydrocodone 8.16 mg-acetaminophen 325 mg tablet
- 1 tablet by oral route every 4-6 hours as needed
4.08 mg-325 mg tablet
- 1 tablet by oral route every 4-6 hours as needed
6.12 mg-325 mg tablet
- 1 tablet by oral route every 4-6 hours as needed
8.16 mg-325 mg tablet
- 1 tablet by oral route every 4-6 hours as needed
Acute pain
- 1 tablet by oral route every 4 hours as needed
- 1 tablet by oral route every 6 hours as needed
- 1 tablet by oral route every 4-6 hours as needed
- 2 tablets by oral route every 6 hours as needed
- 2 tablets by oral route every 4 hours as needed
- 2 tablets by oral route every 4-6 hours as needed
- Depade
- naltrexone
- naltrexone microspheres
- Revia
- Vivitrol
Contraindicated
- amoxicil-clarithromy-lansopraz
- Biaxin
- Biaxin Xl
- Biaxin Xl Pak
- boceprevir
- clarithromycin
- conivaptan in 5 % dextrose
- Crixivan
- Diflucan
- elvitegr-cobicist-emtric-tenof
- Erythrocin
- erythromycin
- erythromycin-sulfisoxazole
- fluconazole
- fluconazole in dextrose(iso-o)
- fluconazole in NaCl (iso-osm)
- Incivek
- indinavir
- Invirase
- itraconazole
- Kaletra
- Ketek
- ketoconazole
- lopinavir-ritonavir
- nefazodone
- nelfinavir
- Norvir
- Norvir Soft Gelatin
- Noxafil
- Omeclamox-pak
- omeprazole-clarith-amoxicillin
- Onmel
- posaconazole
- Prevpac
- ritonavir
- saquinavir mesylate
- sodium oxybate
- Sporanox
- Sporanox Pulsepak
- Stribild
- telaprevir
- telithromycin
- Vaprisol
- Vfend
- Vfend Iv
- Victrelis
- Viracept
- voriconazole
- Xyrem
Severe
Moderate
- Acid Reducer (cimetidine)
- Acid Relief (cimetidine)
- aprepitant
- atazanavir
- Buprenex
- buprenorphine
- buprenorphine-naloxone
- butorphanol tartrate
- Butrans
- Calan
- Calan Sr
- Cardizem
- Cardizem Cd
- Cardizem La
- Cartia Xt
- cimetidine
- Cipro
- Cipro In D5W
- Cipro Xr
- ciprofloxacin
- ciprofloxacin (mixture)
- ciprofloxacin in D5W
- Coumadin
- darunavir
- Dilacor Xr
- Dilt-xr
- diltiazem HCl
- dronedarone
- Emend
- Fanatrex
- fosamprenavir
- fosaprepitant
- gabapentin
- gabapentin enacarbil
- Gleevec
- Gralise
- Gralise 30-day Starter Pack
- Heartburn Relief
- Horizant
- imatinib
- isoniazid
- isoniazid-rifamp-pyrazinamide
- Jantoven
- Lexiva
- Matzim La
- Multaq
- nalbuphine
- Neurontin
- Prezista
- Reyataz
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- Rifater
- Suboxone
- Tagamet Hb
- Tarka
- Taztia Xt
- Tiazac
- trandolapril-verapamil
- verapamil
- Verelan
- Verelan Pm
- warfarin
- Zubsolv
- Acetaminophen overdose
- Acute hepatic failure
- Acute hepatitis C
- Acutely deteriorating asthma
- Paralytic ileus
- Sleep apnea
Contraindicated
- Alcohol intoxication
- Coma
- Dehydration
- Disease of liver
- Drug abuse
- Gastrointestinal obstruction
- History of opioid overdose
- Hypercapnia
- Hypotension
- Inflammatory bowel disease
- Intracranial hypertension
- Kidney disease with reduction in GFR
- Morbid obesity
- Neoplasm of brain
- Protein-calorie malnutrition
- Respiratory depression
- Severe hepatic disease
- Severe renal impairment
- Shock
- Systemic mastocytosis
- Toxic psychosis
- Untreated hypothyroidism
- Urethral stricture
- Urinary retention
Severe
Moderate
- Acute abdominal pain
- Acute pancreatitis
- Adrenal cortical insufficiency
- Alcohol withdrawal delirium
- Benign prostatic hyperplasia
- Biliary spasm
- Bradycardia
- Chronic obstructive pulmonary disease
- Constipation
- Cor pulmonale
- Debilitation
- Esophageal dysmotility
- Gallbladder disease
- Gastrointestinal tract surgery
- Primary adrenocortical insufficiency
- Seizure disorder
APADAZ (benzhydrocodone HCl/acetaminophen)
- Acute pain
- None
- Constipation
- Dizziness
- Drowsy
- General weakness
- Hypotension
- Malaise
- Nausea
- Sedation
- Syncope
More Frequent
Severe
Less Severe
- Abnormal hepatic function tests
- Angioedema
- Atelectasis
- Bradycardia
- Bronchospastic pulmonary disease
- CNS depression
- Dyspnea
- Laryngeal edema
- Laryngismus
- Pulse changes
- Respiratory depression
- Tachycardia
- Acute abdominal pain
- Acute confusion
- Anorexia
- Arthralgias
- Back pain
- Blurred vision
- Diplopia
- Dysphoric mood
- False sense of well-being
- Fatigue
- Flushing
- Gastroesophageal reflux disease
- Headache disorder
- Hyperhidrosis
- Lethargy
- Mood changes
- Muscle spasm
- Myalgias
- Nervousness
- Night sweats
- Opioid dependence
- Orthostatic hypotension
- Peripheral edema
- Symptoms of anxiety
- Tremor
- Upper respiratory infection
- Ureteral spasm
- Urinary tract infection
- Visual changes
- Vomiting
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Accidental fall
- Acute generalized exanthematous pustulosis
- Acute hepatic failure
- Adrenal cortical insufficiency
- Agranulocytosis
- Allergic dermatitis
- Anaphylaxis
- Angioedema
- Biliary spasm
- Dehydration
- Depression
- Disorder of adrenal gland
- Drug-induced hepatitis
- Female hypogonadism
- Fever
- Hallucinations
- Hearing loss
- Hypertension
- Hypokalemia
- Ileus
- Increased cerebrospinal fluid pressure
- Involuntary muscle movement
- Ischemic colitis
- Laryngeal edema
- Leukopenia
- Maculopapular rash
- Male hypogonadism
- Muscle rigidity
- Neutropenic disorder
- Pancreatitis
- Paralytic ileus
- Seizure disorder
- Skin rash
- Stevens-johnson syndrome
- Thrombocytopenic disorder
- Tinnitus
- Toxic epidermal necrolysis
- Urticaria
Less Severe
- Androgen deficiency
- Ataxia
- Dysgeusia
- Dysphagia
- Elevated serum amylase
- Erectile dysfunction
- Erythema
- Gastrointestinal irritation
- Infertility
- Insomnia
- Libido changes
- Medication overuse headache
- Migraine
- Musculoskeletal pain
- Neck pain
- Nightmares
- Paresthesia
- Pruritus of skin
- Skin rash
- Urticaria
Contraindicated
None
Severe Precaution
Benzhydrocodone
Risk of respiratory and CNS depression. No safety/efficacy age < 18 years.
- 1 Day – 18 Years
- Risk of respiratory and CNS depression. No safety/efficacy age < 18 years.
Management or Monitoring Precaution
Acetaminophen (oral,rectal)
Use weight based dosing in children less than 12 years.
- 1 Day – 12 Years
- Use weight based dosing in children less than 12 years.
Benzhydrocodone-acetaminophen
- Severity Level:
2
- Additional Notes: Neonatal withdrawal/resp.depress. w/chronic or high dose
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Acetaminophen/benzhydrocodone
Monitor for changes in respiration, gi effects, sedation, feeding patterns
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Excreted | Not known; no or inclusive data | Monitor for changes in respiration, gi effects, sedation, feeding patterns |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Acetaminophen (oral,rectal)
Hepatic-Elderly may be more susceptible to hepatotoxicity. Strict adherence to a maximum daily dose is recommended, and the maximum dose recommendation varies between 3000-3800 mg depending on strength used and source of the recommendation.
Pulmonary-Respiratory depression is more likely to occur in elderly due to altered pharmacokinetics (poor fat stores, muscle wasting, or altered clearance). Consider naloxone Rx. Neuro/Psych-Risk for confusion, delirium and falls. Avoid treatment with 3 or more CNS active agents. Gastrointestinal-Constipation risk. Renal-Impaired function may lead to increased toxicity due to accumulation of parent compound and metabolites. Cardiovascular-Monitor for hypotension with high doses.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | Y | N | N | N | N |
BEERS: N HEDIS: N STOPP: N
Benzhydrocodone
Hepatic-Elderly may be more susceptible to hepatotoxicity. Strict adherence to a maximum daily dose is recommended, and the maximum dose recommendation varies between 3000-3800 mg depending on strength used and source of the recommendation.
Pulmonary-Respiratory depression is more likely to occur in elderly due to altered pharmacokinetics (poor fat stores, muscle wasting, or altered clearance). Consider naloxone Rx. Neuro/Psych-Risk for confusion, delirium and falls. Avoid treatment with 3 or more CNS active agents. Gastrointestinal-Constipation risk. Renal-Impaired function may lead to increased toxicity due to accumulation of parent compound and metabolites. Cardiovascular-Monitor for hypotension with high doses.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | Y | Y | Y | Y | N |
BEERS: Y HEDIS: N STOPP: Y
No Known Risk
None
- Benzhydrocodone/acetaminophen has a risk for abuse and addiction, which can lead to overdose and death. Benzhydrocodone/acetaminophen may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of benzhydrocodone/acetaminophen that works, and take it for the shortest possible time.<br /><br />See also How to Use section for more information about addiction. The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death.<br /><br />Also, other medications can affect the removal of benzhydrocodone/acetaminophen from your body, which may affect how benzhydrocodone/acetaminophen works. Be sure you know how to take benzhydrocodone/acetaminophen and what other drugs you should avoid taking with it. See also Drug Interactions section.<br /><br /> Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up. Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.<br /><br /> One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day.<br /><br />People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take. Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first.<br /><br />Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products). Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure. Get medical help right away if you take too much acetaminophen (overdose), even if you feel well.<br /><br />Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine. Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.<br /><br /> Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed.<br /><br />It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time.<br /><br /> Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
| Acute pain | |
| G89.1 | Acute pain, not elsewhere classified |
| G89.11 | Acute pain due to trauma |
| G89.18 | Other acute postprocedural pain |
| 0-9 | A-Z |
|---|---|
| G89.1 | Acute pain, not elsewhere classified |
| G89.11 | Acute pain due to trauma |
| G89.18 | Other acute postprocedural pain |
Formulary Reference Tool