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Acetaminophen / Benzhydrocodone Dosage

Medically reviewed by Drugs.com. Last updated on Apr 17, 2019.

Applies to the following strengths: 325 mg-4.08 mg; 325 mg-6.12 mg; 325 mg-8.16 mg

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 hours
Maximum acetaminophen dose (including all acetaminophen-containing products): 4000 mg in a 24-hour period
Duration of therapy: 7 to 14 days

Equivalence 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 mg

Comments:
-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.

Renal Dose Adjustments

Caution recommended; patients with renal impairment may have higher plasma concentrations; monitor closely for adverse events

Liver Dose Adjustments

Caution recommended; patients with hepatic impairment may have higher plasma concentrations; monitor closely for adverse events

Dose Adjustments

Elderly: Use caution in dose selection generally starting at the lower end of the dosing range and titrating slowly; consider monitoring renal function

Maximum Acetaminophen Dose is 4 g in 24 hours
-Take into account all acetaminophen products when calculating daily dose
-To avoid overdose of acetaminophen, it is best to use just 1 acetaminophen product at a time

Conversion from Hydrocodone bitartrate/Acetaminophen:
-Benzhydrocodone 4.08 mg equivalent hydrocodone bitartrate 5 mg
-Benzhydrocodone 6.12 mg equivalent hydrocodone bitartrate 7.5 mg
-Benzhydrocodone 8.16 mg equivalent hydrocodone bitartrate 10 mg

Conversion from Other Opioids:
-A conservative approach is recommended due to wide inter-patient variability in response to the potency of opioid drugs and formulations; it is safer to underestimate than overestimate and manage an adverse reaction due to overdose

Concomitant use of CYP450 3A4 inducers or inhibitors may require dose adjustment: Consult drug interactions

Discontinuation of Therapy in the Physically Dependent Patient:
-Taper dose gradually, by 25% to 50% every 2 to 4 days
-Monitor for signs and symptoms of withdrawal; if they occur, raise the dose to the previous level and taper more slowly
-Do not abruptly discontinue in the physically dependent patient

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for all opioids intended for outpatient use. The new FDA Opioid Analgesic REMS is a designed to assist in communicating the serious risks of opioid pain medications to patients and health care professionals. It includes a medication guide and elements to assure safe use. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYP450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS:
-Addiction, Abuse, and Misuse: This drug exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.
-Opioid Analgesic REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, a REMS is required for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program; counsel patients and/or their caregivers, with every prescription on safe use, serious risks, storage, and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.
-Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
-Accidental Ingestion: Accidental ingestion, especially by children, can result in a fatal overdose.
-Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, the patient should be advised of the risk of neonatal opioid withdrawal syndrome and ensure appropriate treatment will be available.
-CYP450 3A4 Interaction: Concomitant use of CYP450 3A4 inhibitors may result in increased hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used CYP450 3A4 inducer may result in increased hydrocodone plasma concentrations. Monitor patients concomitantly receiving any CYP450 3A4 inhibitor or inducer.
-Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death; most cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product.
-Concomitant Use with Benzodiazepines or Other CNS Depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Concomitant use should be reserved for use in patients for whom alternative treatment options are inadequate. If needed, limit dose and duration to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.

CONTRAINDICATIONS:
-Significant respiratory depression
-Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
-Known or suspected gastrointestinal obstruction, including paralytic ileus
-Hypersensitivity to the active components or any of the product ingredients (e.g., anaphylaxis)

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration advice:
-Take orally with or without food

General:
-The total acetaminophen dose should not exceed 4 g in 24 hours; be sure to account for all acetaminophen use when calculating total daily dose.
-Because of the risks of addiction, abuse and misuse, the lowest dose for the shortest duration consistent with individual patient treatment goals should be used.
-Frequent communication between members of the healthcare team, patients, and their caregiver/family is important during periods of changing analgesic requirements; if the level of pain increases after dose stabilization, an attempt should be made to identify the source of increased pain before increasing the dose of pain medication.

Monitoring:
-Monitor for respiratory depression, especially during initiation and following any increase in dose; close monitoring will be necessary in patients at increased risk and/or those receiving concomitant medications that increase the risk of respiratory depression
-Monitor for signs of hypotension
-Monitor for signs of constipation
-Monitor for the development of behaviors indicative of addiction, abuse, or misuse

Patient advice:
-Patients should be instructed to read the US FDA-approved Medication Guide each time this drug is dispensed; they should understand the safe use, serious risks, and proper storage and disposal of this drug.
-Patients should understand that this drug, even when taken as recommended can result in addiction, abuse, and misuse; instruct patients not to share their drug with others and protect their drug from theft or misuse; patients to store this drug safely out of the sight and reach of children; accidental use by a child is a medical emergency and can result in death.
-Patients should understand the risks of life-threatening respiratory depression, and be informed as to when this risk is greatest; patients and caregivers should be instructed to get emergency help immediately if too much drug is taken or if breathing problems occur.
-Patients should be instructed to check with their healthcare provider before taking any new medications, including herbal supplements, and over the counter products; patients should understand this drug contains acetaminophen and they should not take any other products containing acetaminophen during therapy without speaking with their healthcare provider.
-Patients should not drink alcohol while taking this drug.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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