Usual Adult Dose for Pain

Oral tablets:
Hydrocodone 5 mg-acetaminophen 325 mg per tablet
Initial dose: 1 to 2 tablets every 4 to 6 hours as needed for pain
Maximum dose: 8 tablets/24 hours

Hydrocodone 7.5 mg-acetaminophen 325 mg and Hydrocodone 10 mg-acetaminophen 325 mg per tablet:
Initial dose: 1 tablet every 4 to 6 hours as needed for pain
Maximum dose: 6 tablets/24 hours

Oral Solution:
Hydrocodone 7.5 mg-acetaminophen 325 mg per 15 mL:
Initial dose: 15 mL every 4 to 6 hours as needed for pain
Maximum dose: 90 mL/24 hours

Hydrocodone 10 mg-acetaminophen 300 mg per 15 mL:
Initial dose: 11.25 mL every 4 to 6 hours as needed for pain
Maximum dose: 67.5 mL/24 hours

Comments:

• Doses should be individually titrated to provide adequate analgesia while minimizing adverse reactions.
• Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Pediatric Dose for Pain

2 years or older; weight less than 46 kg:

Weight-Based Dosing (preferred)
Initial dose: hydrocodone 0.135 mg/kg and acetaminophen 4 or 5.85 mg/kg orally every 4 to 6 hours as needed

• For hydrocodone 7.5 mg-acetaminophen 325 mg per 15 mL Oral Solution: 0.27 mL/kg orally every 4 to 6 hours
• For hydrocodone 10 mg-acetaminophen 300 mg per 15 mL Oral Solution: 0.2 mL/kg orally every 4 to 6 hours

Maximum: 6 doses in 24 hours

Age-Based Dosing:

• Hydrocodone 7.5 mg-acetaminophen 325 mg per 15 mL Oral Solution:

Approximately 2 to 3 years old (12 to 15 kg): Initial dose: 3.75 mL orally every 4 to 6 hours
Approximately 4 to 6 years old (16 to 22 kg): Initial dose: 5 mL orally every 4 to 6 hours
Approximately 7 to 9 years old (23 to 31 kg): Initial dose: 7.5 mL orally every 4 to 6 hours
Approximately 10 to 13 years old (32 to 45 kg): Initial dose: 10 mL orally every 4 to 6 hours

• Hydrocodone 10 mg-acetaminophen 300 mg per 15 mL Oral Elixir:

Approximately 2 to 3 years old (12 to 15 kg): Initial dose: 2.8 mL orally every 4 to 6 hours
Approximately 4 to 6 years old (16 to 22 kg): Initial dose: 3.75 mL orally every 4 to 6 hours
Approximately 7 to 9 years old (23 to 31 kg): Initial dose: 5.6 mL orally every 4 to 6 hours
Approximately 10 to 13 years old (32 to 45 kg): Initial dose: 7.5 mL orally every 4 to 6 hours
Maximum: 6 doses in 24 hours

2 years or older; weight 46 kg or greater:

Hydrocodone 7.5 mg-acetaminophen 325 mg per 15 mL:
Initial dose: 15 mL every 4 to 6 hours as needed for pain
Maximum dose: 6 doses/day not to exceed 90 mL/24 hours

Hydrocodone 10 mg-acetaminophen 300 mg per 15 mL:
Initial dose: 11.25 mL every 4 to 6 hours as needed for pain
Maximum dose: 6 doses/day not to exceed 67.5 mL/24 hours

Comments:

• Weight based dosing is preferred whenever possible; a calibrated measuring device is strongly recommended to ensure accurate dosing.
• Doses should be individually titrated to provide adequate analgesia while minimizing adverse reactions.
• Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the management of 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 hydrocodone plasma concentrations; monitor closely for adverse events.

Liver Dose Adjustments

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

Dose Adjustments

Acetaminophen-hydrocodone should be used with caution in elderly or debilitated patients and those with hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture; generally, start at the lower end of the dosing range and titrate carefully.

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 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

US BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYP450 3A4 INTERACTION; HEPATOTOXICITY; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS and RISKS OF MEDICATION ERRORS:

• 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.
• Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur, 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.
• Risks of Medication Errors: Ensure accuracy when prescribing, dispensing, and administering hydrocodone/acetaminophen oral solution; dosing errors due to confusion between mg and mL, and other hydrocodone/acetaminophen oral solutions of different concentrations can result in accidental overdose and death.

Safety and efficacy have not been established for oral liquid/solution in patients younger than 2 years.
Safety and efficacy have not been established for oral tablets 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

Oral Solution:

• Verify dose in mg and mL prior to administration
• Measure dose with a calibrated measuring device

Storage requirements:

• Protect from light and moisture

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:

• Advise 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 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 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 right away 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, 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.
• Patients should be instructed in proper disposal.