Usual Adult Dose for Pain

1 tablet orally every 4 to 6 hours as needed
Maximum dose: 5 tablets in 24 hours
Duration of therapy: Generally less than 10 days

Comments:

• The lowest effective dose or the longest dosing interval should be sought for each patient.
• Each tablet provides a combination of ibuprofen 200 mg and either hydrocodone 2.5, 5, 7.5, or 10 mg.
• Because of the risks of addiction and abuse, this drug should be reserved for use in patients for whom alternative treatment options 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: For the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Pediatric Dose for Pain

16 years or older:

1 tablet orally every 4 to 6 hours as needed
Maximum dose: 5 tablets in 24 hours
Duration of therapy: Generally less than 10 days

Comments:

• The lowest effective dose or the longest dosing interval should be sought for each patient.
• Each tablet provides a combination of ibuprofen 200 mg and either hydrocodone 2.5, 5, 7.5, or 10 mg.
• Because of the risks of addiction and abuse, this drug should be reserved for use in patients for whom alternative treatment options 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: 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

Severe renal impairment: Avoid use unless benefits are expected to outweigh the risk of worsening renal
Renal impairment: Use with caution; start with a lower initial dose and monitor closely for respiratory depression, sedation, and hypotension.

Liver Dose Adjustments

Severe hepatic impairment: Use a lower initial dose; monitor closely for respiratory depression, sedation, and hypotension

Dose Adjustments

Elderly: Low initial doses and increased monitoring are advised due to a greater risk of NSAID-associated serious cardiovascular, gastrointestinal, and renal adverse reactions, as well as a possible increased risk of respiratory depression with opioid use

CYP450 3A4 Interactions:

• Monitor patients concomitantly taking any CYP450 3A4 inhibitor or upon discontinuation of a CYP450 3A4 inducer for signs and symptoms of respiratory depression and sedation.

Discontinuation in Physically Dependent Patients:

• Taper gradually by 25% to 50% every 2 to 4 days
• If signs or symptoms of withdrawal develop, raise the dose to the previous level and taper more slowly
• Do not abruptly discontinue this drug in a 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: 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 this drug and monitor all patients regularly for the development of these behaviors or conditions.

RISK EVALUATION AND MITIGATION STRATEGY (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 with use. Monitor for respiratory depression, especially during initiation of therapy or following a dose increase.
• ACCIDENTAL INGESTION of even one dose, especially by children, can result in a fatal overdose of hydrocodone.
• 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; treatment requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
• CYP450 3A4 INTERACTION: The concomitant use with all CYP450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations which could cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used CYP450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients receiving any CYP450 3A4 inhibitor or upon discontinuation of a CYP450 3A4 inducer for signs and symptoms of respiratory depression and sedation.
• RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant use for patients whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression.
• SERIOUS CARDIOVASCULAR EVENTS Cardiovascular Thrombotic Events: Nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
• SERIOUS GASTROINTESTINAL EVENTS: NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.

Safety and efficacy have not been established in patients younger than 16 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally with food to minimize gastrointestinal upset

Dispense in a light resistant bottle

General:

• This drug should not be used for the treatment of chronic conditions such as osteoarthritis or rheumatoid arthritis.
• Patients should be continually assessed as to their level of pain control and adverse reactions; frequent communication is important among prescriber, members of the healthcare team, patient, and caregiver during periods of changing analgesic requirements, including initial titration.

Monitoring:

• Consider monitoring CBC and blood chemistry periodically
• Monitor for the development 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 seek medical attention immediately if signs/symptoms of cardiovascular events occur including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
• Advise patients to store this drug safely out of the sight and reach of children; accidental use by a child should be considered a medical emergency as it 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 should seek medical advice for signs and symptoms of gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
• Women of child bearing potential should understand that prolonged opioid use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.
• Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; NSAIDs should not be used at 20 weeks or later in pregnancy unless specifically advised to do so by their health care professional.
• Patients should not consume alcoholic beverages, or prescription or nonprescription products containing alcohol, while on treatment; patients should avoid driving or operating machinery while taking this drug.