What are the guidelines for using hydrocodone (opioid) for pain management and cough suppression?

Hydrocodone Guidelines for Pain Management and Cough Suppression

Pain Management

For pain management, hydrocodone should be reserved for severe pain when nonopioid alternatives are inadequate, starting at the lowest effective dose (typically 5 mg hydrocodone/325 mg acetaminophen every 4-6 hours as needed, not scheduled), for the shortest duration necessary, with careful attention to total morphine milligram equivalents (MME) to minimize addiction, overdose, and mortality risks. 1, 2

Indications and Patient Selection

• Hydrocodone is indicated only for pain severe enough to require an opioid analgesic when alternative treatments (nonopioid analgesics) have not been tolerated, have not provided adequate analgesia, or are not expected to be adequate. 2

• Opioid therapy has an important role for acute pain related to severe traumatic injuries (including crush injuries and burns), invasive surgeries with moderate to severe postoperative pain, and other severe acute pain when NSAIDs and other therapies are contraindicated or likely ineffective. 1

• Nonopioid therapies are at least as effective as opioids for many common acute pain conditions including low back pain, neck pain, musculoskeletal injuries, minor surgeries, dental pain, kidney stones, and headaches—hydrocodone should NOT be first-line for these conditions. 1

Dosing Principles

Starting Dose:

• For opioid-naïve patients, start with the lowest effective dose: typically 5-10 mg hydrocodone (equivalent to 5-10 MME per single dose) or 20-30 MME/day total. 1

• Prescribe as "as needed" rather than scheduled dosing (e.g., "hydrocodone 5 mg/acetaminophen 325 mg, one tablet not more frequently than every 4 hours as needed for moderate to severe pain" rather than "one tablet every 4 hours"). 1

• Product labeling for hydrocodone 5 mg/acetaminophen 300-325 mg states usual adult dosage is one or two tablets every 4-6 hours as needed, with maximum of eight tablets daily. 1

MME Conversion:

• Hydrocodone has a conversion factor of 1.0 (meaning 1 mg hydrocodone = 1 MME). 1

• Example: Hydrocodone 5 mg/acetaminophen 325 mg taken four times daily = 20 mg hydrocodone daily = 20 MME/day. 1

Critical Dosage Thresholds

≥50 MME/day threshold:

• Before increasing total opioid dosage to ≥50 MME/day, clinicians must pause and carefully reassess individual benefits versus risks, as many patients do not experience improved pain or function at this level while overdose risk progressively increases. 1

• If dosage reaches or exceeds 50 MME/day, implement additional precautions including increased follow-up frequency and offer naloxone with overdose prevention education to patient and household members. 1

• If increasing beyond 50 MME/day, use caution and increase by the smallest practical amount. 1

Beyond 50 MME/day:

• Additional dosage increases beyond 50 MME/day yield progressively diminishing returns in pain relief and function relative to escalating risks. 1

Special Populations

Elderly and organ dysfunction:

• Use additional caution when initiating opioids for patients ≥65 years and those with renal or hepatic insufficiency due to smaller therapeutic window between safe dosages and those associated with respiratory depression and overdose. 1

• Lower-dose formulations (e.g., hydrocodone 2.5 mg/acetaminophen 325 mg) are available and should be used when additional caution is needed. 1

• Consider longer dosing intervals in patients with renal or hepatic dysfunction due to decreased drug clearance leading to accumulation to toxic levels. 1

Acetaminophen considerations:

• Monitor cumulative acetaminophen dosages from all sources (including over-the-counter medications) to prevent hepatotoxicity. 1

• FDA has limited added acetaminophen to 325 mg per dose of hydrocodone. 3

Formulation Selection

Immediate-release vs. extended-release:

• Do NOT treat acute pain with extended-release/long-acting (ER/LA) opioids. 1

• Do NOT initiate opioid treatment for subacute or chronic pain with ER/LA formulations. 1

• ER/LA hydrocodone should be reserved for severe, continuous pain and only for patients who have received certain dosages of immediate-release opioids daily (e.g., 60 mg oral morphine, 30 mg oral oxycodone, or equianalgesic doses) for at least 1 week. 1

• ER/LA opioids should not be prescribed for intermittent or as-needed use. 1

Duration of Therapy

• Prescribe hydrocodone only for the expected duration of pain severe enough to require opioids. 1

• If hydrocodone is taken around the clock for more than a few days, implement a taper to minimize withdrawal symptoms and prevent prolonged opioid use. 1

• Evidence shows that even short-term opioid use for acute pain increases risk for long-term opioid use. 1

Monitoring and Safety

Concurrent medications:

• Use particular caution when prescribing benzodiazepines or other sedating medications with hydrocodone due to severe drowsiness, decreased awareness, breathing problems, coma, and death risk. 2

• Check prescription drug monitoring program (PDMP) database to ensure new hydrocodone prescription will not contribute to cumulative dosages or medication combinations that increase overdose risk. 1

Naloxone:

• Offer naloxone, particularly if patient or household member has risk factors for opioid overdose. 1

Contraindications:

• Do not prescribe hydrocodone to patients with severe asthma, breathing problems, other lung problems, bowel obstruction, or narrowing of stomach/intestines. 2

• Known hypersensitivity to hydrocodone or acetaminophen is a contraindication. 2

Cough Suppression

Hydrocodone-containing cough medications should NOT be used for cough treatment in patients under 18 years of age due to unfavorable benefit-risk profile, including lack of efficacy evidence and serious safety concerns including respiratory depression and death. 4

Pediatric Contraindication

• The FDA determined that hydrocodone-containing cough and cold medications should no longer be indicated for treatment of cough in patients <18 years. 4

• A comprehensive benefit-risk review found no robust efficacy data for hydrocodone in relief of cough and upper respiratory symptoms in patients aged 6 to <18 years. 4

• Safety data revealed fatalities in pediatric patients, with nine deaths due to overdose among ten reported deaths in children taking hydrocodone-containing cough medicines. 4

Adult Use for Cough

• While hydrocodone has been used for decades as an antitussive agent in adults, clinical trials demonstrating efficacy have been conducted primarily in adults ≥18 years. 4

• Hydrocodone/chlorpheniramine is licensed in the USA for relief of cough and upper respiratory symptoms associated with allergy or cold in adults only. 4

Common Pitfalls to Avoid

• Do NOT use hydrocodone as first-line therapy for common pain conditions (low back pain, neck pain, musculoskeletal injuries, minor surgeries, dental pain, kidney stones, headaches) where nonopioid alternatives are equally effective. 1

• Do NOT prescribe on a scheduled basis rather than as-needed. 1

• Do NOT fail to taper if used around the clock for more than a few days. 1

• Do NOT prescribe ER/LA hydrocodone for acute pain or as initial therapy for chronic pain. 1

• Do NOT increase dosage to ≥50 MME/day without pausing to carefully reassess benefits versus risks. 1

• Do NOT prescribe hydrocodone-containing cough medications to patients <18 years. 4

• Do NOT ignore cumulative acetaminophen intake from all sources. 1