Narcotic analgesics:

Indications for: Hydrocodone/Acetaminophen (325mg)

Acute pain severe enough to require opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use:

Reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate.

Adult Dosage:

Use lowest effective dose for shortest duration. Individualize. 5mg/325mg: 1–2 tabs every 4–6hrs as needed; max 8 tabs/day. 7.5mg/325mg, 10mg/325mg: 1 tab every 4–6hrs as needed; max 6 tabs/day. Conversion to/from other opioids: see full labeling.

Children Dosage:

Not established.

Hydrocodone/Acetaminophen (325mg) Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

Boxed Warning:

Addiction, abuse, and misuse. Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Cytochrome P450 3A4 interaction. Hepatotoxicity. Risks from concomitant use with benzodiazepines or other CNS depressants.

Hydrocodone/Acetaminophen (325mg) Warnings/Precautions:

Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Increased risk of hepatotoxicity with underlying liver disease, concomitant alcohol, acetaminophen doses >4g/day or involving >1 acetaminophen-containing product. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Acute abdominal conditions. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment; monitor. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy (Cat.C); potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

Hydrocodone/Acetaminophen (325mg) Classification:

Opioid + analgesic.

Hydrocodone/Acetaminophen (325mg) Interactions:

Avoid concomitant other acetaminophen-containing drugs. Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May increase serum amylase. Acetaminophen may cause false (+) test results for urinary 5-hydroxyindoleacetic acid.

Adverse Reactions:

Light-headedness, dizziness, sedation, nausea, vomiting, constipation, somnolence; respiratory depression, severe hypotension, syncope, hepatotoxicity; rare: serious skin reactions or anaphylaxis; discontinue if occurs.

Note:

Formerly known under the brand name Norco.

How Supplied:

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