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Xodol Generic Name & Formulations
Legal Class
CII
General Description
Hydrocodone bitartrate, acetaminophen; 5mg/300mg, 7.5mg/300mg, 10mg/300mg; scored tabs.
Pharmacological Class
Opioid + analgesic.
How Supplied
Tabs—100
Manufacturer
Xodol Indications
Indications
Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Xodol Dosage and Administration
Adult
Use lowest effective dose for shortest duration. 5mg/300mg: 1–2 tabs every 4–6 hrs as needed; max 8 tabs/24hrs. 7.5mg/300mg, 10mg/300mg: 1 tab every 4–6 hrs as needed; max 6 tabs/24hrs. Renal or hepatic impairment: initiate at lower doses; monitor. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually by 25–50% every 2–4 days.
Children
Not established.
Xodol Contraindications
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.
Xodol Boxed Warnings
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.
Xodol Warnings/Precautions
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 acetaminophen doses >4g/day, alcohol abusers. Underlying liver disease. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Discontinue at the 1st sign of rash or any other hypersensitivity. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Labor & delivery: not recommended. Pregnancy (Cat.C); potential neonatal opioid withdrawal syndrome during prolonged use. Nursing mothers: monitor infants.
Xodol Pharmacokinetics
See Literature
Xodol Interactions
Interactions
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. Avoid concomitant other acetaminophen-containing products. 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/or 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 cause false (+) urine test for 5-hydroxyindoleacetic acid.
Xodol Adverse Reactions
Adverse Reactions
Lightheadedness, dizziness, sedation, other CNS effects, nausea, vomiting, constipation, pruritus, urinary retention, ototoxicity; respiratory depression, severe hypotension, syncope, hepatotoxicity (overdosage); rare: serious skin or hypersensitivity reactions.
Xodol Clinical Trials
See Literature
Xodol Note
Not Applicable
Xodol Patient Counseling
See Literature
