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Drug Name:


Generic Name and Formulations:
Codeine phosphate 30mg, butalbital 50mg, aspirin 325mg, caffeine 40mg; caps.


Therapeutic Use:

Indications for FIORINAL w. CODEINE:

Tension (or muscle contraction) headache.


Use lowest effective dose for shortest duration. 1–2 caps every 4hrs, as needed; max 6 caps/day. Also with Codeine: concomitant use or discontinuation of CYP2D6 inhibitors, CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually by 25–50% every 2–4 days.


Not established.


Hemophilia. Reye's Syndrome. NSAID allergy. Syndrome of asthma, rhinitis, and nasal polyps. Also with Codeine: 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. During or within 14 days of MAOIs. Post-op pain management in children who have undergone tonsillectomy and/or adenoidectomy.

Boxed Warning:

Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Risks from concomitant benzodiazepines or other CNS depressants. Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children. Neonatal opioid withdrawal syndrome. Interactions with drugs affecting CYP450 isoenzymes.

Boxed Warning:

Abuse, addiction, and misuse. Life threatening respiratory depression. Accidental ingestion (may be fatal). Risks from concomitant use of drugs affecting CYP450 isoenzymes, benzodiazepines, or CNS depressants. Neonatal opioid withdrawal syndrome. Ultra-rapid metabolism of codeine to morphine (may be fatal).


Peptic ulcer disease; avoid. Monitor for ulceration and bleeding. Coagulation abnormalities. Bleeding disorders. Also with Codeine: abuse potential (monitor). 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. Risk of respiratory depression and death related to ultra-rapid metabolizers of codeine (esp. children in post-op tonsillectomy and/or adenoidectomy). Obstructive sleep apnea. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Reevaluate periodically. Avoid abrupt cessation. Severe renal failure (GFR<10mL/min): avoid. Hepatic impairment: initiate lower doses; monitor. Drug abusers. Elderly. Cachectic. Debilitated. Pregnancy (avoid starting at 30wks gestation); potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: not recommended.

See Also:


Pharmacological Class:

Opioid + barbiturate + salicylate + methylxanthine.


Increased risk of bleeding with concomitant NSAIDs (avoid), anticoagulants, chronic, heavy alcohol use; monitor. Avoid concomitant uricosurics (eg, probenecid), corticosteroids. May antagonize ACEIs, beta-blockers; monitor BP. May potentiate carbonic anhydrase inhibitors (eg, acetazolamide); consider reducing dose of these. May potentiate hypoglycemic agents (eg, insulin, glimepiride, glipizide). Concomitant methotrexate: monitor for toxicity esp. in elderly or renal impairment. Monitor renal function closely with concomitant nephrotoxic agents. Caution with phenytoin, valproic acid. Also with Codeine: 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. 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. May be affected by CYP2D6 inhibitors (eg, amiodarone, quinidine, fluoxetine, paroxetine, bupropion). 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. Codeine may increase serum amylase levels.

Adverse Reactions:

Nausea, abdominal pain, drowsiness, dizziness. Also with Codeine: respiratory depression, severe hypotension, syncope.



How Supplied:

Caps—100, 500; W. Codeine—100

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