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Registry Hub
Peer-Reviewed Evidence
HomeDrug RegistryCompareFLOLAN vs ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Comparative Pharmacology

FLOLAN vs ACETAMINOPHEN AND HYDROCODONE BITARTRATE Comparison

Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.

Clinical EssentialsPharmacokineticsSpecial PopulationsSafety & MonitoringPregnancy & LactationClinical Insights
Differential Analysis

FLOLAN vs ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.

View FLOLAN Monograph View ACETAMINOPHEN AND HYDROCODONE BITARTRATE Monograph
FLOLAN
Prostacyclin Vasodilator
Category C
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Opioid Agonist
Category D/X
TL;DR — Key Differences
  • Drug class: FLOLAN is a Prostacyclin Vasodilator; ACETAMINOPHEN AND HYDROCODONE BITARTRATE is a Opioid Agonist.
  • Half-life: FLOLAN has a half-life of 3–5 minutes (terminal elimination half-life; rapid inactivation necessitates continuous IV infusion).; ACETAMINOPHEN AND HYDROCODONE BITARTRATE has Acetaminophen: 2-3 hours in adults; prolonged in hepatic impairment (up to 5 hours). Hydrocodone: 3.8-4.5 hours (range 3-5 hours) in healthy adults; prolonged in elderly or hepatic/renal impairment. Clinical context: repeated dosing may require extended intervals in renal impairment..
  • No direct drug-drug interaction has been documented between FLOLAN and ACETAMINOPHEN AND HYDROCODONE BITARTRATE.
  • Pregnancy: FLOLAN is rated Category C; ACETAMINOPHEN AND HYDROCODONE BITARTRATE is rated Category D/X.

Last clinically reviewed: July 2026 · OpiCalc Medical Review Team

Clinical Essentials

FLOLAN
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Mechanism of Action
FLOLAN

Epoprostenol is a prostaglandin I2 (prostacyclin) analogue that directly vasodilates pulmonary and systemic arterial beds, inhibits platelet aggregation, and has antiproliferative effects on vascular smooth muscle.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: analgesic and antipyretic effects via inhibition of cyclooxygenase (COX) and activation of descending serotonergic pathways; central action. Hydrocodone: mu-opioid receptor agonist; activates G-protein coupled receptors to modulate pain perception and emotional response.

Indications
FLOLAN

Pulmonary arterial hypertension (PAH) (WHO Group I) in NYHA Class III-IV patients to improve exercise capacity and hemodynamics,Pulmonary arterial hypertension in patients who require chronic IV therapy,Off-label: Severe Raynaud's phenomenon, primary pulmonary hypertension in neonates, and as a bridge to lung transplantation

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Moderate to moderately severe pain,Cough suppression (hydrocodone; off-label)

Standard Dosing
FLOLAN

Initial: 4 ng/kg/min via continuous IV infusion, then titrated in increments of 1-2 ng/kg/min at intervals of at least 15 minutes based on clinical response. Typical maintenance dose: 20-40 ng/kg/min; range: 10-80 ng/kg/min.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

1-2 tablets (containing 5-10 mg hydrocodone and 300-325 mg acetaminophen) orally every 4-6 hours as needed for pain; maximum 8 tablets per day.

Direct Interaction
FLOLAN
No Direct Interaction
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
No Direct Interaction

Pharmacokinetics

FLOLAN
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Half-Life
FLOLAN

3–5 minutes (terminal elimination half-life; rapid inactivation necessitates continuous IV infusion).

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: 2-3 hours in adults; prolonged in hepatic impairment (up to 5 hours). Hydrocodone: 3.8-4.5 hours (range 3-5 hours) in healthy adults; prolonged in elderly or hepatic/renal impairment. Clinical context: repeated dosing may require extended intervals in renal impairment.

Metabolism
FLOLAN

Epoprostenol undergoes rapid hydrolysis at neutral p H and is also metabolized by enzymes including 15-hydroxyprostaglandin dehydrogenase to inactive metabolites (6-keto-PGF1alpha, 6,15-diketo-PGF1alpha, and 6,15-diketo-13,14-dihydro-PGF1alpha).

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: primarily via glucuronidation (UGT1A1, UGT1A6, UGT1A9) and sulfation; minor CYP2E1 oxidation to NAPQI (toxic metabolite). Hydrocodone: CYP3A4 and CYP2D6; N-demethylation to norhydrocodone; O-demethylation to hydromorphone (CYP2D6).

Excretion
FLOLAN

Renal: 70% (as inactive metabolites); biliary/fecal: negligible.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: primarily renal excretion of conjugated metabolites (glucuronide and sulfate) with approximately 5% excreted unchanged. Hydrocodone: renal excretion as unchanged drug and metabolites (O-demethylated and N-demethylated); total renal excretion accounts for about 60-70% of dose (parent and metabolites). Biliary/fecal elimination is minimal.

Protein Binding
FLOLAN

Approximately 50% bound to albumin.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: 10-25% bound, nonspecific binding to albumin. Hydrocodone: 25-50% bound, primarily to albumin and alpha-1-acid glycoprotein.

VD (L/kg)
FLOLAN

0.03–0.1 L/kg; small Vd consistent with limited extravascular distribution.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: 0.8-1.0 L/kg, indicating distribution into total body water; clinically relevant for loading dose calculations. Hydrocodone: 3.0-4.0 L/kg, suggesting extensive tissue distribution; higher Vd may require higher loading doses but has no clinical target.

Bioavailability
FLOLAN

Intravenous: 100% (only route of administration).

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: oral bioavailability 85-95% (first-pass metabolism minimal). Hydrocodone: oral bioavailability about 25-45% due to first-pass hepatic metabolism; significant interindividual variability.

Special Populations

FLOLAN
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Renal Adjustments
FLOLAN

No specific dose adjustment required; monitor fluid and electrolyte balance due to potential hypotension.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

GFR 10-50 m L/min: administer every 6 hours; GFR <10 m L/min: administer every 8 hours; avoid in severe impairment due to acetaminophen metabolite accumulation.

Hepatic Adjustments
FLOLAN

No specific dose adjustment required; consider reduced clearance in severe hepatic impairment (Child-Pugh class C) with cautious titration.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50% or extend interval; Child-Pugh C: use with caution, avoid if possible, consider alternative therapy.

Pediatric Dosing
FLOLAN

Initial: 2 ng/kg/min via continuous IV infusion, titrate by 1-2 ng/kg/min every 15 minutes as tolerated. Maximum dose not established; typical range 5-40 ng/kg/min.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Dosing based on hydrocodone component: 0.1-0.2 mg/kg/dose every 4-6 hours; maximum daily acetaminophen limit: 75 mg/kg/day; not recommended for children <2 years.

Geriatric Dosing
FLOLAN

No specific dose adjustment; start at lower end of dosing range (4 ng/kg/min) and titrate cautiously due to increased sensitivity to hemodynamic effects.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Initiate at lowest effective dose, typically 1 tablet (2.5-5 mg hydrocodone) every 6 hours; monitor for respiratory depression and acetaminophen toxicity; avoid in frail elderly with hepatic impairment.

Safety & Monitoring

FLOLAN
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Black Box Warnings
FLOLAN
FDA Black Box Warning

FLOLAN is a potent vasodilator and must be administered by continuous IV infusion through a permanent central venous catheter. Abrupt discontinuation or sudden large dose reductions may result in worsening pulmonary hypertension and death. Only clinicians experienced in PAH treatment should prescribe FLOLAN.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE
FDA Black Box Warning

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion of acetaminophen; neonatal opioid withdrawal syndrome; interaction with alcohol; risk of medication errors.

Warnings/Precautions
FLOLAN

Do not abruptly discontinue infusion (risk of rebound pulmonary hypertension), monitor for pulmonary edema (if suspect veno-occlusive disease), may cause bleeding complications (due to antiplatelet effects), monitor for sepsis/thrombosis from chronic IV catheter, use caution in patients with hepatic or renal impairment.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Hepatotoxicity from acetaminophen overdose; respiratory depression; increased intracranial pressure; CNS depression; elderly/debilitated patients; renal impairment; opioid-induced hyperalgesia; serotonin syndrome; interaction with CNS depressants; risk of adrenal insufficiency; severe hypotension; use in patients with gastrointestinal obstruction; convulsion risk; severe hepatic impairment; urinary retention; acute abdominal conditions; hypothyroidism; prostatic hypertrophy; adrenocortical insufficiency; pregnancy/lactation; pediatric use; geriatric use; renal impairment; hepatic impairment.

Contraindications
FLOLAN

Long-term use in patients with pulmonary veno-occlusive disease (PVOD), hypersensitivity to epoprostenol or structurally related drugs, or severe left ventricular systolic dysfunction (NYHA Class III-IV heart failure) due to risk of pulmonary edema.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Hypersensitivity to acetaminophen or hydrocodone; significant respiratory depression; acute or severe bronchial asthma; upper airway obstruction; known or suspected gastrointestinal obstruction; paralytic ileus; concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days; severe hepatic impairment (acetaminophen toxicity risk); acute alcoholism.

Adverse Reactions
FLOLAN
Data Pending
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Data Pending
Food Interactions
FLOLAN

No specific food interactions are reported for epoprostenol. Avoid excessive alcohol as it may worsen hypotension.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Avoid alcohol consumption during therapy; ethanol increases acetaminophen hepatotoxicity risk and enhances CNS depression. Grapefruit juice may inhibit CYP2D6 (minor effect) but no significant clinical interaction. No other specific food restrictions.

Pregnancy & Lactation

FLOLAN
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Teratogenic Risk
FLOLAN

FDA Pregnancy Category B. No evidence of teratogenicity in animal studies; however, no adequate and well-controlled studies in pregnant women. Epoprostenol is a potent vasodilator and inhibitor of platelet aggregation; theoretical risk of hemorrhage in the fetus. Use only if clearly needed.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

First trimester: Acetaminophen considered low risk; hydrocodone is a pregnancy category C drug. Data from retrospective studies suggest a small increased risk of certain congenital malformations (e.g., neural tube defects, cleft palate) with first trimester opioid use, but absolute risk is low. Second trimester: Low risk as above. Third trimester: Prolonged use of hydrocodone can cause neonatal opioid withdrawal syndrome (NOWS); acetaminophen is safe. Use only if benefit outweighs risk.

Lactation Summary
FLOLAN

Epoprostenol is not recommended during breastfeeding. No data on presence in human milk, effects on the breastfed infant, or milk production. Due to potential for serious adverse reactions (e.g., hypotension, bleeding), breastfeeding should be discontinued during treatment.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen excretion in breast milk is low (M/P ratio ~0.9). Hydrocodone is excreted in small amounts (M/P ratio ~2.1). The relative infant dose is estimated to be 2.5-3.5% of maternal weight-adjusted dose for hydrocodone. Monitor infant for sedation and respiratory depression. Consider benefit to mother and potential neonatal opioid withdrawal if used chronically.

Pregnancy Dosing
FLOLAN

Pregnancy may alter pharmacokinetics; increase in plasma volume may require dose adjustments. No formal studies; titrate dose based on clinical response (e.g., symptoms of pulmonary arterial hypertension). Monitor for signs of overdose (hypotension, tachycardia) or underdose (worsening dyspnea).

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

During pregnancy, increased plasma volume and enhanced hepatic clearance may reduce serum concentrations of both drugs. However, dosing adjustments are not routinely recommended due to risk of undertreatment. Use the lowest effective dose of hydrocodone for the shortest duration. For acetaminophen, maximum daily dose should not exceed 3000 mg to avoid hepatotoxicity.

Maternal Safety Status
FLOLAN
Category C
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Category D/X

Clinical Insights

FLOLAN
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Clinical Pearls
FLOLAN

FLOLAN (epoprostenol) is a prostacyclin used for pulmonary arterial hypertension (PAH). It has a very short half-life (3-5 minutes) and must be administered via continuous IV infusion. Abrupt interruption can cause life-threatening rebound pulmonary hypertension. The drug is unstable at room temperature; requires ice packs during administration. Dose titration is done based on symptoms and side effects (e.g., jaw pain, flushing, headache, diarrhea).

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen-hydrocodone is contraindicated in severe respiratory depression, acute or severe bronchial asthma, and known hypersensitivity. Monitor for respiratory depression, especially in elderly or debilitated patients. Avoid use with other acetaminophen-containing products to prevent hepatotoxicity. Hydrocodone is a prodrug metabolized by CYP2D6 to hydromorphone; CYP2D6 ultrarapid metabolizers may experience toxicity. Use with caution in patients with head injury, increased intracranial pressure, or severe hepatic impairment. Naloxone is the reversal agent for opioid effects; acetylcysteine for acetaminophen overdose.

Patient Counseling
FLOLAN

This medication is given continuously through an intravenous (IV) line using a portable infusion pump.,Never stop the infusion suddenly; sudden stoppage can cause severe worsening of your condition.,Keep the medication cold (with ice packs) during infusion; it degrades at room temperature.,Report any signs of infection at the IV site, such as redness, swelling, or pain.,Common side effects include headache, jaw pain, flushing, nausea, and diarrhea; these may improve over time.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Take exactly as prescribed; do not increase dose or frequency without consulting your doctor.,Avoid alcohol and other CNS depressants (e.g., benzodiazepines, sedatives) as they increase risk of severe drowsiness and respiratory depression.,Do not exceed 4000 mg of acetaminophen per day from all sources; check labels of other medications.,This medication may cause dizziness or drowsiness; avoid driving or operating heavy machinery until you know how it affects you.,Store securely out of reach of others, especially children, as misuse can cause overdose and death.,Do not stop abruptly; withdrawal may occur. Taper under medical supervision.,Contact emergency if you experience trouble breathing, extreme drowsiness, or signs of allergic reaction.,Report any history of substance abuse, as this medication has abuse potential.

Safety Verification

Known Interactions

FLOLAN Risks

No interactions on record

ACETAMINOPHEN AND HYDROCODONE BITARTRATE Risks3
Hydrocodone + Scopolamine
moderate

"Hydrocodone, an opioid agonist, and scopolamine, an anticholinergic agent, both exhibit central nervous system (CNS) depressant effects. When co-administered, their combined activity can lead to additive CNS depression, resulting in enhanced sedation, respiratory depression, and cognitive impairment. This interaction may also increase the risk of constipation and urinary retention due to additive anticholinergic effects from both drugs."

Pargyline + Hydrocodone
moderate

"Pargyline, a monoamine oxidase inhibitor (MAOI), irreversibly inhibits the metabolism of amines, leading to increased intraneuronal stores of norepinephrine. Hydrocodone, a semisynthetic opioid, can release these stored catecholamines, potentially causing a hypertensive crisis, serotonin syndrome, or CNS excitation. Coadministration may also result in excessive sedation and respiratory depression due to additive CNS depressant effects, requiring immediate clinical attention."

Hydrocodone + Oxprenolol
moderate

"Hydrocodone, an opioid agonist, and oxprenolol, a non-selective beta-adrenoceptor antagonist, are both central nervous system (CNS) depressants. Their combined use can lead to additive CNS depression, resulting in excessive sedation, respiratory depression, hypotension, and bradycardia. This interaction is particularly dangerous in patients with compromised cardiac or respiratory function, potentially leading to coma or death."

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Clinical Q&A

Frequently Asked Questions

Common clinical questions about FLOLAN vs ACETAMINOPHEN AND HYDROCODONE BITARTRATE, answered by our medical review team.

1. What is the main difference between FLOLAN and ACETAMINOPHEN AND HYDROCODONE BITARTRATE?

FLOLAN is a Prostacyclin Vasodilator that works by Epoprostenol is a prostaglandin I2 (prostacyclin) analogue that directly vasodilates pulmonary and systemic arterial beds, inhibits platelet aggregation, and has antiproliferative effects on vascular smooth muscle.. ACETAMINOPHEN AND HYDROCODONE BITARTRATE is a Opioid Agonist that works by Acetaminophen: analgesic and antipyretic effects via inhibition of cyclooxygenase (COX) and activation of descending serotonergic pathways; central action. Hydrocodone: mu-opioid receptor agonist; activates G-protein coupled receptors to modulate pain perception and emotional response.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.

2. Which is stronger: FLOLAN or ACETAMINOPHEN AND HYDROCODONE BITARTRATE?

Potency comparisons between FLOLAN and ACETAMINOPHEN AND HYDROCODONE BITARTRATE depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.

3. What is the standard dosing for FLOLAN vs ACETAMINOPHEN AND HYDROCODONE BITARTRATE?

The standard adult dose of FLOLAN is: Initial: 4 ng/kg/min via continuous IV infusion, then titrated in increments of 1-2 ng/kg/min at intervals of at least 15 minutes based on clinical response. Typical maintenance dose: 20-40 ng/kg/min; range: 10-80 ng/kg/min.. The standard adult dose of ACETAMINOPHEN AND HYDROCODONE BITARTRATE is: 1-2 tablets (containing 5-10 mg hydrocodone and 300-325 mg acetaminophen) orally every 4-6 hours as needed for pain; maximum 8 tablets per day.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.

4. Can you take FLOLAN and ACETAMINOPHEN AND HYDROCODONE BITARTRATE together?

No direct drug-drug interaction has been formally documented between FLOLAN and ACETAMINOPHEN AND HYDROCODONE BITARTRATE in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.

5. Are FLOLAN and ACETAMINOPHEN AND HYDROCODONE BITARTRATE safe during pregnancy?

The maternal-fetal safety profiles differ. FLOLAN is classified as Category C. FDA Pregnancy Category B. No evidence of teratogenicity in animal studies; however, no adequate and well-controlled studies in pregnant women. Epoprostenol is a potent vasodilator . ACETAMINOPHEN AND HYDROCODONE BITARTRATE is classified as Category D/X. First trimester: Acetaminophen considered low risk; hydrocodone is a pregnancy category C drug. Data from retrospective studies suggest a small increased risk of certain congenital. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.