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Registry Hub
Peer-Reviewed Evidence
HomeDrug RegistryCompareACETAMINOPHEN AND HYDROCODONE BITARTRATE vs DIGOXIN PEDIATRIC
Comparative Pharmacology

ACETAMINOPHEN AND HYDROCODONE BITARTRATE vs DIGOXIN PEDIATRIC 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

ACETAMINOPHEN AND HYDROCODONE BITARTRATE vs DIGOXIN PEDIATRIC

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

View ACETAMINOPHEN AND HYDROCODONE BITARTRATE Monograph View DIGOXIN PEDIATRIC Monograph
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Opioid Agonist
Category D/X
DIGOXIN PEDIATRIC
Cardiac Glycoside
Category A/B
TL;DR — Key Differences
  • Drug class: ACETAMINOPHEN AND HYDROCODONE BITARTRATE is a Opioid Agonist; DIGOXIN PEDIATRIC is a Cardiac Glycoside.
  • Half-life: ACETAMINOPHEN AND HYDROCODONE BITARTRATE has a half-life of 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.; DIGOXIN PEDIATRIC has Terminal elimination half-life in neonates is 35-70 hours, infants 18-30 hours, children 12-30 hours, and adults 36-48 hours; prolonged in renal impairment and hypothyroidism..
  • No direct drug-drug interaction has been documented between ACETAMINOPHEN AND HYDROCODONE BITARTRATE and DIGOXIN PEDIATRIC.
  • Pregnancy: ACETAMINOPHEN AND HYDROCODONE BITARTRATE is rated Category D/X; DIGOXIN PEDIATRIC is rated Category A/B.

Last clinically reviewed: July 2026 · OpiCalc Medical Review Team

Clinical Essentials

ACETAMINOPHEN AND HYDROCODONE BITARTRATE
DIGOXIN PEDIATRIC
Mechanism of Action
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.

DIGOXIN PEDIATRIC

Inhibits sodium-potassium ATPase, increasing intracellular sodium, which promotes calcium influx via sodium-calcium exchanger, enhancing cardiac contractility. Also increases vagal tone, slowing AV conduction.

Indications
ACETAMINOPHEN AND HYDROCODONE BITARTRATE

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

DIGOXIN PEDIATRIC

Heart failure (FDA-approved for pediatric patients with heart failure),Atrial fibrillation (off-label for rate control in pediatric patients)

Standard Dosing
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.

DIGOXIN PEDIATRIC

For pediatric patients, digoxin pediatric dosing is weight-based; no standard adult dose. Typical pediatric loading dose: 10-12 mcg/kg orally divided every 6-8 hours, with maintenance: 5-10 mcg/kg/day divided every 12 hours. For infants <1 month, loading: 10-15 mcg/kg, maintenance: 4-6 mcg/kg/day. For children 1-24 months, loading: 15-20 mcg/kg, maintenance: 5-8 mcg/kg/day. For children >2 years, loading: 10-15 mcg/kg, maintenance: 3-5 mcg/kg/day.

Direct Interaction
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
No Direct Interaction
DIGOXIN PEDIATRIC
No Direct Interaction

Pharmacokinetics

ACETAMINOPHEN AND HYDROCODONE BITARTRATE
DIGOXIN PEDIATRIC
Half-Life
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.

DIGOXIN PEDIATRIC

Terminal elimination half-life in neonates is 35-70 hours, infants 18-30 hours, children 12-30 hours, and adults 36-48 hours; prolonged in renal impairment and hypothyroidism.

Metabolism
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).

DIGOXIN PEDIATRIC

Primarily renally excreted unchanged; minimal hepatic metabolism (mostly via reduction, hydrolysis, and conjugation in older children).

Excretion
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.

DIGOXIN PEDIATRIC

Renal excretion accounts for 50-70% of elimination as unchanged drug; biliary/fecal excretion accounts for 30-40%, primarily as metabolites; enterohepatic recirculation occurs.

Protein Binding
ACETAMINOPHEN AND HYDROCODONE BITARTRATE

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

DIGOXIN PEDIATRIC

25% bound to serum albumin; binding decreases in uremia and hyperbilirubinemia.

VD (L/kg)
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.

DIGOXIN PEDIATRIC

Vd: 6-10 L/kg in infants and children, 5-7 L/kg in adults; large Vd indicates extensive tissue binding, particularly to cardiac muscle (Na+/K+-ATPase).

Bioavailability
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.

DIGOXIN PEDIATRIC

Oral: 60-80% (elixir 70-85%, tablets 60-75%); IM: 70-85% (but erratic absorption and pain limit use); IV: 100%.

Special Populations

ACETAMINOPHEN AND HYDROCODONE BITARTRATE
DIGOXIN PEDIATRIC
Renal Adjustments
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.

DIGOXIN PEDIATRIC

Digoxin is primarily renally excreted. For pediatric patients, if GFR <30 m L/min/1.73m2, reduce maintenance dose by 50% and monitor serum levels. For GFR 30-60, reduce dose by 25-50%. In neonates with renal impairment, dose reduction proportional to creatinine clearance.

Hepatic Adjustments
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.

DIGOXIN PEDIATRIC

Digoxin is minimally hepatically metabolized; no dose adjustment required for hepatic impairment. However, in Child-Pugh class C, monitor levels due to potential altered distribution.

Pediatric Dosing
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.

DIGOXIN PEDIATRIC

See standard_dosing. Weight-based dosing: total digitalizing dose (TDD) and maintenance as above. For premature infants, TDD 10-15 mcg/kg, maintenance 3-5 mcg/kg/day divided q12h. For full term neonates, TDD 15-20 mcg/kg, maintenance 5-7 mcg/kg/day. For infants 1-24 months, TDD 20-25 mcg/kg, maintenance 7-10 mcg/kg/day. For children 2-10 years, TDD 10-15 mcg/kg, maintenance 5-7 mcg/kg/day. For children >10 years, TDD 10-15 mcg/kg, maintenance 3-5 mcg/kg/day. Divide TDD into 3-4 doses every 6-8 hours. Maintenance started 12 hours after last loading dose.

Geriatric Dosing
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.

DIGOXIN PEDIATRIC

Not applicable for pediatric formulation. For elderly, use adult digoxin dosing with caution: reduced renal function may require lower maintenance doses. Typical adult maintenance: 0.0625-0.25 mg daily based on renal function and lean body mass.

Safety & Monitoring

ACETAMINOPHEN AND HYDROCODONE BITARTRATE
DIGOXIN PEDIATRIC
Black Box Warnings
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.

DIGOXIN PEDIATRIC
FDA Black Box Warning

Toxicity can be life-threatening. Use caution in renal impairment, electrolyte disturbances (hypokalemia, hypomagnesemia, hypercalcemia). Narrow therapeutic index requires monitoring.

Warnings/Precautions
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.

DIGOXIN PEDIATRIC

Monitor serum digoxin levels, renal function, electrolytes (potassium, magnesium, calcium). Risk of arrhythmias (including ventricular fibrillation, bradycardia, AV block). Use with caution in patients with thyroid disease, acute myocardial infarction, or myocarditis.

Contraindications
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.

DIGOXIN PEDIATRIC

Ventricular fibrillation, hypersensitivity to digitalis preparations, hypokalemia (uncorrected), hypercalcemia (uncorrected), AV block (second or third degree) unless pacemaker present.

Adverse Reactions
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Data Pending
DIGOXIN PEDIATRIC
Data Pending
Food Interactions
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.

DIGOXIN PEDIATRIC

High-fiber foods may decrease absorption; take digoxin 1 hour before or 2 hours after meals. Avoid natural licorice, which can cause hypokalemia and increase toxicity. Maintain consistent dietary potassium intake.

Pregnancy & Lactation

ACETAMINOPHEN AND HYDROCODONE BITARTRATE
DIGOXIN PEDIATRIC
Teratogenic Risk
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.

DIGOXIN PEDIATRIC

Digoxin crosses the placenta. First trimester: No increased risk of major malformations reported in human studies. Second/third trimester: Potential for fetal toxicity (e.g., bradycardia, cardiac arrhythmias) at maternal toxic doses. No known teratogenicity at therapeutic doses.

Lactation Summary
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.

DIGOXIN PEDIATRIC

Digoxin is excreted into breast milk in low concentrations. M/P ratio approximately 0.6–0.9. Infant dose via milk is <1% of maternal weight-adjusted dose, unlikely to cause adverse effects in term infants. Caution in preterm or neonates with renal impairment.

Pregnancy Dosing
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.

DIGOXIN PEDIATRIC

During pregnancy, increased volume of distribution and renal clearance may reduce serum digoxin levels. Dose adjustments may be required based on therapeutic drug monitoring; typical dose increase of 20–30% in third trimester. Postpartum, reduce dose to prepregnancy level to avoid toxicity.

Maternal Safety Status
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Category D/X
DIGOXIN PEDIATRIC
Category A/B

Clinical Insights

ACETAMINOPHEN AND HYDROCODONE BITARTRATE
DIGOXIN PEDIATRIC
Clinical Pearls
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.

DIGOXIN PEDIATRIC

Monitor serum digoxin levels (therapeutic range 0.5-2 ng/m L) and renal function, especially in neonates. Correct hypokalemia, hypomagnesemia, and hypercalcemia before administration to reduce toxicity risk. Use with caution in patients with WPW, hypertrophic cardiomyopathy, or incomplete heart block. Dosing in infants and children is based on weight and renal function.

Patient Counseling
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.

DIGOXIN PEDIATRIC

Take exactly as prescribed; do not double up doses.,Monitor for signs of toxicity: nausea, vomiting, vision changes (yellow-green halos), arrhythmias.,Keep medication out of reach of children; immediate medical attention if overdose suspected.,Do not stop abruptly without consulting healthcare provider.,Inform healthcare provider of all medications, including OTC and herbal supplements.

Safety Verification

Known Interactions

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."

DIGOXIN PEDIATRIC Risks3
Eflornithine + Digoxin
moderate

"Eflornithine, an ornithine decarboxylase inhibitor used in the treatment of African trypanosomiasis and hirsutism, may reduce the therapeutic efficacy of digoxin, a cardiotonic glycoside used for heart failure and atrial fibrillation. The proposed mechanism involves eflornithine-induced alterations in gastrointestinal motility or absorption, potentially decreasing digoxin bioavailability. This could lead to subtherapeutic digoxin levels, diminished inotropic and chronotropic effects, and increased risk of arrhythmias or worsening heart failure."

Digoxin + Osimertinib
moderate

"Osimertinib, a tyrosine kinase inhibitor used in non-small cell lung cancer, can inhibit P-glycoprotein (P-gp) transport in the gastrointestinal tract and kidneys, leading to increased absorption and reduced renal clearance of digoxin. This elevation in serum digoxin concentration heightens the risk of digoxin toxicity, including cardiac arrhythmias (e.g., bradycardia, atrial tachycardia with block) and gastrointestinal symptoms such as nausea and vomiting. Clinical monitoring for digoxin toxicity is warranted, especially when initiating or adjusting osimertinib therapy."

Lenvatinib + Digoxin
moderate

"Lenvatinib, a tyrosine kinase inhibitor, may reduce the therapeutic efficacy of digoxin by interfering with its cardiotonic effects. This interaction could lead to decreased inotropic support in patients with heart failure, potentially worsening cardiac function and clinical outcomes. The clinical consequence is a possible loss of rate control in atrial fibrillation or diminished contractility in systolic dysfunction."

Compare Alternatives

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Clinical Q&A

Frequently Asked Questions

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

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

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.. DIGOXIN PEDIATRIC is a Cardiac Glycoside that works by Inhibits sodium-potassium ATPase, increasing intracellular sodium, which promotes calcium influx via sodium-calcium exchanger, enhancing cardiac contractility. Also increases vagal tone, slowing AV conduction.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.

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

Potency comparisons between ACETAMINOPHEN AND HYDROCODONE BITARTRATE and DIGOXIN PEDIATRIC 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 ACETAMINOPHEN AND HYDROCODONE BITARTRATE vs DIGOXIN PEDIATRIC?

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.. The standard adult dose of DIGOXIN PEDIATRIC is: For pediatric patients, digoxin pediatric dosing is weight-based; no standard adult dose. Typical pediatric loading dose: 10-12 mcg/kg orally divided every 6-8 hours, with maintenance: 5-10 mcg/kg/day divided every 12 hours. For infants <1 month, loading: 10-15 mcg/kg, maintenance: 4-6 mcg/kg/day. For children 1-24 months, loading: 15-20 mcg/kg, maintenance: 5-8 mcg/kg/day. For children >2 years, loading: 10-15 mcg/kg, maintenance: 3-5 mcg/kg/day.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.

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

No direct drug-drug interaction has been formally documented between ACETAMINOPHEN AND HYDROCODONE BITARTRATE and DIGOXIN PEDIATRIC 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 ACETAMINOPHEN AND HYDROCODONE BITARTRATE and DIGOXIN PEDIATRIC safe during pregnancy?

The maternal-fetal safety profiles differ. 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. DIGOXIN PEDIATRIC is classified as Category A/B. Digoxin crosses the placenta. First trimester: No increased risk of major malformations reported in human studies. Second/third trimester: Potential for fetal toxicity (e.g., brady. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.