PREVPAC (COPACKAGED)

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PREVPAC (COPACKAGED) (PREVPAC (COPACKAGED)).

How it works

PrevPac is a copackaged product containing lansoprazole (proton pump inhibitor that inhibits gastric acid secretion by binding to H+/K+-ATPase in gastric parietal cells), amoxicillin (bactericidal beta-lactam antibiotic that inhibits bacterial cell wall synthesis), and clarithromycin (macrolide antibiotic that inhibits protein synthesis by binding to 50S ribosomal subunit).

What the body does with it

Metabolism	Lansoprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4; amoxicillin is partially metabolized by hydrolysis; clarithromycin is metabolized primarily by CYP3A4 to active metabolite 14-hydroxyclarithromycin.
Excretion	Amoxicillin: ~60% renal (unchanged), ~10% biliary; Clarithromycin: ~30% renal (unchanged), ~50% hepatic (metabolized) with fecal elimination; Lansoprazole: minimal renal (mostly as metabolites), ~33% biliary/fecal.
Half-life	Amoxicillin: ~1.0-1.5 h (prolonged in renal impairment); Clarithromycin: ~3-4 h (parent drug), ~5-7 h (14-hydroxy metabolite); Lansoprazole: ~1.5 h (elimination half-life, no accumulation).
Protein binding	Amoxicillin: ~17% (low, primarily albumin); Clarithromycin: ~70% (primarily albumin); Lansoprazole: ~97% (albumin).
Volume of Distribution	Amoxicillin: ~0.3-0.4 L/kg (distributes well into tissues); Clarithromycin: ~3-4 L/kg (extensive tissue penetration); Lansoprazole: ~0.5 L/kg (mainly extracellular fluid).
Bioavailability	Amoxicillin: ~80-90% oral (food does not affect); Clarithromycin: ~50-55% oral (food delays but does not reduce absorption); Lansoprazole: ~80% oral (fasting enhances absorption).
Onset of Action	Amoxicillin: ~1-2 h (oral, bactericidal effect); Clarithromycin: ~2-4 h (oral, bacteriostatic); Lansoprazole: ~1-2 h (oral, acid suppression begins within hours).
Duration of Action	Amoxicillin: 6-8 h (dosing interval 8-12 h); Clarithromycin: 12-24 h (dosing BID); Lansoprazole: ~24 h (once-daily dosing for acid suppression).

Classification & Brands

Dosing & administration

Amoxicillin 1g, clarithromycin 500mg, and lansoprazole 30mg each taken twice daily for 10-14 days. All three components administered orally with or without food.

Dosage form	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS
Renal impairment	CrCl <30 mL/min: Amoxicillin and clarithromycin contraindicated; lansoprazole no adjustment. CrCl 30-50 mL/min: Clarithromycin dose reduce by 50% (maximum 250mg twice daily); amoxicillin and lansoprazole no adjustment.
Liver impairment	Child-Pugh Class B or C: Lansoprazole maximum dose 30mg daily (not twice daily); clarithromycin contraindicated in severe hepatic impairment; amoxicillin no adjustment.
Pediatric use	Not FDA approved for pediatric patients. Alternative regimens recommended for children (e.g., amoxicillin 50mg/kg/day divided twice daily, clarithromycin 15mg/kg/day divided twice daily, and a PPI).
Geriatric use	Use with caution due to age-related renal and hepatic decline. Monitor renal function; no specific dose adjustment but consider lower clarithromycin dose if CrCl <50 mL/min.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for PREVPAC (COPACKAGED) (PREVPAC (COPACKAGED)).

Breastfeeding	Lansoprazole: excreted in breast milk in low amounts, M/P ratio not well established; amoxicillin: low levels in milk, M/P ratio ~0.01-0.04; clarithromycin: present, M/P ratio ~0.25-0.50. Generally considered compatible with breastfeeding, but monitor infant for diarrhea, rash, or fungal infection.
Teratogenic Risk	First trimester: lansoprazole has no evidence of teratogenicity; amoxicillin and clarithromycin are category B with no increased risk in human studies. Second and third trimesters: amoxicillin and clarithromycin are safe; lansoprazole no known risk. Overall risk is low.

Warnings & precautions

■ FDA Black Box Warning

Clarithromycin component: Increased risk of cardiovascular events (including mortality) in patients with coronary artery disease. Do not use in patients with known QT prolongation or history of ventricular arrhythmias.

Side Effect Profile

Serious Effects

Absolute Contraindications

History of hypersensitivity to any component (lansoprazole, amoxicillin, clarithromycin) or other beta-lactams/macrolides; concomitant use with pimozide, ergot alkaloids, colchicine (in renal/hepatic impairment), statins metabolized by CYP3A4 (e.g., simvastatin, lovastatin), or with ranolazine; history of cholestatic jaundice/hepatic dysfunction with clarithromycin; QT prolongation or ventricular arrhythmia history.

Clinical Precautions

Precautions

Clostridium difficile-associated diarrhea; increased INR with warfarin; hypomagnesemia with prolonged PPI use; acute interstitial nephritis; cutaneous lupus erythematosus; serious skin reactions (e.g., SJS/TEN); exacerbation of myasthenia gravis with clarithromycin; QT prolongation with clarithromycin.

Clinical Tips & Counseling

Drug interactions

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PREVPAC (COPACKAGED)

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PREVPAC (COPACKAGED) (PREVPAC (COPACKAGED)).

How it works

What the body does with it

Metabolism	Lansoprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4; amoxicillin is partially metabolized by hydrolysis; clarithromycin is metabolized primarily by CYP3A4 to active metabolite 14-hydroxyclarithromycin.
Excretion	Amoxicillin: ~60% renal (unchanged), ~10% biliary; Clarithromycin: ~30% renal (unchanged), ~50% hepatic (metabolized) with fecal elimination; Lansoprazole: minimal renal (mostly as metabolites), ~33% biliary/fecal.
Half-life	Amoxicillin: ~1.0-1.5 h (prolonged in renal impairment); Clarithromycin: ~3-4 h (parent drug), ~5-7 h (14-hydroxy metabolite); Lansoprazole: ~1.5 h (elimination half-life, no accumulation).
Protein binding	Amoxicillin: ~17% (low, primarily albumin); Clarithromycin: ~70% (primarily albumin); Lansoprazole: ~97% (albumin).
Volume of Distribution	Amoxicillin: ~0.3-0.4 L/kg (distributes well into tissues); Clarithromycin: ~3-4 L/kg (extensive tissue penetration); Lansoprazole: ~0.5 L/kg (mainly extracellular fluid).
Bioavailability	Amoxicillin: ~80-90% oral (food does not affect); Clarithromycin: ~50-55% oral (food delays but does not reduce absorption); Lansoprazole: ~80% oral (fasting enhances absorption).
Onset of Action	Amoxicillin: ~1-2 h (oral, bactericidal effect); Clarithromycin: ~2-4 h (oral, bacteriostatic); Lansoprazole: ~1-2 h (oral, acid suppression begins within hours).
Duration of Action	Amoxicillin: 6-8 h (dosing interval 8-12 h); Clarithromycin: 12-24 h (dosing BID); Lansoprazole: ~24 h (once-daily dosing for acid suppression).

Classification & Brands

Dosing & administration

Amoxicillin 1g, clarithromycin 500mg, and lansoprazole 30mg each taken twice daily for 10-14 days. All three components administered orally with or without food.

Dosage form	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS
Renal impairment	CrCl <30 mL/min: Amoxicillin and clarithromycin contraindicated; lansoprazole no adjustment. CrCl 30-50 mL/min: Clarithromycin dose reduce by 50% (maximum 250mg twice daily); amoxicillin and lansoprazole no adjustment.
Liver impairment	Child-Pugh Class B or C: Lansoprazole maximum dose 30mg daily (not twice daily); clarithromycin contraindicated in severe hepatic impairment; amoxicillin no adjustment.
Pediatric use	Not FDA approved for pediatric patients. Alternative regimens recommended for children (e.g., amoxicillin 50mg/kg/day divided twice daily, clarithromycin 15mg/kg/day divided twice daily, and a PPI).
Geriatric use	Use with caution due to age-related renal and hepatic decline. Monitor renal function; no specific dose adjustment but consider lower clarithromycin dose if CrCl <50 mL/min.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for PREVPAC (COPACKAGED) (PREVPAC (COPACKAGED)).

Breastfeeding	Lansoprazole: excreted in breast milk in low amounts, M/P ratio not well established; amoxicillin: low levels in milk, M/P ratio ~0.01-0.04; clarithromycin: present, M/P ratio ~0.25-0.50. Generally considered compatible with breastfeeding, but monitor infant for diarrhea, rash, or fungal infection.
Teratogenic Risk	First trimester: lansoprazole has no evidence of teratogenicity; amoxicillin and clarithromycin are category B with no increased risk in human studies. Second and third trimesters: amoxicillin and clarithromycin are safe; lansoprazole no known risk. Overall risk is low.