VOQUEZNA TRIPLE PAK
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VOQUEZNA TRIPLE PAK (VOQUEZNA TRIPLE PAK).
Vonoprazan is a potassium-competitive acid blocker (P-CAB) that reversibly inhibits gastric H+, K+-ATPase in a pH-independent manner. Amoxicillin and clarithromycin are antibiotics that inhibit bacterial cell wall synthesis and protein synthesis, respectively, to eradicate Helicobacter pylori.
| Metabolism | Vonoprazan: primarily metabolized by CYP3A4/5; Amoxicillin: renal elimination; Clarithromycin: primarily metabolized by CYP3A4. |
| Excretion | Amoxicillin: 60-80% excreted unchanged in urine via glomerular filtration and tubular secretion; Clarithromycin: 20-30% excreted unchanged in urine, remainder metabolized to 14-hydroxyclarithromycin (active) and other metabolites, with renal and biliary excretion; Vonoprazan: primarily metabolized, negligible unchanged drug in urine, with 1-3% excreted in feces as unchanged and metabolites. |
| Half-life | Amoxicillin: 1-1.5 hours (prolonged in renal impairment); Clarithromycin: 3-4 hours (up to 5-7 hours for 14-hydroxy metabolite); Vonoprazan: approximately 8 hours (range 6-10 hours), supporting once-daily dosing for acid suppression. |
| Protein binding | Amoxicillin: 17-20% bound to serum albumin; Clarithromycin: 70% bound to albumin and alpha-1-acid glycoprotein; Vonoprazan: 88-94% bound to albumin. |
| Volume of Distribution | Amoxicillin: 0.3-0.4 L/kg; distributes widely into body tissues and fluids; Clarithromycin: 3-5 L/kg; extensive tissue distribution exceeding plasma; Vonoprazan: 0.49 L/kg (approx. 35 L), indicating moderate distribution into total body water. |
| Bioavailability | Amoxicillin: 60-80% oral bioavailability; Clarithromycin: 50-55% oral bioavailability (reduces with high doses); Vonoprazan: 36-52% oral bioavailability (mean 39%), with high interindividual variability. |
| Onset of Action | Vonoprazan: acid suppression begins within 1 hour of oral administration; Amoxicillin and Clarithromycin achieve therapeutic plasma concentrations within 1-2 hours; clinical effect (symptom relief) may be seen within 1-3 days of triple therapy initiation. |
| Duration of Action | Vonoprazan: acid suppression persists for 24 hours; Clarithromycin: antibacterial effect requires twice-daily dosing to maintain levels; Amoxicillin: dosing every 12 hours maintains adequate levels; the triple pack is administered for 14 days for H. pylori eradication. |
| Molecular Weight | 359.48 Da |
Each carton contains a 14-day course: amoxicillin 1 g orally twice daily, clarithromycin 500 mg orally twice daily, and vonoprazan 20 mg orally twice daily, taken for 14 days.
| Dosage form | CAPSULE, TABLET, TABLET |
| Renal impairment | For CrCl 30-59 mL/min: reduce clarithromycin dose by 50% or use alternative; for CrCl <30 mL/min: avoid clarithromycin and vonoprazan not recommended. Amoxicillin: dose adjustment per guidelines for CrCl <30 mL/min (e.g., 250-500 mg every 12 hours). |
| Liver impairment | For severe hepatic impairment (Child-Pugh C): avoid clarithromycin; vonoprazan no dose adjustment recommended, amoxicillin use with caution. For moderate impairment (Child-Pugh B): clarithromycin no adjustment, monitor. |
| Pediatric use | Not established; safety and efficacy not studied in patients <18 years. |
| Geriatric use | No specific dose adjustment required; monitor renal function and consider age-related decline in CrCl; adjust clarithromycin and/or amoxicillin based on renal function. |
| 1st trimester | Avoid during first trimester due to potential teratogenic effects; limited human data, but animal studies suggest risk. |
| 2nd trimester | Use only if clearly needed; no well-controlled studies in pregnant women. |
| 3rd trimester | Use only if clearly needed; may cause adverse effects in fetus (e.g., metabolic acidosis). |
Clinical note
Comprehensive clinical and safety monograph for VOQUEZNA TRIPLE PAK (VOQUEZNA TRIPLE PAK).
| Placental transfer | Placental transfer is likely based on molecular weight and drug properties; specific data not available. |
| Breastfeeding | Excretion into breast milk is unknown; caution due to possible adverse effects in nursing infants (e.g., diarrhea, rash). |
| Lactation Rating |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to any component (amoxicillin, clarithromycin, vonoprazan, or penicillin)Concomitant use with cisapride, pimozide, ergot alkaloids, HMG-CoA reductase inhibitors metabolized by CYP3A4 (e.g., lovastatin, simvastatin)History of cholestatic jaundice/hepatic dysfunction with clarithromycin or amoxicillinSevere hepatic or renal impairment (CrCl <30 mL/min) for clarithromycin component
| Precautions | Clostridioides difficile-associated diarrhea, Hypersensitivity reactions including anaphylaxis, Severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome), Acute interstitial nephritis, Clarithromycin increases risk of cardiac events (e.g., QT prolongation, arrhythmias) in patients with coronary artery disease, Potential for drug interactions with clarithromycin due to CYP3A4 inhibition |
| Food/Dietary | Take with food to enhance absorption and reduce GI upset. Avoid alcohol during therapy. No specific food restrictions; however, high-fat meals may delay absorption of some components. Avoid grapefruit products as clarithromycin may interact with grapefruit (increased clarithromycin levels). |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | VOQUEZNA TRIPLE PAK contains omeprazole, amoxicillin, and clarithromycin. Omeprazole: Animal studies showed no evidence of teratogenicity; human data from cohort studies suggest no major congenital malformations. Amoxicillin: Penicillins are considered low risk; no teratogenic effects in animal studies. Clarithromycin: Animal studies demonstrated embryotoxicity and malformations; human data limited but may increase risk of spontaneous abortion and malformations. FDA Pregnancy Category C for clarithromycin; category B for omeprazole and amoxicillin. First trimester: Potential risk with clarithromycin. Second and third trimesters: No known fetal risks from omeprazole or amoxicillin; clarithromycin should be avoided unless benefit outweighs risk. |
| Fetal Monitoring | Monitor for maternal adverse effects: allergic reactions (especially amoxicillin and clarithromycin), hepatotoxicity (clarithromycin), QT interval prolongation (clarithromycin). Fetal monitoring: ultrasound assessment for fetal growth and anatomy if used in second or third trimester. Assess for signs of fetal distress or preterm labor if prolonged use. Monitor infant for diarrhea, rash, or candidiasis if used near term. |
| Fertility Effects | Omeprazole: No known effect on human fertility. Amoxicillin: No known effect on fertility. Clarithromycin: Animal studies showed reduced fertility at high doses; human data lacking. Combination therapy may disrupt vaginal flora, potentially affecting fertility; no direct contraceptive effect. Based on available evidence, no significant impact on fertility is expected. |
| Clinical Pearls | VOQUEZNA TRIPLE PAK contains vonoprazan, amoxicillin, and clarithromycin for H. pylori eradication. Vonoprazan is a potassium-competitive acid blocker (PCAB) with rapid, potent acid suppression; avoid coadministration with atazanavir, nelfinavir, or rilpivirine. Amoxicillin: caution in penicillin allergy; adjust dose in renal impairment (CrCl <10 mL/min). Clarithromycin: QT prolongation risk; contraindicated with colchicine, HMG-CoA reductase inhibitors (e.g., simvastatin, lovastatin), and ergot derivatives. Dual therapy with amoxicillin: contraindicated in severe renal impairment. Triple therapy: contraindicated in patients with previous allergic reactions to any component. Monitor for diarrhea, including Clostridioides difficile infection. |
| Patient Advice | Take this medication exactly as prescribed; do not skip doses. · Complete the entire course of therapy even if you feel better. · Take with food to reduce gastrointestinal side effects. · Swallow capsules whole; do not crush or chew. · Avoid alcohol during treatment and for at least 48 hours after finishing. · Report any signs of allergic reaction (rash, hives, swelling, difficulty breathing) immediately. · Inform your doctor if you have diarrhea that is watery or bloody. · Use effective contraception during treatment and for 1 month after finishing if you are of childbearing potential. · Do not take antacids or acid reducers (e.g., omeprazole, ranitidine) while on this therapy without consulting your doctor. · Keep all medications out of reach of children. |