VOQUEZNA DUAL PAK
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VOQUEZNA DUAL PAK (VOQUEZNA DUAL PAK).
VOQUEZNA DUAL PAK contains vonoprazan, a potassium-competitive acid blocker (P-CAB) that reversibly inhibits H+/K+-ATPase in gastric parietal cells, providing rapid and sustained acid suppression. It also contains amoxicillin, a beta-lactam antibiotic that inhibits bacterial cell wall synthesis.
| Metabolism | Vonoprazan is primarily metabolized by CYP3A4/5 and to a lesser extent by CYP2B6, CYP2C19, CYP2D6, and SULT2A1. Amoxicillin is partially metabolized by hydrolysis to penicilloic acid. |
| Excretion | Primarily renal excretion (approximately 80% as metabolites, <1% unchanged); minor biliary/fecal elimination (~15%) |
| Half-life | Terminal elimination half-life ~6-8 hours; clinically, once-daily dosing is sufficient due to pharmacodynamic effect (acid suppression) outlasting plasma levels |
| Protein binding | Approximately 95% bound to plasma proteins (primarily albumin) |
| Volume of Distribution | ~11-17 L (approx 0.15-0.25 L/kg); indicates moderate tissue distribution |
| Bioavailability | Oral: Absolute bioavailability ~70-80%; food does not significantly affect absorption |
| Onset of Action | Oral: Onset of acid suppression within 1 hour; maximum effect by 2-3 hours |
| Duration of Action | Acid suppression persists for up to 24 hours with once-daily dosing; gastric pH >4 maintained for 14-17 hours post-dose |
VOQUEZNA DUAL PAK consists of vonoprazan 20 mg (morning) and amoxicillin 1000 mg (morning and evening) for 14 days.
| Dosage form | CAPSULE, TABLET |
| Renal impairment | Contraindicated if CrCl <30 mL/min. For CrCl 30-59 mL/min, no dose adjustment needed. For CrCl <30 mL/min, not recommended. |
| Liver impairment | No dose adjustment required for mild (Child-Pugh A) or moderate (Child-Pugh B) impairment. Not studied in severe (Child-Pugh C) impairment; use with caution. |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dose adjustment recommended, but monitor renal function due to age-related decline; adjust based on renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VOQUEZNA DUAL PAK (VOQUEZNA DUAL PAK).
| Breastfeeding | Amoxicillin is excreted into breast milk in low amounts with an M/P ratio of approximately 0.01-0.02. Vonoprazan is not known to be excreted in human milk; however, based on its molecular weight and properties, it is likely to be present in low concentrations. The American Academy of Pediatrics considers amoxicillin compatible with breastfeeding. Caution is advised due to potential effects on infant gut flora. No specific M/P ratio for vonoprazan is available. |
| Teratogenic Risk | Based on animal studies and limited human data, amoxicillin and vonoprazan are not expected to increase the risk of major birth defects. Vonoprazan has no evidence of teratogenicity in animal studies at doses up to 25 times the human exposure. Amoxicillin is considered low risk in all trimesters. However, no adequate human studies exist for the combination. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to vonoprazan, amoxicillin, or any other component","Concomitant use with rilpivirine-containing products"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome)","Clostridium difficile-associated diarrhea","Potential for increased risk of gastric malignancies with long-term acid suppression","Interference with laboratory tests (e.g., urine protein tests)","Use in patients with renal impairment: dose adjustment for amoxicillin"] |
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| Fetal Monitoring | Monitor maternal renal function and for signs of hypersensitivity reactions. In pregnant women, standard prenatal care includes ultrasound for fetal growth assessment if prolonged therapy is needed. No specific fetal monitoring required for this drug combination. |
| Fertility Effects | No adverse effects on fertility have been reported for amoxicillin or vonoprazan in animal studies. Human data are insufficient to draw conclusions. |