PREVACID NAPRAPAC 250 (COPACKAGED)
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PREVACID NAPRAPAC 250 (COPACKAGED) (PREVACID NAPRAPAC 250 (COPACKAGED)).
Lansoprazole: Proton pump inhibitor that irreversibly inhibits H+/K+ ATPase in gastric parietal cells, reducing gastric acid secretion. Naproxen: Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis.
| Metabolism | Lansoprazole: Primarily hepatic via CYP2C19 and CYP3A4; metabolites inactive. Naproxen: Hepatic metabolism via glucuronidation and CYP2C9; minor pathways. |
| Excretion | Naproxen: Renal (95% as unchanged drug and metabolites, primarily 6-O-desmethyl naproxen), fecal (<5%). Lansoprazole: Renal (20% as metabolites), fecal (80% as metabolites). |
| Half-life | Naproxen: 12-17 hours (terminal), allows twice-daily dosing. Lansoprazole: 1-2 hours (terminal), but acid suppression persists due to accumulation in parietal cells. |
| Protein binding | Naproxen: >99% bound to albumin. Lansoprazole: 97% bound to albumin. |
| Volume of Distribution | Naproxen: 0.16 L/kg (low, indicates limited extravascular distribution). Lansoprazole: 0.5 L/kg (moderate, distributes into gastric parietal cells). |
| Bioavailability | Naproxen: 95% (oral). Lansoprazole: 80-91% (oral), reduced by food. |
| Onset of Action | Naproxen: 1 hour (oral) for analgesic effect. Lansoprazole: 1-3 hours (oral) for acid suppression. |
| Duration of Action | Naproxen: 7-12 hours (analgesic). Lansoprazole: Up to 24 hours (acid suppression) with once-daily dosing. |
Lansoprazole 15 mg plus naproxen 250 mg orally twice daily.
| Dosage form | CAPSULE, DELAYED REL PELLETS, TABLET |
| Renal impairment | Naproxen: Avoid if GFR <30 mL/min/1.73 m2. For GFR 30-89, no dose adjustment needed. Lansoprazole: No adjustment required. |
| Liver impairment | Naproxen: Avoid in severe hepatic impairment (Child-Pugh C). Lansoprazole: Dose reduction not specified; use caution in severe impairment. |
| Pediatric use | Safety and efficacy not established; recommended only for adults. |
| Geriatric use | Start at lower end of dosing due to increased risk of GI, renal, and cardiovascular adverse events. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PREVACID NAPRAPAC 250 (COPACKAGED) (PREVACID NAPRAPAC 250 (COPACKAGED)).
| Breastfeeding | Naproxen: Minimal excretion into breast milk (M/P ratio ~0.01). Lansoprazole: Not detected in breast milk; considered compatible with breastfeeding. |
| Teratogenic Risk | First trimester: Animal studies suggest low risk; human data limited. Second and third trimesters: NSAIDs (naproxen) may cause premature closure of ductus arteriosus and oligohydramnios; avoid after 30 weeks. Lansoprazole shows no major teratogenic risk across trimesters. |
| Fetal Monitoring |
■ FDA Black Box Warning
Naproxen: Cardiovascular thrombotic events (including MI and stroke) risk, especially with prolonged use or in patients with CV risk factors; serious gastrointestinal adverse events (bleeding, ulceration, perforation) which can be fatal. Lansoprazole: Not applicable.
| Common Effects | Abdominal pain Bruise Diarrhea Hematoma Nosebleeds Gastrointestinal bleeding Dyspepsia |
| Serious Effects |
Hypersensitivity to naproxen, lansoprazole, or any components; history of asthma, urticaria, or allergic reactions after NSAIDs; perioperative pain in CABG surgery; advanced renal disease; history of GI bleeding or perforation with NSAIDs; concomitant use with other NSAIDs or aspirin (unless prescribed for cardioprotection).
| Precautions | Cardiovascular: Increased risk of thrombotic events, MI, and stroke; caution with CV disease. Gastrointestinal: Risk of bleeding, ulceration, perforation; use lowest effective dose. Renal: Can cause renal impairment or failure. Hepatic: May elevate liver enzymes; avoid in advanced liver disease. Elderly: Increased risk of GI and renal adverse effects. Pregnancy: Avoid in third trimester (premature closure of ductus arteriosus). |
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| Monitor fetal ductus arteriosus and amniotic fluid index via ultrasound if naproxen used beyond 30 weeks. Assess maternal renal function and gastrointestinal symptoms. |
| Fertility Effects | Naproxen may impair female fertility via prostaglandin-mediated effects on ovulation, reversible upon discontinuation. Lansoprazole not known to affect fertility. |