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. |
| Molecular Weight | Lansoprazole: 369.36 Da; Naproxen: 230.26 Da |
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 | Lansoprazole: Limited human data, animal studies show no risk. Naproxen: Avoid due to risk of miscarriage and congenital malformations. Use only if benefit outweighs risk. |
| 2nd trimester | Lansoprazole: No known risk. Naproxen: Avoid due to risk of oligohydramnios and fetal renal dysfunction. |
| 3rd trimester | Lansoprazole: No known risk. Naproxen: Contraindicated due to risk of premature closure of ductus arteriosus and oligohydramnios. |
Clinical note
Comprehensive clinical and safety monograph for PREVACID NAPRAPAC 250 (COPACKAGED) (PREVACID NAPRAPAC 250 (COPACKAGED)).
| Placental transfer | Lansoprazole: Extensive placental transfer in animals; limited human data. Naproxen: Readily crosses placenta; fetal concentrations approximately 87% of maternal. |
| Breastfeeding | Lansoprazole: Excreted in milk in low amounts; considered compatible. Naproxen: Excreted in milk; avoid due to potential adverse effects on infant (e.g., gastrointestinal bleeding, renal impairment). Use caution if used. |
■ 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 |
History of hypersensitivity to lansoprazole, naproxen, or any component of the formulationAsthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDsUse in setting of coronary artery bypass graft (CABG) surgeryThird trimester of pregnancy (naproxen component)
| 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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| Lactation Rating | Lansoprazole: L2 (Safer); Naproxen: L3 (Moderately Safe) but generally avoided. |
| 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 | 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. |
| Food/Dietary | Take lansoprazole on an empty stomach, at least 30 minutes before food. Avoid high-fat meals which may delay absorption. Naproxen can be taken with food or milk to reduce GI upset. Avoid grapefruit juice as it may increase naproxen levels. |
| Clinical Pearls | This copackaged product contains lansoprazole (PPI) and naproxen (NSAID). Use the lowest effective dose for the shortest duration to minimize CV and GI risks. Naproxen may reduce the efficacy of antihypertensives and increase bleeding risk, especially with anticoagulants. Lansoprazole may cause acute interstitial nephritis and hypomagnesemia with prolonged use. |
| Patient Advice | Take this medication at least 30 minutes before a meal for best absorption. · Swallow the lansoprazole capsule whole; do not crush or chew. · Avoid alcohol and NSAIDs (e.g., ibuprofen, aspirin) while taking naproxen to reduce risk of stomach bleeding. · Report signs of bleeding: black/tarry stools, coffee-ground vomit, easy bruising. · Do not take with other acid reducers without doctor approval. |