Naproxen + Esomeprazole


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis Each tab contains naproxen 375 mg and esomeprazole 20 mg or naproxen 500 mg and esomeprazole 20 mg: 1 tab bid.
Dosage Details
Oral
Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis
Adult: Available preparations:
Naproxen 375 mg and esomeprazole 20 mg
Naproxen 500 mg and esomeprazole 20 mg

1 tab bid.

Oral
Juvenile idiopathic arthritis
Child: Available preparations:
Naproxen 375 mg and esomeprazole 20 mg
Naproxen 500 mg and esomeprazole 20 mg

≥12 years 38-<50 kg: 1 tab (375 mg/20 mg) bid; ≥50 kg: 1 tab (375 mg/20 mg or 500 mg/20 mg) bid.
Renal Impairment
CrCl (mL/min) Dosage 
<30 Contraindicated.
Hepatic Impairment
Severe: Contraindicated.
Administration
Modified-Release Tab: Should be taken on an empty stomach. Take at least 30 min prior to food intake. Swallow whole, do not split/chew/crush.
Contraindications
Hypersensitivity to naproxen, aspirin or other NSAIDs. Active peptic ulceration or GI bleeding, cerebrovasular bleeding and other bleeding disorders, severe heart failure, aspirin-sensitive asthma. Treatment of perioperative pain in the setting of CABG surgery. Severe renal and hepatic impairment. Concomitant use with antiretroviral agents.
Special Precautions
Patient with known CV disease (e.g. CHF, uncontrolled hypertension, ischaemic heart disease) or risk factors for CV disease (e.g. diabetes mellitus, hyperlipidaemia, smoking), history of GI bleeding or peptic ulceration, systemic lupus erythematosus, history of ulcerative colitis or Crohn’s disease, hypovolaemia, pre-existing asthma. Patient undergoing surgical or dental procedure. Mild to moderate renal and hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Hypertension, hyperkalaemia, hypomagnesaemia, active and clinically significant bleeding from any source, SLE, bone fractures, anaemia, acute interstitial nephritis, vitamin B12 malabsorption, jaundice, increased risk of Clostridium difficile-associated diarrhoea.
Blood and lymphatic system disorders: Rarely, agranulocytosis, thrombocytopenia, aplastic anaemia.
Cardiac disorders: Palpitations.
Ear and labyrinth disorders: Hearing disturbance, tinnitus.
Eye disorders: Conjunctivitis, abnormal vision.
Gastrointestinal disorders: Gastritis, diarrhoea, constipation, flatulence, nausea, vomiting, upper abdominal pain, dysgeusia, dyspepsia, diverticulitis.
General disorders and administration site conditions: Peripheral oedema.
Investigations: Hepatic enzyme increased.
Musculoskeletal and connective tissue disorders: Arthralgia.
Nervous system disorders: Dizziness, headache, lightheadedness, vertigo.
Psychiatric disorders: Depression, insomnia.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, dyspnoea.
Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Anaphylactic reactions, MI, stroke, exfoliative dermatitis, Stevens- Johnson syndrome, toxic epidermal necrolysis, fulminant hepatitis, hepatic necrosis, hepatic failure, renal failure, and gastrointestinal bleeding, ulceration and perforation.
PO: C, D (in 3rd trimester)
Patient Counseling Information
This drug may cause dizziness, drowsiness, or blurred vision, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor CBC, chemistry profile, occult blood loss, LFT, renal function tests, blood pressure, and periodic ophthalmic exam in patients receiving long-term therapy.
Drug Interactions
Naproxen: Increased risk of serious gastrointestinal events (e.g. ulcer) with aspirin or warfarin. May reduce the natriuretic effects of furosemide or thiazide diuretics. May increase serum lithium concentrations and reduce renal lithium clearance. May interfere with the antihypertensive effects of β-blockers (e.g. propranolol), ACE inhibitors, angiotensin receptor blockers. Increased serum levels with probenecid.
Esomeprazole: Reduces the antiplatelet effects of clopidogrel. Increased risk of digoxin- induced cardiotoxic effects. Increased risk of hypomagnesaemia with diuretics. May increase serum concentration of tacrolimus, methotrexate. May interfere with the elimination of drugs metabolised by CYP2C19 (e.g. diazepam). May decrease the bioavailability of ketoconazole, erlotinib and Fe salts.
Potentially Fatal: May decrease serum concentration and pharmacological effects of antiretroviral agents (e.g. rilpivirine, atazanavir and nelfinavir).
Food Interaction
Delayed absorption with food. Avoid St John’s wort as it may decrease the serum levels of esomeprazole.
Lab Interference
May cause false positive results in diagnostic investigations for neuroendocrine tumours.
Action
Description: Naproxen, a propionic acid derivative, is a prototypical NSAID. It reversibly inhibits the cyclooxygenase-1 and cyclooxygenase-2 (COX-1 and COX-2) enzymes, thus resulting in reduced synthesis of prostaglandin precursors. It can inhibit platelet aggregation, has anti-inflammatory, analgesic and antipyretic actions.
Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting H+/K+-ATPase in the gastric parietal cells. It is the S-isomer of omeprazole.
Onset: Naproxen: Analgesic: 30-60 minutes.
Duration: Naproxen: Analgesic: <12 hours.
Pharmacokinetics:
Absorption: Naproxen: Readily absorbed from the gastrointestinal tract. Food reduces the rate of absorption. Bioavailability: 95%. Time to peak plasma concentration: Approx 2-4 hours.
Esomeprazole: Rapidly absorbed. Absorption is delayed and reduced with food. Bioavailability: Approx 90%. Time to peak plasma concentrations: 1-2 hours.
Distribution: Naproxen: Diffuses into synovial fluid, crosses the placenta and distributed into breast milk (small amounts). Volume of distribution: 0.16 L/kg. Plasma protein binding: >99%.
Esomeprazole: Plasma protein binding: Approx 97%.
Metabolism: Naproxen: Undergoes extensive hepatic metabolism by CYP1A2 and CYP2C9 isoenzymes to 6-O-desmethylnaproxen which is further metabolised to acylglucuronide conjugated metabolites.
Esomeprazole: Extensively metabolised in the liver, mainly by CYP2C19 enzyme to form hydroxy and, desmethyl metabolites, and the remainder by CYP3A4 enzyme to form esomeprazole sulfone.
Excretion: Naproxen: Via urine (approx 95%, as unchanged drug and metabolites); faeces (<5%). Elimination half-life: Approx 12-17 hours.
Esomeprazole: Mainly via urine (approx 80%, primarily as inactive metabolites); faeces (20%). Plasma elimination half-life: Approx 1.3 hours.
Chemical Structure

Chemical Structure Image
Naproxen

Source: National Center for Biotechnology Information. PubChem Database. Naproxen, CID=156391, https://pubchem.ncbi.nlm.nih.gov/compound/Naproxen (accessed on Jan. 22, 2020)


Chemical Structure Image
Esomeprazole

Source: National Center for Biotechnology Information. PubChem Database. Esomeprazole, CID=9568614, https://pubchem.ncbi.nlm.nih.gov/compound/Esomeprazole (accessed on Jan. 22, 2020)

Storage
Store at 25°C. Protect from moisture.
ATC Classification
M01AE52 - naproxen and esomeprazole ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
References
Anon. Esomeprazole. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/02/2018.

Anon. Naproxen and Esomeprazole. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/02/2018.

Anon. Naproxen. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/02/2018.

Buckingham R (ed). Naproxen. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/02/2018.

Joint Formulary Committee. Naproxen with Esomeprazole. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/02/2018.

McEvoy GK, Snow EK, Miller J et al (eds). Esomeprazole Magnesium, Esomeprazole Sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 09/02/2018.

Vimovo 375 mg/20 mg Tablet, Delayed Release (Horizon Pharma Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 01/02/2018 .

Vimovo 500 mg/20 mg Tablet, Delayed Release (Horizon Pharma Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/02/2018.

Disclaimer: This information is independently developed by MIMS based on Naproxen + Esomeprazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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