![](https://ajzon.com/public/uploads/all/C7LrGVQKqkZxOkvBc5Bz1yK23plUQw7RTxIE3Ul7.webp)
![](https://ajzon.com/public/uploads/all/3khnlyfZlE9g8arQIxh3oMdhr03B4tSkG0fIg4rG.webp)
![](https://ajzon.com/public/uploads/all/C7LrGVQKqkZxOkvBc5Bz1yK23plUQw7RTxIE3Ul7.webp)
![](https://ajzon.com/public/uploads/all/3khnlyfZlE9g8arQIxh3oMdhr03B4tSkG0fIg4rG.webp)
-
৳50.00
-
৳400.00
-
৳250.00
-
৳130.00
-
৳330.00
-
৳375.00
Reviews & Ratings
Product Information
NAPEXA
Presentation
NapExa 375/20 tablet: Yellow, oval shaped tablet; each tablet contains delayed-release Naproxen USP 375mg and immediate-release
Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20mg.
NapExa 500/20 tablet: Red, oval shaped tablet; each tablet contains delayed-release Naproxen USP 500mg and immediate-release
Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20mg.
Indication
NapExa (Naproxen and Esomeprazole) tablets are indicated in adults for the symptomatic treatment of osteoarthritis, rheumatoid
arthritis and ankylosing spondylitis, in patients who are at risk for developing Non-Steroidal Anti-Inflammatory Drug
(NSAID)-associated gastric and/or duodenal ulcers and where treatment with lower doses of Naproxen or of other NSAIDs is not
considered sufficient.
Dosage and administration
The recommended dose is one NapExa 500/20 (Naproxen 500mg and Esomeprazole 20mg) tablet twice daily. Undesirable effects of
Naproxen may be minimized by using the lowest effective dose for the shortest duration possible. In patients not treated with a
NSAID previously, a lower daily dose of one NapExa 375/20 (Naproxen 375mg and Esomeprazole 20mg) tablet twice daily or of another
NSAID should be considered. When total daily dose of 1000 mg of Naproxen (500mg twice daily) is not considered appropriate,
alternative treatment with lower strength of one NapExa 375/20 (Naproxen 375mg and Esomeprazole 20mg) tablet twice daily or of
other NSAIDs as non-fixed combination should be utilised. Treatment should be continued to achieve individual treatment goals,
reviewed at regular intervals and discontinued if no benefit or if worsening is seen. Due to the delayed release of Naproxen from
the enteric-coated formulation (3-5 hours), NapExa (Naproxen and Esomeprazole) tablets are not intended for rapid relief of acute
pain conditions (such as dental pain). However, flares of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis may be
treated with NapExa (Naproxen and Esomeprazole) tablets.
Method of administration: Oral use. NapExa (Naproxen and Esomeprazole) tablets must be swallowed whole with sufficient quantity of
water. They must not be chewed or crushed. It is recommended that NapExa (Naproxen and Esomeprazole) tablets are taken at least 30
minutes prior to food intake.
Contra-indication, warnings, etc.
Contra-indication: Naproxen and Esomeprazole tablet is contra-indicated in patient with hypersensitivity to the Naproxen or
Esomeprazole, history of asthma, urticaria or allergic-type reactions induced by administration of acetylsalicylic acid or other
NSAIDs, third trimester of pregnancy, severe hepatic impairment (e.g. Childs-Pugh C), severe heart failure, severe renal
impairment, active peptic ulceration, gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders. Naproxen
and Esomeprazole tablet must not be used concomitantly with atazanavir and nelfinavir.
Warnings and precautions: General: The combination of Naproxen and Esomeprazole tablet and NSAIDs including cyclooxygenase-2
selective inhibitors should be avoided because of the cumulative risks of inducing serious NSAID-related adverse events. Naproxen
and Esomeprazole tablet can be used with low dose acetylsalicylic acid. Undesirable effects may be minimized by using the lowest
effective dose for the shortest duration necessary to control symptoms. Risk-factors to develop NSAID related gastro-intestinal
complications include high age, concomitant use of anticoagulants, corticosteroids, other NSAIDs including low-dose
acetylsalicylic acid, debilitating cardiovascular disease, Helicobacter pylori infection, and a history of gastric and/or duodenal
ulcers and upper gastrointestinal bleeding. In patients with the conditions such as Inducible porphyries, Systemic lupus
erythematosis and mixed connective tissue disease, Naproxen should only be used after a rigorous benefit-risk ratio. Patients on
long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance. Older people:
Naproxen: Older people have an increased frequency of adverse reactions especially gastro-intestinal bleeding, and perforation,
which may be fatal. The esomeprazole component of Naproxen and Esomeprazole tablet decreased the incidence of ulcers in older
people. Gastrointestinal effects: Naproxen: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all
NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI
bleeding, ulceration or perforation with NSAIDs is higher with increasing NSAID doses, in patients with a history of ulcer,
particularly if complicated with haemorrhage or perforation, and in older people. These patients should begin treatment on the
lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be
considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid, or other drugs likely to
increase gastrointestinal risk. Patients with a history of GI toxicity, particularly older people, should report any unusual
abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients
receiving NSAIDs with concomitant medications which could increase the risk of ulceration or bleeding, such as oral
corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as
acetylsalicylic acid. When GI bleeding or ulceration occurs in patients receiving Naproxen and Esomeprazole Tablet, the treatment
should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis,
Crohn’s disease) as these conditions may be exacerbated. Esomeprazole: Dyspesia could still occur despite the addition of
Esomperazole to the combination tablet. Treatment with proton pump inhibitors may lead to slightly increased risk of
gastrointestinal infections such as Salmonella and Campylobacter. Esomeprazole, as all acid-blocking medicines, might reduce the
absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body
stores or risk factors of reduced vitamin B12 absorption on long-term therapy. Cardiovascular and cerebrovascular effects:
Naproxen: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate
congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Patients with
uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or
cerebrovascular disease should only be treated with Naproxen after careful consideration. Similar consideration should be made
before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension,
hyperlipidaemia, diabetes mellitus, smoking). Renal effects: Naproxen: Long-term administration of NSAIDs has resulted in renal
papillary necrosis and other renal injury. Use in patients with impaired renal function: As Naproxen and its metabolites are
eliminated to a large extent (95%) by urinary excretion via glomerular filtration, it should be used with great caution in
patients with impaired renal function and the monitoring of serum creatinine and/or creatinine clearance is advised in these
patients. Naproxen and Esomeprazole tablet is contraindicated in patients having a baseline creatinine clearance of less than 30
ml/minute. Haemodialysis does not decrease the plasma concentration of Naproxen because of the high degree of protein binding.
Certain patients, specifically those whose renal blood flow is compromised, because of extracellular volume depletion, cirrhosis
of the liver, sodium restriction, congestive heart failure, and pre-existing renal disease, should have renal function assessed
before and during Naproxen and Esomeprazole tablet therapy. A reduction in daily dosage should be considered to avoid the
possibility of excessive accumulation of Naproxen metabolites in some patients (older patients in whom impaired renal function may
be expected, as well as patients using diuretics, ACE-inhibitors or angiotensin II receptor antagonists). Hepatic effects:
Borderline elevations of one or more liver tests may occur in patients taking NSAIDs. Hepatic abnormalities may be the result of
hypersensitivity rather than direct toxicity. Hepatorenal syndrome: The use of NSAIDs may be associated with acute renal failure
in patients with severe hepato-cirrhosis. These patients frequently also have concomitant coagulopathy related to inadequate
synthesis of clotting factors. Antiplatelet effects associated with Naproxen could further increase risk of severe bleeding in
these patients. Haematological effects: Naproxen: Patients who have coagulation disorders or are receiving drug therapy that
interferes with haemostasis should be carefully observed if Naproxen-containing products are administered. Patients at high risk
of bleeding and those on full anti-coagulation therapy (e.g. dicoumarol derivates) may be at increased risk of bleeding if given
Naproxen-containing products concurrently. Naproxen decreases platelet aggregation and prolongs bleeding time. This effect should
be kept in mind when bleeding times are determined. When active and clinically significant bleeding from any source occurs in
patients receiving Naproxen and Esomeprazole tablet, the treatment should be withdrawn. Dermatological effects: Naproxen and
Esomeprazole tablet should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of
hypersensitivity. Anaphylactic (anaphylactoid) reactions: Naproxen: Hypersensitivity reactions may occur in susceptible
individuals. Anaphylactic (anaphylactoid) reactions may occur both in patients with and without a history of hypersensitivity or
exposure to acetylsalicylic acid, other NSAIDs or Naproxen-containing products. They may also occur in individuals with a history
of angio-oedema, bronchospastic reactivity (e.g. asthma), rhinitis and nasal polyps. Pre-existing asthma: Naproxen: Naproxen and
Esomeprazole tablet should not be administered to patients with acetylsalicylic acid sensitivity and should be used with caution
in patients with pre-existing asthma. Female fertility: The use of Naproxen and Esomeprazole tablet, as with any drug known to
inhibit cyclooxygenase / prostaglandin synthesis, may impair female fertility and is not recommended in women attempting to
conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Naproxen and
Esomeprazole tablet should be considered. Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with
proton pump inhibitors (PPIs) like esomeprazole for at least three months, and in most cases for a year. Serious manifestations of
hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin
insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation
of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause
hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI
treatment and periodically during treatment. Bone fracture: Proton pump inhibitors, especially if used in high doses and over long
durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in older people or in presence
of other recognised risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines
and they should have an adequate intake of vitamin D and calcium.
Drug interactions: Antiretroviral agents: Omeprazole, the racemate of D+S omeprazole (esomeprazole), has been reported to interact
with some antiretroviral drugs. Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral
drug. Other possible interaction mechanisms are via CYP2C19. For some antiretroviral drugs, such as atazanavir and nelfinavir,
decreased serum levels have been reported when given together with omeprazole. Co-administration of omeprazole (40 mg once daily)
with atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure
(approximately 75% decrease in AUC, Cmax and Cmin). Co-administration of omeprazole (40 mg qd) reduced mean nelfinavir AUC, Cmax
and Cmin by 36-39% and mean AUC, Cmax and Cmin for the pharmacologically active metabolite M8 was reduced by 75-92%. For other
antiretroviral drugs, such as saquinavir, increased serum levels have been reported. However, due to the similar pharmacodynamic
and pharmacokinetic properties of omeprazole and esomeprazole, the concomitant use of atazanavir and nelfinavir with esomeprazole
is not recommended and concomitant administration with Naproxen and Esomeprazole tablet is contraindicated. Concomitant use with
precaution: Other analgesics including cyclooxygenase-2 selective inhibitors: Concomitant use of two or more NSAIDs should be
avoided as this may increase the risk of adverse effects, especially gastrointestinal ulcers and bleeding. The concomitant use of
Naproxen and Esomeprazole tablet with other NSAIDs, except for low-dose acetylsalicylic acid (< 325 mg/day), is not recommended.
Acetylsalicylic acid: Naproxen and Esomeprazole tablet can be administered with low-dose acetylsalicylic acid (325 mg/day)
therapy. The concurrent use of acetylsalicylic acid and Naproxen and Esomeprazole tablet may still increase the risk of serious
adverse events. Tacrolimus: There is a possible risk of nephrotoxicity when Naproxen is co-administered with tacrolimus.
Concomitant administration of esomeprazole has been reported to increase the serum levels of tacrolimus. During treatment with
Naproxen and Esomeprazole tablet, a reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine
clearance) should be performed, and dosage of tacrolimus adjusted if needed. Ciclosporin: As with all NSAIDs, caution is advised
when ciclosporin is co-administered because of the increased risk of nephrotoxicity.Diuretics: Clinical studies, as well as
postmarketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients.
This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the
patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy. Selective Serotonin
Reuptake Inhibitors (SSRIs: Concomitant use of NSAIDs, including COX-2 selective inhibitors, and SSRIs increases the risk of
gastrointestinal bleeding. Corticosteroids: There is an increased risk of gastrointestinal bleeding when corticosteroids are
combined with NSAIDs including COX-2 selective inhibitors. Caution should be used when NSAIDs are administered concomitantly with
corticosteroids. ACE-inhibitors/Angiotensin II receptor antagonists: Reports suggest that NSAIDs may diminish the antihypertensive
effect of ACE-inhibitors and angiotensin II receptor antagonists. NSAIDs may also increase the risk of renal impairment associated
with the use of ACE-inhibitors or angiotensin II receptor antagonists. The combination of NSAIDs and ACE-inhibitors or angiotensin
II receptor antagonists should be given with caution in patients who are older, volume-depleted, or with impaired renal function.
Digoxin: NSAIDs may increase plasma cardiac glycoside levels when co-administered with cardiac glycosides such as digoxin.
Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. These effects have
been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered
concurrently, subjects should be observed carefully for signs of lithium toxicity. Methotrexate: When given together with proton
pump inhibitors, methotrexate levels have been reported to increase in some patients. NSAIDs have been reported to reduce the
tubular secretion of methotrexate in an animal model. This may indicate that both esomeprazole and Naproxen could enhance the
toxicity of methotrexate. Caution should be used when Naproxen and Esomeprazole tablet is administered concomitantly with
methotrexate. In high-dose methotrexate administration a temporary withdrawal of Naproxen and Esomeprazole tablet is recommended.
Clopidogrel: As a precaution, concomitant use of Naproxen and Esomeprazole tablet and clopidogrel should be discouraged.
Anti-coagulants and thrombocyte aggregation inhibitors: NSAIDs may enhance the effects of oral anti-coagulants (e.g. warfarin,
dicoumarol) heparins and thrombocyte aggregation inhibitors. Concomitant administration of 40 mg esomeprazole to warfarin-treated
patients showed that, despite a slight elevation in the trough plasma concentration of the less potent R isomer of warfarin, the
coagulation times were within the accepted range. Close monitoring is recommended when initiating and ending treatment with
warfarin or other coumarine derivatives. Beta receptor-blockers: Naproxen and other NSAIDs can reduce the antihypertensive effect
of propranolol and other beta-blockers. Probenecid: Probenecid given concurrently increases Naproxen anion plasma levels and
extends its plasma half-life significantly. Drugs with gastric pH-dependent absorption: The gastric acid suppression during
treatment with esomeprazole and other PPIs might decrease or increase the absorption of drugs with a gastric pH dependent
absorption. Concomitant use with posaconazole and erlotinib should be avoided. Concomitant treatment with omeprazole (20 mg daily)
and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (up to 30% in two out of ten subjects). Other
information concerning drug interactions: Studies evaluating concomitant administration of esomeprazole and either Naproxen
(non-selective NSAID) or rofecoxib (COX-2-selective NSAID) did not identify any clinically relevant interaction.As with other
NSAIDs, concomitant administration of cholestyramine can delay the absorption of Naproxen.In healthy volunteers, concomitant
administration of 40 mg esomeprazole resulted in a 32% increase in area under the plasma concentration-time curve (AUC) and a 31%
prolongation of elimination half-life (t1/2) but no significant increase in peak plasma levels of cisapride. Esomeprazole has been
shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin and quinidine. CYP2C19 is the major
esomeprazole metabolising enzyme. Esomeprazole is also metabolised by CYP3A4. The following have been observed in relation to
these enzymes: Concomitant administration of 30 mg esomeprazole resulted in a 45% decrease in clearance of the CYP2C19 substrate
diazepam. Concomitant administration of 40 mg esomeprazole resulted in a 13% increase in plasma levels of phenytoin in epileptic
patients, Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4, such as voriconazole, may
result in more than doubling of the esomeprazole exposure, Concomitant administration of esomeprazole and a CYP3A4 inhibitor,
clarithromycin (500 mg twice daily), resulted in a doubling of the exposure (AUC) to esomeprazole. Dose adjustment of esomeprazole
is not required in any of these cases. Drugs known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John’s Wort)
may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism. Patients taking quinolones may have an
increased risk of developing convulsions.
Use in pregnancy and lactation: Pregnancy: Naproxen: In women attempting to conceive or during the first and second trimester of
pregnancy, Naproxen and Esomeprazole tablet should not be given unless the potential benefit to the patient outweighs the
potential risk to the foetus. Naproxen and Esomeprazole tablet is contraindicated during the third trimester of pregnancy.
Breast-feeding: Naproxen is excreted in low quantities in human milk. It is unknown whether esomeprazole is excreted in human
milk. Naproxen and Esomeprazole tablet should not be used during breastfeeding. Fertility: The use of NSAIDs like Naproxen may
impair female fertility. The use of Naproxen and Esomeprazole tablet is not recommended in women attempting to conceive.
Side effects: Immediate release esomeprazole has been included in the tablet formulation to decrease the incidence of
gastrointestinal side effects from Naproxen. Naproxen and Esomeprazole tablet has been shown to significantly decrease the
occurrence of gastric ulcers and NSAID associated upper gastrointestinal adverse events compared to Naproxen alone. Naproxen:
Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long-term
treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or
stroke). Although data suggest that the use of Naproxen (1000 mg daily) may be associated with a lower risk, some risk cannot be
excluded. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. The most commonly
observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly
in older people, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena,
haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less
frequently, gastritis has been observed.
Overdose: Symptoms: Related to Naproxen overdose- Significant Naproxen overdosage may be characterized by lethargy, dizziness,
drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function,
hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting. Gastrointestinal bleeding can
occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have
been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. It is not known what dose of the drug
would be life-threatening. Related to esomeprazole overdose- The symptoms described in connection with deliberate esomeprazole
overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg esomeprazole were uneventful.
Management: Related to Naproxen- Patients should be managed by symptomatic and supportive care following a NSAID overdose,
particularly with respect to GI effects and renal damage. There are no specific antidotes. Hemodialysis does not decrease the
plasma concentration of Naproxen because of the high degree of its protein binding. Emesis and/or activated charcoal (60 to 100 g
in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with
symptoms or following a large overdose. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful due to high
protein binding. Related to Esomeprazole- No specific antidote is known. Esomeprazole is extensively plasma protein bound and is
therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures
should be utilised.
Pharmaceutical precautions
Store in a cool and dry place, protected from light.
Packaging quantities
NapExa 375/20 tablet: Cartons containing 28 tablets in Alu-Alu blister pack. NapExa 500/20 tablet: Cartons containing 28 tablets
in Alu-Alu blister pack.
Related products
Ecosprin Tablet 75mg
Febustat Tablet 40mg
Tufnil Tablet 200mg
Myolax Tablet 50mg
Tory Tablet 90mg
Tory Tablet 60mg
Relatro 25mg
Penrif Cream 30%+8%
Flexilax Tablet 10mg
Product Queries (0)
Login or Registerto submit your questions to seller
Other Questions
No none asked to seller yet
-
৳50.00
-
৳400.00
-
৳250.00
-
৳130.00
-
৳330.00
-
৳375.00