Nexopraz 40

Nexopraz 40

esomeprazole

Manufacturer:

Saga Lab

Distributor:

Hexagon Pharma
Full Prescribing Info
Contents
Esomeprazole.
Description
Each enteric coated tablet contains: Esomeprazole Magnesium Trihydrate equivalent to Esomeprazole 40 mg.
Action
Pharmacology: Pharmacokinetics: Esomeprazole is rapidly absorbed after oral doses with peak plasma levels occurring after about 1 to 2 hours. It is acid labile and an enteric-coated formulation has been developed. Bioavailability of esomeprazole increases with both dose and repeated administration to about 68 and 89% for doses of 20 and 40 mg respectively. Food delays and decreases the absorption of esomeprazole, but this does not significantly change its effect on intragastric acidity. Esomeprazole is about 97% bound to plasma proteins. It is extensively metabolised in the liver by the cytochrome P450 isoenzyme CYP2C219 to hydroxy and desmethyl metabolites, which have no effect on gastric acid secretion. The remainder is metabolised by the cytochrome P450 isoenzyme CYP3A4 to esomeprazole sulfone. With repeated dosage, there is a decrease in first-pass metabolism and systemic clearance, probably causes by an inhibition of the CYP2C19 isoenzyme. However, there is no accumulation during once daily use. The plasma elimination half-life is about 1.3 hours. Almost 80% of an oral dose is eliminated as metabolites in the urine, the remainder in the faeces.
Indications/Uses
Esomeprazole is the S-isomer of the proton pump inhibitor omeprazole and is used similarly in the treatment of peptic ulcer disease and NSAID-associated ulceration, in gastroesophageal reflux disease, and the Zollinger-Ellison syndrome.
Dosage/Direction for Use
Usual doses for peptic ulcer disease, as a component of a triple therapy regimen with amoxicillin and clarithromycin, are the equivalent of 20 mg esomeprazole orally twice daily for 7 days, or 40 mg once daily for 10 days.
Oral doses of 20 mg daily, for 4 to 8 weeks, are used in the treatment of NSAID-associated ulceration; a dose of 20 mg daily may also be used for prophylaxis in patients at risk of such lesions who require continued NSAID treatment.
For the treatment of Zollinger-Ellison syndrome, the recommended initial oral dose of esomeprazole is 40 mg twice daily, which is then adjusted as needed. The majority of patients can be controlled on doses of 240 mg have been given. Doses above 80 mg daily should be given in 2 divided doses.
Special Precautions
Before giving other proton pump inhibitors to patients with gastric ulcers the possibility of malignancy should be excluded since these drugs may make symptoms and delay diagnosis. Other proton pump inhibitors should be used with caution in hepatic impairment and dose adjustment may be required.
Adverse Reactions
Proton pump inhibitors are generally well tolerated, and adverse effects are relatively infrequent. The adverse effects reported most often with other proton pump inhibitors have been headache, diarrhea, and skin rashes; they have been sometimes been severe enough to require stopping treatment. Other effects include pruritus, dizziness, fatigue, constipation, nausea and vomiting, flatulence, abdominal pain, arthralgia and myalgia, urticaria, and dry mouth. Isolated cases of photosensitivity, bullous eruption, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have occurred. Hypersensitivity reactions, including fever, bronchospasm, angioedema, and anaphylaxis have been reported. Effects on the CNS include occasional insomnia, somnolence, and vertigo; reversible confusional states, agitation, depression, and hallucinations have occurred in severely ill patients. Raised liver enzymes, and isolated cases of hepatitis, jaundice, hepatic failure, and hepatic encephalopathy, have been reported. Other adverse effects reported rarely include paraesthesia, blurred vision, alopecia, stomatitis, increased sweating, taste disturbances, peripheral oedema, malaise, hyponatremia, blood disorders (including agranulocytosis, leucopenia, and thrombocytopenia), gynaecomastia, impotence and interstitial nephritis.
Proton pump inhibitors may increase the risk of gastrointestinal infections because of their acid suppressive effects.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
EC tab 40 mg x 100's.
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