Nexium

Nexium Dosage/Direction for Use

esomeprazole

Manufacturer:

AstraZeneca

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Tablet: The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed.
For patients who have difficulty in swallowing, the tablets can also be dispersed in half a glass of non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.
For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered through a gastric tube. It is important that the appropriateness of the selected syringe and tube is carefully tested. For preparation and handling instructions see Instructions for use and handling under Cautions For Usage.
Adults and adolescents from the age of 12 years: Gastroesophageal Reflux Disease (GERD): Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.
Long-term management of patients with healed esophagitis to prevent relapse: 20 mg once daily.
Symptomatic treatment of gastroesophageal reflux disease (GERD): 20 mg once daily in patients without esophagitis. If symptom control has not been achieved after four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on demand regimen taking 20 mg once daily, when needed. In NSAID treated risk patients subsequent symptom control using on demand treatment is not recommended.
Adults: Patients requiring continued NSAID therapy: Treatment of upper gastrointestinal symptoms associated with NSAID therapy: 20 mg once daily in patients requiring NSAID therapy. If symptom control has not been achieved after 4 weeks, the patient should be further investigated.
Healing of gastric ulcers associated with NSAID therapy: 20 mg or 40 mg once daily for 4 to 8 weeks.
Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk: 20 mg or 40 mg once daily.
In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and healing of Helicobacter pylori associated duodenal ulcer and prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers: 20 mg 'NEXIUM' with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days. For the eradication of Helicobacter pylori and healing of Helicobacter pylori associated duodenal ulcers, also for prevention of relapse of peptic ulcers for Helicobacter pylori sensitive to combined antibacterial therapeutic regimen.
Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion: The recommended initial dosage is 'NEXIUM' 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. Based on the clinical data available, the majority of patients can be controlled on doses between 80 to 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice daily.
Maintenance of haemostasis and prevention of rebleeding of gastric or duodenal ulcers following treatment with 'NEXIUM' for infusion: 40 mg once daily for 4 weeks. The oral treatment period should be preceded by acid-suppression therapy with 'NEXIUM' for infusion 80 mg administered as a bolus infusion over 30 minutes followed by a continuous intravenous infusion of 8 mg/h given over 3 days (72 h), see prescribing information for 'NEXIUM' powder for solution for injection and infusion.
Children below the age of 12 years: 'NEXIUM' should not be used in children younger than 12 years since no data is available.
Injection: Gastric antisecretory treatment when the oral route is not possible: Patients who cannot take oral medication may be treated parenterally with 20-40 mg once daily. Patients with reflux oesophagitis should be treated with 40 mg once daily. Patients treated symptomatically for reflux disease should be treated with 20 mg once daily.
For healing of gastric ulcers associated with NSAID therapy the usual dose in 20 mg once daily. For prevention of gastric and duodenal ulcers associated with NSAID therapy, patients at risk should be treated with 20 mg once daily.
Usually the IV treatment duration is short and transfer to oral treatment should be made as soon as possible.
Maintenance of haemostasis and prevention of rebleeding of gastric and duodenal ulcers: Following therapeutic endoscopy for acute bleeding of gastric or duodenal ulcers, 80 mg should be administered as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/h given over 3 days (72 hours).
The parenteral treatment period should be followed by acid-suppression therapy with 'NEXIUM' 40 mg tablets once daily for 4 weeks (see prescribing information of 'NEXIUM' gastro-resistant tablets as previously mentioned).
Method of administration: Injection: 40 mg dose: The reconstituted solution should be given as an intravenous injection over a period of at least 3 minutes.
20 mg dose: Half of the reconstituted solution should be given as an intravenous injection over a period of approximately 3 minutes. Any unused solution should be discarded.
Infusion: 40 mg dose: The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.
20 mg dose: Half of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded.
80 mg bolus dose: The reconstituted solution should be given as a continuous intravenous infusion over 30 minutes.
8 mg/h dose: The reconstituted solution should be given as a continuous intravenous infusion over a period of 71.5 hours (calculated rate of infusion of 8 mg/h).
Children and adolescents: 'NEXIUM' IV should not be used in children since no data is available.
Impaired hepatic function: Bleeding ulcers: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, following an initial bolus dose of 80 mg 'NEXIUM' for infusion, a continuous intravenous infusion dose of 4 mg/h for 71.5 hours may be sufficient (see Pharmacology: Pharmacokinetics under Actions).
Impaired renal function: Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution (see Pharmacology: Pharmacokinetics under Actions).
Impaired hepatic function: GERD (for Injection only): Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum dose of 20 mg 'NEXIUM' should not be exceeded (see Pharmacology: Pharmacokinetics under Actions).
Elderly: Dose adjustment is not required in the elderly.
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