Esoferr

Esoferr Dosage/Direction for Use

esomeprazole

Manufacturer:

Ferron
Full Prescribing Info
Dosage/Direction for Use
DR cap: The capsules should be swallowed whole with liquid. The capsules should not be chewed or crushed. For patients who have difficulty in swallowing, the contents of a capsule can also be mixed in half a glass of noncarbonated water. No other liquids should be used as the enteric coating pellets may be dissolved. Stir the content of the capsules inside the glass filled with noncarbonated water. 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 contents of a capsule can be mixed 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 administration instructions see Instructions for use and handling under Cautions for Usage.
Adults: 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. Esomeprazole 40 mg should only be administered for patients with mucosal break of grade C and D under the LA classification system, the grade of which should be confirmed by endoscopic or radiological diagnosis. Patients who have GERD with erosive esophagitis of Grade A and B are recommended to be treated with esomeprazole 20 mg.
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 20 mg once daily. In adults, an on-demand regimen taking 20 mg once daily, when needed, can be used. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on-demand regimen is not recommended.
In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori: Healing of Helicobacter pylori associated duodenal ulcer: 20 mg esomeprazole with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.
Patients requiring continued NSAID therapy: Healing of gastric ulcers associated with NSAID therapy: The usual dose is 20 mg once daily. The treatment duration is 4-8 weeks.
Prevention of gastric and duodenal ulcers associated with NSAID therapy in patient at risk: 20 mg once daily.
Treatment of Zollinger-Ellison syndrome: The recommended initial dosage is esomeprazole 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. 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.
Children 12-18 years: Gastroesophageal Reflux Disease (GERD): 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 20 mg once daily, under medical supervision.
Children below the age of 12 years: Esomeprazole should not be used in children younger than 12 years since no data is available.
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: 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 esomeprazole should not be exceeded (see Pharmacology: Pharmacokinetics under Actions).
Elderly: Dose adjustment is not required in the elderly.
Powd for inj: Gastric antisecretory treatment when the oral route is not possible.
Patients who cannot take oral medicines may be treated parenterally with 20-40 mg once daily. Patients with reflux esophagitis should be treated with 40 mg once daily. Patients with symptomatically for reflux disease should be treated with 20 mg once daily.
For healing of gastric ulcers associated with NSAID therapy the usual dose is 20 mg once daily.
Usually the IV treatment durations short and transfer to oral treatment should be made as soon as possible.
Maintenance of hemostasis and prevention of rebleeding of gastric and duodenal ulcers following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers, 80 mg should be administered as a bolus infusion over 30 minutes, followed by continuous intravenous infusion of 8 mg/hour given over 3 days (72 hours).
The parenteral treatment period should be followed by acid-suppression therapy with esomeprazole 40 mg gastro-resistant tablet once daily for 4 weeks.
Children and adolescent: Esomeprazole IV should not be used in children and adolescent since no data is available.
Impaired hepatic function: Treatment for bleeding ulcer patients with severe liver impairment, following an initial bolus dose of 80 mg esomeprazole for infusion, a continuous intravenous infusion dose of 4 mg/hour for 71.5 hours may be sufficient.
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/hour 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/hour).
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