Nexium/Nexium MUPS

Nexium/Nexium MUPS Dosage/Direction for Use

esomeprazole

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Nexium: 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 is 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 intravenous treatment duration is short and transfer to oral treatment should be made as soon as possible. Treatment with Nexium IV can be given for up to 10 days as part of a full treatment period for the specified indications.
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 a continuous intravenous infusion of 8 mg/h given over 3 days (72 hours).
The parenteral treatment period should be followed by oral acid suppression therapy.
Method of Administration: For preparation of reconstituted solution, see "Instructions for Use and Handling" under Cautions for Usage.
Injection: 40 mg dose: 5 ml of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes.
20 mg dose: 2.5 ml or half of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 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 should not be used in children 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: GERD: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg Nexium should not be exceeded (see Pharmacology: "Pharmacokinetics" under Actions).
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).
Elderly: Dose adjustment is not required in the elderly.
Nexium MUPS: 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 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 administration instructions please 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 4 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 20mg once daily, when needed, can be used. In NSAID treated patients at risk of developing gastric cancer and duodenal ulcers, subsequent symptom treatment using an on demand regimen is not recommended.
Adults: 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 MUPS 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 patients at risk: 20 mg once daily.
Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers: 40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers.
Treatment of Zollinger Ellison Syndrome: The recommended initial dosage is Nexium MUPS 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.
Children below the age of 12 years: Nexium MUPS 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 Nexium MUPS should not be exceeded (see Pharmacology: "Pharmacokinetics" under Actions).
Elderly: Dose adjustment is not required in the elderly.
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