Clinical Studies (14.1) ]The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks of treatment may be considered.
Controlled studies did not extend beyond six months.
If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
Doses over 1 mg/kg/day have not been studied.
The dosage of NEXIUM in patients with pathological hypersecretory conditions varies with the individual patient. Dosage regimens should be adjusted to individual patient needs.
Doses up to 240 mg daily have been administered [see Drug Interactions (7)].
Indication
Dose
Frequency
Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
20 mg or 40 mg
Once Daily for 4 to 8 Weeks*
Maintenance of Healing of Erosive Esophagitis
20 mg
Once Daily†
Symptomatic Gastroesophageal Reflux Disease
20 mg
Once Daily for 4 Weeks‡
Pediatric GERD
12 to 17 Year Olds
Short-term Treatment of GERD
20 mg or 40 mg
Once Daily for up to 8 Weeks
1 to 11 Year Olds
Short-term Treatment of Symptomatic GERD
10 mg
Once Daily for up to 8 Weeks
Healing of Erosive Esophagitis
weight < 20 kg
10 mg
Once Daily for 8 Weeks
weight ≥ 20 kg
10 mg or 20 mg
Once Daily for 8 Weeks
Risk Reduction of NSAID-Associated Gastric Ulcer
20 mg or 40 mg
Once Daily for up to 6 months†
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy:
NEXIUM
40 mg
Once Daily for 10 Days
Amoxicillin
1000 mg
Twice Daily for 10 Days
Clarithromycin
500 mg
Twice Daily for 10 Days
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
40 mg
Twice Daily
Please refer to amoxicillin and clarithromycin full prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients.
Special Populations
Geriatric
No dosage adjustment is necessary [see Clinical Pharmacology (12.3)].
Renal Insufficiency
No dosage adjustment is necessary [see Clinical Pharmacology (12.3)].
Hepatic Insufficiency
In patients with mild to moderate liver impairment (Child Pugh Classes A and B), no dosage adjustment is necessary. For patients with severe liver impairment (Child Pugh Class C), a dose of 20 mg of NEXIUM should not be exceeded [see Clinical Pharmacology (12.3)].
Gender
No dosage adjustment is necessary [see Clinical Pharmacology (12.3)].
Administration Options
Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below.
Table 2
Administration Options
(See text following table for additional instructions.)
Type Route Options
Delayed-Release Capsule
Oral
Capsule can be swallowed whole.
-or-
Capsule can be opened and mixed with applesauce.
Delayed-Release Capsule
Nasogastric Tube
Capsule can be opened and the intact granules emptied into a syringe and delivered through the nasogastric tube.
For Delayed-Release Oral Suspension
Oral
Mix contents of packet with 1 tablespoon (15 mL) of water, leave 2 to 3 minutes |
