NEXIUM

NEXIUM- esomeprazole magnesium capsule, delayed release
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

1.1 Healing of Erosive Esophagitis (EE)

Adults

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of NEXIUM may be considered.

Pediatric Patients 12 Years to 17 Years of Age

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age.

Pediatric Patients 1 Year to 11 Years of Age

NEXIUM for delayed-release oral suspension is indicated for the short-term treatment (8 weeks) for the healing of EE in pediatric patients 1 year to 11 years of age.

Pediatric Patients 1 Month to Less Than 1 Year of Age

NEXIUM for delayed-release oral suspension is indicated for short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.

1.2 Maintenance of Healing of EE

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months.

1.3 Treatment of Symptomatic GERD

Adults

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.

Pediatric Patients 12 Years to 17 Years of Age

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age.

Pediatric Patients 1 Year to 11 Years of Age

NEXIUM for delayed-release oral suspension is indicated for short-term treatment (up to 8 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age.

1.4 Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the reduction in

the occurrence of gastric ulcers associated with continuous NSAID therapy in adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric

ulcers. Controlled studies do not extend beyond 6 months.

1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Triple Therapy

NEXIUM delayed-release capsules or NEXIUM for delayed-release oral suspension in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.

In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the prescribing information for clarithromycin].

1.6 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Adults by Indication

Table 1 shows the recommended adult dosage of NEXIUM by indication.

The duration of NEXIUM treatment should be based on available safety and efficacy data specific to the defined indication and dosing frequency and individual patient medical needs. NEXIUM should only be initiated and continued if the benefits outweigh the risks of treatment.

Table 1: Recommended Dosage of NEXIUM in Adults by Indication
*
A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6)] .
Most 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 required to achieve healing [see Clinical Studies (14.1)] .
Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients.
§
A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6)] .

Adult Indication

Recommended Dosage of

NEXIUM d elayed-release capsules and NEXIUM for delayed-release oral suspension

Treatment Duration

Healing of EE

20 mg or 40 mg * once daily

4 to 8 weeks

Maintenance of Healing of EE

20 mg once daily

Controlled studies do not extend beyond 6 months

Treatment of Symptomatic GERD

20 mg once daily

4 weeks; if symptoms do not resolve completely, consider an additional 4 weeks

Risk Reduction of NSAID-Associated Gastric Ulcer

20 mg or 40 mg * once daily

Controlled studies do not extend beyond 6 months

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (Triple Therapy)

NEXIUM 40 mg once daily *

10 days

Amoxicillin 1000 mg twice daily

10 days

Clarithromycin 500 mg twice daily

10 days

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Starting dosage is 40 mg twice daily §; individualize the regimen to patient needs.

Dosages of up to 240 mg/day have been administered [see Clinical Studies (14.7)].

As long as clinically indicated

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