NEXIUM

NEXIUM- esomeprazole magnesium capsule, delayed release
A-S Medication Solutions LLC

1 INDICATIONS AND USAGE

1.1 Treatment of Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis

NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. 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.

Maintenance of Healing of Erosive Esophagitis

NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.

Symptomatic Gastroesophageal Reflux Disease

NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.

1.2 Risk Reduction of NSAID-Associated Gastric Ulcer

NEXIUM is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy (NEXIUM plus amoxicillin and clarithromycin): NEXIUM, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14) and Dosage and Administration. (2)].

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 clarithromycin package insert, Clinical Pharmacology, Microbiology ].

1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

NEXIUM is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

2 DOSAGE AND ADMINISTRATION

NEXIUM is supplied as delayed-release capsules for oral administration or in packets for preparation of delayed-release oral suspensions. The recommended dosages are outlined in the table below. NEXIUM should be taken at least one hour before meals.

The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the Prescribing Information, and individual patient medical needs. Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.

Table 1

Recommended Dosage Schedule of NEXIUM
*
[See 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 to thicken, stir and drink within 30 minutes.

For Delayed-Release Oral Suspension

Nasogastric or Gastric Tube

Add 15 mL of water to a syringe and then add contents of packet. Shake the syringe; leave 2 to 3 minutes to thicken. Shake the syringe and inject through the nasogastric or gastric tube within 30 minutes.

NEXIUM Delayed-Release Capsules

NEXIUM Delayed-Release Capsules should be swallowed whole.

Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the NEXIUM Delayed-Release Capsule can be opened, and the granules inside the capsule carefully emptied onto the applesauce. The granules should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The granules should not be chewed or crushed. The granules/applesauce mixture should not be stored for future use.

For patients who have a nasogastric tube in place, NEXIUM Delayed-Release Capsules can be opened and the intact granules emptied into a 60 mL catheter tipped syringe and mixed with 50 mL of water. It is important to only use a catheter tipped syringe when administering NEXIUM through a nasogastric tube. Replace the plunger and shake the syringe vigorously for 15 seconds. Hold the syringe with the tip up and check for granules remaining in the tip. Attach the syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach. After administering the granules, the nasogastric tube should be flushed with additional water. Do not administer the granules if they have dissolved or disintegrated.

The suspension must be used immediately after preparation.

NEXIUM For Delayed-Release Oral Suspension

NEXIUM For Delayed-Release Oral Suspension should be administered as follows:

  • Empty the contents of a 10 mg, 20 mg, or 40 mg packet into a container containing 1 tablespoon (15 mL) of water.

  • Stir.

  • Leave 2 to 3 minutes to thicken.

  • Stir and drink within 30 minutes.

  • If any material remains after drinking, add more water, stir, and drink immediately.

For patients who have a nasogastric or gastric tube in place, NEXIUM For Delayed-Release Oral Suspension can be administered as follows:

  • Add 15 mL of water to a catheter tipped syringe and then add the contents of a 10 mg, 20 mg, or 40 mg NEXIUM packet. It is important to only use a catheter tipped syringe when administering NEXIUM through a nasogastric tube or gastric tube.

  • Immediately shake the syringe and leave 2 to 3 minutes to thicken.

  • Shake the syringe and inject through the nasogastric or gastric tube, French size 6 or larger, into the stomach within 30 minutes.

  • Refill the syringe with 15 mL of water.

  • Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

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