NEXIUM (Page 2 of 13)

2.2 Recommended Dosage in Pediatric Patients by Indication

Table 2 shows the recommended dosage of NEXIUM in pediatric patients by indication.

Table 2: Recommended Dosage of NEXIUM in Pediatric Patients by Indication

* Dosages over 1 mg/kg/day have not been studied † Dosages over 1.33 mg/kg/day have not been studied
Indication	Patient Age	Recommended Dosage	Duration
Healing of EE	12 years to 17 years	NEXIUM delayed-release capsules or NEXIUM for delayed-release oral suspension: 20 mg or 40 mg once daily	4 to 8 Weeks
	1 year to 11 years *	NEXIUM for delayed-release oral suspension: Less than 20 kg 10 mg once daily 20 kg and greater 10 mg or 20 mg once daily	8 weeks
Treatment of EE due to Acid-Mediated GERD	1 month to less than 1 year †	NEXIUM for delayed-release oral suspension: 3 kg to 5 kg 2.5 mg once daily Greater than 5 kg to 7.5 kg 5 mg once daily Greater than 7.5 kg to 12 kg 10 mg once daily	Up to 6 weeks
Treatment of Symptomatic GERD	12 years to 17 years	NEXIUM delayed-release capsules or NEXIUM for delayed-release oral suspension: 20 mg once daily	4 weeks
	1 year to 11 years	NEXIUM for delayed-release oral suspension: 10 mg once daily1	Up to 8 weeks

2.3 Preparation and Administration Instructions

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Take NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension at least one hour before meals [see Clinical Pharmacology (12.3)].

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Antacids may be used concomitantly with NEXIUM.

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Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time.

NEXIUM Delayed-Release Capsules

Administer NEXIUM delayed-release capsules orally or via a nasogastric tube, as described below.

Oral Administration

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Swallow NEXIUM delayed-release capsules whole; do not chew or crush the capsules.

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For patients who have difficulty swallowing capsules, NEXIUM delayed-release capsules can be opened, and the contents sprinkled on applesauce. Use with other foods has not been evaluated and is not recommended.

1.

Add one tablespoon of applesauce to an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.

2.

Open the NEXIUM delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce.

3.

Mix the granules with the applesauce.

4.

Administer the mixture immediately. Do not chew or crush the granules

5.

Discard any remaining mixture. Do not store the mixture for future use.

Administration via Nasogastric Tube

1.

Open the NEXIUM delayed-release capsule and empty the granules into a 60 mL catheter-tipped syringe.

2.

Mix the granules with 50 mL of water.

3.

Replace the plunger and shake the catheter-tipped syringe vigorously for 15 seconds.

4.

Hold the catheter-tipped syringe with the tip up and check for any granules remaining in the tip.

5.

Attach the catheter-tipped syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach.

6.

After administering the granules, flush the nasogastric tube with additional water.

7.

Use the mixture immediately after preparation. Do not administer the granules if they have dissolved or disintegrated.

NEXIUM For Delayed-Release Oral Suspension

Administer NEXIUM for delayed-release oral suspension orally or via a nasogastric or gastric tube, as described below.

Oral Administration

1.

Empty the contents of a 2.5 mg or 5 mg NEXIUM packet into a container containing 5 mL of water. For the 10 mg, 20 mg, and 40 mg strengths, the contents of a packet should be emptied into a container containing 15 mL of water. If two packets are needed, mix in a similar way add twice the required amount of water.

2.

Stir the packet contents into the water.

3.

Leave 2 to 3 minutes to thicken.

4.

Stir and drink within 30 minutes.

5.

If any of the contents remain after drinking, add more water, stir, and drink immediately.

Administration via Nasogastric or Gastric Tube

1.

Add 5 mL of water to a catheter-tipped syringe and then add the contents of a 2.5 mg or 5 mg NEXIUM packet. For the 10 mg, 20 mg, and 40 mg packet strengths, add at least 15 mL of water to the catheter-tipped syringe.

2.

Immediately shake the catheter-tipped syringe and leave 2 to 3 minutes to thicken.

3.

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

4.

Refill the catheter-tipped syringe with an equal amount of water (5 mL or 15 mL).

5.

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

3 DOSAGE FORMS AND STRENGTHS

NEXIUM Delayed-Release Capsules

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20 mg esomeprazole in opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body.

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40 mg esomeprazole in opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body.

NEXIUM For Delayed-Release Oral Suspension

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2.5 mg, 5 mg, 10 mg, 20 mg or 40 mg esomeprazole in unit dose packets containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale-yellow inactive granules.

4 CONTRAINDICATIONS

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NEXIUM is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)].

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For information about contraindications of amoxicillin and clarithromycin, indicated in combination with NEXIUM for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information.

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Proton pump inhibitors (PPIs), including NEXIUM, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].