NEXIUM - Dosage Esomeprazole magnesium

NEXIUM (esomeprazole magnesium granule, delayed release) comes in different strengths and amounts, which is referred to as the dosing of NEXIUM. The appearance of NEXIUM can differ based on the dosing. Your doctor may change the dosage and prescription of NEXIUM to get you the best results possible.

Dosage & Administration

Population Recommended Adult (2.1) and Pediatric Dosage (2.2)

Healing of EE (1 year and older)

EE due to Acid-Mediated GERD (1 month to less than 1 year)

Adults

20 mg or 40 mg

A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C).

once daily for 4 to 8 weeks; some patients may require an additional 4 to 8 weeks

12 years to 17 years

20 mg or 40 mg

once daily for 4 to 8 weeks

1 month to 11 years

see full prescribing information for weight-based dosing and duration of treatment (2.2)

Maintenance of Healing of EE

Adults

20 mg once daily. Controlled studies do not extend beyond 6 months

Treatment of Symptomatic GERD

Adults

20 mg once daily once daily for 4 weeks some patients may require an additional 4 weeks

12 years to 17 years

20 mg once daily for 4 weeks

1 year to 11 years

10 mg once daily for up to 8 weeks

Risk Reduction of NSAID-Associated Gastric Ulcer

Adults

20 mg or 40 mg

once daily for up to 6 months

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

Adults

NEXIUM 40 mg

once daily for 10 days

Controlled studies do not extend beyond 6 months.

Amoxicillin 1000 mg twice daily for 10 days

Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients.

Clarithromycin500 mg twice daily for 10 days

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Adults

Starting dosage is 40 mg twice daily

A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C).

(varies with the individual patient) as long as clinically indicated.

Preparation and Administration Information

  • Swallow capsules whole; do not crush or chew. For patients who cannot swallow intact capsule, the capsule can be opened, and the contents mixed with applesauce. (2.3)
  • Mix packets with water to create an oral suspension. (2.3)
  • Opened capsules can be administered through a nasogastric tube and oral suspension can be administered through a nasogastric or gastric tube. (2.3)

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

Adult Indication

Recommended Dosage of

NEXIUM delayed-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

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

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

Dosages over 1 mg/kg/day have not been studied

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

Dosages over 1.33 mg/kg/day have not been studied

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

preparation & administration instructions

  • Take NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension at least one hour before meals [see Clinical Pharmacology (12.3)].
  • Antacids may be used concomitantly with NEXIUM.
  • 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

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

Dosage Form & Strengths

NEXIUM Delayed-Release Capsules

  • 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.
  • 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

  • 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.
  • NEXIUM Delayed-Release Capsules: 20 mg and 40 mg. (3)
  • NEXIUM For Delayed-Release Oral Suspension: 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg. (3)

Overdosage

Manifestations in patients exposed to omeprazole, the racemic mixture, at doses up to 2,400 mg (120 times the usual recommended clinical dose) include confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen at recommended dosages. See the full prescribing information for omeprazole for complete safety information. No specific antidote for esomeprazole is known. Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive.

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

Storage & Handling

NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:

NDC 0186-5020-31 unit of use bottles of 30

NDC 0186-5020-54 bottles of 90

NEXIUM Delayed-Release Capsules, 40 mg, esomeprazole, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:

NDC 0186-5040-31 unit of use bottles of 30

NDC 0186-5040-54 bottles of 90

NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:

NDC 0186-4025-01 unit dose packages of 30: 2.5 mg esomeprazole packets

NDC 0186-4050-01 unit dose packages of 30: 5 mg esomeprazole packets

NDC 0186-4010–01 unit dose packages of 30: 10 mg esomeprazole packets

NDC 0186-4020–01 unit dose packages of 30: 20 mg esomeprazole packets

NDC 0186-4040–01 unit dose packages of 30: 40 mg esomeprazole packets

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM delayed-release capsules container tightly closed. Dispense in a tight container if the NEXIUM delayed-release capsules product package is subdivided.

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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