NEXIUM - Dosage Esomeprazole magnesium
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.
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.
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.
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.
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