ZEGERID

ZEGERID- omeprazole and sodium bicarbonate powder, for suspension
ZEGERID- omeprazole and sodium bicarbonate capsule
Santarus, Inc..

1 INDICATIONS AND USAGE

ZEGERID for oral suspension and ZEGERID capsules are indicated in adults for the:

short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
short-term treatment (4 to 8 weeks) of active benign gastric ulcer.
treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.
short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.
The efficacy of ZEGERID used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of ZEGERID may be considered.
maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.

ZEGERID for oral suspension is indicated in adults for the:

reduction of risk of upper GI bleeding in critically ill adult patients.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

ZEGERID (omeprazole and sodium bicarbonate) is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazole for adult use. All recommended doses throughout the labeling are based upon omeprazole.
The sodium content of ZEGERID capsules and ZEGERID for oral suspension should be taken into consideration when prescribing this product [see Warnings and Precautions (5.3)]:
ZEGERID capsule: each 20 mg and 40 mg capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg.
ZEGERID for oral suspension: each 20 mg and 40 mg packet of contains 1,680 mg (20 mEq) of sodium bicarbonate. The total content of sodium in each packet is 460 mg.
Due to the sodium bicarbonate content of ZEGERID:
Do not substitute two packets of 20 mg ZEGERID for oral suspension with one packet of 40 mg ZEGERID for oral suspension.
Do not substitute two 20 mg ZEGERID capsules with one 40 mg ZEGERID capsule.

2.2 Dosage Regimen

The recommended dosage regimen by indication in adults of ZEGERID for oral suspension and ZEGERID capsules is summarized in Table 1. Only 40 mg ZEGERID for oral suspension is indicated for the reduction of risk of upper GI bleeding in critically ill adult patients and the dosage regimen is summarized in Table 2. All recommended dosages are based upon omeprazole content.

Table 1: Recommended Dosage Regimen of ZEGERID for Oral Suspension and ZEGERID Capsules in Adults by Indication
*
Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy [see Clinical Studies (14.1)].
The efficacy of ZEGERID used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of ZEGERID may be considered.

Indication

Dosage of

ZEGERID for oral suspension or ZEGERID capsules

Treatment Duration

Treatment of Active Duodenal Ulcer

20 mg once daily

4 weeks *

Treatment of Active Benign Gastric Ulcer

40 mg once daily

4 to 8 weeks

Treatment of Symptomatic GERD

20 mg once daily

Up to 4 weeks

Treatment of EE due to Acid-Mediated GERD

20 mg once daily

4 to 8 weeks

Maintenance of Healing of EE due to Acid-Mediated GERD

20 mg once daily

Controlled studies do not extend beyond 12 months.

Table 2: Recommended Dosage Regimen of 40 mg ZEGERID for Oral Suspension in Adults by Indication

Indication

Dosage of

40 mg ZEGERID for oral suspension

Treatment Duration

Reduction of Risk of Upper GI Bleeding in Critically Ill Patients

40 mg initially; followed by 40 mg 6 to 8 hours later; and40 mg once daily thereafter

14 days

2.3 Preparation and Administration

ZEGERID Capsules

Swallow capsules intact with water. Do not open the capsule and do not administer with liquids other than water.
Take on an empty stomach at least one hour before a meal [see Clinical Pharmacology (12.3)].

ZEGERID for Oral Suspension

ZEGERID for oral suspension is intended to be mixed with water and administered orally or via a nasogastric (NG) or orogastric (OG) tube.
If administered orally, take on an empty stomach at least one hour before a meal.
If administered via NG or OG tube, suspend enteral feeding approximately 3 hours before and 1 hour after administration of ZEGERID for oral suspension.

Oral Administration

Empty the contents of a packet into a small cup containing 5 to 10 mL of water. Do not mix with liquids or foods other than water.
Stir well and drink immediately.
Refill cup with water and drink immediately.

Nasogastric (NG) or Orogastric (OG) Tube Administration

Add 20 mL of water to a catheter tipped syringe and then add the contents of a packet. Use an appropriately-sized catheter tipped syringe. Do not mix with liquids or foods other than water.
Shake the syringe to dissolve the powder.
Administer through the NG or orogastric tube into the stomach right away.
Refill the syringe with an equal amount of water.
Shake and flush any remaining contents from the NG tube or orogastric tube into the stomach.

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