Fulprazal 40 mg delayed release hard gelatin capsule


Esomeprazole 40 mg


Treatment of Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis

Fulprazal 40 mg 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 FULPRAZAL may be considered.

Risk Reduction of NSAID-Associated Gastric Ulcer

Fulprazal 40 mg 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.

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

Triple Therapy (Fulprazal 40 mg plus amoxicillin and clarithromycin): Fulprazal 40 mg , 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 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 prescribing information for clarithromycin].

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

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


FULPRAZAL 40 mg 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 for FULPRAZAL 40 mg


Indication Dose Frequency
Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis 40 mg Once Daily for 4 to 8 Weeks1
Pediatric GERD 12 to 17 years old
Healing of Erosive Esophagitis 40 mg Once daily for 4 to 8 Weeks
  Risk Reduction of NSAID-Associated Gastric Ulcer 40 mg Once Daily for up to 6 months2
H. pylori  Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy:

FULPRAZAL                                                                                40 mg           Once daily for 10 Days

Amoxicillin                                                                                    1000 mg      Twice daily for 10 Days

Clarithromycin                                                                               500 mg        Twice daily for 10 Days

Pathological Hyper-secretory Conditions Including Zollinger-Ellison Syndrome 40 mg4 Twice Daily3
  1. (See Clinical study section 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 considere
  2. Controlled studies did not extend beyond six months.
  3. Doses up to 240 mg daily have been administered [see Drug Interactions (7)].
  4. The dosage of FULPRAZAL in patients with pathological hypersecretory conditions varies with the individual patient.
  5. Dosage regimens should be adjusted to the individual patient needs.

Please refer to amoxicillin and clarithromycin prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients.


Specific Populations

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), FULPRAZAL 40 mg should not be used.

Directions for use specific to the route and available methods of administration for each of these dosage forms are presented in Table 2.


Table 2:  Administration Options

Administration Options

(See text following table for additional instructions.)

Dosage Form Route Options
Fulprazal Delayed-Release

Capsules 40 mg

Oral Capsule can be swallowed whole.


Capsule can be opened and mixed with applesauce.

Fulprazal Delayed-Release

Capsules 40 mg  mg

Nasogastric Tube Capsule can be opened and the intact granules emptied into a syringe and delivered through the nasogastric tube.


FULPRAZAL 40 mg Delayed-Release Capsules

Fulprazal 40 mg 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 Fulprazal 40 mg 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: do not store for future use. 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. If the granules/applesauce mixture is not used in its entirety, the remaining mixture should be discarded immediately.

For patients who have a nasogastric tube in place, Fulprazal 40 mg 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 Fulprazal 40 mg 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 mixture must be used immediately after preparation.