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.
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 | ||||
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.
-or- 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.
