Zarroprazole

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Indications and Usage

Duodenal Ulcer: Zarroprazole is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Gastric Ulcer: Zarroprazole is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer.Treatment of Gastroesophageal Reflux Disease (GERD) Symptomatic GERD: Zarroprazole is indicated for the treatment of heartburn and other symptoms associated with GERD. Erosive Esophagitis: Zarroprazole is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy. The efficacy of Zarroprazole used for longer than 8 weeks in these patients has not been established. In the rare instance of a patient not responding to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered. Maintenance of Healing of Erosive Esophagitis: Zarroprazole is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients :Zarroprazole Powder for Oral Suspension 20 mg/1680 mg is indicated for the reduction of risk of upper GI bleeding in critically ill patients.

Description

Indications and Usage

Duodenal Ulcer: Zarroprazole is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Gastric Ulcer: Zarroprazole is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer.Treatment of Gastroesophageal Reflux Disease (GERD) Symptomatic GERD: Zarroprazole is indicated for the treatment of heartburn and other symptoms associated with GERD. Erosive Esophagitis: Zarroprazole is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy. The efficacy of Zarroprazole used for longer than 8 weeks in these patients has not been established. In the rare instance of a patient not responding to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered. Maintenance of Healing of Erosive Esophagitis: Zarroprazole is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients :Zarroprazole Powder for Oral Suspension 20 mg/1680 mg is indicated for the reduction of risk of upper GI bleeding in critically ill patients.

Dosage and Administration

Zarroprazole (omeprazole/sodium bicarbonate) is available as a capsule and as a powder for oral suspension in 20 mg strength for adult use. Since both the 20 mg oral suspension packets contain the same amount of sodium bicarbonate (1680 mg), two packets of 20 mg are not equivalent to one packet of Zarroprazole 40 mg; therefore, two 20 mg packets of Zarroprazole should not be substituted for one packet of Zarroprazole 40 mg. Since the 20 mg capsules contain the same amount of sodium bicarbonate (1100 mg), two capsules of 20 mg are not equivalent to 40 mg; therefore, two 20 mg capsules of ZARROPRAZOLE should not be substituted for one capsule of 40 mg. Zarroprazole should be taken on an empty stomach at least one hour before a meal. For patients receiving continuous NG/OG tube feeding, enteral feeding should be suspended approximately 3 hours before and 1 hour after administration of Zarroprazole Powder for Oral Suspension.

Contraindications

Zarroprazole is contraindicated in patients with known hypersensitivity to any components of the formulation.

Side effects

Omeprazole was generally well tolerated. The most frequently reported adverse events with Zarroprazole are headache, diarrhea, and abdominal pain. The incidence of clinical adverse experiences in patients greater than 65 years of age was similar to that in patients 65 years of age or less. Administration of Capsules: Zarroprazole Capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD. Preparation and Administration of Suspension Directions for use: Empty packet contents into a small cup containing 1-2 tablespoons of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Refill cup with water and drink. If Zarroprazole is to be administered through a nasogastric or orogastric tube, the suspension should be constituted with approximately 20 mL of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and administer immediately. An appropriately-sized syringe should be used to instill the suspension in the tube. The suspension should be washed through the tube with 20 mL of water.

Composition

Zarroprazole 20-mg Capsules: Each opaque, hard gelatin, colored light blue and white capsule, imprinted with the Zarro logo, contains 20 mg omeprazole and 1100 mg sodium bicarbonate. Box of 21 capsules.Zarroprazole Powder for Oral Suspension is a white, flavored powder packaged in unit-dose packets. Each packet contains 20 mg omeprazole and 1680 mg sodium bicarbonate. Cartons of 30: 20-mg unit-dose packets.

Storage

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F).

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