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Product Details

Composition:

Rexiet 10mg : Each capsule contains Rabeprazole BP10 mg as enteric coated pellets.

Rexiet 20mg : Each capsule contains Rabeprazole BP20 mg as enteric coated pellets.

 Description:

Rexiet is a preparation of Rabeprazole Sodium HPMC Vegetable Capsule Shell. It is an antisecretory compound that suppresses gastric acid secretion by inhibiting the gastric H+, K+ ATPase at the secretory surface of the gastric parietal cell.

Dosage and administration:

Healing of Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended adult oral dose is Rexiet 20 mg to be taken once daily for 4 to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8 weeks course of Rexiet 20 mg may be considered.

Maintenance of Healing of Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended adult oral dose is Rexiet 20 mg to be taken once daily.

Prevention of Relapse of Gastro-Esophageal Reflux Disease (GERD): The recommended adult oral dose is Rexiet 10 mg to be taken once daily. If needed this dose should be increased to Rexiet 20 mg to be taken once daily.

Treatment of Symptomatic Gastro-Esophageal Reflux Disease (GERD): The recommended adult oral dose is Rexiet 20 mg to be taken once daily for 4 weeks. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.

Treatment should commence at Rexiet 10 mg once daily in patients without esophagitis. If there is no response, the dose should be increased to 20 mg once daily for four weeks. If symptoms do not resolve completely after 4 weeks, the patient should be further investigated.

Once symptoms have resolved, subsequent symptom control can be achieved using an on demand regimen of 10 mg to be taken once daily, when needed.

Healing of Duodenal Ulcers and Gastric Ulcers: The recommended adult oral dose for both duodenal ulcer and gastric ulcer is Rexiet 20 mg to be taken once daily for a period up to 4 weeks. Most patients with duodenal ulcer heal within 4 weeks.

Some patients with duodenal ulcer may respond to Rexiet 10 mg once daily. A few patients may require additional therapy to achieve healing.

Most patients with gastric ulcer heal within 6 weeks. However, again a few patients may require an additional 6 weeks of therapy to achieve healing.

Treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome: The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg once daily and 60 mg BID have been administered.

Treatment of GERD in Pediatric Patients 1 to 11 years of age: The recommended dosage of Rexiet for pediatric patients 1 to 11 years of age by body weight is:

•  15 kg or more: 10 mg once daily for up to 12 weeks.
•  Less than 15 kg: 5 mg once daily for up to 12 weeks with the option to increase to 10 mg if there is inadequate response.

 

Use in children:

Rexiet is indicated for treatment of GERD in children 1 to 11 years of age for up to 12 weeks.

Use in elderly :

No dosage adjustment is necessary in elderly patients. No overall differences in safety and effectiveness were observed between these subjects or younger subjects, and other reported clinical experience has not identified differences between the elderly and younger patients.

Use in patients with hepatic & renal impairment :

No dosage adjustment is necessary in patients with renal impairment or mild to moderate hepatic impairment. There is no information in patients with severe hepatic impairment. Avoid use of Rabeprazole in patients with severe hepatic impairment; however, if treatment is necessary, monitor patients for adverse reactions.

Use in pregnancy & lactation:

No evidence of adverse developmental effects were seen in animal reproduction studies with Rabeprazole administered during organogenesis at 13 and 8 times the human area under the plasma concentration-time curve (AUC) at the recommended dose for GERD, in rats and rabbits, respectively. There are no available human data on Rabeprazole use in pregnant women to inform the drug associated risk and this drug should be used during pregnancy only if clearly needed.

Rabeprazole is excreted in rat milk. Caution should be exercised when Rabeprazole is administered to a lactating woman.

Side effects :

Most common adverse reactions in adults are pain, pharyngitis, flatulence, infection & constipation and most common adverse reactions in adolescents are headache, diarrhea, nausea, vomiting, and abdominal pain.

Contraindications :

Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole, substituted benzimidazoles or to any component of the formulation.

Precautions :

Symptomatic response to therapy with Rabeprazole does not prelude the response of gastric malignancy. There have been reports of increased International Normalized Ratio (INR) and Prothrombin Time (PT) in patients receiving a proton pump inhibitor and Warfarin concomitantly. Patients treated with a proton pump inhibitor and Warfarin concomitantly may need to monitor for increase in INR and prothrombin time.

Drug interactions :

Rabeprazole produces a profound and long lasting inhibition of gastric acid secretion. An interaction with compounds whose absorption is pH dependent may occur. Co-administration of Rabeprazole with Ketoconazole or Itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when Ketoconazole or Itraconazole are taken concomitantly with Rabeprazole.

In clinical trials, antacids were used concomitantly with the administration of Rabeprazole and, in a specific drug-drug interaction study, no interaction with liquid antacids was observed.

Co-administration of Atazanavir 300 mg/Ritonavir 100 mg with Omeprazole (40 mg once daily) or Atazanavir 400 mg with Lansoprazole (60 mg once daily) to healthy volunteers resulted in a substantial reduction in Atazanavir exposure. The absorption of Atazanavir is pH dependent. Although not studied, similar results are expected with other proton pump inhibitors. Therefore PPIs, including Rabeprazole, should not be co-administered with Atazanavir.

Concomitant administration of PPIs and Methotrexate (primarily at high dose) may elevate and prolong serum levels of Methotrexate and/or its metabolite Hydroxymethotrexate. However, no formal drug interaction studies of Methotrexate with PPIs have been conducted.

Overdose :

There has been no experience with large overdoses with Rabeprazole. No specific antidote for Rabeprazole is known. Rabeprazole is extensively protein bound and is not readily dialyzable. In the event of over dosage treatment should be symptomatic and supportive.

Pharmaceutical precaution :

Store below 25C. Protect from light & moisture.

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