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rabeprazole
Overview
What is Rabeprazole Sodium?
The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)3-methyl-2-pyridinyl]-methyl]sulfinyl]-1benzimidazole sodium salt. It has a molecular formula of CHNNaOS and a molecular weight of 381.43. Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is:
Figure 1:
Figure 1:
Rabeprazole sodium delayed-release tablets are available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
Inactive ingredients of the 20 mg tablet are ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium oxide, magnesium stearate, mannitol, medium chain triglycerides, methacrylic acid copolymer, oleic acid, polydextrose, polyethylene glycol, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triacetin and triethyl citrate.
In addition, the black imprinting ink contains black iron oxide, hypromellose and propylene glycol.
What does Rabeprazole Sodium look like?
What are the available doses of Rabeprazole Sodium?
Rabeprazole sodium delayed-release tablets are provided in strength of 20 mg. The tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side.
What should I talk to my health care provider before I take Rabeprazole Sodium?
How should I use Rabeprazole Sodium?
The recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet 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-week course of rabeprazole sodium delayed-release tablets may be considered.
What interacts with Rabeprazole Sodium?
Sorry No Records found
What are the warnings of Rabeprazole Sodium?
Sorry No Records found
What are the precautions of Rabeprazole Sodium?
Sorry No Records found
What are the side effects of Rabeprazole Sodium?
Sorry No records found
What should I look out for while using Rabeprazole Sodium?
Rabeprazole is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation.
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with rabeprazole sodium delayed-release tablets, refer to the section of their package inserts.
What might happen if I take too much Rabeprazole Sodium?
Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug.
Single oral doses of rabeprazole at 786 mg/kg and 1024 mg/kg were lethal to mice and rats, respectively. The single oral dose of 2000 mg/kg was not lethal to dogs. The major symptoms of acute toxicity were hypoactivity, labored respiration, lateral or prone position and convulsion in mice and rats and watery diarrhea, tremor, convulsion and coma in dogs.
How should I store and handle Rabeprazole Sodium?
Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Rabeprazole Sodium Delayed-release Tablets are available containing 20 mg of rabeprazole sodium.The 20 mg tablets are beige, film-coated, round, unscored tablets with over imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:NDC 63187-158-30bottles of 30 tabletsNDC 63187-158-60Bottles of 60 tabletsNDC 63187-158-90Bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H-receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H, KATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor. Rabeprazole blocks the final step of gastric acid secretion.
In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfenamide. When studied , rabeprazole is chemically activated at pH 1.2 with a half-life of 78 seconds. It inhibits acid transport in porcine gastric vesicles with a half-life of 90 seconds.
Non-Clinical Toxicology
Rabeprazole is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation.For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with rabeprazole sodium delayed-release tablets, refer to the section of their package inserts.
As with other drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic inhibition or enhancement, etc.) is a possibility (see
Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy.
Patients with healed GERD were treated for up to 40 months with rabeprazole and monitored with serial gastric biopsies. Patients without infection (221 of 326 patients) had no clinically important pathologic changes in the gastric mucosa. Patients with infection at baseline (105 of 326 patients) had mild or moderate inflammation in the gastric body or mild inflammation in the gastric antrum. Patients with mild grades of infection or inflammation in the gastric body tended to change to moderate, whereas those graded moderate at baseline tended to remain stable. Patients with mild grades of infection or inflammation in the gastric antrum tended to remain stable. At baseline 8% of patients had atrophy of glands in the gastric body and 15% had atrophy in the gastric antrum. At endpoint, 15% of patients had atrophy of glands in the gastric body and 11% had atrophy in the gastric antrum. Approximately 4% of patients had intestinal metaplasia at some point during follow-up, but no consistent changes were seen.
Worldwide, over 2,900 patients have been treated with rabeprazole in Phase II to III clinical trials involving various dosages and durations of treatment.
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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