Rabeprazole Sodium

Rabeprazole Sodium

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Healing of Erosive or Ulcerative GERD in Adults

Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). 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.

1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults

Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.

1.3 Treatment of Symptomatic GERD in Adults

Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults.

1.4 Healing of Duodenal Ulcers in Adults

Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.

1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults

Rabeprazole sodium delayed-release tablets in combination with amoxicillin and clarithromycin as a three drug regimen, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history 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 Clinical Studies (14.5) and Dosage and Administration (2.5)].

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 (12.2) and the clarithromycin package insert, Clinical Pharmacology (12.2)].

1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults

Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

1.7 Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older

Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

History

There is currently no drug history available for this drug.

Other Information

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]-1H–benzimidazole sodium salt. It has an empirical formula of C18H20N3NaO3S and a molecular weight of 381.42. 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:

structure

Rabeprazole sodium is available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.

Inactive ingredients of the 20 mg tablet are diethyl phthalate, ethyl cellulose, hypromellose phthalate, magnesium oxide, magnesium stearate, mannitol, povidone, sodium starch glycolate, talc, and titanium dioxide. Ferric oxide yellow is the coloring agent for the tablet coating.

Rabeprazole Sodium Manufacturers


  • Preferred Pharmaceuticals Inc.
    Rabeprazole Sodium Tablet, Delayed Release [Preferred Pharmaceuticals Inc.]
  • Proficient Rx Lp
    Rabeprazole Sodium Tablet, Delayed Release [Proficient Rx Lp]
  • Lupin Pharmaceuticals, Inc.
    Rabeprazole Sodium Tablet, Delayed Release [Lupin Pharmaceuticals, Inc.]
  • Kremers Urban Pharmaceuticals Inc.
    Rabeprazole Sodium Tablet, Delayed Release [Kremers Urban Pharmaceuticals Inc.]
  • Mylan Pharmaceuticals Inc.
    Rabeprazole Sodium (Rabeprazole) Tablet, Delayed Release [Mylan Pharmaceuticals Inc.]
  • Teva Pharmaceuticals Usa Inc
    Rabeprazole Sodium Tablet, Delayed Release [Teva Pharmaceuticals Usa Inc]
  • Torrent Pharmaceuticals Limited
    Rabeprazole Sodium Tablet, Delayed Release [Torrent Pharmaceuticals Limited]
  • Avkare, Inc.
    Rabeprazole Sodium (Rabeprazole Sodium) Tablet, Delayed Release [Avkare, Inc.]
  • Major Pharmaceuticals
    Rabeprazole Sodium Tablet, Delayed Release [Major Pharmaceuticals]
  • Avkare, Inc.
    Rabeprazole Sodium (Rabeprazole Sodium) Tablet, Delayed Release [Avkare, Inc.]
  • Unit Dose Services
    Rabeprazole Sodium Tablet, Delayed Release [Unit Dose Services]
  • Proficient Rx Lp
    Rabeprazole Sodium (Rabeprazole) Tablet, Delayed Release [Proficient Rx Lp]
  • Preferred Pharmaceuticals Inc.
    Rabeprazole Sodium Tablet, Delayed Release [Preferred Pharmaceuticals Inc.]
  • Golden State Medical Supply, Inc.
    Rabeprazole Sodium (Rabeprazole) Tablet, Delayed Release [Golden State Medical Supply, Inc.]
  • Proficient Rx Lp
    Rabeprazole Sodium Tablet, Delayed Release [Proficient Rx Lp]

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