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Uses
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.
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.
Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
Rabeprazole sodium delayed-release tablets are indicated for short-term (up to 4 weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within 4 weeks.
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)].
Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
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 a molecular formula of C18H20N3NaO3S 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.
Sources
Ducord Manufacturers
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Duke University School Of Medicine, Carolinas Cord Blood Bank
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Ducord | Mylan Pharmaceuticals Inc.
2.1 Healing of Erosive or Ulcerative GERD in AdultsThe recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily for 4 to 8 weeks [see Indications and Usage (1.1)]. 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.
2.2 Maintenance of Healing of Erosive or Ulcerative GERD in AdultsThe recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily. Controlled studies do not extend beyond 12 months [see Indications and Usage (1.2)].
2.3 Treatment of Symptomatic GERD in AdultsThe recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily for 4 weeks [see Indications and Usage (1.3)]. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.
2.4 Healing of Duodenal Ulcers in AdultsThe recommended adult oral dose is one rabeprazole sodium 20 mg delayed-release tablet to be taken once daily after the morning meal for a period up to 4 weeks [see Indications and Usage (1.5)]. Most patients with duodenal ulcer heal within 4 weeks. A few patients may require additional therapy to achieve healing.
2.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults Table 1: Three Drug Regimen* All three medications should be taken twice daily with the morning and evening meals. * It is important that patients comply with the full 7-day regimen [see Clinical Studies (14.5)].Rabeprazole Sodium Delayed-Release Tablet
20 mg
Twice Daily for 7 Days
Amoxicillin
1000 mg
Twice Daily for 7 Days
Clarithromycin
500 mg
Twice Daily for 7 Days
2.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in AdultsThe dosage of rabeprazole sodium delayed-release tablets in patients with pathologic hypersecretory conditions varies with the individual patient. 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 QD and 60 mg BID have been administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with rabeprazole sodium delayed-release tablets for up to one year.
2.7 Short-Term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and OlderThe recommended oral dose for adolescents 12 years of age and older is one 20 mg delayed-release tablet once daily for up to 8 weeks [see Use in Specific Populations (8.4) and Clinical Studies (14.7)].
2.9 Elderly, Renal, and Hepatic Impaired PatientsNo dosage adjustment is necessary in elderly patients, in patients with renal disease, or in patients with mild to moderate hepatic impairment. Administration of rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.
2.10 Administration Recommendations Table 2: Administration RecommendationsFormulation
Population
Instructions
Delayed-Release Tablet
Adults and adolescents 12 years of age and older
Swallow tablets whole. Do not chew, crush, or split tablets.
Tablets can be taken with or without food.
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