Rabeprazole Sodium (Rabeprazole Sodium)

Trade Name : Rabeprazole Sodium

Teva Pharmaceuticals USA, Inc.

TABLET, DELAYED RELEASE

Strength 20 mg/1

RABEPRAZOLE SODIUM Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Rabeprazole Sodium (Rabeprazole Sodium) which is also known as Rabeprazole Sodium and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 20 mg/1 per ml. Read more

Rabeprazole Sodium (Rabeprazole Sodium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions, Fundic Gland Polyps () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a006/2018
  • Rabeprazole sodium delayed-release tablets are a proton-pump inhibitor (PPI) indicated in adults for:
  • In adolescent patients 12 years of age and older for:
  • Table 1 shows the recommended dosage of rabeprazole sodium delayed-release tablets in adults and adolescent patients 12 years of age and older. The use of rabeprazole sodium delayed-release tablets is not recommended for use in pediatric patients 1 year to less than 12 years of age because the lowest available tablet strength (20 mg) exceeds the recommended dose for these patients. Use another rabeprazole formulation for pediatric patients 1 year to less than 12 years of age.
  • Administration Instructions
  • Administration Instructions (
  • )
  • 2
  • Swallow rabeprazole sodium delayed-release tablets whole. Do not chew, crush or split the tablets.
  • For the treatment of duodenal ulcers take rabeprazole sodium delayed-release tablets after a meal.
  • For eradication take rabeprazole sodium delayed-release tablets with food.
  • For all other indications rabeprazole sodium delayed-release tablets can be taken with or without food.
  • Rabeprazole sodium delayed-release tablets are provided in one strength, 20 mg. The tablets are enteric-coated, delayed-release, unscored, yellow, round tablets, imprinted on one side of the tablet with black ink u201c93u201d u201c64u201d.
  • Delayed-Release Tablets: 20 mg ().
  • No data
  • Patients with a history of hypersensitivity to rabeprazole ().
  • PPIs, including rabeprazole sodium delayed-release tablets, are contraindicated in patients receiving rilpivirine-containing productsu00a0 (, ).
  • Refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with rabeprazole sodium delayed-release tablets ().
  • No data
  • Gastric Malignancy
  • Use with Warfarin
  • Acute Interstitial Nephritis
  • Arrayn- Clostridium difficile
  • Bone Fracture
  • Cutaneous and Systemic Lupus Erythematosus
  • Cyanocobalamin (Vitamin B-12) Deficiency
  • Hypomagnesemia
  • Interaction with Methotrexate
  • Fundic Gland Polyps
  • The following serious adverse reactions are described below and elsewhere in labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Most common adverse reactions in adults (> 2%) are pain, pharyngitis, flatulence, infection, and constipation ().
  • Most common adverse reactions in adolescents (u2265 2%) are headache, diarrhea, nausea, vomiting, and abdominal pain ().
  • Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with rabeprazole sodium delayed-release tablets and instructions for preventing or managing them.
  • Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
  • See full prescribing information for a list of clinically important drug interactions ().
  • Pediatric Use
  • 2
  • 8.4
  • Seven reports of accidental overdosage with rabeprazole have been received. The maximum reported overdose was 80 mg. There were no clinical signs or symptoms associated with any reported overdose. Patients with Zollinger-Ellison syndrome have been treated with up to 120 mg rabeprazole once daily. No specific antidote for rabeprazole is known. Rabeprazole is extensively protein bound and is not readily dialyzable.
  • In the event of overdosage, treatment should be symptomatic and supportive.
  • If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
  • The active ingredient in Rabeprazole Sodium Delayed-release Tablets is rabeprazole sodium, USP, 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. Rabeprazole sodium, USP 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, USP is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural formula is:
  • CHNNaOS M.W. 381.43
  • Rabeprazole is available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium, USP.
  • Inactive ingredients of the 20 mg tablet are D&C Yellow #10 Lake, FD&C Yellow #6 Lake, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, iron oxide black, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac glaze, stearic acid, titanium dioxide, and triethyl citrate.
  • No data
  • In an 88/104 week carcinogenicity study in CD-1 mice, rabeprazole at oral doses up to 100 mg/kg/day did not produce any increased tumor occurrence. The highest tested dose produced a systemic exposure to rabeprazole (AUC) of 1.40 mcgu2022hr/mL which is 1.6 times the human exposure (plasma AUC = 0.88 mcgu2022hr/mL) at the recommended dose for GERD (20 mg/day). In a 28 week carcinogenicity study in p53 transgenic mice, rabeprazole at oral doses of 20, 60, and 200 mg/kg/day did not cause an increase in the incidence rates of tumors but produced gastric mucosal hyperplasia at all doses. The systemic exposure to rabeprazole at 200 mg/kg/day is about 17 to 24 times the human exposure at the recommended dose for GERD. In a 104 week carcinogenicity study in Sprague-Dawley rats, males were treated with oral doses of 5, 15, 30 and 60 mg/kg/day and females with 5, 15, 30, 60, and 120 mg/kg/day. Rabeprazole produced gastric enterochromaffin-like (ECL) cell hyperplasia in male and female rats and ECL cell carcinoid tumors in female rats at all doses including the lowest tested dose. The lowest dose (5 mg/kg/day) produced a systemic exposure to rabeprazole (AUC) of about 0.1 mcgu2022hr/mL which is about 0.1 times the human exposure at the recommended dose for GERD. In male rats, no treatment related tumors were observed at doses up to 60 mg/kg/day producing a rabeprazole plasma exposure (AUC) of about 0.2 mcgu2022hr/mL (0.2 times the human exposure at the recommended dose for GERD).
  • Rabeprazole was positive in the Ames test, the Chinese hamster ovary cell (CHO/HGPRT) forward gene mutation test, and the mouse lymphoma cell (L5178Y/TK+/u2013) forward gene mutation test. Its demethylated-metabolite was also positive in the Ames test. Rabeprazole was negative in the Chinese hamster lung cell chromosome aberration test, the mouse micronucleus test, and the and rat hepatocyte unscheduled DNA synthesis (UDS) tests.
  • Rabeprazole at intravenous doses up to 30 mg/kg/day (plasma AUC of 8.8 mcgu2022hr/mL, about 10 times the human exposure at the recommended dose for GERD) was found to have no effect on fertility and reproductive performance of male and female rats.
  • No data
  • 1. Clinical and Laboratory Standards Institute (CLSI). u2014Tenth Edition. CLSI Document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania, 19087, USA 2015.
  • Rabeprazole Sodium Delayed-release Tablets, 20 mg are supplied as enteric-coated, delayed-release, unscored, yellow, round tablets, imprinted on one side of the tablet with black ink u201c93u201d u201c64u201d. They are available in bottles of 30 (NDC 0093-0064-56).
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from moisture.
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Acute Interstitial Nephritis
  • Advise the patient or caregiver to call the patientu2019s healthcare provider immediately if they experience signs and/or symptoms associated with acute interstitial nephritis .
  • Arrayn- -Associated Diarrhea
  • Advise the patient or caregiver to immediately call the patientu2019s healthcare provider if they experience diarrhea that does not improve .
  • Bone Fracture
  • Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patientu2019s healthcare provider .
  • Cutaneous and Systemic Lupus Erythematosus
  • Advise the patient or caregiver to immediately call the patientu2019s healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus .
  • Cyanocobalamin (Vitamin B-12) Deficiency
  • Advise the patient or caregiver to report any clinical symptoms that may be associated with cyanocobalamin deficiency to the patientu2019s healthcare provider if they have been receiving rabeprazole sodium delayed-release tablets for longer than 3 years .
  • Hypomagnesemia
  • Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia to the patientu2019s healthcare provider, if they have been receiving rabeprazole sodium delayed-release tablets for at least 3 months n n
  • Drug Interactions
  • Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products , warfarin, digoxin or high-dose methotrexate .
  • Administration
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. J 7/2018
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. H 7/2018
  • No data

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