Pantoprazole Sodium (Pantoprazole Sodium)

Trade Name : Pantoprazole Sodium

Teva Pharmaceuticals USA, Inc.

TABLET, DELAYED RELEASE

Strength 20 mg/1

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

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

Pantoprazole Sodium (Pantoprazole 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.

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
  • Pantoprazole sodium delayed-release tablets are indicated for:
  • Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated for the following:
  • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (n n
  • Maintenance of Healing of Erosive Esophagitis (n n
  • Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (n n
  • See full prescribing information for administration instructions
  • Delayed-Release Tablets:
  • Delayed-Release Tablets: 20 mg and 40 mgu00a0pantoprazole ()
  • No data
  • Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles ()
  • Patients receiving rilpivirine-containing products (, )
  • No data
  • Gastric Malignancy
  • Acute Interstitial Nephritis
  • Arrayn- -Associated Diarrhean- Clostridium difficile
  • Bone Fracture
  • Cutaneous and Systemic Lupus Erythematosus
  • Cyanocobalamin (Vitamin B-12) Deficiency
  • Hypomagnesemia
  • Fundic Gland Polyps:
  • The following serious adverse reactions are described below and elsewhere in labeling:
  • Most common adverse reactions are:
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc.u00a0at 1-888-838-2872 or FDA at 1-800-FDA-1088 or .
  • For adult use (> 2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. ()
  • For pediatric use (> 4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. ()
  • Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium 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 ()
  • Pregnancy
  • 8.1
  • Experience in patients taking very high doses of pantoprazole (greater than 240 mg) is limited. Spontaneous postmarketing reports of overdose are generally within the known safety profile of pantoprazole.
  • Pantoprazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive.
  • Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.
  • If overexposure to pantoprazole 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 Pantoprazole Sodium Delayed-Release Tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. The structural formula is:
  • CHFNNaOSu20221.5 HO M.W. 432.37
  • Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.
  • The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.
  • Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg).
  • Each Pantoprazole Sodium Delayed-Release Tablet USPu00a0contains 45.1 mg or 22.55 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium carbonate, calcium stearate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, low-substituted hydroxypropyl cellulose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac glaze, sodium carbonate anhydrous, stearic acid, talc, titanium dioxide, and triethyl citrate.
  • No data
  • In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with pantoprazole doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times the exposure on a body surface area basis of a 50 kg person dosed with 40 mg/day. In the gastric fundus, treatment with 0.5 to 200 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related manner. In the forestomach, treatment with 50 and 200 mg/kg/day (about 10 and 40 times the recommended human dose on a body surface area basis) produced benign squamous cell papillomas and malignant squamous cell carcinomas. Rare gastrointestinal tumors associated with pantoprazole treatment included an adenocarcinoma of the duodenum with 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus with 200 mg/kg/day. In the liver, treatment with 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomas. In the thyroid gland, treatment with 200 mg/kg/day produced increased incidences of follicular cell adenomas and carcinomas for both male and female rats.
  • In a 24-month carcinogenicity study, Fischer 344 rats were treated orally with doses of 5 to 50 mg/kg/day of pantoprazole, approximately 1 to 10 times the recommended human dose based on body surface area. In the gastric fundus, treatment with 5 to 50 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. Dose selection for this study may not have been adequate to comprehensively evaluate the carcinogenic potential of pantoprazole.
  • In a 24-month carcinogenicity study, B6C3F1 mice were treated orally with doses of 5 to 150 mg/kg/day of pantoprazole, 0.5 to 15 times the recommended human dose based on body surface area. In the liver, treatment with 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female mice. Treatment with 5 to 150 mg/kg/day also produced gastric-fundic ECL cell hyperplasia.
  • A 26-week p53 +/- transgenic mouse carcinogenicity study was not positive.
  • Pantoprazole was positive in the human lymphocyte chromosomal aberration assays, in one of two mouse micronucleus tests for clastogenic effects, and in the Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effects. Equivocal results were observed in the rat liver DNA covalent binding assay. Pantoprazole was negative in the Ames mutation assay, the unscheduled DNA synthesis (UDS) assay with rat hepatocytes, the AS52/GPT mammalian cell-forward gene mutation assay, the thymidine kinase mutation test with mouse lymphoma L5178Y cells, and the rat bone marrow cell chromosomal aberration assay.
  • There were no effects on fertility or reproductive performance when pantoprazole was given at oral doses up to 500 mg/kg/day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/kg/day in female rats (88 times the recommended human dose based on body surface area).
  • Pantoprazole sodium delayed-release tablets were used in the following clinical trials.
  • How Supplied
  • Pantoprazole Sodium Delayed-Release Tablets USP are available as follows:
  • 20 mg: Yellow, oval shaped, unscored tablets imprinted with black ink on one side of the tablet u201c93/11u201d and plain on the other side. They are available in bottles of 90 tablets (NDC 0093-0011-98).
  • 40 mg: Yellow, oval shaped, unscored tablets imprinted with black ink on one side of the tablet u201c93/12u201d and plain on the other side. They are available in bottles of 90 tablets (NDC 0093-0012-98).
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Gastric Malignancy
  • Advise patients to return to their healthcare provider if they have a suboptimal response or an early symptomatic relapse [].
  • Acute Interstitial Nephritis
  • Advise patients to call their healthcare provider immediately if they experience signs and/or symptoms associated with acute interstitial nephritis [].
  • Arrayn- -Associated Diarrhea
  • Advise patients to immediately call their healthcare provider if they experience diarrhea that does not improve [n n ].
  • Bone Fracture
  • Advise patients to report any fractures, especially of the hip, wrist or spine, to their healthcare provider [n n ].
  • Cutaneous and Systemic Lupus Erythematosus
  • Advise patients to immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [n n ].
  • Cyanocobalamin (Vitamin B-12) Deficiency
  • Advise patients to report any clinical symptoms that may be associated with cyanocobalamin deficiency to their healthcare provider if they have been receiving pantoprazole sodium for longer than 3 years [n n ].
  • Hypomagnesemia
  • Advise patients to report any clinical symptoms that may be associated with hypomagnesemia to their healthcare provider, if they have been receiving pantoprazole sodium for at least 3 months [n n ].
  • Drug Interactions
  • Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [n n ] digoxin [] and high dose methotrexate [n n ].
  • Pregnancy
  • Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [].n
  • Administration
  • Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time.
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Manufactured For:n North Wales, PA 19454
  • Rev. T 11/2019
  • No data
  • No data
  • No data

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