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Pantoprazole Sodium - Delayed-Release (Protonix)

Trade Name : Protonix

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

TABLET, DELAYED RELEASE

Strength 40 mg/1

PANTOPRAZOLE 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 Pantoprazole Sodium - Delayed-Release (Protonix) which is also known as Protonix and Manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. It is available in strength of 40 mg/1 per ml. Read more

Pantoprazole Sodium - Delayed-Release (Protonix) 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
  • No data
  • PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:
  • PROTONIX is a proton pump inhibitor (PPI) indicated for the following:
  • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ()
  • Maintenance of Healing of Erosive Esophagitis ()
  • Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome ()
  • See full prescribing information for administration instructions
  • Delayed-Release Tablets:
  • For Delayed-Release Oral Suspension:
  • Delayed-Release Tablets: 20 mg and 40 mg pantoprazole ()
  • For Delayed-Release Oral Suspension: 40 mg pantoprazole ()
  • 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- 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 Pfizer Inc at 1-800-438-1985 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 PROTONIX 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 PROTONIX (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of PROTONIX.
  • 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 PROTONIX 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 PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets, 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. Its empirical formula is CHFNNaOS u00d7 1.5 HO, with a molecular weight of 432.4. The structural formula is:
  • 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.
  • PROTONIX is supplied as a for delayed-release oral suspension in unit dose packets, available in one strength 40 mg pantoprazole, (equivalent to 45.1 mg of pantoprazole sodium), and as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium).
  • PROTONIX Delayed-Release Tablets contains the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. PROTONIX Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2.
  • PROTONIX For Delayed-Release Oral Suspension contains the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.
  • 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).
  • PROTONIX Delayed-Release Tablets were used in the following clinical trials.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • under license fromTakeda GmbHD78467 Konstanz, Germany
  • LAB-0459-18.0
  • No data
  • PROTONIX for delayed-release oral suspension (PROTONIX for oral suspension)n
  • Important information:
  • How should I store PROTONIX?
  • Store PROTONIX at room temperature between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
  • Keep PROTONIX and all medicines out of the reach of children.
  • This Medication Guide and Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • This product's label may have been updated. For current full prescribing information, please go to www.pfizer.com.
  • under license fromTakeda GmbHD78467 Konstanz, Germany
  • LAB-0574-14.0
  • Revised: April 2019
  • ALWAYS DISPENSE WITHMEDICATION GUIDE
  • Pfizer
  • Protonixn- delayed-release tablets
  • 20 mg
  • Swallow tablets whole.
  • 90 Tabletsn n
  • ALWAYS DISPENSE WITHMEDICATION GUIDE
  • Pfizer
  • Protonixn- delayed-release tablets
  • 40 mg
  • Swallow tablets whole.
  • 90 Tabletsn n
  • NDC 0008-0844-01
  • Pfizer
  • Protonixn 40 mg(pantoprazole sodium)
  • For Delayed-Release Oral Suspension**suspension in apple juice or applesauce only
  • Each packet contains: Pantoprazole 40 mg (equivalent to 45.1 mg of pantoprazole sodium)
  • 14287101 F.2/0518/6103546 Code 40
  • Rx only
  • Pfizer
  • NDC 0008-0844-02
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Protonixn 40 mg(pantoprazole sodium)
  • For Delayed-Release Oral Suspension**suspension in apple juice or applesauce only
  • Rx only30 Packets

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