Pantoprazole Sodium - I.v. (Protonix)

Trade Name : Protonix

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INJECTION, POWDER, FOR SOLUTION

Strength 40 mg/10mL

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 - I.v. (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/10mL per ml. Read more

Pantoprazole Sodium - I.v. (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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No data

No data

PROTONIX is a proton pump inhibitor (PPI) indicated in adults for the following:

Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). ()
Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. ()

GERD Associated with EE ():
Pathological Hypersecretion Conditions, Including ZE Syndrome ():
Administration (, ):

For Injection: 40 mg of pantoprazole white to off-white freeze-dried powder in a single-dose vial for reconstitution.

For Injection: 40 mg pantoprazole freeze-dried powder in a single-dose vial for reconstitution. ()

No data

Patients with a known hypersensitivity to any component of the formulation or to substituted benzimidazoles. ()
Patients receiving rilpivirine-containing products. (, )

No data

Gastric Malignancy
Hypersensitivity and Severe Skin Reactions
Injection Site Reactions
Potential Exacerbation of Zinc-Deficiency
Acute Interstitial Nephritis
Arrayn- Clostridium difficile
Bone Fracture
Cutaneous and Systemic Lupus Erythematosus
Hepatic Effects
Hypomagnesemia
Fundic Gland Polyps:

The following serious adverse reactions are described below and elsewhere in labeling:
Most common adverse reactions (>2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. ()
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or n

Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PROTONIX I.V. and instructions for preventing or managing them.
Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
See the full prescribing information for a list of clinically important drug interactions. ()

Pregnancy: Based on animal data, may cause fetal harm. ()

Experience in patients taking very high doses of pantoprazole (greater than 240 mg) is limited. Adverse reactions seen in spontaneous reports of overdose generally reflect the known safety profile of pantoprazole.
Pantoprazole is not removed by hemodialysis. In case of overdose, treatment should be symptomatic and supportive.
Single intravenous doses of pantoprazole at 378, 230, and 266 mg/kg (38, 46, and 177 times the recommended human dose based on body surface area) 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.

The active ingredient in PROTONIX I.V. (pantoprazole sodium), a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is CHFNNaOS, with a molecular weight of 405.4. The structural formula is:
Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium 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. The reconstituted solution of PROTONIX I.V. for injection is in the pH range 9.0 to 10.5.
PROTONIX I.V. is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH.

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 at 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 pantoprazole doses of 5 to 50 mg/kg/day, 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 pantoprazole doses of 5 to 150 mg/kg/day, 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).

No data

PROTONIX I.V. (pantoprazole sodium) is supplied in a single-dose vial as a white to off-white freeze-dried powder for reconstitution containing 40 mg of pantoprazole.
PROTONIX I.V. is available as follows:
Storage and Handling
Store PROTONIX I.V. at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) .
Protect from light.

No data

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
Distributed byWyeth Pharmaceuticals LLCA subsidiary of Pfizer IncPhiladelphia, PA 19101
under license fromTakeda GmbHD78467 Konstanz, Germany
PREMIERProRx is a registered trademark of Premier Healthcare Alliance, L.P., used under license.
LAB-0661-10.0

NDC 0008-4001-01
PROTONIX I.V.
40 mg
Sterile For Intravenous Infusion Only Single-dose vial
Rx only
PREMIER

NDC 0008-4001-01 n n
PROTONIX I.V.
40 mg
Sterile For Intravenous Infusion Only Single-dose vial
Contains 1 mg edetate disodium n n
PREMIER

Each vial contains:Pantoprazole40 mg(equivalent to 45.1 mg of pantoprazolesodium)Contains 1 mg edetate disodiumStore at 20u00b0-25u00b0C (68u00b0-77u00b0F);excursions permitted to 15u00b0-30u00b0C(59u00b0-86u00b0F). [See USP Controlled RoomTemperature].Protect vials from light; use of vialcarton is recommended.Dist. by Wyeth Pharmaceuticals LLCA subsidiary of Pfizer IncPhiladelphia, PA 19101Under license from Takeda GmbHD78467 Konstanz, GermanyPREMIERProRxu00ae is a registered trademarkof Premier Healthcare Alliance, L.P.,used under license.MADE IN FRANCER02/0518/6171043 14285302
1 Bundle of 10 unit cartons
PROTONIX I.V.
40 mg
Sterile For Intravenous Infusion Only Single-dose vial
PREMIER
Rx only
LOT
EXP
SN
GTIN: 00300084001109

NDC 0008-4001-25Contains 25 of NDC 0008-4001-01Rx only
25 x 40 mg Vials
PROTONIX I.V.n
40 mg
Sterile For Intravenous Infusion OnlySingle-dose vial
PREMIERProRx

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Pantoprazole Sodium - I.v. (Protonix)

Trade Name : Protonix

INJECTION, POWDER, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Pantoprazole Sodium - I.v. (Protonix)

Trade Name : Protonix

INJECTION, POWDER, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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