Pantoprazole Sodium (Pantoprazole Sodium)

Trade Name : Pantoprazole Sodium

West-Ward Pharmaceuticals Corp

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

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 (Pantoprazole Sodium) which is also known as Pantoprazole Sodium and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 40 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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Warnings and Precautions, Fundic Gland Polyps (5.11)u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 10/2018

Pantoprazole Sodium for Injection is a proton pump inhibitor (PPI) indicated in adults for the following:
u2022 u00a0Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE). ()
u2022 u00a0Pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome. ()

GERD Associated with EE
u2022 u00a0The recommended adult dosage is 40 mg administered once daily by intravenous infusion for 7 to 10 days.
Pathological Hypersecretory Conditions, Including ZE Syndrome
u2022 The recommended adult dosage is 80 mg administered every 12 hours by intravenous infusion. See the full prescribing information for information on how to adjust dosing for individual patient needs.
Administration

Only for intravenous infusion.
The intravenous infusion can be administered over 2 minutes or 15 minutes.
For information on how to prepare and administer for each indication, see the full prescribing information.

For Injection: 40 mg pantoprazole white to off-white lyophilized powder in a single-dose vial for reconstitution.
For Injection: 40 mg pantoprazole lyophilized powder in a single-dose vial for reconstitution ()

u2022u00a0u00a0u00a0u00a0 Pantoprazole Sodium for Injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria .
u2022u00a0u00a0u00a0u00a0 Proton pump inhibitors (PPIs), including Pantoprazole Sodium for Injection, are contraindicated in patients receiving rilpivirine-containing products .
u2022 Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles. ()
u2022 Patients receiving rilpivirine-containing products (, )

u2022 : In adults, symptomatic response to therapy with Pantoprazole Sodium for Injection does not preclude the presence of gastric u00a0malignancy. u00a0Consider u00a0additional u00a0follow-up u00a0and u00a0diagnostic testing. ()
u2022 : Anaphylaxis has been reported. ()
u2022 : Thrombophlebitis is associated with intravenous use. ()
u2022 : Observed in patients taking PPIs. ()
u2022 n : PPI therapy may be associated with increased risk. ()
u2022 : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ()
u2022 : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Pantoprazole Sodium for Injection and refer to specialist for evaluation. ()
u2022 : Elevations of transaminases observed. ()
u2022 Reported rarely with prolonged treatment with PPIs. ()
u2022: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. (5.12)

The following serious adverse reactions are described below and elsewhere in labeling:
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hypersensitivity and Severe Skin Reactions n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Injection Site Reactions n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Acute Interstitial Nephritis n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n Associated Diarrhea n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Bone Fracture n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Cutaneous and Systemic Lupus Erythematosus n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hepatic Effects n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hypomagnesemia n
u2022u00a0 u00a0 u00a0 u00a0u00a0Fundic Gland Polyps n
Most common adverse reactions (>2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. ()
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or .

Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Pantoprazole Sodium for Injection and instructions for preventing or managing them.
Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
Tn- able 2: Clinically Relevant Interactions Affecting Drugs Co-Administered with n- Pn- antoprazole Sodium for Injection and Interaction with Diagnostics
See 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 Pantoprazole Sodium for Injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl]-1-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is CHFNNaOSu20221.5 HO, with a molecular weight of 432.37. The structural formula is:
Pantoprazole sodium is a white to off-white crystalline powder and is racemic. 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 Pantoprazole Sodium for Injection is in the pH range 9.5 to 11.5.
Pantoprazole Sodium for Injection is supplied for intravenous administration as a sterile lyophilized 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), 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 at 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 at 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female mice. Treatment at 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).

The safety and efficacy of Pantoprazole Sodium for Injection have been established based on adequate and well-controlled adult studies of another intravenous formulation of pantoprazole sodium in GERD associated with a history of EE and pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Below is a display of the results of these adequate and well-controlled studies of pantoprazole sodium in these conditions.

How Supplied
Pantoprazole Sodium for Injection is supplied in a single-dose vial as a white to off-white sterile lyophilized powder for reconstitution containing 40 mg of pantoprazole.
Pantoprazole Sodium for Injection is available as follows:
Sn- torage and Handling
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
Protect from light.

Adverse Reactions
Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hypersensitivity and Severe Skin Reactions n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Injection Site Reactions n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Acute Interstitial Nephritis n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n Associated Diarrhea n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Bone Fracture n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Cutaneous and Systemic Lupus Erythematosus n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hepatic Effects n
u2022 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hypomagnesemia n
Drug Interactions
Advise patients to report to their healthcare provider before they start treatment with any of the following:
u2022u00a0u00a0u00a0u00a0 Rilpivirine-containing products n
u2022u00a0u00a0u00a0u00a0 High-dose methotrexate .
Pn- ren- gn- nn- an- ncy
Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy n
u00a0
Manufactured by:
Distributed by:n
NOVAPLUS is a registered trademark of Vizient, Inc.
NOVAPLUSu00ae
PIN485-NOV/3

NDC 0143-9300-01u00a0u00a0 u00a0u00a0Rx onlyn Equivalent ton pantoprazole per vialn n
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NDC 0143-9300-10u00a0 u00a0u00a0Rx onlyn Equivalent ton pantoprazole per vialn n
Arrayn- Array
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Pantoprazole Sodium (Pantoprazole Sodium)

Trade Name : Pantoprazole Sodium

INJECTION, POWDER, LYOPHILIZED, 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 (Pantoprazole Sodium)

Trade Name : Pantoprazole Sodium

INJECTION, POWDER, LYOPHILIZED, 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)

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