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Protonix

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Overview

What is Protonix?

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.



What does Protonix look like?



What are the available doses of Protonix?

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

What should I talk to my health care provider before I take Protonix?

How should I use Protonix?

PROTONIX I.V. is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE).

Safety and efficacy of PROTONIX I.V. as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.

The recommended adult dosage of PROTONIX I.V. is 40 mg given once daily by intravenous infusion for 7 to 10 days.

Discontinue treatment with PROTONIX I.V. as soon as the patient is able to receive treatment with PROTONIX Delayed-Release Tablets or Oral Suspension.

Data on the safe and effective dosing for conditions other than those described such as life-threatening upper gastrointestinal bleeds, are not available. PROTONIX I.V. 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.


What interacts with Protonix?

Sorry No Records found


What are the warnings of Protonix?

Sorry No Records found


What are the precautions of Protonix?

Sorry No Records found


What are the side effects of Protonix?

Sorry No records found


What should I look out for while using Protonix?

Patients with a known hypersensitivity to any component of the formulation or to substituted benzimidazoles. ()

Patients receiving rilpivirine-containing products. (,)


What might happen if I take too much Protonix?

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.


How should I store and handle Protonix?

VORICONAZOLE Tablets should be stored at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].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: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:


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H, K)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the (H, K)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).

Non-Clinical Toxicology
Patients with a known hypersensitivity to any component of the formulation or to substituted benzimidazoles. ()

Patients receiving rilpivirine-containing products. (,)

When given concurrently the following drugs may interact with thiazide diuretics.

Alcohol, barbiturates or narcotics-

Antidiabetic drugs-(

Other antihypertensive drugs-

Cholestyramine and colestipol resins-

Corticosteroids, ACTH-

Pressor amines (e.g., norepinephrine)-

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine)-

Lithium-

Non-steroidal Anti-inflammatory Drugs-

In adults, symptomatic response to therapy with PROTONIX I.V. does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

The following serious adverse reactions are described below and elsewhere in labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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