PANTOPRAZOLE (Protonix): What is used for?

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What is Pantoprazole?

Pantoprazole (Pantoprazol) is a drug used to treat diseases related to the acid of the stomach and intestine. The product ingredients are: Pantoprazole magnesium, Pantoprazole magnesium hemipentahydrate, Pantoprazole sodium.

The brand names of pantoprazole are: Protonix and Protonix IV.

Mechanism of action (MOA) of Pantoprazole

Inhibits acid secretion in the stomach. It binds to the proton pump in the gastric parietal cell, inhibiting the transport of H+ to the gastric lumen.

Therapeutic Indications, Uses, Benefits and Dosage of Pantoprazole

Oral (fasting, not chewing). Intravenous: for 2-15 min.

Adults and adolescents ≥ 12 years:
– Symptomatic GERD: oral, 20 mg/24 h, 2-8 weeks; in reappearance after achieving control, 20 mg/24 h, “on demand”, if this is not possible, assess continuous treatment.
– Long-term treatment and prevention of relapses of esophagitis due to reflux: oral, maintenance: 20 mg/24 h, if relapse occurs, increase to 40 mg/24 h.
– Moderate and severe reflux esophagitis: oral, 40-80 mg/24 h, 4-8 weeks.

Adults:
– Prevention of gastroduodenal ulcers induced by non-selective NSAIDs in patients at risk on continued treatment with NSAIDs: oral, 20 mg/24 h.

– Duodenal ulcer. Intravenous: 40 mg/24 h; oral: 40-80 mg/24 h, 2-4 weeks.
– Gastric ulcer. Intravenous: 40 mg/24 h; oral: 40-80 mg/24 h, 4-8 weeks.
– Moderate and severe reflux esophagitis: Intravenous: 40 mg/24 h.
– S. Zollinger-Ellison and other hypersecretory diseases: Intravenous or oral: 80 mg/24 h, in case of higher dose, divide by 2. Transitionally, daily dose > 160 mg. In rapid control of acid secretion: Intravenous: 160 mg.
– Eradication of H. pylori, oral, 40 mg 2 times/day, 7-14 days, associated with 2 adequate antibiotics in peptic ulcer:
1) 1 g amoxicillin + 500 mg clarithromycin, 2 times/day.
2) 1 g amoxicillin + 400-500 mg metronidazole, 2 times/day.
3) 400-500 mg metronidazole (or 500 mg tinidazole) + 250-500 mg clarithromycin, 2 times/day.

– Symptomatic gastro-esophageal reflux disease: 20 mg/24 h, 2-3 days, max. 4 weeks.
Severe liver failure: max. 40 mg/48 h (oral) or 20 mg/24 h (oral or intravenous).
Kidney failure: max. 40 mg/24 h (oral or intravenous).
Elderly: max. 40 mg/24 h (oral or intravenous). Except in combination treatment for eradication of H. pylori: oral, 40 mg/12 h, 7 days.

Method of administration of Pantoprazole

Gastro-resistant tablets: should be taken one hour before breakfast. If your dosage is two daily doses, the second tablet should be taken before dinner.

Contraindications of Pantoprazole

Hypersensitivity to the active substance or to substituted benzimidazoles.

Warnings and precautions with Pantoprazole

Severe liver failure, adjust doses, monitor liver enzymes, and discontinue treatment if they increase. Kidney failure. Elderly.
Exclude malignancy. May reduce absorption of vit. B12 , monitor symptoms of deficit in s. Zollinger-Ellison, long-term treatment and vit. B12 deficiency, or risk factors for reduced absorption.

Possible increased risk of gastrointestinal infection caused by bacteria (e.g., Salmonella, Campylobacter, C. difficile). Atazanavir is not recommended for risk of decreased bioavailability (if necessary, monitor clinically and increase atazanavir dose to 400 mg + 100 mg ritonavir and not to exceed 20 mg pantoprazole/day). Regular revision in prolonged treatment (> 1 year). Risk of hypomagnesemia in prolonged treatment and concomitance with digoxin or other drugs that may reduce plasma Mg level (e.g. diuretics); consider plasma Mg control at baseline and periodically during treatment.

At high doses and in prolonged treatment, increases the risk of fracture of the hip, wrist and spine, especially in the elderly or in the presence of other risk factors, ensure intake of Ca and vit. D if there is a risk of osteoporosis. Children < 12 years, limited data. Intravenous use not recommended in < 18 years.
Risk of subacute cutaneous lupus erythematosus (LECS) (if lesions occur, especially in sun-exposed areas of skin, accompanied by arthralgia, consider discontinuing treatment).

Possible increase in chromogranin A (CgA) levels that may interfere with neuroendocrine tumor explorations (discontinue treatment at least 5 days prior, if CgA and gastrin levels do not return to the reference interval after the initial measurement, repeat 14 days later).

Liver failure

Contraindicated in eradication of H. pylori in patients with moderate-severe liver failure. Caution in severe liver failure; adjust dose: max. 40 mg/48 h (oral) or 20 mg/24 h (oral or intravenous); monitor liver enzymes.

Kidney failure

Contraindicated in eradication of H. pylori in patients with moderate-severe renal insufficiency. Caution in renal insufficiency; max. dose 40 mg/24 h (oral or intravenous).

Interactions with Pantoprazole

• Reduces absorption of: ketoconazole, itraconazole, posaconazole, erlotinib.
• Monitor INR/prothrombin time, along with: cumarin anticoagulants.
• Increases levels of: methotrexate (at high doses).

Pregnancy and Pantoprazole

There is not enough data. Animal studies show reproductive toxicity, slight fetotoxicity at doses > 5 mg/kg. Concentration in the foetus rises shortly before birth.

Breastfeeding

Animal studies have shown the excretion of pantoprazole in breast milk. It has been reported that in humans pantoprazole is excreted in breast milk.

Therefore, the decision to continue or discontinue breastfeeding or treatment with pantoprazole should be made taking into account the benefit of breastfeeding for the infant and the benefit of pantoprazole treatment for the mother.

Effects on driving ability

Pantoprazole is not likely to affect the ability to drive or use machines. Adverse reactions to medications such as dizziness and visual disturbances may occur. If they do occur, patients should not drive or use machines.

Adverse reactions and side effects of Pantoprazole

Fundic (benign) gland polyps; thrombophlebitis at the injection site. Also: paresthesia, hypocalcemia.

⭐⭐⭐⭐⭐ VIDEO OF PANTOPRAZOLE/PROTONIX (DRUG)

Source: The content of this active ingredient has been written taking into account the clinical and molecular information of all medicines authorised and marketed in the United States under the Unique Ingredient Identifier (UNII) by the Substance Registration System (SRS) of the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP).

In order to know in detail the information authorized by the FDA for each drug, you should consult the corresponding medication guide authorized by the FDA.

Resources:

UNII: D8TST4O562
ChemIDplus
DrugPortal
PubChem CID: 4679
NCI Thesaurus: C29346