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Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockage of the proton pumps of the parietal cells. Pantoprazole is converted to its active form in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i. e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both basal and stimulated acid secretion. Pantoprazole reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible.
Absorption: Pantoprazole is well absorbed. It undergoes little first-pass metabolism resulting in an absolute bioavailability of approximately 77%. Distribution: Pantoprazole’s serum protein binding is about 98 %. Volume of distribution is about 0.15 l/kg. Metabolism: Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4. Elimination: After administration of a single intravenous dose of 14C-labeled pantoprazole to healthy, normal metabolizer subjects, approximately 71% of the dose was excreted in the urine with 18% excreted in the feces through biliary excretion.
Reflux oesophagitis. Gastric and duodenal ulcer. Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
Gastric and duodenal ulcer, reflux oesophagitis the recommended intravenous dose is one vial of 40 mg pantoprazole per day. Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions for the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg. Method of Administration A ready-to-use solution is prepared in 10 ml of sodium chloride 9 mg/ml (0.9 % w/v) solution for injection. The prepared solution may be administered directly or may be administered after mixing it with 100 ml sodium chloride 9 mg/ml (0.9 %w/v) solution for injection or glucose 55 mg/ml (5 %) solution for injection. The medicinal product should be administered intravenously over 2 – 15 minutes.
Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients.
Hepatic Impairment In patients with severe liver impairment, the liver enzymes should be monitored during therapy. In the case of a rise of the liver enzymes, the treatment should be discontinued. Co-administration with atazanavir Co-administration of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir. Gastrointestinal infections caused by bacteria Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with Protium may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter. Hypomagnesaemia Severe hypomagnesaemia has been reported in patients treated with PPIs like pantoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and dis-continuation of the PPI. Bone fractures Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors.
Effect of pantoprazole on the absorption of other medicinal products Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may reduce the absorption of drugs with a gastric pH dependent bioavailability, e.g some azole antifungals as ketoconazole, itraconazole, posaconazole and other medicine as erlotinib. HIV medications (atazanavir) Co-administration of atazanavir and other HIV medications whose absorption is pH-dependent with proton-pump inhibitors, might result in a substantial reduction in the bioavailability of these HIV medications and might impact the efficacy of these medicines. Therefore, the co-administration of proton pump inhibitors with atazanavir is not recommended Coumarin anticoagulants (phenprocoumon or warfarin) Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalised Ratio (INR) have been reported during concomitant treatment in the post-marketing period.
Pregnancy There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown & should not be used during pregnancy, unless clearly necessary. Lactation Animal studies have shown excretion of pantoprazole in breast milk. Excretion into human milk has been reported. Therefore, a decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Pantoprazole should be made taking into account the benefit of breast-feeding to the child, and the benefit of Pantoprazole therapy to women.
Pregnancy There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown & should not be used during pregnancy, unless clearly necessary. Lactation Animal studies have shown excretion of pantoprazole in breast milk. Excretion into human milk has been reported. Therefore, a decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Pantoprazole should be made taking into account the benefit of breast-feeding to the child, and the benefit of Pantoprazole therapy to women.
Adverse drug reactions such as dizziness and visual disturbances may occur. If affected, patients should not drive or operate machines.
Proton Pump Inhibitors associated Acute Kidney Injury Acute kidney injury has been reported with the use of Proton pump inhibitors (PPIs) including Pantoprazole, Omeprazole, lansoperazole, Esomeprazole, Rabeprazole etc. Approximately 5 % of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADR is injection site thrombophlebitis. Diarrhoea and headache occurred in approxi-mately 1 % of patients. General : In-general, various undesirable effects have been reported upon pantoprazole administration as follows: Diarrhoea, Nausea/ vomiting, Abdominal distension and bloating; Constipation; Dry mouth; Abdominal pain and discomfort, Headache, Dizziness, Sleep disorders, Rash/ exanthema/ eruption; Pruritus, Fundic gland polyps (benign), Urticaria, Angioedema, Asthenia, fatigue and malaise and Injection site thrombophlebitis.
There are no known symptoms of overdose in man. Systemic exposure with up to 240 mg administered intravenously over 2 minutes, were well tolerated. As pantoprazole is extensively protein bound, it is not readily dialysable. In the case of an overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
Pantoprazole injection should not be prepared or mixed with other medicinal preparations.
Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockage of the proton pumps of the parietal cells.
Pantoprazole is converted to its active form in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i. e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both basal and stimulated acid secretion. Pantoprazole reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible.
Absorption: Pantoprazole is well absorbed. It undergoes little first-pass metabolism resulting in an absolute bioavailability of approximately 77%.
Distribution: Pantoprazole’s serum protein binding is about 98 %. Volume of distribution is about 0.15 l/kg.
Metabolism: Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4.
Elimination: After administration of a single intravenous dose of 14C-labeled pantoprazole to healthy, normal metabolizer subjects, approximately 71% of the dose was excreted in the urine with 18% excreted in the feces through biliary excretion.
Method of Administration
A ready-to-use solution is prepared in 10 ml of sodium chloride 9 mg/ml (0.9 % w/v) solution for injection. The prepared solution may be administered directly or may be administered after mixing it with 100 ml sodium chloride 9 mg/ml (0.9 %w/v) solution for injection or glucose 55 mg/ml (5 %) solution for injection. The medicinal product should be administered intravenously over 2 – 15 minutes.
Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients.
Hepatic Impairment
In patients with severe liver impairment, the liver enzymes should be monitored during therapy. In the case of a rise of the liver enzymes, the treatment should be discontinued.
Co-administration with atazanavir
Co-administration of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir.
Gastrointestinal infections caused by bacteria
Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with Protium may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.
Hypomagnesaemia
Severe hypomagnesaemia has been reported in patients treated with PPIs like pantoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and dis-continuation of the PPI.
Bone fractures
Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors.
Effect of pantoprazole on the absorption of other medicinal products
Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may reduce the absorption of drugs with a gastric pH dependent bioavailability, e.g some azole antifungals as ketoconazole, itraconazole, posaconazole and other medicine as erlotinib.
HIV medications (atazanavir)
Pregnancy
There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown & should not be used during pregnancy, unless clearly necessary.
Lactation
Animal studies have shown excretion of pantoprazole in breast milk. Excretion into human milk has been reported. Therefore, a decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Pantoprazole should be made taking into account the benefit of breast-feeding to the child, and the benefit of Pantoprazole therapy to women.
Adverse drug reactions such as dizziness and visual disturbances may occur. If affected, patients should not drive or operate machines.
Proton Pump Inhibitors associated Acute Kidney Injury
General : In-general, various undesirable effects have been reported upon pantoprazole administration as follows: Diarrhoea, Nausea/ vomiting, Abdominal distension and bloating; Constipation; Dry mouth; Abdominal pain and discomfort, Headache, Dizziness, Sleep disorders, Rash/ exanthema/ eruption; Pruritus, Fundic gland polyps (benign), Urticaria, Angioedema, Asthenia, fatigue and malaise and Injection site thrombophlebitis.
There are no known symptoms of overdose in man. Systemic exposure with up to 240 mg administered intravenously over 2 minutes, were well tolerated. As pantoprazole is extensively protein bound, it is not readily dialysable. In the case of an overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
Pantoprazole injection should not be prepared or mixed with other medicinal preparations.