Reflux oesophagitis. Peptic ulcer of the stomach and duodenum. Zollinger-Ellison syndrome and other conditions caused by abnormal, excessive secretion of hydrochloric acid.
Composition:
1 vial contains 40 mg Pantoprazole in the form of sodium pantoprazole semi-professional. The medicine contains less than 1 mmol sodium (23 mg) per vial.
Action:
A drug that inhibits the secretion of hydrochloric acid in the parietal cells of the stomach as a result of selective blocking of H activity+, K+-ATPase. The effect of the drug depends on the dose and leads to the inhibition of both basal secretion and stimulated secretion. It reduces the acidity of gastric contents and, secondarily, in a reversible manner, increases gastrin secretion to an extent proportional to the decrease in acidity. Pantoprazole is approximately 98% bound to plasma proteins. It is metabolized in the liver, excreted in about 80% by the kidneys in the form of metabolites, the remaining part is excreted in the faeces. T0,5 in the elimination phase, it is about 1 hour.
Contraindications:
Hypersensitivity to Pantoprazole, substituted benzoimidazole or any of the excipients.
Precautions:
In the event of alarming symptoms (eg significant unintentional weight loss, recurrent vomiting, dysphagia (dysphagia), bloody vomiting, anemia or tarry stools) and if there is suspicion or evidence of gastric ulcer, their cancerous background should be excluded, as treatment with pantoprazole may ameliorate symptoms of cancer and delay its diagnosis. If the symptoms persist despite proper treatment, further tests should be performed. In patients with severe hepatic impairment during therapy, liver enzymes should be monitored; if enzyme activity is increased, intravenous pantoprazole should be discontinued. It can be expected that pantoprazole, like all proton pump inhibitors, increases the amount of bacteria normally found in the upper gastrointestinal tract. Treatment with pantoprazole may lead to a small increase in the risk of food-borne infections caused by, for example, bacteriaSalmonella andCampylobacter. The use of intravenous pantoprazole in patients under 18 years is not recommended. The medicine contains less than 1 mmol sodium (23 mg) per vial, that is, it is considered to be "sodium-free".
Pregnancy and lactation:
The drug can be used during pregnancy only if clearly necessary. There are no data on the use of pantoprazole in pregnant women. Animal studies have shown reproductive toxicity. Pantoprazole is excreted in human milk - the decision to continue / stop breastfeeding or to continue / stop pantoprazole should be considered, taking into account the benefit of breastfeeding for the child and the benefits of pantoprazole for the mother.
Side effects:
Common: thrombophlebitis at the injection site. Uncommon: sleep disorders; headache, dizziness of central origin; diarrhea, nausea / vomiting, abdominal distension and bloating, constipation, dry mouth, abdominal pain and discomfort; increase in liver enzymes (aminotransferase, γ-GT); rash / skin rash / cracking, pruritus; weakness, tiredness and malaise. Rare: hypersensitivity (including anaphylactic reactions and anaphylactic shock); hyperlipidemia and increase in lipids (triglycerides, cholesterol); change in body weight; depression (and its exacerbation); blurred vision / blurred vision; increase in bilirubin; urticaria, angioneurotic edema; joint pain, muscle pain; gynecomastia; increased body temperature, peripheral edema. Very rare: thrombocytopenia, leukopenia; disorientation (and its exacerbation). Frequency unknown: hyponatremia; hallucinations: confusion (especially in patients with predispositions, as well as the severity of symptoms in the event of their earlier existence); liver cell damage, jaundice, hepatic failure; Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, hypersensitivity to light; interstitial nephritis.
Dosage:
Intravenously.Intravenous pantoprazole is only recommended in cases where the oral form can not be used. The available data refer to intravenous administration lasting a maximum of 7 days, so whenever possible, oral treatment should be discontinued and pantoprazole should be discontinued and replaced with 40 mg tablets. Adults.Peptic ulcer of the stomach and duodenum, reflux oesophagitisThe recommended dose is 40 mg (1 vial) per day.Zollinger-Ellison syndrome and other conditions caused by abnormal, excessive secretion of hydrochloric acid: the starting dose is 80 mg per day, then the dose can be increased or decreased depending on the results of the measurement of gastric acid secretion in the stomach; doses greater than 80 mg should be divided and administered twice a day, it is possible to temporarily increase the dose to more than 160 mg, but it should not be used longer than required to obtain adequate control of hydrochloric acid excretion. If a rapid reduction in acid secretion is required, in the majority of patients, intravenous administration of pantoprazole at a starting dose of 2 x 80 mg is sufficient to achieve within 1 h of secretion in the target range (<10 mEq / h). In patients with severe hepatic impairment, a daily dose of 20 mg should not be exceeded. The drug should be administered intravenously for 2 to 15 minutes.
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