Index of drugs

Gastroesophageal reflux disease. Peptic ulcer of the stomach and duodenum. Zollinger-Ellison syndrome and other conditions associated with excessive abnormal secretion of hydrochloric acid.

1 vial contains 40 mg Pantoprazole in the form of semi-professional sodium pantoprazole. The preparation contains sodium citrate and sodium hydroxide.

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. T_0,5 in the elimination phase it is about 1 hour.

Hypersensitivity to Pantoprazole, substituted benzoimidazole or any of the excipients.

In the case of disturbing symptoms (eg unintended significant weight loss, recurrent vomiting, swallowing disorders, bloody vomiting, anemia or tarry stools) and when stomach ulcers are suspected or diagnosed, a cancerous base should be excluded, as treatment with pantoprazole may relieve the symptoms of cancer and delay her diagnosis. In patients with severe hepatic impairment during therapy, liver enzymes should be monitored. If their activity increases, the administration of pantoprazole in the form of injections should be discontinued. Treatment with pantoprazole may lead to a slight increase in the risk of food-borne infections caused bySalmonella spp.,Campylobacter spp. And C. difficile. In patients treated with proton pump inhibitors such as pantoprazole, for at least 3 months and in most cases for 1 year, severe hypomagnesaemia has been reported, improvement occurred after supplementing Magnesium deficiency and discontinuing PPI. Patients who are prescribed for long-term therapy with proton pump inhibitors (PPI) or patients who will take PPI with Digoxin or drugs that can cause hypomagnesaemia (e.g. diuretics) should consider magnesium determination before starting PPI and periodically in time of treatment. PPIs, especially when used in high doses and for a long time (> 1 year), may slightly increase the risk of hip fractures, wrist and spine. This is particularly true for elderly patients or for other known risk factors. Research suggests that PPI can increase the overall risk of fractures by 10-40%. Patients at risk for osteoporosis should be under the proper care and take the appropriate dose of vitamin D and calcium. Due to limited data, pantoprazole i.v. not recommended for use in children <18 years.

It should not be used during pregnancy unless clearly necessary. Pantoprazole is excreted in breast milk. A decision should be made to continue / terminate breastfeeding or continue / discontinue treatment with pantoprazole, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the woman.

Common: thrombophlebitis at the injection site. Uncommon: sleep disorders; headache, dizziness of central origin; diarrhea, nausea / vomiting, feeling of fullness in the abdomen, bloating, constipation, dry mouth, pain and discomfort in the abdomen; increased liver enzymes (ALAT, AST, γ-GT); rash, eruptions, pruritus; fracture of the hip, wrist or spine; weakness, tiredness and malaise.Rare: agranulocytosis, hypersensitivity (including anaphylactic reactions and anaphylactic shock); hyperlipidemia and increased triglycerides and cholesterol; change in body weight; depression (and its exacerbation); taste disorders, blurred vision / blurred vision; increased bilirubin; hives; angioneurotic edema; painful joints, muscle pain; gynecomastia; increased body temperature, peripheral edema. Very rare: thrombocytopenia, leukopenia, pancytopenia; disorientation (and its exacerbation). Frequency unknown: hyponatraemia, hypomagnesemia; hypocalcemia associated with hypomagnesemia, hypokalemia; hallucinations, confusion (especially in sensitive patients, intensification of these symptoms in the event of their previous occurrence); paresthesia; hepatocyte damage, jaundice, hepatocyte failure; Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, hypersensitivity to light; muscle cramps associated with electrolyte disturbances; interstitial nephritis (with possible development to renal failure).

Intravenously. The drug administered for 2-15 minutes. 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.Peptic ulcer of the stomach and duodenum, gastroesophageal reflux disease40 mg daily.Zollinger-Ellison syndrome and other conditions associated with excessive abnormal 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. The daily dose> 80 mg should be given in 2 doses. It is possible to temporarily increase the dose> 160 mg, but it should not be used for longer than required to obtain adequate control of hydrochloric acid excretion. In case when fast control of hydrochloric acid secretion is required, in the majority of patients the initial dose of 2 x 80 mg allows obtaining within 1 h of secretion at the target level of <10 mEq / h.Special groups of patients. In patients with severe hepatic impairment, the maximum daily dose is 20 mg. In patients with impaired renal function and in elderly patients, no dosage adjustment is necessary.Way of giving. The ready-to-administer solution is prepared by dissolving the powder in 10 ml of sodium chloride 9 mg / ml (0.9%) solution for injection. The solution thus prepared may be administered directly or after mixing it with 100 ml of sodium chloride 9 mg / ml (0.9%) solution for injection or Glucose 50 mg / ml (5%) solution for injection. After preparation, the solution must be used within 12 hours.