Pantoprazol lyophilisate for solution for infusions 40 mg. vial №1

Description

Pantoprazol composition
active substance: pantoprazole;
1 vial contains pantoprazole sodium sesquihydrate equivalent to pantoprazole 40.0 mg;
Excipients: disodium edetate, sodium hydroxide.

Dosage form
Lyophilisate for solution for injection.

Pharmacological properties
Pantoprazol is a substituted benzimidazole that inhibits the secretion of hydrochloric acid in the stomach by specific blockade of parietal cell proton pumps. Pantoprazol is transformed into the active form in an acidic environment in parietal cells, where it inhibits the enzyme H + -K + -ATPase, ie blocks the final stage of production of hydrochloric acid in the stomach. Inhibition is dose-dependent and inhibits both basal and stimulated acid secretion. These symptoms disappear in most patients within 2 weeks. The use of pantoprazole, like other proton pump inhibitors (PPIs) and H2-receptor inhibitors, reduces gastric acidity and thus increases gastrin secretion in proportion to the decrease in acidity. Increased gastrin secretion is reversible. Because pantoprazole binds the enzyme distally to the cell receptor, it can inhibit the secretion of hydrochloric acid regardless of stimulation by other substances (acetylcholine, histamine, gastrin). The effect of oral and intravenous administration of the drug is the same.
The use of Pantoprazol increases the level of gastrin on an empty stomach. With short-term use of pantoprazole gastrin level in most cases does not exceed the upper limit of normal. With long-term treatment, the level of gastrin in most cases doubles. Excessive gastrin enlargement, however, is rare. As a result, sometimes with long-term treatment there is a slight or moderate increase in the number of enterochromaffin-like cells (ECL cells) in the stomach (similar to adenomatoid hyperplasia). However, according to current studies, the formation of progenitor cells of neuroendocrine tumors (atypical hyperplasia) or neuroendocrine tumors of the stomach in humans was not observed.

Indication:

• reflux esophagitis;
• Duodenal ulcer;
• gastric ulcer;
• Zollinger-Ellison syndrome and other hypersecretory pathological conditions.

Contraindication
Hypersensitivity to pantoprazole, benzimidazole derivatives or to any other components of the drug.

Children
It is not recommended for use in children (under 18 years of age), as data on the safety and efficacy of the drug for this age group are limited.

Use during pregnancy or breastfeeding
Available data on use in pregnant women indicate no embryonic or feto / neonatal toxicity. Reproductive toxicity was observed in animal studies. As a precautionary measure, the drug should be avoided in pregnant women.
Animal studies have shown excretion of pantoprazole in breast milk. There are insufficient data on the excretion of pantoprazole in human breast milk, but such excretion has been reported. The risk to newborns / infants cannot be ruled out. The decision to discontinue breast-feeding or to discontinue / abstain from treatment should be made taking into account the benefit of breast-feeding to the child and the benefit of treatment to the woman.

Method of application and dosage
The drug should be used by adults as prescribed and under the direct supervision of a physician.
Intravenous use of the drug is recommended only if it is impossible to use the oral form of the drug. There are data on the duration of intravenous treatment up to 7 days. Therefore, if clinically possible, the transition from intravenous to pantoprazole to oral.
Reflux esophagitis, duodenal ulcer, gastric ulcer
The recommended dose is 40 mg of Pantoprazol (1 vial) per day intravenously.
Treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions
For long-term treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions, the recommended starting dose of pantoprazole is 80 mg per day. If necessary, the dose can be titrated, increasing or decreasing, depending on the acid secretion in the stomach. Doses in excess of 80 mg per day should be divided into two administrations. A temporary increase in the dose of pantoprazole to more than 160 mg is possible, but the duration of use should be limited to the period necessary for adequate control of acid secretion.
If a rapid decrease in acidity is required, an initial dose of 2 × 80 mg is sufficient for most patients to reach the desired level (<10 mEq / h) within 1 hour.
Preparation for use
Dissolve the powder in 10 ml of 0.9% sodium chloride solution added to the vial. The solution can be administered directly or after mixing with 100 ml of 0.9% sodium chloride solution or 5% glucose solution in plastic or glass vials.
After dilution, the chemical and physical stability of the drug is maintained for 12 hours at a temperature of 25 ° C. From a microbiological point of view, the diluted drug should be used immediately.
Do not prepare or mix with solvents other than those mentioned above.
Intravenous administration of the drug should be carried out within 2-15 minutes.
The bottle is for single use only. Before use, it is necessary to visually check the vials with the drug (including color change, the presence of sediment).
The diluted solution should have a clear yellowish color.

Overdose
Symptoms of overdose are unknown.
Doses up to 240 mg administered intravenously over 2 minutes were well tolerated. Because pantoprazole is extensively bound to blood proteins, it is not a drug that can be easily removed by dialysis.
In case of overdose with the appearance of clinical signs of intoxication, symptomatic and supportive therapy should be used. There are no recommendations for specific therapy.

Side effects:

• From the blood and lymphatic system: agranulocytosis.
• From the immune system: hypersensitivity reactions (including anaphylactic reactions, anaphylactic shock).
• Metabolism and metabolic disorders: hyperlipidemia and elevated lipids (triglycerides, cholesterol), changes in body weight.
• Mental disorders: sleep disorders.
• From the nervous system: headache, dizziness, taste disorders.
• On the part of the visual organs: visual impairment, blurred vision.
• From the digestive tract: polyps from the fundus glands (benign).
• From the hepatobiliary system: increased levels of liver enzymes (transaminases, g-HT).
• From the skin and subcutaneous tissue: skin rash, exanthema, itching, urticaria, angioneurotic edema.
• From the musculoskeletal system: fractures of the thigh, wrist, spine, arthralgia, myalgia.
• From the kidneys and urinary system: interstitial nephritis (with possible development of renal failure).
• From the reproductive system and mammary glands: gynecomastia.
• General disorders: thrombophlebitis at the injection site.

Expiration date
2 years.

Storage conditions
Store in the original package at a temperature not exceeding 25 ° C. Keep out of reach of children.