Short-term treatment of the symptoms of gastroesophageal reflux disease (eg heartburn, regurgitation of stomach contents) in adults.
Composition:
1 tabl enterally contains 20 mg of Pantoprazole (as sodium Pantoprazole, semi-professional). The drug contains maltitol and lecithin.
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+-ATP-azy (the so-called proton pump). 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 way) increases gastrin secretion to an extent proportional to the decrease in acidity. After oral administration, pantoprazole is rapidly absorbed from the gastrointestinal tract, reaching a maximum concentration in the blood within 2 - 2.5 h. The bioavailability is about 77%, the food does not reduce the bioavailability, it can only delay the absorption of the drug. About 98% is 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 is about 1.5 hours.
Contraindications:
Hypersensitivity to pantoprazole, benzimidazole derivatives, lecithin (derived from soybean oil) or to any of the excipients. Co-administration with atazanavir.
Precautions:
Caution should be exercised in patients with: weight loss not caused by intentional weight loss, anemia, gastrointestinal bleeding, dysphagia, persistent or bloody vomiting (treatment with pantoprazole may relieve the symptoms of severe disease and delay its diagnosis; in these cases, the neoplastic disease should be excluded) ; history of peptic ulcer or gastrointestinal surgery; treating symptoms of indigestion or heartburn continuously lasting longer than 4 weeks; jaundice, dysfunction or liver disease; other severe diseases affecting general well-being; and also if the patient is over 55 years of age and has experienced new symptoms or has changed the nature of the previously observed symptoms. Patients with long-term recurrent symptoms of indigestion or heartburn should undergo regular medical check-ups. Patients should not simultaneously take other proton pump inhibitors or histamine H receptor antagonists2. The drug is not intended for immediate removal of symptoms and for prophylactic use. The use of drugs that reduce the secretion of acid, leads to a slightly higher risk of gastrointestinal infections, such as infectionSalmonella, Campylobacter orC. difficile. The use of the drug is not recommended in children and adolescents, due to the limited number of data collected on safety and efficacy. The drug contains maltitol - do not use in patients with rare hereditary disorders associated with fructose intolerance. In addition, the drug contains lecithin derived from soybean oil - do not use in patients with hypersensitivity to peanut or soya.
Pregnancy and lactation:
The drug is contraindicated for use during pregnancy and breastfeeding. There are no adequate data on the use of pantoprazole in pregnant women and on the penetration of pantoprazole in breast milk. Animal studies have shown its reproductive toxicity and the penetration of pantoprazole into milk. In preclinical studies, no evidence of fertility or teratogenic impairment was demonstrated.
Side effects:
Uncommon: sleep disorders; headaches, dizziness; diarrhea, nausea, vomiting, feeling of fullness in the abdomen and bloating, constipation, dry mouth, pain and discomfort in the epigastrium; increased activity of liver enzymes (aminotransferases, γ-GT); skin rash, erythema, skin eruptions, pruritus; weakness, fatigue, feeling unwell.Rare: agranulocytosis, hypersensitivity (including anaphylactic reactions and anaphylactic shock); hyperlipidemia, weight change; depression (and worsening of the mental state); taste disorders; blurred vision, blurred vision; increase in bilirubin; urticaria, angioneurotic edema; painful joints, muscle pain; gynecomastia; increase in body temperature; peripheral edema. Very rare: thrombocytopenia, leukopenia, pancytopenia; disorientation (and deterioration of mental state). Frequency unknown: hyponatraemia, hypomagnesemia; hallucinations, confusion (especially in susceptible patients, as well as the severity of similar symptoms in the event of their previous occurrence); liver cell damage, jaundice, hepatic cell failure; Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, hypersensitivity to light; interstitial nephritis.
Dosage:
Orally. Adults: the recommended dose is 1 tablet. once a day. In order to achieve relief of symptoms, it may be necessary to use the medicine for another 2-3 days. After complete relief of symptoms, treatment should be discontinued. Without consultation with a doctor, treatment should not last longer than 4 weeks. The patient should be instructed to consult a physician if symptoms do not improve within 2 weeks of treatment. Table. do not chew or chew. They should be taken before a meal swallowing whole and washed down with water.
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