Sanpraz pills coated 40mg N30
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Active ingredients
Pantoprazole
Release form
Pills
Composition
1 tab. contains pantoprazole sodium sesquihydrate 45.1 mg, which corresponds to the content of pantoprazole 40 mg. Auxiliary substances: magnesium oxide - 18 mg, calcium carbonate - 81.4 mg, crospovidone - 35 mg, sodium lauryl sulfate - 5 mg, calcium stearate - 3 mg, colloidal silicon dioxide - 5 mg. The composition of the shell: copolymer of methacrylic acid and ethyl acrylate (1: 1) - 11 mg, triethyl citrate - 1.1 mg, copovidone - 7 mg, talc - 10.7 mg, titanium dioxide (E171) - 0.8 mg, ferric oxide yellow (E172) - 0.2 mg , macrogol 6000 - 0.35 mg.
Pharmacological effect
H + -K + -ATP-ase inhibitor. Blocks the final stage of secretion of hydrochloric (hydrochloric) acid, reducing basal and stimulated (regardless of the nature of the stimulus) secretion. In duodenal ulcers associated with Helicobacter pylori, a decrease in gastric secretion increases the sensitivity of microorganism to antibiotics. After taking pills, the therapeutic effect occurs within an hour, reaching a maximum in 2-4 hours. 3-4 days after the end of the reception of the remedy, the secretion of hydrochloric acid and other substances returns to normal. The substance is stable, at neutral pH does not affect the oxidase system of the liver, which depends on the enzyme cytochrome P450. When taken orally, the active substance is rapidly absorbed in the gastrointestinal tract. Cmax in plasma of 2-3 μg per ml is reached after 3 hours. About 98% of Pantoprazole is bound to plasma proteins. Parallel food intake does not affect pharmacokinetic parameters. With frequent and long-term use, this indicator remains constant. The half-life is one hour. The drug undergoes metabolic reactions in the liver. Metabolites are excreted through the kidneys and with stool masses. The drug is not cumulated in the body. For persons suffering from renal failure on hemodialysis, dose adjustment is not required. In liver cirrhosis, the elimination half-life increases to 7-9 hours, the maximum concentration is 1.5 times greater. In elderly people, the maximum concentration in the blood and the AUC of the drug increases. However, the adjustment of the daily dose is not required. When administered intravenously, the indicators are similar to taking pills
Pharmacokinetics
In the dose range from 10 to 80 mg, the pharmacokinetic parameters of pantoprazole have a linear relationship after iv administration. The drug does not accumulate. Values of pharmacokinetic parameters of pantoprazole with repeated and single administrations are comparable. The distribution of Vd is 0.15 l / kg.Basically the drug is distributed in the extracellular fluid. Plasma protein binding is 98%. Metabolism Intensively metabolized in the liver, mainly with the participation of the CYP2C19 enzyme system. The main metabolite in plasma and urine is desmethylpanthoprazole conjugated with sulfate. Removal of T1 / 2 after i / v administration is on average 1 hour. Most of the drug is excreted by the kidneys in the form of inactive metabolites. In small quantities excreted through the intestines. Pharmacokinetics in special clinical situations in patients with renal insufficiency The pharmacokinetics do not change significantly. In liver failure, the duration of T1 / 2 increases to 7-9 hours. AUC values are 5-7 times higher and Cmax 1.5 times higher in patients with hepatic insufficiency compared to with volunteers
Indications
Peptic ulcer of the stomach or duodenum in the acute phase; erosive gastritis (including associated with Helicobacter pylori); erosive and ulcerative lesions of the stomach and duodenum associated with the intake of NSAIDs;
Contraindications
Children's age (due to the lack of data on the use of the drug in pediatric practice); - dyspepsia of neurotic genesis; - malignant diseases of the gastrointestinal tract; - hypersensitivity to pantoprazole.
Precautionary measures
Be wary appoint the drug for liver failure. In patients with severely impaired liver function, the dose should be reduced to 40 mg 1 time in 2 days, while it is necessary to monitor blood biochemical parameters. At increase of activity of liver enzymes the drug should be canceled.
Use during pregnancy and lactation
Be wary of prescribing the drug during pregnancy and lactation (breastfeeding).
Dosage and administration
In case of gastric ulcer and duodenal ulcer, erosive gastritis, the drug is prescribed at 40-80 mg / day. The course of treatment for acute exacerbation of duodenal ulcer is 2 weeks, and gastric ulcer is 4-8 weeks. To prevent exacerbations of gastric ulcer and duodenal ulcer, 20 mg / day is prescribed. in combination with antimicrobial agents.The course of therapy is 7-14 days. In case of erosive and ulcerative lesions of the stomach and duodenum, associated with the intake of NSAIDs, prescribed 40-80 mg / day. The course of treatment is 4-8 weeks. For the prevention of erosive lesions on the background of long-term use of NSAIDs - 20 mg / day. When reflux esophagitis, 20-40 mg / day is prescribed. The course of therapy is 4-8 weeks. For the prevention of exacerbations take 20 mg / day. In patients with severely impaired liver function, the dose should be reduced to 40 mg 1 time in 2 days, while it is necessary to monitor blood biochemical parameters. With increasing activity of liver enzymes, the drug should be canceled. Tablets are taken entirely inside (without crushing and dissolving), drinking a sufficient amount of liquid. The drug is recommended to take 1 hour before breakfast, with a frequency of 2 times / day the second dose - 1 hour before dinner
Side effects
From the side of the central nervous system: headache; very rarely - depression, weakness, dizziness, blurred vision. On the part of the digestive system: diarrhea, nausea, pain in the upper abdomen, constipation, flatulence; in rare cases (1 case per 106 patients) - severe hepatocellular liver damage with jaundice, abnormal liver function. Allergic reactions: skin rash, itching, skin flushing, anaphylactic reactions (up to shock). Others: painful breast tension, hyperthermia
Overdose
Symptoms of an overdose in humans are not known. Doses up to 240 mg with a / in the introduction of well tolerated
Interaction with other drugs
With the simultaneous use of pantoprazole can reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach (for example, ketoconazole)
special instructions
Before and after the end of therapy, endoscopic control is necessary (if necessary with a biopsy) to exclude a malignant neoplasm of the stomach or esophagus, since use of the drug may delay the correct diagnosis