Sanpraz
Sanpraz: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Sunpraz
ATX code: A02BC02
Active ingredient: pantoprazole (pantoprazole)
Producer: San Pharmaceutical Industries, Ltd. (Sun Pharmaceutical Industries, Ltd.) (India)
Description and photo updated: 28.08.
Prices in pharmacies: from 160 rubles.
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Sanpraz is an antiulcer drug. It is an inhibitor of H + -K + -ATPase.
Release form and composition
Sanpraz is available in two dosage forms:
- lyophilisate for the preparation of a solution for intravenous administration: pure white or almost white; the solvent is a clear solution without color (40 mg in glass colorless vials with a volume of 10 ml, in a cardboard box one vial complete with an ampoule with solvent)
- enteric coated tablets: biconvex, round, yellow (in aluminum strips, 10 pieces, in a cardboard box 1-3 strips).
Each pack also contains instructions for the use of Sanpraz.
Composition for one bottle with lyophilisate:
- active substance: pantoprazole (in the form of pantoprazole sodium sesquihydrate) - 40 mg;
- auxiliary component (solvent): isotonic sodium chloride solution - 10 ml.
Composition for one tablet:
- active substance: pantoprazole (in the form of pantoprazole sodium sesquihydrate) - 40 mg;
- auxiliary components: calcium stearate, magnesium oxide, colloidal silicon dioxide, sodium lauryl sulfate, calcium carbonate, crospovidone;
- enteric coating: copovidone, macrogol 6000, copolymer of methacrylic acid and ethyl acrylate, titanium dioxide, triethyl citrate, yellow iron oxide, talc.
Pharmacological properties
Pharmacodynamics
The active substance in the composition of the drug Sanpraz - pantoprazole, is an inhibitor of hydrogen-potassium adenosine triphosphatase (H + / K + -ATPase). It blocks the last stage of hydrochloric acid (HCl) secretion, thereby reducing its basal and stimulated secretion, regardless of the nature of the stimulus. Pantoprazole in patients with duodenal ulcer associated with Helicobacter pylori reduces gastric secretion and increases the sensitivity of bacteria to antibiotics.
When taken orally, Sanpraz does not affect the motility of the gastrointestinal tract (GIT).
Intravenous administration of pantoprazole at a dose of 80 mg provides the maximum antisecretory effect after 1 hour and retains it for 24 hours. The secretory activity is normalized 3-4 days after the completion of the therapeutic course.
Pharmacokinetics
After oral administration of Sanpraz, pantoprazole is rapidly absorbed from the gastrointestinal tract. The maximum concentration (C max) in plasma reaches 2.5 hours later, this figure is 2–3 mg / l, remaining unchanged even after repeated administration. Other characteristics: bioavailability - 65-77%, half-life (T 1/2) - about 1 hour.
After intravenous administration in the dose range of 10–80 mg, the pharmacokinetic parameters of pantoprazole show a linear dependence, their values for multiple and single use are comparable. The drug does not accumulate in the body.
The volume of distribution (V d) is 0.15 l / kg, Sanpraz is distributed mainly in the extracellular fluid. It binds to plasma proteins at a level of 98%.
Pantoprazole is extensively metabolized in the liver, mainly with the participation of the cytochrome P450 CYP2C19 system. The main metabolite detected in urine and blood plasma is desmethylpantoprazole sulfate conjugated.
After parenteral administration, T 1/2 on average is 1 hour. The main part of pantoprazole is excreted in the form of inactive metabolites by the kidneys. A small amount is excreted through the intestines.
In renal failure, the pharmacokinetics of pantoprazole does not change significantly.
In patients with hepatic insufficiency, T 1/2 increases to 7-9 hours. The area under the concentration-time curve (AUC) increases 5-7 times, and C max - 1.5 times in comparison with similar indicators in healthy volunteers.
Indications for use
- gastrinoma (Zollinger-Ellison syndrome);
- destruction of the bacteria Helicobacter pylori (Helicobacter pylori) (as part of combination therapy with antibacterial agents);
- exacerbation of gastric ulcer and 12 duodenal ulcer;
- erosive (hemorrhagic) gastritis associated with the bacterium Helicobacter pylori;
- erosive and ulcerative lesions of the stomach and duodenum, caused by the intake of NSAIDs (non-steroidal anti-inflammatory drugs);
- treatment of GERD (gastroesophageal reflux disease);
- treatment and prevention of stress ulcers, as well as their complications (bleeding, ulcer penetration, perforation).
Contraindications
- dyspeptic disorders of neurotic etiology;
- malignant neoplasms of the gastrointestinal tract;
- children and adolescents up to 18 years old (since there is no data on the use of Sanpraz in pediatric practice);
- lactation period (for solution);
- increased individual sensitivity to any component of the drug.
Sanpraz is prescribed with caution to pregnant women and patients with hepatic insufficiency.
As prescribed by a doctor, the drug in the form of tablets can be used with caution during breastfeeding.
Sanpraz, instructions for use: method and dosage
Sanpraz tablets are intended for oral administration. The drug is taken in the morning, one hour before meals. When prescribed twice a day, the second dose is taken before dinner (one hour in advance). The tablet is swallowed whole and washed down with a sufficient amount of liquid.
For adult patients, Sanpraz is prescribed in the following doses:
- destruction of Helicobacter pylori: 1 tablet twice a day. The course is 1-2 weeks. Treatment is combined with taking antimicrobial drugs;
- hemorrhagic gastritis, gastric ulcer and 12 duodenal ulcer: 1-2 tablets per day. The course of treatment: exacerbation of gastric ulcer - 1–2 months, exacerbation of duodenal ulcer - 2 weeks;
- erosive and ulcerative damage caused by taking NSAIDs: 1-2 tablets per day. The course of treatment is 1–2 months. With prolonged use of NSAIDs, Sanpraz is used for prophylactic purposes, ½ tablet per day;
- GERD: ½-1 tablet per day, the course of treatment is 1-2 months; for the prevention of possible complications - ½ tablet per day.
In severe liver dysfunction, dosage adjustment is required. Sanpraz is taken every other day, 1 tablet, regularly monitoring the biochemical parameters of the blood. With an increase in the activity of liver enzymes, Sanpraz should be canceled.
If oral administration is impossible, intravenous administration of the drug is used. As soon as it becomes possible to take Sanpraz inside, the patient is transferred to the oral form of the drug.
To prepare the solution, it is necessary to restore the vial with the lyophilisate using the solvent that comes with the kit. The resulting solution of Sanpraz is administered intravenously in a stream or as an infusion lasting from 2 to 15 minutes. To prepare an infusion solution, the reconstituted lyophilisate is mixed with 100 ml of isotonic NaCl solution or 5% or 10% glucose solution. The prepared solution should have a pH of 9-10. The shelf life of the infusion solution is 3 hours from the date of preparation.
For intravenous administration of Sanpraz, the recommended dose is 40 mg once a day. The duration of therapy is 7-10 days, if necessary, the course of treatment can be extended.
With Zollinger-Ellison syndrome, Sanpraz is used for a long time, while the initial daily dose can be up to 80 mg, and then it is adjusted (increased or decreased). When the drug is prescribed in a dose of more than 80 mg per day, it is divided into two administrations. In some cases, a temporary increase in the daily dose to 160 mg is required.
In order to eradicate the bacteria Helicobacter pylori Sanpraz is prescribed in a daily dose of 80 mg in two administrations. Duration of use is from 7 to 10 days (treatment is carried out in combination with antimicrobial agents).
In severe liver dysfunction, dose adjustment is required. The daily dose of the drug should not exceed 20 mg. Regular monitoring of blood biochemical parameters is required. With an increase in the activity of liver enzymes, Sanpraz should be canceled.
Elderly patients and persons with impaired renal function are prescribed the drug in the recommended doses; no dosage adjustment is required.
Side effects
- digestive system: dry mouth, pain in the upper abdomen, nausea and vomiting, constipation or diarrhea, functional insufficiency of liver cells with jaundice, flatulence, increased activity of liver enzymes;
- nervous system: blurred vision, headache, disorientation, dizziness, confusion, depression, weakness, hallucinations;
- hematopoietic system: a decrease in the number of leukocytes and platelets;
- musculoskeletal system: myalgia, arthralgia;
- dermatological and allergic reactions: urticaria, itching and rash on the skin, photosensitivity, angioedema, Lyell's syndrome, erythema multiforme, anaphylactic shock, Stevens-Johnson syndrome;
- local reactions at the injection site: thrombophlebitis and phlebitis;
- general reactions: peripheral edema, tenderness and tension of the mammary glands, interstitial nephritis, hyperthermia, increased triglyceride levels.
When using the drug according to indications and in prescribed doses, undesirable effects occur very rarely.
Overdose
Data on an overdose of Sanpraz when taken orally have not been reported. With parenteral administration of the drug, doses up to 240 mg were well tolerated. Symptoms of a pantoprazole overdose in humans are not known.
In case of an overdose with signs of intoxication, it is recommended to carry out general detoxification measures, symptomatic therapy, hemodialysis.
special instructions
Treatment with Sanpraz can mask the signs of malignant neoplasms of the stomach or esophagus, therefore, a mandatory endoscopic examination is recommended before starting pantoprazole and after the end of therapy.
In dyspeptic disorders of neurogenic etiology, the drug is ineffective.
Influence on the ability to drive vehicles and complex mechanisms
Sanpraz did not affect the patient's ability to drive motor vehicles and engage in other potentially hazardous work associated with a high risk of harm to human health and life.
Application during pregnancy and lactation
The experience of using Sanpraz during pregnancy / lactation is limited. In the course of experimental studies of the effect of the drug on reproductive function, slight embryotoxicity was observed with parenteral administration of pantoprazole at a dose of more than 5 mg / kg.
Recommendations for use, depending on the form of release:
- film-coated tablets: during pregnancy / lactation, appoint with caution;
- lyophilisate for the preparation of a solution for intravenous administration: during pregnancy, it is used if the benefit to the mother exceeds the possible risk to the fetus; since there is no data on the excretion of pantoprazole in breast milk, breastfeeding should be discontinued during therapy.
Pediatric use
It is contraindicated to use Sanpraz in pediatrics for the treatment of children and adolescents under 18 years of age.
With impaired renal function
Patients with renal insufficiency, including those on hemodialysis, do not need to increase the daily dose of pantoprazole above 40 mg.
For violations of liver function
In case of severe (severe) violations of liver function, it is recommended to take the following doses of pantoprazole:
- film-coated tablets: 40 mg once every two days;
- lyophilisate for the preparation of a solution for intravenous administration: 20 mg per day.
Patients with impaired hepatic function require regular monitoring of blood biochemical parameters. In case of increased activity of liver enzymes, Sanpraz is canceled.
Use in the elderly
Elderly patients do not need to increase the daily dose of pantoprazole above 40 mg.
Drug interactions
With the simultaneous use of the drug Sanpraz with ritonavir, ketoconazole and iron salts, the rate of their absorption decreases; with atazanavir - the effectiveness of atazanavir decreases; with warfarin - prothrombin time increases and the risk of bleeding, sometimes fatal, increases.
No clinically significant drug interactions were found with the following drugs: ethinylestradiol / levonorgestrel, nifedipine, ethanol, amoxicillin, caffeine, digoxin, metronidazole, diclofenac, cisapride, naproxen, glibenclamide, cyclosporin, diazepam, levothyroxine, tacrolicamicamol, fenizimaz, phenazone, theophylline, clarithromycin, metoprolol.
Analogs
Analogues of Sanpraz are: Zipantol, Controloc, Krosatsid, Nolpaza, Pantaz, Panum, Peptazol, Pizhenum-sanovel, Pulloref, Ultera, etc.
Terms and conditions of storage
Store in a dry, dark place, out of the reach of children, at a temperature not exceeding 25 ° C. Shelf life: tablets - 3 years, lyophilisate - 2 years, solvent - 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Sanpraz
Due to its high efficiency, ease of administration, convenient release form, most of the reviews about Sanpraz, especially in the form of tablets, are positive. The drug successfully suppresses the secretion of hydrochloric acid in the stomach, quickly and permanently relieves heartburn. The effect of admission comes quickly, and there are practically no complaints from patients about side effects.
The high cost of the drug is often cited as a disadvantage.
Price for Sanpraz in pharmacies
The approximate price of Sanpraz for enteric tablets, film-coated, with a dosage of 40 mg is: 10 pcs. in the package - 230–303 rubles, 30 pcs. in the package - 420-560 rubles.
Sanpraz: prices in online pharmacies
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Drug name Price Pharmacy |
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Sanpraz 40 mg enteric-coated tablets 10 pcs. RUB 160 Buy |
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Sanpraz 40 mg enteric-coated tablets 30 pcs. 190 RUB Buy |
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Sanpraz tablets p.p. 40mg 30 pcs. 296 r Buy |
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Sanpraz 40 mg lyophilisate for preparation of solution for intravenous administration 1 pc. 389 r Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
