Pulloref
Puloref: 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: Puloref
ATX code: A02BC02
Active ingredient: pantoprazole (Pantoprazolum)
Manufacturer: Nobelpharma Ilach Sanayi Ve Tijaret A. Sh. (Nobelpharma Ilac Sanayii Ve Ticaret, AS) (Turkey)
Description and photo update: 2019-29-11
Prices in pharmacies: from 164 rubles.
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Puloref - a drug that lowers the secretion of stomach glands; proton pump inhibitor.
Release form and composition
Dosage form - enteric-coated tablets: oval, from light yellow to yellow, at the break - white-cream color (in a cardboard box 1 or 2 blisters containing 14 tablets each, and instructions for using Puloref).
Composition of 1 tablet:
- active substance: pantoprazole sodium sesquihydrate (in terms of pantoprazole) - 40 mg;
- auxiliary components: sodium stearyl fumarate - 3.4 mg; crospovidone - 50 mg; croscarmellose sodium-7MHR - 3 mg; isomalt LM-PF - 58.5 mg; sodium phosphate - 10 mg;
- first coat: propylene glycol - 3.446 mg; material for film coating No. 9 [Sepisperse AP 3232 Jaune Yellow, 30% (iron oxide yellow E172 - up to 5%; titanium dioxide - 20-30%; propylene glycol - 10-30%; hypromellose E464 - 1-7%; purified water - 45-55%)] - 1.28 mg; povidone K25 - 0.32 mg; hypromellose - 15.85 mg;
- enteric coating: simethicone emulsion 30% - 0.04 mg; triethyl citrate - 1.36 mg; eudragit L 30 D-55 30% [30% dispersion of methacrylic acid and ethacrylate copolymer (1: 1), sodium lauryl sulfate and polysorbate-80] - 13.6 mg.
Pharmacological properties
Pharmacodynamics
Puloref is a proton pump inhibitor (H + K + adenosine triphosphatase). Regardless of the origin of the irritant, the drug blocks the final stage of the secretion of hydrochloric acid by reducing the basal and stimulated secretion.
The drug has an antisecretory effect, the onset of which after oral administration of 1 tablet is noted after 1 hour and reaches a maximum after 2–4 hours. Against the background of duodenal ulcer associated with Helicobacter pylori, a decrease in gastric secretion increases the sensitivity of microorganisms to antibacterial agents. Puloref has no effect on the motility of the gastrointestinal tract (GIT). In 3-4 days after the end of therapy, secretory activity is normalized.
Pantoprazole, in comparison with other proton pump inhibitors, has a lower potential for interaction with the liver oxidase system, which depends on cytochrome P 450, and has greater chemical stability at neutral pH. In this regard, the substance does not interact with many other common drugs.
Pharmacokinetics
After oral administration, pantoprazole is rapidly absorbed, and its maximum plasma concentration (C max) is reached after the first dose (1 tablet of 40 mg). On average, C max varies from 0.002 to 0.003 mg per 1 ml and is reached after 2.5 hours. This indicator remains constant after repeated use of the drug.
The volume of distribution of pantoprazole is 0.15 l per 1 kg, the clearance is 0.1 l per hour per 1 kg of body weight, the half-life is 1 hour. The pharmacokinetics of Puloref are the same after a single or multiple dose.
Communication with blood plasma proteins - 98%. The substance is metabolized in the liver. The main route of its excretion is through the kidneys (almost 80%) in the form of metabolites, a small amount is excreted with feces. In urine and blood plasma, the main metabolite is desmethylpantoprazole, which is conjugated with sulfate.
The absolute bioavailability of pantoprazole in tablet form is 77%. C max and the area under the concentration-time curve (AUC) do not change with the simultaneous use of the drug with food.
Correction of the dosage regimen for patients with limited renal function (including patients on hemodialysis) is not required. The half-life of the drug in them, as in healthy patients, is short. Only a very small part of pantoprazole is dialyzed. The substance does not accumulate in the body.
Against the background of liver cirrhosis (according to the Child-Pugh classification - classes A and B), the half-life increases to 7-9 hours when 40 mg of pantoprazole is taken. AUC increases 5-7 times, and C max - 1.5 times in comparison with healthy patients. A slight increase in these indicators in elderly patients is not clinically significant.
Indications for use
- exacerbation of gastric ulcer and duodenal ulcer, erosive gastritis [including those associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs)];
- gastroesophageal reflux disease (GERD): therapy for erosive reflux esophagitis, symptomatic treatment of non-erosive reflux disease (NERD);
- Zollinger-Ellison syndrome;
- eradication of Helicobacter pylori - in combination with antibiotics.
Contraindications
Absolute:
- dyspepsia of neurotic origin;
- age under 18;
- individual intolerance to the components of the drug.
Relative (Pulloref is prescribed under medical supervision):
- liver failure;
- pregnancy;
- period of breastfeeding.
Puloref, instructions for use: method and dosage
Pulloref tablets are taken orally, whole (they cannot be dissolved or crushed), with a liquid, before or during breakfast.
With erosive gastritis and gastric ulcer and duodenal ulcer, including those associated with taking NSAIDs, appoint 1-2 tablets per day. The duration of therapy for exacerbation of duodenal ulcer is 14 days, with exacerbation of gastric ulcer - from 28 to 56 days.
In cases of eradication, Helicobacter pylori is taken 1 tablet 2 times a day in combination with one of the following drug combinations:
- 1 g of amoxicillin 2 times a day + 0.5 g of clarithromycin 2 times a day;
- 0.25-0.5 g of clarithromycin 2 times a day + 0.4-0.5 g of metronidazole 2 times a day;
- 1 g of amoxicillin 2 times a day + 0.4-0.5 g of metronidazole 2 times a day.
The second Pulloref tablet is taken before meals. Combined therapy must be adhered to for 14 days. Taking the drug after the end of treatment can be continued in order to heal the ulcer. Patients with duodenal ulcer can prolong the use of the drug for a period of 7 to 21 days.
The recommended dose for reflux esophagitis is 1 tablet a day. The duration of the course of treatment varies from 28 to 56 days.
With Zollinger-Ellison syndrome and other pathological conditions associated with increased secretion, 1-2 tablets are prescribed per day.
The dose for patients with severe hepatic impairment is 1 tablet per day (no more). In the case of severe liver dysfunctions, it is reduced to 1 tablet 1 time in 2 days. In this case, it is important to control the biochemical parameters of the blood. If there is an increase in the level of liver enzymes, Puloref therapy is discontinued.
Dose for patients with impaired renal function - 1 tablet per day (no more). Correction of the Puloref dosing regimen for patients with renal failure is not required. However, eradication therapy for Helicobacter pylori is not prescribed to such patients, since they cannot exceed the recommended daily dose (1 tablet).
Correction of the dosage regimen for elderly patients is not required, but it is not recommended for them to take more than 1 tablet per day daily. An exception for elderly patients is the eradication treatment of Helicobacter pylori, when patients of this age group should take Puloref in the usual dose (1 tablet 2 times a day) for 7 days.
Side effects
Possible adverse reactions (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01%, including isolated messages - very rare):
- hematopoietic and lymphatic system: very rarely - thrombocytopenia, leukopenia;
- immune system: very rarely - anaphylactic reactions, including anaphylactic shock;
- nervous system: often - headache; infrequently - visual impairment, dizziness; very rarely - disorientation, hallucinations, depression, clouding of consciousness, especially in predisposed patients, aggravation of these signs in cases of their presence earlier;
- Gastrointestinal tract: often - flatulence, constipation, diarrhea, pain in the upper abdomen; infrequently - vomiting, nausea; rarely - dry mouth;
- liver and biliary tract: very rarely - severe damage to the liver parenchyma, which leads to jaundice with or without liver failure;
- skin and subcutaneous fat: infrequently - skin rash / itching; very rarely - angioedema, urticaria, severe skin reactions such as photosensitivity, Lyell's syndrome, erythema multiforme, Stevens-Johnson syndrome;
- musculoskeletal system: rarely - arthralgia; very rarely - myalgia;
- urinary system: very rarely - interstitial nephritis;
- the body as a whole: very rarely - an increase in body temperature, peripheral edema;
- laboratory indicators: very rarely - an increase in the concentration of triglycerides, liver enzymes (glutamyl transpeptidase, transaminase).
Overdose
The main symptoms of Puloref overdose in humans are unknown.
In the presence of clinical manifestations, symptomatic and supportive treatment is performed.
special instructions
It is important to regularly monitor the activity of liver enzymes in blood plasma when using Pulloref in patients with severe hepatic insufficiency, especially during prolonged therapy. The drug is canceled when the level of transaminases in the blood increases.
The use of the drug in a dose of 40 mg (1 tablet) for the prevention of gastric ulcer and duodenal ulcer caused by NSAID therapy should be limited in persons who have been receiving NSAIDs for a long time and have an increased risk of gastrointestinal complications.
To exclude the likelihood of the presence of malignant pathologies of the esophagus and stomach, before and after the application of Puloref, mandatory endoscopic control should be carried out, since the treatment carried out can mask the symptoms and complicate the correct diagnosis.
A decrease in the acidity of gastric juice increases the number of bacteria in the stomach, which leads to the appearance of infectious diseases of the gastrointestinal tract caused by Campylobacter and Salmonella.
The drug reduces the absorption of cobalamin (vitamin B 12) due to hypo- and achlorhydria.
If no therapeutic effect is noted within 28 days of using Puloref, the patient should be examined.
With prolonged use of tablets, regular medical supervision is required.
Influence on the ability to drive vehicles and complex mechanisms
Since taking Puloref can lead to the development of dizziness, it is important for patients during treatment to be careful when driving and conducting potentially hazardous activities, the implementation of which requires increased attention and speed of psychomotor reactions.
Application during pregnancy and lactation
Puloref during pregnancy / lactation can be used only in cases where the intended benefits of therapy to the mother outweigh the potential risks to the fetus / child.
Pediatric use
For patients under 18 years of age, Puloref is not prescribed due to the lack of data on the efficacy and safety of its use in patients of this age group.
With impaired renal function
Patients with impaired renal function should not take more than 1 Puloref tablet per day.
For violations of liver function
In case of liver failure, Puloref is taken with caution.
Patients with severely impaired liver function are not recommended to take more than 1 Pulloref tablet per day. If necessary, the dose should be reduced to 1 tablet once every 2 days.
Use in the elderly
Elderly patients should not take more than 1 Puloref tablet per day.
Drug interactions
The absorption of drugs, the bioavailability of which depends on the pH of the stomach environment (for example, ketoconazole, iron salts), may decrease in the presence of combined use with pantoprazole.
Unlike other proton pump inhibitors (lansoprazole, omeprazole), Puloref can be used without the risk of drug interactions for the following conditions / diseases:
- pathologies of the cardiovascular system, in which patients receive metoprolol (beta-blockers), nifedipine (blockers of slow calcium channels), digoxin (cardiac glycosides);
- diseases of the gastrointestinal tract, for the treatment of which patients take antibacterial agents (clarithromycin, amoxicillin), antacids;
- pathologies of the endocrine system, for the treatment of which levothyroxine, glibenclamide are prescribed;
- anxiety and sleep disorders in which patients receive diazepam;
- epilepsy, in which patients take phenytoin and carbamazepine.
Pulloref's drug interactions were also not noted in the following cases:
- combined use of oral contraceptives;
- combination therapy of NSAIDs (piroxicam, naproxen, phenazone, diclofenac);
- simultaneous administration of indirect anticoagulants (phenprocoumon, warfarin);
- transplantation, after which treatment with tacrolimus, cyclosporine was prescribed.
Also, there was no drug interaction of pantoprazole with ethanol, caffeine, theophylline.
Pulloref can interact with ritonavir and atazanavir.
Analogs
The analogues of Puloref are Panum, Sanpraz, Controloc, Pantoprazole Canon, Pizhenum-sanovel, Peptazol, Pantoprazol-Akrikhin, Pantaz, Krosatsid, Zipantola, etc.
Terms and conditions of storage
Store in a place protected from light and moisture at temperatures up to 30 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Puloref
There are few reviews about Puloref, indicating its effectiveness.
Price for Pulloref in pharmacies
The approximate price for Puloref is 154 rubles. for a pack of 14 tablets and 288 rubles. per pack of 28 tablets.
Puloref: prices in online pharmacies
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Drug name Price Pharmacy |
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Pulloref tablets p.p. enteric solution. 40mg 14 Pcs. 164 RUB 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!
