Pulorreph - instructions for use, doses, side effects, contraindications

Excipients: sodium phosphate 10.00 mg, isomalt LM-PF 58.50 mg, croscarmellose sodium-7MXR 3.00 mg, crospovidone 50.00 mg, sodium stearyl fumarate 3.40 mg;

first coat: hypromellose 15.85 mg, povidone K25 0.32 mg, film coating material No. 9 (Sepisperse AR 3232 Jaune Yellow) (30%) * 1.28 mg, propylene glycol 3.446 mg;

enteric membrane: eudragit L 30 D-55 30% (30% dispersion of methacrylic acid and ethacrylate copolymer [1: 1], sodium lauryl sulfate and polysorbate-80) 13.60 mg, triethyl citrate 1.36 mg, simethicone emulsion 30% 0.04 mg.

Film coating composition No. 9 (Sepisperse AR 3232 Jaune Yellow) (30%): purified water 45-55%, hypromellose E464 1-7%, propylene glycol 10-30%, titanium dioxide 20-30%, iron oxide yellow E172 up to 5%.

Description:Oval tablets from yellow to light yellow color, on a break of white-cream color.

Pharmacotherapeutic group:a drug that reduces the secretion of the glands of the stomach - the proton pump inhibitor.

ATX: & nbsp

A.02.B.C Proton pump inhibitors

A.02.B.C.02 Pantoprazole

Pharmacodynamics:

Proton pump inhibitor (H + K + ATPase). It blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus.

Antisecretory activity.

After oral administration of 40 mg of the drug Pulorre® antisecretory effect occurs in 1 hour and reaches a maximum after 2-4 hours. duodenal ulcer associated with Helicobacter pylori, decrease in gastric secretion increases the sensitivity of microorganisms to antibiotics. Does not affect the motility of the gastrointestinal tract. Secretory activity is normalized 3-4 days after the end of admission.

Compared with other proton pump inhibitors pantoprazole has a greater chemical stability at neutral pH, and a lower interaction potential with a liver oxidase system dependent on cytochrome P450. therefore pantoprazole does not interact with many other common drugs.

Pharmacokinetics:

Pantoprazole is rapidly absorbed after ingestion. The maximum concentration in the blood plasma (Cmah) for oral use is achieved after the first dose of 40 mg. On average, Cmax 2.0 - 3.0 μg / ml is achieved after 2.5 hours. This indicator remains constant after repeated use of this drug.

The volume of distribution is 0.15 l / kg, the clearance is 0.1 l / h / kg.

Half-life of the drug 1h.

Pharmacokinetics is the same as after a single, and after repeated use of the drug.

The binding of pantoprazole to plasma proteins is 98%. Metabolised in the liver.The main way of excretion - through the kidneys (about 80%) in the form of metabolites of pantoprazole, in a small amount is excreted with feces. The main metabolite in the blood plasma and in urine is desmethylpentoprazole, conjugating with sulfate.

Absolute bioavailability of pantoprazole tablets is 77%. Simultaneous, their use with food does not affect AUC and Cmax.

When pantoprazole is used in patients with limited renal function (including patients on hemodialysis), no dose reduction is required. As in healthy patients, the half-life of pantoprazole is short. Only a very small part of the drug is dialyzed. Does not accumulate.

In patients with cirrhosis of the liver (Classes A and B by classification Child) the value of the elimination half-life increases to 7-9 hours when pantoprazole is administered at a dosage of 40 mg. Index AUC increases 5 to 7 times. Cmax increases in 1,5 times in comparison with healthy patients. A slight increase in the indicator AUC and Cmax in the elderly is not clinically significant.

Indications:

- peptic ulcer of the stomach and duodenum (in the phase of exacerbation), erosive gastritis (including those associated with taking non-steroidal anti-inflammatory drugs (NSAIDs);

- gastroesophageal reflux disease (GERD): erosive reflux-esophagitis (treatment), symptomatic treatment of GERD (ie NERB - non-erosive reflux disease);

- Zollinger-Ellison syndrome;

- eradication Helicobacter pylori in combination with antibacterial agents.

Contraindications:

Hypersensitivity to the drug components, dyspepsia of neurotic genesis; age under 18 years (no data on safety and efficacy).

Carefully:Hepatic insufficiency, pregnancy, lactation.

Pregnancy and lactation:

Data on the use of the drug in pregnant women are limited. Use pantoprazole during pregnancy and during lactation should be provided that the expected benefit for the mother exceeds the possible risk to the fetus or child.

Dosing and Administration:

The drug is used orally, squeezed with liquid and swallowed whole (tablets can not be crushed or dissolved). Tablet pantoprazole 40 mg is recommended before or during breakfast.

Peptic ulcer of the stomach and duodenum, erosive gastritis (including, associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). The recommended dose is 40-80 mg per day.A course of treatment - 2 weeks with exacerbation of duodenal ulcer and 4-8 weeks with peptic ulcer exacerbation.

Eradication Helicobacter pylori. The recommended dose is 40 mg 2 times a day in combination with one of the following combinations:

- amoxicillin 1 g 2 times a day + clarithromycin 500 mg 2 times a day.

- clarithromycin 250-500 mg 2 times a day + metronidazole 400-500 mg 2 times a day.

- amoxicillin 1 g 2 times a day + metronidazole 400-500 mg 2 times a day.

The second tablet of pantoprazole should be taken before meals. The combined treatment should be followed for 14 days. After the end of treatment, the use of pantoprazole can be continued for the purpose of ulcer healing. With an ulcer of the duodenum, pantoprazole may be extended from 1 to 3 weeks.

Reflux esophagitis.

The recommended dose is 40 mg per day. The course of treatment is 4-8 weeks.

Zollinger-Ellison syndrome and other pathological conditions associated with increased secretion.

The recommended dose is 40-80 mg per day. In patients with severe impairment of liver function, the dose should be reduced to 40 mg once every 2 days. In this case it is necessary to control the biochemical parameters of the blood. With an increase in the level of liver enzymes should stop using the drug.

Elderly patients, as well as patients with impaired renal function, can not exceed a daily dose of 40 mg. An exception is the use of combined antimicrobial therapy in relation to Helicobacter pylori, when elderly patients should apply pantoprazole 40 mg 2 times a day.

Elderly patients

Correction of the dose is not required. However, do not take more than 40 mg per day daily. An exception is eradication therapy Ya. pylori, when elderly patients should take the usual dose of pantoprazole (2x40 mg / day) for 1 week.

Patients with renal insufficiency

Correction of the dose is not required. However, do not take more than 40 mg per day daily. For this reason, H. eradication therapy pylori is not assigned to such patients.

Patients with severe hepatic insufficiency

The daily dose should not exceed 40 mg.

Side effects:

often more than 1/100 and less than 1/10,

infrequently - more than 1/1000 and less than 1/100,

rarely - more than 1/10000 and less than 1/1000,

very rarely - less than 1/10000, including individual cases.

From the hematopoietic and lymphatic system: very rarely - leukopenia, thrombocytopenia.

From the immune system: rarely - Anaphylactic reactions, including anaphylactic shock.

From the nervous system: often - headache; infrequent - dizziness, visual impairment; very rarely - depression, hallucinations, disorientation, confusion, especially in predisposed patients, weighting of these symptoms, if they are present earlier.

From the gastrointestinal tract: often - pain in the upper abdomen, diarrhea, constipation, flatulence; infrequently - nausea / vomiting; rarely dry mouth.

From the liver and bile ducts: very rarely - severe damage to the liver parenchyma, leading to jaundice with or without liver failure.

From the skin and subcutaneous fat: infrequently - itching and skin rash; very rarely - hives, angioedema, severe skin reactions such as Stevens-Johnson syndrome, erythema multiforme, Lyell's syndrome, photosensitivity.

From the musculoskeletal system: rarely - arthralgia; very rarely - myalgia.

From the urinary system: very rarely - interstitial nephritis.

On the part of the body as a whole: very rarely - peripheral edema, fever.

From the laboratory indicators: very rarely - increased liver enzymes (transaminases,glutamyltranspeptidase), an increase in the triglyceride content.

Overdose:

Symptoms of an overdose in humans are unknown.

When an overdose occurs in the presence of clinical manifestations, symptomatic and supportive treatment is performed.

Interaction:

- The simultaneous use of the drug Pulorreph can reduce the absorption of drugs whose bioavailability depends on the pH of the stomach (for example, iron salts, ketoconazole).

Puloreph®, unlike other proton pump inhibitors (omeprazole and lansoprazole), can be prescribed without the risk of drug interaction:

- patients with cardiovascular diseases receiving cardiac glycosides (digoxin), blockers of slow calcium channels (nifedipine), beta-blockers (metoprolol);

- patients with diseases of the gastrointestinal tract taking antacids, antibiotics (amoxicillin, clarithromycin);

- patients taking oral contraceptives;

- patients taking non-steroidal anti-inflammatory drugs (diclofenac, phenazone, naproxen, piroxicam);

- patients with diseases of the endocrine system who receive glibenclamide, levothyroxine;

- patients with anxiety and sleep disorders receiving diazepam;

- patients with epilepsy receiving carbamazepine and phenytoin;

- patients receiving indirect anticoagulants, such as warfarin and fenprokumone,

- patients who have undergone transplantation, receive ciclosporin, tacrolimus.

There was also a lack of drug interaction with theophylline, caffeine and ethanol. Possible interaction with atazanavir and ritonavir.

Special instructions:

It is necessary to regularly monitor the activity of liver enzymes in blood plasma when pantoprazole is prescribed to patients with severe hepatic insufficiency, especially with prolonged use. With an increase in the level of transaminases in the blood, the drug should be discontinued.

The use of pantoprazole in a dose of 40 mg for the prevention of stomach ulcer and duodenal ulcer caused by NSAIDs should be limited in patients receiving long-term NSAIDs and having an increased risk of complications from the gastrointestinal tract.

Before and after treatment, endoscopic control is necessary to exclude the possibility of having malignant diseases of the stomach or esophagus,

t. to.treatment can mask the symptoms and make it difficult to properly diagnose. Lowering the acidity of gastric juice increases the number of bacteria in the stomach, leading to the development of infectious diseases of the gastrointestinal tract caused by salmonella and campylobacter.

Pantoprazole reduces the absorption of vitamin B12 due to hypo- and achlorhydria.

Patients in whom treatment did not result in an effect within 4 weeks need to be examined.

With prolonged use of pantoprazole, patients need regular medical supervision.

The drug is not recommended for use in children under 18 years due to the lack of safety and efficacy data for this age group.

Effect on the ability to drive transp. cf. and fur:

Since the drug may cause dizziness, the patient should be warned that it is necessary to operate the vehicles and work with the mechanisms with care.

Form release / dosage:Tablets, coated with enteric coating, 40 mg.

Packaging:

For 14 tablets in a foil blister, aluminum printed. For 1 or 2 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 of the year. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001271

Date of registration:24.11.2011

The owner of the registration certificate:Nobel Ilach Sanayi Ve Tidjaret A.Sh.Nobel Ilach Sanayi Ve Tidjaret A.Sh. Turkey

Manufacturer: & nbsp

NOBELPHARMA ILAC SANAYII VE TICARET, A.S. Turkey

Representation: & nbspNobel Ilach Sanayi Ve Tidjaret A.Sh.Nobel Ilach Sanayi Ve Tidjaret A.Sh.Russia

Information update date: & nbsp23.08.2015

Illustrated instructions

Instructions

Puloreph ® (Puloref)