Pantoprazole tablets p / o 20mg, No. 30

• Peptic ulcer of the stomach or duodenum in the acute phase,

• Zollinger-Ellison syndrome,

• eradication of Helicobacter pylori (in combination with antibiotic therapy),

• reflux esophagitis.

The average therapeutic dose is 40 mg / day. The maximum daily dose is 80 mg. The duration of the course of therapy is set depending on the indications, but it should not exceed 8 weeks.

Enteric-soluble tablets, film-coated, light green or green with a bluish tinge, round, biconvex; in cross section - almost white.

1 tab.

pantoprazole sodium sesquihydrate 22.57 mg,

which corresponds to the content of pantoprazole 20 mg

Excipients: heavy magnesium hydroxycarbonate - 7.53 mg, macrogol (polyethylene glycol) - 1.2 mg, mannitol - 63 mg, calcium stearate - 1.2 mg, colloidal silicon dioxide - 1 mg, crospovidone - 20 mg, Povidone K30 - 3.5 mg.

• Dyspepsia of neurotic genesis,

• malignant diseases of the gastrointestinal tract,

• hypersensitivity to pantoprazole.

Trade name: Pantoprazole Canon

International non-proprietary name of the drug: pantoprazole

Dosage form:

enteric film-coated tablets

Composition
1 enteric tablet. film-coated, 20 mg contains:
active substance : pantoprazole sodium sesquihydrate 22.57 mg, in terms of pantoprazole 20 mg;
excipients : heavy magnesium hydroxycarbonate 7.53 mg, macrogol (polyethylene glycol) 1.2 mg, mannitol 63 mg, calcium stearate 1.2 mg, colloidal silicon dioxide 1 mg, crospovidone 20 mg, povidone K-30 3.5 mg;
film shell composition: Opadry transparent 2.4 mg (including: hypromellose (hydroxypropyl methylcellulose) 1.920 mg, macrogol (polyethylene glycol) 0.48 mg), Acryl-Iz green 8.6 mg (including: methacrylic acid and ethyl acrylate copolymer [1: 1] 5.676 mg, colloidal silicon dioxide 0.086 mg, sodium bicarbonate 0.086 mg, sodium lauryl sulfate 0.043 mg, iron oxide yellow 0.06 mg, indigo carmine dye 0.069 mg, brilliant blue dye 0.026 mg, talc 1.419 mg, titanium dioxide 1.135 mg). Triethyl citrate 1 mg.
1 tablet enteric, film-coated, 40 mg contains:
active substance: pantoprazole sodium sesquihydrate 45.14 mg, in terms of pantoprazole 40 mg;
Excipients: heavy magnesium hydroxycarbonate 15.06 mg, macrogol (polyethylene glycol) 2.4 mg, mannitol 126 mg, calcium stearate 2.4 mg, colloidal silicon dioxide 2 mg, crospovidone 40 mg, povidone K-30 7 mg;
composition of the film shell : Opadry transparent 4.8 mg (including: hypromellose (hydroxypropyl methylcellulose) 3.84 mg, macrogol (polyethylene glycol) 0.96 mg), Acryl-Iz green 17.2 mg (including: methacrylic acid and ethyl acrylate copolymer [1: 1] 11.352 mg, colloidal silicon dioxide 0.172 mg, sodium bicarbonate 0.172 mg, sodium lauryl sulfate 0.086 mg, iron oxide yellow 0.12 mg, indigo carmine dye 0.138 mg, brilliant blue dye 0.052 mg, talc 2.838 mg, titanium dioxide 2.27 mg). Triethyl citrate 2 mg.

Description
Round, biconvex film-coated tablets of light green or green color with a bluish tinge. In cross section, it is almost white.

Pharmacotherapeutic group:

An agent that lowers the secretion of gastric glands - a proton pump inhibitor.

ATX code: A02BC02

Pharmacological properties
Pharmacodynamics
Proton pump inhibitor (H + / K + -ATPase). 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 the drug Pantoprazole Canon, the antisecretory effect occurs after 1 hour and reaches a maximum after 2-4 hours. In duodenal ulcer disease associated with Helicobacter pylori , a 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 the intake.
Compared to other proton pump inhibitors, pantoprazole has greater chemical stability at neutral pH and a lower potential for interaction with the liver oxidase system, which depends on cytochrome P450. Therefore, pantoprazole does not interact with many other common drugs.

Pharmacokinetics
Absorption
Pantoprazole is rapidly absorbed after oral administration. The maximum concentration (Cmax) in blood plasma after oral administration is achieved after the first dose of 20 mg or 40 mg. On average, Cmax, equal to 1.0 - 1.5 ?g / ml, is achieved after 2-2.5 hours for a dosage of 20 mg, and equal to 2.0 -3.0 ?g / ml - after 2.5 hours for a dosage 40 mg. This indicator remains constant after repeated use of the drug. The absolute bioavailability is 77%. The simultaneous use of pantoprazole with food does not affect the area under the concentration-time pharmacokinetic curve (AUC) and Cmax.
Distribution
Plasma protein binding is 98%. The volume of distribution is 0.15 l / kg, the clearance is 0.1 l / h / kg.
Metabolism
It is metabolized in the liver. The main metabolite in blood plasma and urine is desmethylpantoprazole, conjugated with sulfate.
Withdrawal
The half-life (T?) Of pantoprazole is 1 hour, the metabolite is 1.5 hours. The main route of excretion is through the kidneys (about 80%) in the form of pantoprazole metabolites, in a small amount is excreted through the intestines.
Pharmacokinetics in different patient groups
Age : A slight increase in AUC and Cmax in the elderly is not clinically significant.
Renal failure : When using pantoprazole in patients with impaired renal function (including patients on hemodialysis), dose reduction is not required. As in healthy patients, the drug is excreted rather quickly and does not accumulate.
Liver failure : In patients with liver cirrhosis (classes A and B according to the Child-Pugh classification), the T? increases to 3-6 hours when using pantoprazole at a dosage of 20 mg and up to 7-9 hours when using pantoprazole at a dosage of 40 mg. The AUC indicator increases 3-5 times (for a dosage of 20 mg) and 5-7 times (for a dosage of 40 mg). Cmax increases 1.3 times (for a dosage of 20 mg) and 1.5 times (for a dosage of 40 mg) compared with healthy patients.

Indications for use

• peptic ulcer and duodenal ulcer (in the acute phase), erosive gastritis (including those associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs));

• treating symptoms of mild gastroesophageal reflux disease (such as heartburn, nausea, sour belching);

• Zollinger-Ellison syndrome;

• eradication of Helicobacter pylori in combination with antibacterial agents.

Contraindications

• hypersensitivity to the components of the drug;

• dyspepsia of neurotic genesis;

• children under 18 years of age (safety and effectiveness in pediatrics have not been established);

• malignant diseases of the gastrointestinal tract;

• simultaneous use with atazanavir;

• eradication of Helicobacter pylori in patients with severe renal failure (creatinine clearance <20 ml / min);

• period of breastfeeding.

Carefully

• liver failure;

• pregnancy;

• elderly age;

• in patients with an increased risk of developing complications from the gastrointestinal tract and long-term receiving non-steroidal anti-inflammatory drugs as anti-relapse treatment of gastric ulcer or duodenal ulcer at a dose of 20 mg.

Application during pregnancy and during breastfeeding.
The drug Pantoprazole Canon can be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
In experimental studies, it was found that pantoprazole is excreted in breast milk, therefore, if it is necessary to use the drug Pantoprazole Canon, breastfeeding should be discontinued.

Dosing and Administration
Inside. The tablet should be swallowed whole, without chewing or breaking, with a small amount of liquid, before meals, usually before breakfast. If taken twice, the second dose of the drug is recommended to be taken before dinner.
Peptic ulcer and duodenal ulcer, erosive gastritis (including those associated with taking NSAIDs) The
recommended dose is 40-80 mg per day. The course of treatment is 2 weeks with exacerbation of duodenal ulcer and 4-8 weeks with exacerbation of gastric ulcer.
Anti-relapse treatment of gastric ulcer and duodenal ulcer - 20 mg per day.
Helicobacter pylori eradication The
following combinations are used as a triple therapy:

1. Pantoprazole Canon 20-40 mg 2 times a day + amoxicillin 1000 mg 2 times a day + clarithromycin 500 mg 2 times a day. The course of treatment is 7-14 days.

2. Pantoprazole Canon 20-40 mg 2 times a day + metronidazole 500 mg 2 times a day + clarithromycin 500 mg 2 times a day. The course of treatment is 7-14 days.

3. Pantoprazole Canon 20-40 mg 2 times a day + amoxicillin 1000 mg 2 times a day + metronidazole 500 mg 2 times a day. The course of treatment is 7-14 days.

After the end of the combination therapy, the administration of the drug Pantoprazole Canon can be continued in order to heal the ulcer. In case of duodenal ulcer, the administration of Pantoprazole Canon can be extended from 1 to 3 weeks.
Patients with severe renal impairment (creatinine clearance <20 ml / min), or those on hemodialysis, are not prescribed eradication therapy with Helicobacter pylori .
Treating symptoms of mild gastroesophageal reflux disease (such as heartburn, nausea, sour belching)
The recommended dose of the drug is 20 mg per day. To achieve positive dynamics in eliminating symptoms, you may need to take the drug for 2-3 days, however, to completely eliminate the symptoms, you may need to take the drug for 7 days. If the condition worsens during the first 3 days of treatment, it is recommended to consult a specialist. The drug should be discontinued as soon as symptoms disappear.
Zollinger-Ellison syndrome The
recommended dose is 40-80 mg per day. In patients with severe hepatic dysfunction, the dose should be reduced to 40 mg every 2 days. In this case, it is necessary to monitor the biochemical parameters of the blood. With an increase in the activity of liver enzymes, the drug should be discontinued.
Elderly patients
No dose adjustment is required. However, elderly patients should not exceed a daily dose of 40 mg. An exception is the use of combined antimicrobial therapy against Helicobacter pylori , when elderly patients should also use Pantoprazole Canon 40 mg 2 times a day.
Patients with renal impairment
Patients with severe renal impairment (creatinine clearance <20 ml / min), or on hemodialysis should not exceed a daily dose of 40 mg. For this reason, Helicobacter pylori eradication therapy is not prescribed to such patients.
You should not take the drug Pantoprazole Canon for prophylaxis.

Side effect
WHO classification of the incidence of side effects:
very often - > 1/10 appointments (> 10%)
often - from > 1/100 to <1/10 appointments (> 1% and <10%)
infrequently - from > 1 / 1000 to <1/100 appointments (> 0.1% and <1%)
rarely - > 1/10000 to <1/1000 appointments (> 0.01% and <0.1%)
very rarely - <1/10000 appointments (<0.01% )
frequency unknown - cannot be estimated from the available data.
Disturbances from the blood and lymphatic system:
rarely - agranulocytosis;
very rarely - leukopenia, thrombocytopenia, pancytopenia.
Immune system disorders:
very rarely - anaphylactic reactions, including anaphylactic shock.
Mental disorders :
infrequently - sleep disturbances;
rarely - depression, hallucinations, disorientation, clouding of consciousness, especially in patients predisposed to this, as well as an increase in these symptoms if they were previously observed in patients.
Nervous system disorders :
often - headache;
infrequently - dizziness;
rarely - dysgeusia.
Violation of the organ of vision:
infrequently - visual impairment (blurred vision).
Disorders from the gastrointestinal tract:
often - pain in the upper abdomen, diarrhea, constipation, flatulence;
infrequently - nausea / vomiting;
rarely dry mouth.
Disorders of the liver and biliary tract:
very rarely - severe damage to the liver parenchyma, leading to jaundice with or without liver failure.
Violations of the skin and subcutaneous tissues:
infrequently - itching and skin rash;
very rarely - urticaria, angioedema, malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, Lyell's syndrome, photosensitivity.
Musculoskeletal and connective tissue disorders:
rarely - arthralgia;
very rarely - myalgia.
Metabolic disorders:
rarely - hyperlipidemia, changes in body weight;
frequency unknown - hyponatremia, hypomagnesemia.
Disturbances from the urinary system:
very rarely - interstitial nephritis.
Violations of the genitals and mammary gland:
rarely - gynecomastia.
General disorders:
infrequently - weakness, fatigue and malaise;
very rarely - peripheral edema, increased body temperature.
Laboratory and instrumental data:
rarely - an increase in the content of bilirubin;
very rarely - an increase in the activity of 'liver' enzymes (aspartate aminotransaminase, gamma-glutamyl transferase), an increase in triglycerides.

Overdose
Until now, the phenomena of overdose as a result of the use of pantoprazole have not been noted. Doses in excess of 240 mg IV were administered within 2 minutes and were well tolerated.
However, in case of overdose and only in the presence of clinical manifestations, symptomatic and supportive treatment is carried out. Hemodialysis is ineffective.

Interaction with other drugs The
simultaneous use of pantoprazole can reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach environment (for example, iron salts, ketoconazole, atazanavir).
The absorption of ritonavir is also known to be pH dependent. Therefore, caution should be exercised when using pantoprazole in conjunction with ritonavir, due to a possible decrease in the bioavailability of ritonavir.
Pantoprazole, unlike other proton pump inhibitors, can be prescribed without the risk of drug interactions:

• patients with diseases of the cardiovascular system, taking cardiac glycosides (digoxin), blockers of 'slow' calcium channels (nifedipine), beta-blockers (metoprolol);

• patients with diseases of the gastrointestinal tract taking 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 taking glibenclamide, levothyroxine sodium;

• patients with anxiety and sleep disorders taking diazepam;

• patients with epilepsy taking carbamazepine and phenytoin;

• transplant patients taking cyclosporine, tacrolimus.

There are no data on the simultaneous interaction of pantoprazole with antacids.
With simultaneous use with warfarin, the international normalized ratio (INR) may increase, control of this indicator is necessary.
The absence of drug interactions with theophylline, caffeine and ethanol was also noted.

Special instructions
It is necessary to regularly monitor the activity of liver enzymes in the blood plasma when using the drug Pantoprazole Canon for patients with severe hepatic impairment, especially with prolonged use. With an increase in the activity of transaminases in the blood plasma, treatment with the drug should be discontinued.
In patients who have an increased risk of developing complications from the gastrointestinal tract and who have been receiving non-steroidal anti-inflammatory drugs for a long time, Pantoprazole Canon at a dose of 20 mg for the prevention of gastric ulcer and duodenal ulcer should be used with caution.
It is necessary to use the drug Pantoprazole Canon with caution in elderly patients (over 65 years old) with a history of gastric ulcer or duodenal ulcer, as well as bleeding from the upper gastrointestinal tract.
Before and after treatment, endoscopic control is required to exclude the possibility of the presence of malignant diseases of the stomach and esophagus, since treatment with Pantoprazole Canon can mask symptoms and complicate correct diagnosis.
A decrease in gastric acidity increases the number of bacteria in the stomach, leading to the development of infectious diseases of the gastrointestinal tract caused by Salmonella spp. , and Campylobacter spp.Pantoprazole reduces the absorption of vitamin B12 due to hypo- and achlorhydria. This should be taken into account in long-term therapy in patients with low body weight or with an increased risk of decreased absorption of vitamin B12. Patients in whom treatment has not led to an effect within 4 weeks need to be examined.
With prolonged use of the drug Pantoprazole Canon, patients need regular medical supervision.

¬ли¤ние на способность управлени¤ транспортными средствами и зан¤ти¤ другими потенциально опасными видами де¤тельности
—ледует обратить внимание на то, что во врем¤ лечени¤ может развитьс¤ головокружение, в св¤зи с чем необходимо соблюдать осторожность при управлении автотранспортом и зан¤тии другими потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций.

Release form
Enteric tablets, film-coated 20 mg and 40 mg.
7, 10, 14 or 28 tablets in a blister strip made of polyvinyl chloride film or PVC / PVDC film or PVC / PCTFE film and lacquered aluminum foil.
1.2, 4 blister packs of 7, 10 or 14 tablets or 1.2 blister packs of 28 tablets, together with instructions for use, are placed in a cardboard box.

Storage conditions
In a dry, dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life is
2 years.
Do not use after the expiration date.

Pharmacy
Dispensing Conditions Prescription.