Antopral 40 mg 14 tablets

Tradename:

Antopral

Antopral

Composition:

Each tablet contains: 40mg pantoprazole

Auxiliary components:

Calcium stearate, microcrystalline cellulose, crospividone, hiprolos, sodium carbonate, anhydrous silicon, anhydrous collodion.

Properties:

It has antibacterial activity against Helicobacter pylori and contributes to the manifestation of the anti-Helicobacter effect of other drugs. The MIC is 128 mg / l. The therapeutic effect after a single dose comes quickly and lasts for 24 hours. Provides a rapid reduction in symptoms and healing of duodenal ulcers. When taken in a dose of 40 mg, pH values> 3 persist for than 19 hours. After 2 weeks of treatment ( mg daily), complete healing of duodenal ulcers is observed in 89% of patients. After 4 weeks of treatment (40 mg), 88% of patients experience complete healing of the gastric ulcer. The recurrence rate of peptic ulcers after treatment is 55%. Within 4 weeks of treatment at a dose of 40 mg / day provides complete remission in 82% of patients with gastroesophageal reflux disease stage Il-Ill (according to Savary – Miller), after 8 weeks in 92%. Complete endoscopic remission in 57% of children aged 6—13 years with stage lc / Il gastroesophageal reflux disease (according to Vandeplas) is achieved after 4 weeks of therapy at a dose of 20 mg / day. During 4—8 weeks of treatment, the level of gastrin in plasma increases 1.5 times. Maintenance therapy (40—80 mg daily for more than 3 years) in patients with peptic ulcer disease was accompanied by a slight increase in the number of enterochromaffin-like (ECL-) cells.

Experimental studies of carcinogenicity indicate that long-term use of pantoprazole is associated with an increased risk of ECL cell hyperplasia and the occurrence of gastric carcinoid, liver adenoma and carcinoma, and neoplastic processes in the thyroid gland.

Indications:

Peptic ulcer of the duodenum or stomach in

the acute phase, incl. associated with taking NSAlDs, or refractory to therapy with histamine H2 receptor blockers; gastroesophageal reflux disease (moderate to severe); Zollinger-Ellison syndrome; combined anti-Helicobacter pylori eradication therapy in patients with peptic ulcers in order to reduce the frequency of relapses.

Mode of application:

Inside, before meals (usually before breakfast), with the required amount of water. The tablets should be swallowed whole without chewing.

Adults and adolescents over the age of 12: Treatment of gastroesophageal reflux disease, reflux esophagitis:

1 tablet of pantoprazole per day. In some cases, the dose can be increased to 2 pantoprazole tablets per day. It usually takes 4 weeks for reflux esophageal inflammation to heal. If necessary, the duration of treatment is increased to 8 weeks.

Adults:

Eradication of Helicobacter pylori (in combination therapy):

In Helicobacter pylori-positive patients with gastric and duodenal ulcers, the eradication of the microorganism should be achieved usinq

combination therapy.

Official local guidelines (eg national guidelines) should be consulted on bacterial resistance and the appropriate prescription and use of antibacterial agents. Depending on the spectrum of resistance, the following combinations can be recommended:

1. One pantoprozole tablet twice a day

• 1000 mg of amoxicillin twice a day
• 500 mg clarithromycin twice daily

1. One pantoprazole tablet twice a day

• 400-500 mg metronidazole (or 500 mg tinidazole) twice a day
• 250-500 mg clarithromycin twice a day

1. One pantoprazole tablet twice a day

• 1000 mg of amoxicillin twice a day
• 400-500 mg of metronidazole (or 500 mg of

tinidazole) twice a day.

When carrying out eradication therapy, the second pantoprazole tablet should be taken 1 hour before the evening meal. Combination therapy is usually carried out for 7 days and can be continued for another 7 days for a total duration of 14 days. To ensure healing of the ulcers, further therapy with pantoprazole is then indicated using the doses recommended for duodenal and gastric ulcers.

If combination therapy is not indicated (Helicobacter pylori-negative patient), the following dosage regimens for pantoprazole monotherapy should be followed.

Stomach ulcer treatment:

1 tablet of pantoprazole per day. In some cases, the dose can be increased to 2 pantoprazole tablets per day. It usually takes 4 weeks for a stomach ulcer to heal. If necessary, the duration of treatment is increased to 8 weeks.

Duodenal ulcer treatment:

1 tablet of pantoprazole per day. In some cases, the dose can be increased to 2 pantoprazole tablets per day. It usually takes 2 weeks for a duodenal ulcer to heal. If necessary, the duration of treatment is increased to 4 weeks.

Zollinger-Ellison syndrome and other pathological hypersecretory diseases:

For long-term treatment of Zollinger-Ellison syndrome and other pathological hypersecretory diseases, treatment begins with a daily dose of 80 mg (2 tablets of 40 mg pantoprazole). After that, the dose can be increased or decreased as needed, guided by the indicators of gastric acid secretion. With a daily dosage of over 80 mg, the dose must be divided and applied twice a day. It is possible to temporarily increase the dosage to more than 160 mg, but only for the time necessary to adequately suppress the secretion of hydrochloric acid. The duration of treatment for Zollinger-Ellison syndrome and other pathological hypersecretory diseases is not limited and can be carried out in accordanc with clinical need.

Children under the age of 12:

Pantoprazole is not recommended for use in children under 12 years of age due to limited safety and efficacy data in this age group.

Special patient groups

Patients with impaired liver function

In patients with severe hepatic impairment, the daily dose of pantoprazole 20 mg should not be exceeded (other drugs with a dosage of 20 mg should be used). During treatment with pantoprazole, it is necessary to monitor the level of liver enzymes in the blood plasma in such patients. In case of an increase in the activity of liver enzymes, it is necessary to stop taking pantoprazole. Pantoprazole should not be used as part of combination therapy for the eradication of Helicobacter pylori in patients with moderate or severe hepatic impairment, since there are currently no data on the efficacy and safety of using pantoprazole a part of combination therapy in such patient

Patients with impaired renal function

No dose adjustment is required in patients with impaired renal function. The drug should not be used as part of combination therapy for the eradication of Helicobacter pylori with impaired renal function, since there are currently no data on the efficacy and safety of pantoprazole as part of combination therapy in such patients.

Elderly patients

No dose adjustment is required.

Contraindications:

Hypersensitivity to pantoprazole, benzimidazole derivatives or other components of the drug. Simultaneous administration of atazanavir. Due to insufficient data, the use of pantoprazole for the treatment of children under 12 is not recommended.

Carefully:

pregnancy, lactation, liver failure.

Precautions:

Malignant neoplasm of the stomach

In the presence of any alarming symptom (eg, significant weight loss, repeated vomiting, dysphagia, vomiting of blood, anemia, melena) and if a gastric ulcer is present or suspected, malignant neoplasm should be ruled out, since pantoprazole treatment may relieve symptoms and delay staging diagnosis.

Consideration should be given to the need for additional testing if symptoms persist despite adequate therapy.

Concomitant use with HIV protease inhibitors

The combined use of pantoprazole with HIV protease inhibitors, the absorption of which depends on the acidity of the pH of the stomach, such as atazanavir, is not recommended, due to a significant decrease in their bioavailability.

Effect on the absorption of vitamin B12

In patients with Zollinger-Ellison syndrome and

other pathological hypersecretory conditions requiring long-term therapy, pantoprazole, like all antisecretory agents, can reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be taken into account in patients with reduced stores of this vitamin or in the presence of risk factors for reducing its absorption during prolonged therapy or in the presence of appropriate clinical symptoms.

Long-term treatment

When carrying out long-term therapy, especially when it exceeds a period of one year, patients should be monitored regularly.

Bacterial gastrointestinal infections

Pantoprazole treatment may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. Difficile.

Hypomagnesemia

Severe hypomagnesemia has been reported in

patients treated with proton pump inhibitors for at least three months (in most cases, within a year). Serious manifestations of hypomagnesemia, such as fatigue, tetany, delirium, seizures, dizziness, and ventricular arrhythmias, may occur, but they may begin latently and may go unnoticed. In most patients, hypomagnesemia was stopped by the administration of magnesium against the background of the withdrawal of proton pump inhibitors.

For patients anticipating long-term treatment or taking proton pump inhibitors with digoxin or drugs that may cause hypomagnesemia (such as diuretics), healthcare providers should consider measuring blood magnesium levels before starting treatment and periodically during treatment.

Side effects:

About 5% of patients may experience side effects from the drug.

The most common side effects: diarrhea and headache – occur in about 1% of patients.

The following unwanted side effects from

pantoprazole have been reported:

From the side of hematopoiesis: rarely agranulocytosis. Very rarely thrombocytopenia, leukopenia, pancytopenia.

From the nervous system and sensory organs: infrequently – headache, dizziness, sleep disturbance. Rarely, visual acuity, depression (and aggravation). Very rarely – disorientation, paresthesia. The frequency is unknown hallucinations, confusion (especially in predisposed patients, as well as exacerbation of these symptoms if they were present earlier).

From the gastrointestinal tract: often – stomach polyps (benign). Uncommon – diarrhea, nausea / vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain and discomfort.

From the kidneys and urinary tract: the frequency is unknown – interstitial nephritis (with possible progression to renal failure).

Skin and subcutaneous tissue disorders:

infrequently – rash / exanthema, itching. Rarely – urticaria, Quincke’s edema. Frequency unknown: Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme, photosensitivity, subacute cutaneous lupus erythematosus.

Musculoskeletal and connective tissue disorders: rarely – arthralgia, myalgia.

From the side of metabolism and waterelectrolyte metabolism: rarely – hyperlipidemia and increased levels of fats (triglycerides, cholesterol), changes in body weight. Frequency unknown – hyponatremia, hypomagnesemia, hypocalcemia, hypokalemia.

From the immune system: rarely hypersensitivity (including anaphylactic reactions and anaphylactic shock).

From the liver and biliary tract: infrequently an increase in the level of liver enzymes (transaminases, y-GT). Rarely – an increase in the level of bilirubin. Frequency unknown damage to hepatocytes, jaundice, hepatocellular insufficiency.

From the genitals and mammary gland: rarely –

gynecomastia.

Others: infrequently – asthenia, dysphoria, fatigue. Rarely – increased body temperature, peripheral edema.

Storage:

Keep out of reach of children at a temperature not exceeding 24’C

Packaging:

The cardboard box contains 1 or 2 blisters of 7 tab.