Antopral 20 mg 14 tablets

Antopral

Ingredients:

Each tablet contains: 20mg pantoprazole

Auxiliary components:

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

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 more than 19 hours. After 2 weeks of treatment (40 mg daily), complete healing of the duodenal ulcer 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 II-III (according to Savary-Miller), after 8 weeks – in 92%. Complete endoscopic remission in 57% of children 6–13 years old with gastroesophageal reflux disease stage Ic / II (according to Vandeplas) is achieved after 4 weeks of therapy at a dose of 20 mg / day. During 4–8 weeks of treatment, the plasma gastrin level 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 NSAIDs, 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 ulcer 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 aged 12 years and older

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 dose can be increased to 40 mg once a day.

Special cases

Children under 12 years old:

Antopral 20 is recommended for children under 12 only after consulting a doctor

Hepatic disorders:

The daily dose should not exceed 20 mg

Renal disorders:

Consultation with a doctor is recommended to weigh all the risks

Contraindications:

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

Carefully:

pregnancy, lactation, liver failure.

Precautions:

Malignant neoplasm of the stomach

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

Influence 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 Sal

monella 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 the majority of patients, hypomagnesemia was stopped by the administration of magnesium against the background of the withdrawal of proton pump inhibitors.

For patients who are expected to have long-term treatment or are taking proton pump inhibitors with digoxin or drugs that can 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 undesirable side effects of pantoprazole have been reported:

From the side of the hematopoietic organs: 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.

On the part of 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 water-electrolyte 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, γ-GT). Rarely – an increase in the level of bilirubin. Frequency unknown – damage to hepatocytes, jaundice, hepatocellular insufficiency.

On the part of the genitals and mammary gland: rarely – gynecomastia.

Others:

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

Packaging:

The cardboard box contains 2 blisters, 7 tablets each.