PANORAM [Pantoprazole] 40 mg Enteric-coated tablets

PANORAM

instructions for medical use of the medicinal product

Tradename

Panoram, Панорам

International non-proprietary name

Pantoprazole, Пантопразол

Composition

Each film-coated tablet contains:

active ingredient: pantoprazole (as sodium salt) C P 40 mg

excipients: mannitol, anhydrous disodium hydrogen phosphate, crospovidoneg, povidone, magnesium stearate.

Dosage form

Tablets.

Pharmacotherapeutic group

proton pump inhibitors.

Pharmacological properties

Pharmacodynamics

Pantoprazole is a substituted benzimidazole that inhibits gastric acid secretion by specific blockade of the parietal cell proton pump. Pantoprazole is converted to its active form, cyclic sulfenamide, in an acidic environment in parietal cells, where it inhibits the enzyme H ⁺ , K ⁺ -ATPase, i.e. the final stage in the formation of hydrochloric acid in the stomach.

The inhibition is dose dependent and affects both basal and stimulated acid secretion. Relief of symptoms of heartburn and acid reflux is achieved within two weeks. As with other proton pump inhibitors and H2 receptor inhibitors, treatment with pantoprazole reduces acidity in the stomach and thereby increases gastrin levels in proportion to the decrease in acidity. The increase in gastrin content is reversible . Because the drug binds to an enzyme distal to the receptor, it can inhibit the secretion of hydrochloric acid, regardless of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same regardless of whether the active substance is taken orally or intravenously.

Pharmacokinetics

Pantoprazole is rapidly absorbed after oral administration. The maximum concentration (Cmax) in plasma when administered orally is achieved after the first dose of 40 mg. On average, Cmax, equal to 2.0 - 3.0 μg / ml - after 2.5 hours. This indicator remains constant after repeated use of the drug. 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.

Plasma protein binding is 98%. The volume of distribution is 0.15 l/kg, the clearance is 0.1 l/h/kg.

Metabolized in the liver. The main metabolite in plasma and urine is desmethylpantoprazole, conjugated with sulfate.

The half-life (T1 / 2) of pantoprazole is 1 hour, the metabolite is 1.5 hours. The main route of elimination is through the kidneys (about 80%) in the form of metabolites of pantoprazole, a small amount is excreted through the intestines.

Indications for use

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.

Contraindications

Dyspepsia of neurotic origin, malignant diseases of the gastrointestinal tract, hypersensitivity to pantoprazole, children under 18 years of age.

Dosage and administration

inside. Tablets should be swallowed whole, without chewing, with a sufficient amount of liquid, before meals .

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.

Special instructions and precautions

Before starting treatment with the drug, the possibility of a malignant neoplasm should be excluded, since the drug may mask the symptoms and delay the correct diagnosis.

The diagnosis of reflux esophagitis requires mandatory endoscopic confirmation.

Pantoprazole is not recommended for use together with HIV protease inhibitors, the absorption of which depends on the pH of the stomach (for example, atazanovir), due to a significant decrease in their bioavailability.

Long-term therapy, especially for more than 1 year, requires regular monitoring of patients.

In patients with severe hepatic impairment, liver enzymes should be regularly monitored during treatment with pantoprazole, especially with long-term use. In case of increased activity of liver enzymes, treatment should be discontinued.

In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term therapy, pantoprazole, like all antisecretory agents, may reduce the absorption of vitamin B ₁₂ (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced stores of this vitamin or in the presence of risk factors for reducing its absorption during long-term therapy or in the presence of relevant clinical symptoms.

Treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or   C. difficile .

Patients over the age of 55 with new or recently changed symptoms should consult a physician.

Influence on the ability to drive vehicles and mechanisms

You should refrain from driving vehicles and other mechanisms that require increased attention, due to the likelihood of dizziness.

Use during pregnancy and during breastfeeding

During pregnancy, it is possible only under strict indications, when the benefit to the mother outweighs the potential risk to the fetus. At the time of treatment should stop breastfeeding.

Interaction with other drugs

If you are taking any other medicines, be sure to inform your doctor, and if you are self-treating, consult your doctor about the possibility of using the drug.

Attention should be paid to concomitant use with drugs whose absorption is pH-dependent (ketoconazole, itraconazole, posaconazole, erlotinib), due to changes in the absorption of these drugs.
When used together, it significantly reduces the effectiveness of atazanavir.

In the setting of high-dose methotrexate for cancer and psoriasis, temporary withdrawal of pantoprazole may be considered.
Side effect

On the part of the digestive system: polyps from the fundic glands (benign), diarrhea, nausea, vomiting, bloating, constipation, dry mouth, abdominal pain and discomfort, microscopic colitis, increased levels of liver enzymes (transaminases, g-HT), increased bilirubin level.

From the nervous system: headache, dizziness, taste disturbances, sleep disorders, depression, confusion.

On the part of the organs of vision: blurred vision, blurred vision.

From the skin and subcutaneous tissues: skin rash, rash, itching, urticaria, angioedema, Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme.

From the blood and lymphatic system: agranulocytosis, leukopenia, thrombocytopenia.

Metabolism and metabolic disorders: hyperlipidemia and increased lipid levels (triglycerides, cholesterol), changes in body weight.

General disorders: asthenia, fatigue, malaise, fever, peripheral edema.

Overdose

In case of overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, there are no separate therapeutic recommendations.

Storage conditions

Store in a place protected from light, at ^a temperature not exceeding 30 ° C.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the package.

Holiday conditions

Released by prescription.

Release form

7 tablets in an aluminum foil blister. 2 blisters with instructions for use in a cardboard box.