Zolopent (pantoprazole) coated tablets 40 mg. №14

Description

Zolopent (pantoprazole) coated tablets 40 mg. №14

Composition

active substance: pantorrazole;

1 tablet contains pantoprazole sodium sesquihydrate equivalent to pantoprazole 40 mg;

Excipients: anhydrous sodium carbonate, mannitol (E 421), crospovidone, hydroxypropylcellulose, calcium stearate, oidragite L30D55, triethyl citrate, sodium lauryl sulphate, titanium dioxide (E 171), iron oxide yellow * white 03 * E 035.

* Opadry 03F58750 white: hypromellose, titanium dioxide (E 171), polyethylene glycol, talc.

Dosage form

Coated tablets are enteric.

Main physical and chemical properties: oval biconvex tablets, yellow coated.

Pharmacotherapeutic group

Drugs for the treatment of acid-dependent diseases. Proton pump inhibitor.

ATX code A02B C02.

Pharmacological properties

Pantoprazole is a substituted benzimidazole that inhibits the secretion of hydrochloric acid in the stomach by specifically blocking the proton pumps of parietal cells. Pantoprazole is transformed into the active form in an acidic environment in parietal cells, where it inhibits the enzyme H + -K + -ATPase, ie blocks the final stage of production of hydrochloric acid in the stomach. Inhibition is dose-dependent and inhibits both basal and stimulated acid secretion. Most patients are relieved of symptoms within 2 weeks. The use of pantoprazole, like other proton pump inhibitors (PPIs) and H2-receptor inhibitors, reduces gastric acidity and thus increases gastrin secretion in proportion to the decrease in acidity. Increased gastrin secretion is reversible. Because pantoprazole binds the enzyme distally to the cellular receptor, it can inhibit hydrochloric acid secretion regardless of stimulation by other substances (acetylcholine, histamine, gastrin). The effect of oral and intravenous administration of the drug is the same.

Indication:

• symptomatic treatment of gastroesophageal reflux disease;
• long-term treatment and prevention of recurrence of reflux esophagitis;
• prevention of gastric and duodenal ulcers caused by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk who should use NSAIDs for a long time.

Contraindication

Hypersensitivity to the active substance or to any component of the drug, to benzimidazole derivatives.

Method of application and dosage

Zolopent (pantoprazole) coated tablets, 20 mg, tablets should be taken 1 hour before meals whole, not chewed or crushed, washed down with water.

Recommended dosage:

• Adults and children from 12 years old.
  Symptomatic treatment of gastroesophageal reflux disease
  The recommended dose is 20 mg (1 tablet) of Zolopent (pantoprazole) coated tablets per day. The symptoms of heartburn usually disappear within 2-4 weeks. If this period is not enough, treatment is continued for the next 4 weeks. After the disappearance of symptoms, the recurrence of symptoms can be controlled by using, if necessary, 20 mg of the drug once a day, taking 1 tablet when necessary. The transition to long-term therapy should be considered in the event that satisfactory control of symptoms is not provided during on-demand therapy.
• Long-term treatment and prevention of recurrence of reflux esophagitis
  For long-term treatment, the maintenance dose is 20 mg (1 tablet) of Zolopent (pantoprazole) coated tablets per day, with exacerbation of the disease may increase the dose to 40 mg per day. In this case, it is recommended to take Zolopent (pantoprazole) coated tablets 40 mg tablets. After elimination of recurrence the dose can be reduced again to 20 mg of drug a day.
• Prevention of gastric and duodenal ulcers caused by non-selective anti-inflammatory drugs (NSAIDs) in patients at risk who have to take NSAIDs for a long time.
  The recommended dose is 20 mg (1 tablet) of Zolopent (pantoprazole) coated tablets per day.
• Liver dysfunction
  Patients with severe hepatic impairment should not exceed a dose of 20 mg (1 tablet) per day.

Overdose

Symptoms of overdose are unknown.

Doses up to 240 mg administered intravenously over 2 minutes were well tolerated. Because pantoprazole is extensively protein bound, it is not a dialysis drug that cannot be easily removed by dialysis.

In case of overdose with the appearance of clinical signs of intoxication, symptomatic and supportive therapy is used. There are no recommendations for specific therapy.

Side effects:

• from the blood and lymphatic system: agranulocytosis, leukopenia, thrombocytopenia, pancytopenia;
• from the immune system: hypersensitivity reactions (including anaphylactic reactions, anaphylactic shock);
• metabolism and metabolic disorders: hyperlipidemia and elevated lipids (triglycerides, cholesterol); weight change, hyponatremia, hypomagnesemia, hypocalcemia, hypokalemia;
• from the psyche: sleep disorders, depression (including exacerbations), disorientation (including exacerbations), hallucinations, confusion (especially in patients with a predisposition to these disorders, as well as exacerbation of these symptoms in case of their re-existence);
• from the nervous system: headache, dizziness, taste disturbances, paresthesia;
• on the part of the visual organs: visual impairment / blurred vision;
• from the digestive tract: diarrhea, nausea, vomiting, bloating, constipation, dry mouth, abdominal pain and discomfort, polyps from the fundus glands (benign);
• from the hepatobiliary system: increased levels of liver enzymes (transaminases, g-HT), increased bilirubin, hepatocyte lesions, jaundice, hepatocellular insufficiency;
• skin and subcutaneous tissue disorders: skin rash, exanthema, pruritus, urticaria, angioneurotic edema, Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme, photosensitivity, subacute cutaneous lupus erythematosus.