Ulsepan (pantoprazole) enteric tablets 40 mg. №14

Description

Ulsepan (pantoprazole) enteric tablets 40 mg. №14

Composition

active ingredient: pantoprazole;

1 enteric tablet contains pantoprazole (in the form of sodium pantoprazole sesquihydrate) 40 mg;

Excipients:

core: mannitol (E 421), calcium carbonate, crospovidone, povidone, sucrose stearate, calcium stearate;

film coating: Opadry white YS-1-7027 (hypromelose, titanium dioxide (E 171), glycerol triacetate);

enteric coating: Acryl-Eze yellow 93092157 (methacrylate copolymer (type C), talc, titanium dioxide (E 171), triethyl citrate, colloidal anhydrous silicon dioxide, sodium bicarbonate, iron oxide yellow (E 172), sodium lauryl sulfate).

Dosage form

The tablets are enteric.

Basic physical and chemical properties: yellow, oval biconvex film-coated tablets.

Pharmacological group

A drug for the treatment of acid-related diseases. proton pump inhibitors. ATX code A02B C02.

Pharmacological properties

This medication causes a decrease in gastric acid production. It acts by specifically affecting the proton pumps of the parietal cells of the stomach, in the acidic environment of which it turns into its active form. The severity of oppression depends on the dose and concerns both basal and stimulated gastric secretion.

Indications

Ulsepan is used:

•  for the treatment of peptic ulcer;
•  to treat reflux disease and eliminate its symptoms (heartburn, nausea, belching);
•  for the treatment or prevention of recurrence of reflux esophagitis (damage to the esophagus caused by the reflux of gastric contents);
•  to prevent the occurrence of ulcers and erosions of the stomach / intestines caused by long-term use of drugs (NSAIDs) in individuals at risk;
•  as part of therapy aimed at eradication of Helicobacter pylori;
•  for the treatment of Zollinger-Ellison syndrome.

Contraindications

Ulsepan is contraindicated in case of intolerance to the ingredients of the drug.

Application during pregnancy and lactation

It is allowed to use in pregnant / nursing mothers only as directed by a doctor.
Method of administration and dosage
The solution is used intravenously (only if oral administration is impossible).
Recommended doses (for adults or children over 12 years old):

•  with reflux disease – 20 mg / day for 2-4 weeks, associated esophagitis – 4-8 weeks;
•  for the prevention of ulcers and erosions of the stomach / intestine caused by taking NSAIDs, in individuals at risk – 20 mg / day;
•  with reflux esophagitis – 20 mg-40 mg / day;
•  for the treatment of Zollinger-Ellison syndrome – 80 mg / day for 2 doses (possibly a temporary increase to 160 mg), the duration of treatment is not limited.

Overdose

There is no data on overdose. In studies, when administered at a dose of 240 mg, there were no negative effects. In the event of symptoms of poisoning, general measures are taken to accelerate the removal of the active substance of the drug from the body, supportive therapy is prescribed.

Side effects:

• mental disorders: sleep disorders;
• from the nervous system: headache, dizziness;
• from the digestive tract: polyps from the fundic glands (benign), diarrhea, nausea, vomiting, bloating, constipation, dry mouth, abdominal pain and discomfort;
• from the hepatobiliary system: increased levels of liver enzymes (transaminases, g-HT);
• from the side of the skin and subcutaneous tissues: skin rash, exanthema, itching;
• general disorders: thrombophlebitis at the injection site.