Trade name:
Pariet®
Rabeprazole sodium 20 mg
14 gastro-resistant tablets
Composition:
Each tablet contains:
Rabeprazole sodium 20 mg (corresponds to the content of rabeprazole 18.85 mg)
Inactive ingredients: Mannitol (mannitol), magnesium oxide, hydroxypropyl cellulose, magnesium stearate, ethyl cellulose, hypromellose phthalate, diacetylated monoglyceride, talc, titanium dioxide, iron oxide yellow, carnauba wax, food grade red A1 ink, iron oxide red, carnauba wax, glyceric acid ester, dehydrated ethanol, 1-Butanol)
Properties:
Anti-ulcer agent, H+-K+-ATPase (proton pump) inhibitor. Mechanism of action is associated with inhibition of H+-K+-ATP-ase enzyme in gastric parietal cells, which leads to blocking the final stage of hydrochloric acid formation. This action is dose-dependent and leads to inhibition of both basal and stimulated secretion of hydrochloric acid regardless of the nature of the stimulus.
Indications:
Gastric and duodenal ulcer in the acute phase; gastric and duodenal ulcer associated with Helicobacter pylori (in combination with antibiotics); gastroesophageal reflux.
Dosage and administration:
The optimal dosing regimen is determined by a physician. Compliance of the used dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.
The recommended dose is 20 mg once or twice a day before a meal.
Side effects:
Digestive system: diarrhea, nausea, abdominal pain, vomiting, flatulence, constipation; rarely – dry mouth, dyspepsia, belching; in isolated cases – anorexia, gastritis, stomatitis, increased activity of hepatic transaminases.
CNS and peripheral nervous system: headache, asthenia, dizziness, insomnia; rarely – nervousness, somnolence; in isolated cases – depression, visual and taste disturbances.
Respiratory system: possible – rhinitis, pharyngitis, cough; rarely – sinusitis, bronchitis.
Allergic reactions: rarely – skin rash; in isolated cases – itching.
Other: back pain, flu-like syndrome; rarely – myalgia, chest pain, chills, cramps of calf muscles, urinary tract infection, arthralgia, fever; in isolated cases – weight gain, increased sweating, leukocytosis.
Contraindications:
Pregnancy, lactation period (breastfeeding), hypersensitivity to rabeprazole sodium or substituted benzimidazoles.
Warnings and Precautions:
-Gastric malignancies should be excluded before initiating therapy, as the use of rabeprazole may mask symptoms and delay proper diagnosis.
-Dose adjustment is not required in patients with hepatic or renal dysfunction, but in patients with severe hepatic dysfunction rabeprazole should be used with caution.
-Doses of ketoconazole and digoxin should be adjusted in concomitant use with rabeprazole.
-Carcinogenic action of rabeprazole was not established in experimental studies, however, when studying mutagenicity, ambiguous results were obtained. Tests on lymphoma cells in mice were positive, while the micronucleus test in vivo and DNA repair test in vivo and in vitro were negative.
Storage:
In a cool dry place at a temperature not exceeding 30°C.
Package:
Carton box holds 2 blisters of 7 tablets each, paper instruction.