Beret
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Bereta is a proton pump inhibitor, an agent that lowers the secretion of gastric glands.
Release form and composition
Dosage form - enteric-coated tablets: round, convex on both sides, from light pink to reddish-pink (10 mg tablets) or from light yellow to yellow (20 mg tablets); on a cross-section, the core is white or white with a yellowish tinge (7, 10 and 14 pcs. in blisters, in a cardboard box 1 pack of 14 tab., or 2 packs of 10 tab., or 2 packs of 7 tab.); 14 and 20 pcs. in polymer bottles with first opening control, in a cardboard box 1 bottle).
Active ingredient: rabeprazole sodium, 1 tablet - 10 or 20 mg.
Auxiliary components:
- outer shell: triethyl citrate, 10 mg tablets - acrylic-pink (aluminum varnish based on the dye sunset yellow, aluminum varnish based on the dye azorubin, talc, methacrylic acid copolymer, sodium lauryl sulfate, sodium bicarbonate, titanium dioxide), 20 mg tablets - acrylic from yellow (iron dye yellow oxide, talc, sodium lauryl sulfate, sodium bicarbonate, titanium dioxide, methacrylic acid copolymer, colloidal silicon dioxide);
- inner shell (sublayer): magnesium oxide (Marinco OH), ethylcellulose;
- core: low-substituted hyprolose (L-HPC), hyprolose (Klucel), mannitol (Mannogem EZ Spray Dried), magnesium stearate, magnesium oxide (Marinco OH).
Indications for use
- peptic ulcer and 12 duodenal ulcer during an exacerbation;
- anastomotic ulcer;
- non-erosive reflux disease (NERD);
- reflux esophagitis, erosive and ulcerative gastroesophageal reflux disease (GERD) (treatment and maintenance therapy);
- Zollinger-Ellison syndrome and other conditions accompanied by pathological hypersecretion.
Combination therapy:
- eradication of Helicobacter pylori in patients with chronic gastritis, gastric ulcer and 12 duodenal ulcer;
- treatment and prevention of recurrence of peptic ulcer disease associated with Helicobacter pylori.
Contraindications
- age up to 12 years;
- pregnancy;
- lactation;
- hypersensitivity to the individual components of the drug.
With care: severe hepatic and renal impairment.
Method of administration and dosage
The beret should be taken orally: swallow the tablets whole, without crushing or chewing.
Recommended dosing regimens for adults:
- anastomotic ulcer, stomach ulcer in the acute stage: 10–20 mg 1 time per day for 6 weeks, if necessary, therapy is extended for another 6 weeks;
- peptic ulcer of the duodenal ulcer in the stage of exacerbation: 10–20 mg 1 time per day for 2–4 weeks, if necessary, the course is extended for another 4 weeks;
- reflux esophagitis, GERD: 10–20 mg once a day for 4–8 weeks, if necessary, treatment is extended for another 8 weeks;
- maintenance therapy for GERD: 10–20 mg once a day, the duration of treatment is determined individually, depending on the patient's condition;
- NERD without esophagitis: 10–20 mg once a day for 4 weeks. If at the end of the course the symptoms do not disappear, the patient is referred for additional examination. If the symptoms can be stopped, then, in order to avoid their recurrence, the drug is recommended to be taken on demand in a dose of 10 mg 1 time per day;
- Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion: the initial dose is 60 mg once a day, then - 60 mg 2 times a day or 100 mg 1 time a day. Treatment is long-term, it can reach 12 months;
- eradication of Helicobacter pylori: 20 mg 2 times a day in combination with appropriate antibacterial agents for 7 days.
Teenagers from 12 years old are prescribed 20 mg 1 time per day for a course of up to 8 days.
Side effects
The beret is generally well tolerated. If undesirable reactions occur, then, as a rule, they are weakly expressed and are transient.
Possible side effects:
- from the gastrointestinal tract: often (from> 1/100 to 1/10 000 to <1/1000) - jaundice, hepatitis, hepatic encephalopathy (in patients with liver cirrhosis);
- from the nervous system: infrequently (from> 1/1000 to <1/100) - headache, dizziness;
- from the side of the kidneys: very rarely (<1/10 000) - interstitial nephritis;
- on the part of the musculoskeletal system: rarely - myalgia, arthralgia;
- dermatological and allergic reactions: rarely - bullous rashes, urticaria; very rarely - toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome;
- laboratory parameters: rarely - leukocytosis, neutropenia, thrombocytopenia, leukopenia, increased activity of liver enzymes.
special instructions
Before prescribing Bereta, a thorough examination of the patient should be carried out in order to exclude the presence of a malignant formation of the digestive system, since the drug can mask its symptoms, thereby making it difficult to make a timely diagnosis.
Time of day and food intake do not affect the effectiveness of rabeprazole. However, in cases where the drug is prescribed once a day, it is recommended to take it in the morning before meals, since it is easier to adhere to the treatment regimen.
Given the characteristics of the pharmacodynamics of rabeprazole, the drug does not affect the reaction rate and the ability to concentrate. However, some patients may develop side effects such as dizziness and drowsiness, in which case one should refrain from driving and performing any potentially hazardous work.
Drug interactions
Rabeprazole interacts with drugs, the absorption of which depends on the acidity of the stomach contents. For example, it reduces the concentration of ketoconazole in the blood plasma by 30%, increases the level of digoxin by 22%. With the simultaneous use of such funds, it is necessary to adjust their doses.
It is not recommended to prescribe Beret in combination with atazanavir (the effectiveness of the latter is significantly reduced).
In the case of the combined use of rabeprazole and clarithromycin, an increase in the concentration of both substances is noted. This effect is used to kill Helicobacter pylori.
Rabeprazole inhibits the metabolism of cyclosporine, and also slows down the excretion of some drugs that are metabolized in the liver by microsomal oxidation (for example, indirect anticoagulants, phenytoin, diazepam).
Terms and conditions of storage
Keep out of reach of children at temperatures up to 25 ºС.
Shelf life is 2 years.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
