Description
Latin name
Zulbex
Release form
Enteric coated tablets.
Packing
28 pcs.
Indications
gastric and duodenal ulcer in the acute stage
gastroesophageal reflux disease (GERD): erosive reflux esophagitis (treatment), symptomatic treatment of GERD, including long-term maintenance therapy of
Zollinger-Ellison syndrome
as part of complex therapy: eradication of Helicobacter pylori in patients with peptic ulcer or duodenal ulcer or chronic gastritis
treatment and prevention of relapse of peptic ulcer associated with Helicobacter pylori.
Contraindications
hypersensitivity to the active substance or auxiliary components of the drug
pregnancy
period of breastfeeding
childhood (no experience with the use).
Precautions: severe renal failure.
Use during pregnancy and lactation
Pregnancy. There is no data on the safety of rabeprazole during pregnancy in humans. Reproductive studies in rats and rabbits showed no signs of impaired fertility or the harmful effects of rabeprazole on the fetus.
Zulbeks ® is not used during pregnancy.
Lactation. Studies in women during lactation have not been conducted. It is not known whether rabeprazole is secreted in breast milk, but it is secreted in rat milk.
If you need to use the drug Zulbeks ® during lactation, breastfeeding should be discontinued.
Composition
1 tablet contains:
Active ingredient: rabeprazole sodium 10 mg
Excipients: mannitol (E421) magnesium oxide mild hyprolose hyprolose low-substituted magnesium stearate.
Dosage and administration
Inside, whole, without chewing or breaking.
Peptic ulcer of the stomach and duodenum in the acute stage. 20 mg once a day, in the morning. In most patients, an active duodenal ulcer heals within 4 weeks. However, some patients may need another 4 weeks to completely heal the ulcer. Active benign gastric ulcer in most patients heals within 6 weeks. However, in a small number of patients, it may take another 6 weeks for complete healing.
Gastroesophageal reflux disease (GERD): erosive reflux esophagitis (treatment), symptomatic treatment of GERD. 20 mg once a day for 4 to 8 weeks.
With prolonged therapy, a maintenance dose of Zulbeks ® 10 20 mg once daily may be used, depending on the patient s response to treatment.
Symptomatic treatment of GERD: 10 mg once daily in patients without esophagitis. If symptom control cannot be achieved in 4 weeks, an additional examination of the patient is necessary. After the patient’s condition improves, further symptom control can be carried out with 10 mg once daily, as required.
Zollinger-Ellison Syndrome. The recommended starting dose for adults is 60 mg once a day. The dose can be increased to 120 mg per day, depending on the individual needs of the patient. You can prescribe a daily dose of up to 100 mg once a day. A dose of 120 mg may require multiple doses of 60 mg 2 times a day. Therapy is carried out until while there are relevant clinical indications.
Eradication of H. pylori in patients with peptic ulcer or duodenal ulcer or chronic gastritis: patients with H. pylori should undergo eradication therapy.
The following combinations of drugs are recommended for a course of 7 days:
The drug Zulbeks ® 20 mg 2 times a day + clarithromycin 500 mg 2 times a day and amoxicillin 1 g 2 times a day.
Impaired renal and / or liver function: dose adjustment of Zulbeks ® is not required.
Children’s age: due to insufficient data on the efficacy and safety of rabeprazole, Zulbeks ® is not used in children.
Side effects
From the hematopoietic system: rarely neutropenia, leukopenia, thrombocytopenia, leukocytosis.
On the part of the immune system: rarely – hypersensitivity reactions.
Disorders of metabolism and nutrition: rarely – anorexia, weight gain very rarely – hyponatremia.
From the nervous system: often – headache, dizziness, insomnia infrequently – drowsiness, nervousness rarely – depression very rarely – confusion.
From the sensory organs: rarely – visual disturbance.
From the CCC: very rarely – peripheral edema.
From the respiratory system: often – cough, pharyngitis, rhinitis infrequently – bronchitis, sinusitis.
From the digestive system: often – diarrhea, vomiting, nausea, abdominal pain, constipation, flatulence infrequently – dyspepsia, dry oral mucosa, belching rarely – gastritis, stomatitis, taste change, hepatitis, jaundice, hepatic encephalopathy.
From the skin: infrequently – rash, erythema rarely – itching, sweating, bullous rash very rarely – erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.
From the musculoskeletal system: often – nonspecific pain, back pain infrequently – myalgia, spasms of the calf muscles, arthralgia.
From the urinary system: infrequently – urinary tract infections rarely – interstitial nephritis.
From the reproductive system: very rarely – gynecomastia.
Laboratory indicators: infrequently – increased activity of liver enzymes.
Other: often asthenia, a flu-like illness.
Drug interaction
Rabeprazole causes persistent and prolonged suppression of hydrochloric acid secretion in the stomach. Interaction with drugs may be encountered, the absorption of which depends on the pH values. Concomitant use of rabeprazole with ketoconazole or itraconazole can significantly reduce their plasma concentrations, which may require dose adjustments of these drugs.
Proton pump inhibitors, including rabeprazole, should not be used concomitantly with atazanavir.
Rabeprazole does not have a clinically relevant interaction with amoxicillin and with other drugs metabolised by cytochrome CYP450 enzymes such as warfarin, phenytoin, theophylline and diazepam.
Rabeprazole slows the excretion of certain drugs metabolized in the liver by microsomal oxidation (diazepam, phenytoin, indirect anticoagulants).
Plasma concentrations of rabeprazole and the active metabolite of clarithromycin in plasma are increased by 24% and 50%, respectively. Reduces the concentration of ketoconazole by 33%, digoxin by 22%.
overdose Existing experience with the intentional or accidental overdose of rabeprazole is limited. The maximum prescribed intake of the drug did not exceed 60 mg twice daily or 160 mg once daily. The effects were insignificant, corresponded to the known spectrum of undesirable reactions, passed independently without any additional medical intervention. The specific antidote is unknown. Dialysis is ineffective.
Treatment: symptomatic.
Storage conditions
At a temperature not exceeding 30 ° C.
Expiration
2 years.
Active ingredient
rabeprazole
dosage form
dosage form
tablets
KRKA d.d. Novo mesto AO, Slovenia
