Zulbex coated pills soluble in the intestines 20 mg N28
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Active ingredients
Rabeprazole
Release form
Uncoated Tablets
Composition
Pantoprazole sodium sesquihydrate Excipients: mannitol, crospovidone, anhydrous sodium carbonate, sorbitol, calcium stearate. Shell composition: hypromellose, povidone, titanium dioxide (E171), iron dye yellow oxide (E172), propylene glycol, Eudragit L30D dispersion (copolymer of methacrylic acid and ethyl acrylate (1: 1) dispersion 30%, water, sodium lauryl sulfate, polysorbate-80) , talc, macrogol 6000.
Pharmacological effect
Antiulcer
Pharmacokinetics
Absorption - high, TCmax - 3.5 h. Cmax and AUC are linear in the dose range from 10 to 40 mg. Metabolized in the liver with the participation of cytochrome isoenzymes CYP2C9 and CYP3A. Bioavailability - 52%, does not increase with repeated use. T1 / 2 - 0.7-1.5 h, clearance - 283 + 98 ml / min. In patients with hepatic insufficiency, the AUC increases by 2 times, T1 / 2 - by 2-3 times. In elderly patients, the AUC increases by 2 times, Cmax - by 60%. Communication with plasma proteins - 97%. Excreted by the kidneys - 90% in the form of 2 metabolites: mercapturic acid conjugate (M5) and carboxylic acid (Mb); through the intestines - 10%.
Indications
Peptic ulcer and duodenal ulcer in the acute stage; Gastroesophageal reflux disease (GERD): erosive reflux esophagitis (treatment), symptomatic treatment of GERD, including long-term maintenance therapy; Zollinger-Ellison syndrome; as part of complex therapy: Helicobacter pylori eradication in patients with gastric ulcer and duodenal ulcer or chronic gastritis; treatment and prevention of recurrence of peptic ulcer associated with Helicobacter pylori.
Contraindications
Hypersensitivity to the active substance or auxiliary components of the drug; pregnancy; breastfeeding period; children's age (there is no experience of use). With care: severe renal failure.
Precautionary measures
Elderly patients slightly reduced excretion of rabeprazole. After the use of rabeprazole for 7 days at a daily dose of 20 mg AUC increased about 2 times, and Cmax increased by 60%, T1 / 2 was increased by 30% compared with healthy young volunteers. Signs of accumulation of rabeprazole are not marked.
Use during pregnancy and lactation
Pregnancy.There are no data on the safety of using 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. The drug Zulbex not used during pregnancy. Lactation. Studies in women during lactation were not conducted. It is not known whether rabeprazole is secreted into human milk, but it is secreted into rat milk. If you need to use the drug Zulbex during lactation, breastfeeding should be stopped.
Dosage and administration
Peptic ulcer and duodenal ulcer in the acute stage. At 20 mg 1 time per day, in the morning. In most patients, an active duodenal ulcer heals within 4 weeks. However, some patients may need another 4 weeks. for complete healing of 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 to fully heal. Gastroesophageal reflux disease (GERD): erosive reflux esophagitis (treatment), symptomatic treatment of GERD. 20 mg 1 time per day for 4 to 8 weeks. With prolonged therapy, a maintenance dose of Zulbex can be used - 10–20 mg once a day, depending on the patient’s response to treatment. Symptomatic treatment of GERD: 10 mg 1 time per day in patients without esophagitis. If for 4 weeks. Symptoms cannot be controlled; an additional examination of the patient is necessary. After improving the condition of the patient, further control of the symptoms can be carried out with the intake of 10 mg once a day, as required. Zollinger-Ellison syndrome. The recommended starting dose for adults is 60 mg 1 time per day. The dose can be increased to 120 mg per day, depending on the individual needs of the patient. You can assign a daily dose of up to 100 mg 1 time per day. A dose of 120 mg may require multiple doses, 60 mg 2 times a day. Therapy is carried out as long as there are appropriate clinical indications. Eradication of N. pylori in patients with gastric ulcer and duodenal ulcer or chronic gastritis: patients with H. pylori should undergo eradication therapy.The following combinations of drugs for a course of 7 days are recommended: The drug Zulbex 20 mg 2 times a day + clarithromycin 500 mg 2 times a day and amoxicillin 1 g 2 times a day. If eradication schemes require the use of drugs 1 time per day, the drug Zulbex must be taken in the morning before breakfast; time of day and food intake do not affect the activity of rabeprazole. Impaired renal and / or liver function: dose adjustment of the drug Zulbex is not required. Children age: due to the lack of data on the efficacy and safety of rabeprazole, the drug Zulbex is not used in children.
Side effects
Classification of the incidence of side effects of the World Health Organization (WHO): very often> 1/10 often from> 1/100 to <1/10 rarely from> 1/1000 to <1/100 rarely from> 1/10000 to <1 / 1000 is very rare from <1/10000, including individual messages. In each group, adverse events when taking Zulbex are listed in order of decreasing severity. On the part of the hematopoietic system: rarely: neutropenia, leukopenia, thrombocytopenia, leukocytosis. Immune system side effects: seldom: hypersensitivity reactions. Disturbances of metabolism and nutrition: rarely: anorexia, weight gain; very rarely: hyponatremia. On the part of the nervous system: often: headache, dizziness, insomnia; infrequently: drowsiness, nervousness; rarely: depression; very rarely: confusion. From the senses: rarely: visual disturbance. Since the cardiovascular system: very rare: peripheral edema. On the part of the respiratory system: often: cough, pharyngitis, rhinitis; infrequently: bronchitis, sinusitis. On the part of the digestive system: often: diarrhea, vomiting, nausea, abdominal pain, constipation, flatulence; infrequently: dyspepsia, dryness of the oral mucosa, belching; rarely: gastritis, stomatitis, change in taste, hepatitis, jaundice, hepatic encephalopathy. On the part of the skin: infrequently: rash, erythema; rarely: itching, sweating, bullous rash; very rare: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome. On the part of the musculoskeletal system: often: non-specific pain, back pain; infrequently: myalgia, calf muscle cramps, arthralgia. On the part of the urinary system: infrequently: urinary tract infections; seldom: interstitial nephritis. Reproductive system: very rare: gynecomastia. Laboratory indicators: infrequent: increased activity of liver enzymes. Other: often: asthenia, flu-like illness. The existing experience of deliberate or accidental overdose with rabeprazole is limited. The maximum prescribed amount of the drug did not exceed 60 mg twice a day or 160 mg once a day. The effects were slightly pronounced, consistent with a known spectrum of unwanted reactions, which took place independently without any additional medical intervention. The specific antidote is unknown. Dialysis is ineffective. Symptomatic treatment
Overdose
The existing experience of deliberate or accidental overdose of rabeprazole is limited. The maximum prescribed amount of the drug did not exceed 60 mg twice a day or 160 mg once a day. The effects were slightly pronounced, corresponded to a known spectrum of undesirable reactions, passed independently without any additional medical intervention. The specific antidote is unknown. Dialysis is ineffective. Treatment: symptomatic
Interaction with other drugs
Rabeprazole causes persistent and prolonged suppression of the secretion of hydrochloric acid in the stomach. Interaction with drugs may occur, the absorption of which depends on the PH values. The simultaneous use of rabeprazole with ketoconazole or itraconazole can lead to a significant decrease in their concentration in the blood plasma, and therefore the dose adjustment of these drugs may be required. Proton pump inhibitors, including Zulbex, should not be used concomitantly with atazanovir. Rabeprazole slows down the excretion of certain drugs that are metabolized in the liver by microsomal oxidation (diazepam, phenytoin, indirect anticoagulants). Concentrations of rabeprazole and the active metabolite of clarithromycin in the plasma, while taking it, increase. Reduces the concentration of ketoconazole and digoxin in the blood plasma
special instructions
Reducing the severity of symptoms during therapy with Zulbex does not exclude the presence of malignant neoplasms in the stomach or esophagus, therefore, before starting treatment, it is necessary to conduct an examination to exclude a neoplasm of the gastrointestinal tract. Patients receiving long-term therapy with Zulbex (especially for more than one year) should be regularly examined.The risk of cross-reactions with other proton pump inhibitors or with substituted benzimidazoles cannot be excluded. The patient must be warned that the pill must be swallowed whole, not chewed or broken. The drug Zulbex is not recommended for children; experience with the drug in this group of patients is missing. There are reports of post-marketing research on the development of blood dyscrasia (cases of thrombocytopenia and neutropenia) against the background of the use of rabeprazole. In most cases, when it was not possible to find out the alternative causes of these conditions, they did not give complications and passed after the abolition of rabeprazole. Against the background of the use of the drug Zulbex, a change in the activity of the liver enzymes is possible, which takes place after drug withdrawal. In a study of patients with mild or moderate hepatic impairment, there were no significant problems related to the safety of rabeprazole compared with the control group of healthy patients, matched by gender and age. Due to the lack of clinical data on the use of rabeprazole in patients with severely impaired liver function, it is recommended to use caution when using the drug Zulbex in this group of patients. Influence on the ability to drive motor vehicles and other complex mechanisms: based on the properties of rabeprazole, it is unlikely that the drug Zulbex can impair the ability to drive vehicles or influence the work with technical devices. In the event of the development of side effects (drowsiness, dizziness, confusion of mind), it is necessary to abandon driving and work requiring high concentration of attention and speed of psychomotor reactions.