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1 tablet can include 10 mg or 20 mg of a rabeprazol of sodium – active ingredient.
Additional components: the low-substituted hypro rod, Mannitolum, magnesium oxide, magnesium stearate, a hypro rod.
Cover: white sepifilm LP-761 (gidroksipropilmetiltsellyuloza, cellulose microcrystallic, titanium dioxide, stearic acid).
Cover kishechnorastvorimy (triethyl citrate, gipromelloza phthalate).
Cover: pink Opadry II 31F24127 (tablet of 10 mg): monohydrate of lactose, gidroksipropilmetiltsellyuloz, titanium dioxide, macrogoal 4000, dyes (iron oxide yellow and red)
Cover: yellow opadray II 31F32870 (tablets of 20 mg): monohydrate of lactose, gidroksipropilmetiltsellyuloz, titanium dioxide, macrogoal 4000, dyes (iron oxide yellow, red, black).
The Teva company lets out drug Ontaym in the form of tablets in a kishechnorastvorimy cover (10 mg or 20 mg), on 10; 20 or 30 pieces in secondary packaging.
Pharmacodynamics and pharmacokinetics
Active ingredient of Ontaym – rabeprazol – is the representative of a class of anti-secretory medicines which on the chemical structure belong to the substituted benzimidazoles. Rabeprazol does not block H2 receptors of gastric walls and does not show anticholinergic activity, but depressing influences production of hydrochloric acid by means of specific suppression of enzymatic activity of H+-K +-ATF-azy (a proton pomp). This process depends on the accepted dose of drug and provokes suppression as stimulated (in independence of the influencing irritant), and basal secretion of gastric hydrochloric acid. Rabeprazol is the weak basis in this connection its reception in any doses leads to fast absorption and cumulation of drug in the covering cells possessing acid medium where there is its transformation to sulfenamidny active group and further interaction to cysteines of a proton pomp.
At oral administration of a rabeprazol in a dose of 20 mg anti-secretory effect of drug forms for 60 minutes and reaches maximum efficiency in 2-4 hours. 23 hours later after internal reception of a single dose of a rabeprazol suppression by stimulated food and basal secretion of gastric hydrochloric acid respectively made 82% and 62%, lasting productivity up to 48 watch. In case of daily reception of one dose of drug oppression of production of hydrochloric acid consistently increases, reaching the maximum in 36 hours after the first reception. At refusal of reception of a rabeprazol recovery of the previous secretory activity is observed in 2-3 days.
At the clinical tests of a rabeprazol which are carried out on an extent till 43 months, its single daily dosages made 10 mg or 20 mg. Because of overwhelming impact of a rabeprazol on production of hydrochloric acid serumal concentration of gastrin increased within the first 2-8 weeks of treatment and returned to normal, as a rule, for 7-14 days after oho cancellation. During special clinical researches it is proved that the 36th monthly therapy rabeprazoly does not influence structure of ECL cells of a greater cul-de-sac and its antral department, does not lead to increase in frequency of forming of an intestinal metaplasia and atrophic gastritis, and also Helikobakter of a pilora in parallel limits bacterial distribution.
At the moment there are no data on system influence of a rabeprazol on TsNS, respiratory and cardiovascular systems. The daily dosage of drug of 20 mg accepted for 14 days did not influence an exchange of carbohydrates, functionality of a thyroid gland, and also for plasma levels of parathyroid hormone, estrogen, cortisol, testosterone, cholecystokinin, prolactin, secretin, follicle-stimulating hormone, a glucagon, luteinizing hormone, Aldosteronum, renin and somatotropic hormone.
Because under the influence of hydrochloric acid there is a splitting of a rabeprazol, tablets of drug let out in the special cover which is dissolved only in intestines where its absorption is carried out. At reception of 20 mg of a rabeprazol its plasma Cmax is reached approximately in 3,5 hours. In the range of dosages of 10-40 mg of change of AUC and Cmax of drug differ in linear character. Because of effect of "the first passing" through a liver the indicator of absolute bioavailability at oral administration of 20 mg of a rabeprazol is equal to 52% of that at in introduction. After repeated administrations of drug in its bioavailability does not change. Time of reception of a rabeprazol during the day and meal do not influence its absorption. Communication with plasma proteins happens approximately for 97%.
Metabolic transformations of a rabeprazol are carried out in a liver thanks to system of P450 (CYP450) cytochrome. Biotransformation happens to participation of CYP3A4 and CYP2C19 enzymes with allocation of active products of a metabolism – carboxylic acid and monothioester, and also the metabolites playing a supporting role and being in low concentration – dimethylmonothioester, sulphone and a conjugate of acid mercapturic. Weak anti-secretory properties are inherent only in a dimethyl metabolite which in a blood plasma is not found. The researches in vitro proved what rabeprazol does not inhibit and does not induce a CYP3A4 enzyme metabolism, therefore, it is possible to exclude any interaction of a rabeprazol with Cyclosporine.
At the healthy studied T1/2 of a rabeprazol averaged about 60 minutes (45-90 minutes), and the total clearance was equal to 283±98 ml/min. At one-time oral administration of 20 mg of a rabeprazol marked 14C it was established that its removal in not changed look is not carried out. About 90% of the specified dosage are removed by kidneys generally in the form of two metabolites: carboxylic acid and a conjugate of acid mercapturic, the rest of a dose is removed by intestines.
The single dose of 20 mg of a rabeprazol men and women with similar parameters of growth and body weight did not show any pharmacokinetic distinctions of drug.
At patients with the heavy pathologies of kidneys undergoing procedure of a hemodialysis (KK is less than 5 ml/min.) in comparison with the volunteers who do not have such pathologies small discrepancies in distribution of a rabeprazol were noted. AUC and Cmax of drug were lowered by 35%, average T1/2 during a hemodialysis made 55 minutes, and after the end of procedure – 3,6 hours, the clearance is approximately twice higher.
At moderate pathologies of a liver one-time reception of 20 mg of a rabeprazol showed increase in AUC drug twice and lengthening of its T1/2 by 2-3 times. After reception of the specified dosage of a rabeprazol for 7 days fixed increase in Cmax of drug by 1,2 times, and AUC by 1,5 times, average T1/2 was equal 12,3 hours. The Farmakodinamichesky response to the carried-out treatment (research rn in a stomach) in group of healthy volunteers and patients was clinically comparable to pathologies of a liver.
Removal of a rabeprazol at elderly patients is slowed a little down. After the 7 day reception of 20 mg of a rabeprazol in this group of patients observed increase in Cmax by 60%, and AUC twice, at the same time cumulation of drug was not noted.
Patients with a slow metabolism have CYP2C19 the 7th the dnevny course of reception of 20 mg of a rabeprazol showed increase in Cmax by 40%, AUC by 1,9 times, and T1/2 — by 1,6 times.
Indications to use
Ontaym's appointment is shown at:
- aggravations of a peptic ulcer of a 12-perstny gut and stomach;
- gastroesophageal reflux disease (GERB) of an ulcer or erosive etiology;
- symptomatic therapy of GERB;
- the prolonged supporting treatment of GERB;
- eradikation (destruction) Helikobakter of a pilora in a combination with an antibioticotherapia;
- Zollingera-Ellison's syndrome.
Ontaym's use is contraindicated at:
- feeding by a breast;
- personal hypersensitivity to a rabeprazol, other substituted benzimidazoles and additional components of tablets.
Careful use is demanded by patients with liver pathologies.
As a rule, treatment by drug Ontaym is transferred without the negative phenomena. Rare side effects are characterized as passing.
- allergic manifestations.
Organs of sight:
- lowering of sharpness of visual perception.
- the increased gas generation;
- food faddism;
- abdominal pains;
- dryness of a mucous oral cavity;
- increase of activity of plasma transaminases;
- hepatic encephalopathy.
- mnogoformny erythema;
- epidermal toxic necrolysis;
- violent reactions;
- exudative erythema (malignant).
- dorsodynias (nonspecific);
- spasms in legs;
- intersticial nephrite;
Ontaym, application instruction
Tablets Ontaym are shown to reception peroral (inside). If the course of therapy provides one-time daily reception of the registered dose, it should be accepted till a breakfast in the morning. Though by results of researches meal and time of day of reception of tablets do not influence efficiency of a rabeprazol, this recommendation promotes the best observance by patients of the mode of treatment. As tablets are put into a special cover, soluble in intestines, they should be swallowed whole, in order to avoid destruction of active ingredient in a gastric juice.
At an aggravation of a peptic ulcer of a stomach appoint one-time daily reception of Ontaym in a dose of 20 mg for 6 weeks. This duration of a course of treatment is proved by average indicators of healing of ulcers though continuation of therapy for 6 weeks in certain cases can be necessary.
At an aggravation of a peptic ulcer of a 12-perstny gut, as well as in the previous case, appoint one-time daily reception of Ontaym in a dose of 20 mg, only for 4 weeks. This duration of a course of treatment is proved by average indicators of healing of ulcers though continuation of therapy for 4 weeks in certain cases can be necessary.
At treatment of ulcer or erosive GERB therapy takes place with appointment 20 mg of Ontaym with a single dose at 24 o'clock and lasting treatment of 1-2 months.
At the prolonged supporting treatment of GERB recommend one-time daily reception of Ontaym in doses of 10 mg or 20 mg. Duration and a dosage of therapy are individual and depend on a disease state of the patient and progress of the carried-out treatment.
At symptomatic therapy of GERB the sick, not suffering esophagitis, appoint a 4-week course of reception of Ontaym in a single daily dose of 10 mg. In case of the proceeding symptomatology after carrying out this course the patient needs to pass additional inspection. If manifestations of GERB are not continuous, and have incidental character, appoint one-time reception of 10 mg of Ontaym as required.
At treatment of a syndrome of Zollingera-Ellison practice individual selection of dosages of Ontaym. As a rule, the initial daily dose equals 60 mg, with its possible increase twice (on 60 mg 2 times in 24 hours). As much as possible for once it is possible to accept 100 mg of Ontaym. Therapy continues up to achievement of positive clinical effect.
For an eradikation (destruction) Helikobakter pilor appoint the 7th the dnevny combined course of treatment which includes: 20 mg of Ontaym + 500 mg of Klaritromitsin + 1000 mg of Amoxicillin, this combination accept twice at 24 o'clock.
At pathologies of livers/kidneys of correction of dosages of Ontaym it is not required.
Till today's moment of data on cases of purposeful reception of overdoses Ontaym did not arrive. As a rule, when carrying out therapy most used daily dosage did not exceed 160 mg, at the same time observed side effects, in case of their emergence, usually were slight and did not demand auxiliary treatment.
At accidental overdose recommend carrying out the standard procedures provided in such cases with the supporting and symptomatic therapy. The specific antidote is not known, the hemodialysis is ineffective.
During special researches of interaction of Ontaym with liquid antiacid means it was revealed not.
Because Ontaym's use leads to the long and expressed lowering of production of hydrochloric acid, increasing rn stomach contents, parallel internal administration of drugs which absorption depends on this indicator (including Itrakonazol and Ketokonazol) can demand correction of their doses, because of decrease in plasma concentration.
Terms of sale
Ontaym treats prescription medicines.
The maximum temperature of storage of tablets of Ontaym makes 25 °C.
Period of validity
Tablets will remain for 2 years.
Before beginning therapy using Ontaym, it is necessary to exclude completely a possibility of existence of malignant tumors of a stomach as this treatment can mask their manifestations and by that to delay timely diagnosing.
In case of Ontaym's use throughout a long span the patient is obliged to be under continuous medical supervision.
At patients with slight or moderate pathologies of hepatic function which passed therapy by Ontaym significant increase in frequency and expressiveness of side effects was not noted. However +33+ patients with heavy pathologies of a liver demand the special careful relation, in particular at the first purpose of drug.
Coincidence on the ATH code of the 4th level:
- Helitsid, etc.
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