10 mg tablets, 14 pcs. (Rabeprazole)

Latin name

Pariet

Release form

Enteric coated tablets.



packaging 14 pcs

Pharmacological action

Range - antispasmodic, vasodilator.

Pharmacodynamics

Dibazole (bendazole) is an antispasmodic with myotropic effects. It has a vasodilating, antispasmodic effect.

Papaverine hydrochloride is a myotropic antispasmodic. Reduces the tone of the smooth muscles of internal organs and blood vessels. It causes the expansion of arteries, helps to increase blood flow, including cerebral. renin, aldosterone and sth.

Pharmacokinetics

Absorption of

Rabeprazole is rapidly absorbed from the intestine, and plasma Cmax is reached approximately 3.5 hours after administration at a dose of 20 mg. The change in C max and AUC values ​​of rabeprazole are linear in the dose range from 10 to 40 mg. The absolute bioavailability after oral administration of 20 mg (compared with iv) is about 52%. In addition, bioavailability does not change with multiple doses of rabeprazole. In healthy volunteers, plasma T1 / 2 is about 1 hour (0.7–1.5 hours), and the total clearance is 3.8 ml / min / kg. In patients with chronic liver damage, AUC is doubled compared with those in healthy volunteers, which indicates a decrease in the metabolism of the first passage, and T1 / 2 from plasma is increased by 2-3 times. No time for taking the drug during the day, The clearance of the drug in patients with kidney diseases requiring hemodialysis was approximately 2 times higher than in healthy volunteers.

Chronic compensated cirrhosis. Patients with chronic compensated cirrhosis of the liver tolerate rabeprazole sodium at a dose of 20 mg once a day, although the AUC is doubled and Cmax is increased by 50% compared with healthy volunteers of the corresponding sex.

Elderly patients. In elderly patients, elimination of rabeprazole is somewhat delayed. After 7 days of taking rabeprazole at 20 mg / day in elderly people, the AUC was approximately twice as high, and Cmax increased by 60% compared with young healthy volunteers. However, no signs of cumulation of rabeprazole were noted.

CYP2C19 polymorphism. In patients with a slowed metabolism of CYP2C19, after 7 days of taking rabeprazole at a dose of 20 mg / day, the AUC increases by 1, 9 times, and T1 / 2 - 1.6 times compared with the same parameters for fast metabolizers, while Cmax increases by 40%.

Indications

Symptoms of dyspepsia associated with increased acidity of gastric juice, incl. symptoms of gastroesophageal reflux disease (heartburn, sour belching).

Contraindications

Hypersensitivity to rabeprazole, substituted benzimidazoles or to auxiliary components of the

preparation pregnancy and lactation period

children under 18 years of age.

Precautions: use in patients with severe renal failure.

Composition

Active ingredient:

rabeprazole sodium, 10 mg, which in terms of 9.42 mg rabeprazole, respectively.

Excipients:

mannitol (mannitol) - 26.0 mg,

magnesium oxide - 44.7 mg,

slightly substituted hydroxypropyl cellulose (hyprolose) - 13 mg,

hydroxypropyl cellulose (hyprolose) - 4.0 mg, srdlkt 1 magnesium , 0 mg,

ethyl cellulose - 0.7 mg,

hypromellose phthalate - 8.5 mg,

diacetylated monoglyceride - 0.85 mg,

talc - 0.80 mg, titanium dioxide (E171) - 0.43 mg,

iron oxide red (E172) - 0.02 mg,

carnauba wax - 0.0015 mg,

food grade gray ink F6 (white shellac, black iron oxide, dehydrated ethanol, 1-butanol).

Dosing and Administration

Pariet tablets should be swallowed whole without chewing or crushing. It was found that neither the time of day nor the meal affects the activity of rabeprazole sodium.

In case of peptic ulcer in the exacerbation phase and ulcer of the anastomosis

It is recommended to take orally 10 mg or 20 mg 1 time / day. Usually, cure occurs after 6 weeks of therapy, but in some cases, the duration of treatment can be increased by another 6 weeks.

For peptic ulcer in the exacerbation phase

The drug is recommended to be taken in a dose of 20 mg 1 time / day. In some cases, the therapeutic effect occurs when taking the drug at a dose of 10 mg 1 time / day. The duration of treatment is from 2 to 4 weeks. If necessary, the duration of treatment can be increased by another 4 weeks.

In the treatment of erosive GERD or reflux esophagitis

is recommended to be taken orally at 10-20 mg once a day. The duration of treatment is from 4 to 8 weeks. If necessary, the duration of treatment can be increased by another 8 weeks.

With maintenance therapy for GERD

It is recommended to be taken orally at 10–20 mg 1 time / day. The duration of treatment depends on the patient's condition.

With NERD without esophagitis

It is recommended to take the drug orally at 10-20 mg 1 time / day. If after 4 weeks of treatment the symptoms do not disappear, an additional examination of the patient should be carried out. After stopping the symptoms, to prevent their subsequent occurrence, the drug should be taken orally at a dose of 10 mg 1 time / day as required.

For the treatment of Zollinger-Alison syndrome and other conditions characterized by pathological hypersecretion

, the dose is selected individually. The initial dose is 60 mg / day, then the dose is increased and the drug is prescribed in a dose of up to 100 mg / day with a single dose or 60 mg 2 times / day. For some patients, fractional dosing of the drug is preferred. Treatment should continue as needed. In some patients with Zollinger-Alison syndrome, the duration of treatment with rabeprazole was up to 1 year.

For the eradication of Helicobacter pylori

, it is recommended to take 20 mg orally 2 times / day according to a specific scheme with the appropriate combination of antibiotics. The duration of treatment is 7 days.

Dose adjustment is not required in patients with renal failure.

In patients with mild to moderate hepatic insufficiency, the concentration of rabeprazole in the blood is usually higher than in healthy patients.

Caution should be exercised when prescribing the drug Pariet to patients with severe liver failure.

Elderly patients do not require dose adjustment.

Children

Safety and efficacy of rabeprazole sodium 20 mg for short-term (up to 8 weeks) treatment of GERD in children 12 years of age and older is confirmed by extrapolation of the results of adequate and well-controlled studies confirming the effectiveness of rabeprazole sodium for adults and safety and pharmacokinetics studies for patients children's age. The recommended dose for children aged 12 years and older is 20 mg 1 time per day for up to 8 weeks. The safety and effectiveness of rabeprazole sodium for other indications have not been established for pediatric patients.

Safety and effectiveness of rabeprazole sodium for the treatment of GERD in children under the age of 12 have not been established.

Side effects of the

From the immune system: rarely - acute systemic allergic reactions.

From the hemopoietic system: rarely - thrombocytopenia, neutropenia, leukopenia.

From the side of metabolism: rarely - hypomagnesemia.

From the hepatobiliary system: increased activity of hepatic enzymes rarely - hepatitis, hepatic encephalopathy.

From the urinary system: very rarely - interstitial nephritis.

From the skin and subcutaneous tissues: rarely - bullous rashes, urticaria very rarely - erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.

From the musculoskeletal system: rarely - myalgia, arthralgia.

From the reproductive system: very rarely - gynecomastia.

Drug Interaction

Cytochrome P450

system Rabeprazole sodium, like other proton pump inhibitors (PPIs), is metabolized by the involvement of the cytochrome P450 (CYP450) system in the liver. In vitro studies on human liver microsomes have shown that rabeprazole sodium is metabolized by the CYP2C19 and CYP3A4 isoenzymes. Studies in healthy volunteers have shown that rabeprazole sodium does not have pharmacokinetic or clinically relevant interactions with drugs that are metabolized by the cytochrome P450 system - warfarin, phenytoin, theophylline and diazepam (regardless of whether the patients metabolize diazepam intensely or weakly). A study of combination therapy with antibacterial drugs was conducted. This four-way cross-sectional study involved 16 healthy volunteers who received 20 mg of rabeprazole, 1000 mg of amoxicillin, 500 mg of clarithromycin, or a combination of these three drugs (CANCER: rabeprazole, amoxicillin, clarithromycin). The AUC and Cmax rates for clarithromycin and amoxicillin were similar when compared to combination therapy with monotherapy. AUC and Cmax for rabeprazole increased by 11% and 34%, respectively, and for 14-hydroxy-clarithromycin (the active metabolite of clarithromycin) AUC and Cmax increased by 42% and 46%, respectively, for combination therapy compared with monotherapy. This increase in exposure for rabeprazole and clarithromycin was not considered clinically relevant.

Interactions due to inhibition of gastric juice secretion

Rabeprazole sodium exerts a steady and prolonged suppression of gastric juice secretion. Thus, interactions with substances for which absorption is pH dependent may occur. When co-administered with rabeprazole sodium, ketoconazole absorption is reduced by 30% and digoxin absorption is increased by 22%. Therefore, some patients should be monitored to resolve the need for dose adjustment while co-administered with rabeprazole sodium with ketoconazole, digoxin or other drugs for which absorption is pH dependent.

Atazanavir

A significant reduction in atazanavir exposure was observed with concomitant administration of atazanavir 300 mg / ritonavir 100 mg with omeprazole (40 mg once daily) or with atazanavir 400 mg with lansoprazole (60 mg once daily). Atazanavir absorption is pH dependent. Although co-administration with rabeprazole has not been studied, similar results are expected for other PPIs. Therefore, concomitant administration of atazanavir with proton pump inhibitors, including rabeprazole, is not recommended.

Antacids

In clinical studies, antacids were co-administered with rabeprazole sodium. No clinically relevant interactions of rabeprazole sodium with aluminum hydroxide gel or magnesium hydroxide were observed.

Food intake

In a clinical trial, no clinically relevant interactions were observed during the administration of rabeprazole sodium with low fat foods. Taking rabeprazole sodium at the same time as fat-enriched foods can delay the absorption of rabeprazole for up to 4 hours or more, but Cmax and AUC do not change.

cyclosporine

In vitro experiments using human liver microsomes showed that rabeprazole inhibited cyclosporine metabolism with IC50 of 62 μmol, ie at a concentration 50 times the Cmax for healthy volunteers after 20 days of taking 20 mg of rabeprazole. The degree of inhibition is similar to that for omeprazole for equivalent concentrations.

Methotrexate

According to reports of adverse events, According to published pharmacokinetic studies and retrospective data, it can be assumed that the concomitant administration of PPI and methotrexate (primarily in high doses) may increase the concentration of methotrexate and / or its metabolite hydroxymethotrexate and increase T1 / 2. However, no specific studies of the drug interaction of methotrexate with STIs have been performed.



overdose Symptoms: data on intentional or accidental overdose are minimal. No cases of severe overdose with rabeprazole were noted.

Treatment: conducting symptomatic and supportive therapy. The specific antidote is unknown. Rabeprazole binds well to plasma proteins, so it is poorly excreted in dialysis.

Storage conditions

Store at a temperature not higher than 25 ° С do not freeze.

Expiration

2 years.

Deystvuyuschee substances

Rabeprazole

Pharmacy terms of delivery

OTC

dosage form

dosage form

tablets

Bush Pharmaceuticals, Japan



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