Rabelok - Instructions For Use, Price, Analogs, Reviews, Tablets

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Rabelok

Rabelok: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Instructions for use: method and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. In case of impaired liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Rabeloc

ATX code: A02BC04

Active ingredient: rabeprazole (Rabeprazole)

Manufacturer: Cadila Pharmaceuticals Ltd. (India)

Description and photo update: 2018-23-10

Prices in pharmacies: from 208 rubles.

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Rabelok is a proton pump inhibitor, antiulcer drug.

Release form and composition

Rabelok dosage forms:

• enteric coated tablets: from yellow to light yellow, round, biconvex, smooth surface on both sides (14 pcs. in blisters or blisters, in a cardboard box 1 or 2 blisters or packaging);
• lyophilisate for preparation of a solution for intravenous (iv) administration: lyophilized mass or powder from light yellow to almost white (20 mg in a vial, 1 vial in a cardboard box).

1 Rabelok tablet contains:

• active ingredient: sodium rabeprazole - 10 or 20 mg;
• auxiliary components: mannitol, magnesium oxide, hypromellose, microcrystalline cellulose, starch, carmellose, talc, magnesium stearate, colloidal silicon dioxide;
• shell composition: propylene glycol, hypromellose;
• composition of the enteric shell: dibutyl phthalate, copolymer (type C) of methacrylic acid and ethyl acrylate (1: 1), sodium hydroxide, polysorbate 80, iron dye yellow oxide, titanium dioxide, talc.

1 bottle of Rabelok lyophilisate contains:

• active substance: sodium rabeprazole - 20 mg;
• auxiliary components: mannitol, sodium hydroxide.

Pharmacological properties

Pharmacodynamics

Rabelok is an antiulcer drug, proton pump inhibitor. As a result of the metabolism of the active substance (rabeprazole) in the parietal cells of the stomach, active sulfonamide derivatives are formed, which inactivate the sulfhydryl groups of hydrogen-potassium adenosine triphosphatase. The mechanism of action of the drug is based on blocking the final stage of the secretion of hydrochloric acid, as a result of which, regardless of the nature of the stimulus, the content of basal and stimulated secretion decreases. The high degree of lipophilicity of rabeprazole allows it to easily penetrate the parietal cells of the stomach. Concentrating in them, it has a cytoprotective effect and increases the secretion of bicarbonate.

After taking 20 mg orally, the antisecretory effect of rabeprazole occurs after 1 hour and reaches a maximum within 2-4 hours. 23 hours after taking the first dose, the degree of inhibition of the basal secretion of hydrochloric acid is 62%, and by stimulated food - 82%. After intravenous administration of the drug in the same dose, inhibition of basal and food-stimulated secretion is 86 and 95%, respectively. The effect of the drug lasts for 48 hours.

Secretory activity after discontinuation of the drug is normalized in 2–3 days.

During the first 2–8 weeks of therapy, the level of gastrin in the blood serum rises; it returns to the initial values within 1–2 weeks after the drug is discontinued.

Rabelok has no effect on the cardiovascular, respiratory and central nervous systems. Against the background of its intake, no stable changes were found in the morphological structure of enterochromaffin-like cells, the severity of gastritis and the frequency of atrophic gastritis, intestinal metaplasia, and the spread of Helicobacter pylori infection.

Pharmacokinetics

The bioavailability of rabeprazole with intravenous administration is 100%, with oral administration - 52%. The pharmacokinetic parameters of the drug against the background of repeated use do not change in the dose range from 10 to 40 mg. It is metabolized in the liver with the participation of cytochrome isoenzymes CYP3A and CYP2C9.

Plasma protein binding - 97%.

The high degree of absorption allows you to reach the maximum concentration after taking the drug inside after 3.5 hours.

The half-life is on average 1-2 hours.

90% is excreted by the kidneys [metabolites - carboxylic acid thioester (M6) and mercapturic acid conjugates (M5)], through the intestines - 10%.

The total concentration of rabeprazole in the blood plasma in patients with hepatic insufficiency doubles. The half-life is increased by 2–3 times. In elderly patients, the level of the drug in the blood plasma increases by 2 times, the maximum concentration - by 60%.

Indications for use

• erosive and ulcerative gastroesophageal reflux disease or reflux esophagitis;
• Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion;

In addition, there are separate indications for the use of each of Rabelok's dosage forms.

Enteric-coated tablets

• anastomotic ulcer, an acute form of gastric ulcer and duodenal ulcer;
• maintenance therapy for gastroesophageal reflux disease;
• non-erosive gastroesophageal reflux disease;
• eradication of Helicobacter pylori in chronic gastritis or gastric ulcer and duodenal ulcer - as part of combination therapy.

Lyophilisate for preparation of solution for intravenous administration

• acute gastric ulcer and (or) duodenal ulcer with bleeding or severe erosive damage;
• prevention of aspiration by acidic stomach contents;
• stress-induced damage to the mucous membrane of the gastrointestinal tract;
• stepwise therapy when switching from oral administration of rabeprazole in the case when the patient, for an objective reason, cannot temporarily take oral medications.

Contraindications

• hypersensitivity to substituted benzimidazoles;
• period of pregnancy;
• breast-feeding;
• individual intolerance to the components of the drug.

Age contraindications to Rabelok:

• tablets: up to 12 years old;
• lyophilisate: up to 18 years old.

Care should be taken when prescribing Rabelok to patients with severe hepatic impairment.

In addition, it is recommended to take pills with caution in case of severe renal failure, in childhood.

Instructions for the use of Rabelok: method and dosage

Enteric-coated tablets

Rabelok tablets are taken orally, swallowing whole, without violating the integrity of the enteric coating, regardless of food intake and time of day.

The dose and duration of treatment depend on the clinical indication and the severity of the disease.

Recommended dosage of Rabelok for adults:

• anastomotic ulcer, exacerbation of gastric ulcer: 10–20 mg 1 time per day. The usual duration of the course of therapy is 6 weeks, if necessary, the course can be extended for another period of up to 6 weeks;
• exacerbation of duodenal ulcer: 10–20 mg 1 time per day for 2–4 weeks. In the absence of a sufficient clinical effect, the course of treatment can be extended for another period of up to 4 weeks;
• erosive gastroesophageal reflux disease: 10–20 mg 1 time per day for 4–8 weeks. If necessary, the course of treatment can be extended for another 8 weeks;
• maintenance therapy for gastroesophageal reflux disease: 10–20 mg once a day. The duration of treatment is prescribed individually, taking into account the patient's condition;
• non-erosive gastroesophageal reflux disease: 10–20 mg once a day. After relief of symptoms of the disease, 10 mg should be taken once a day as required. If symptoms persist after four weeks of taking the pills, additional patient research is recommended;
• Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion: the initial dose is 60 mg once a day. Further, the dose is prescribed individually: 100 mg 1 time per day or 60 mg 2 times a day. Reception of Rabelok must be continued until the desired therapeutic effect is achieved, in some cases the course can last up to one year;
• eradication of Helicobacter pylori in combination with antibacterial agents according to a specific treatment regimen: 20 mg 2 times a day for 7 days.

No dose adjustment is required in patients with mild to moderate renal failure or in old age.

The use of Rabelok tablets for the treatment of children aged 12 years and older is indicated only for gastroesophageal reflux disease in a dose of 20 mg once a day. The duration of the course of therapy is no more than 8 weeks.

Lyophilisate for preparation of solution for intravenous administration

A solution prepared from a lyophilisate is intended exclusively for intravenous administration.

Rabelok is prescribed in case of impossibility of oral administration of rabeprazole to patients, and when his condition allows him to take pills, intravenous administration is stopped.

The lyophilisate can only be dissolved in sterile water for injection and 0.9% sodium chloride solution.

For jet intravenous administration, the solution is prepared by diluting the contents of the vial in 5 ml of sterile water for injection. After dissolving the lyophilisate, the solution must be injected within 5-15 minutes.

A solution for intravenous infusion is prepared by mixing a previously dissolved lyophilisate in 5 ml of sterile water for injection with a sufficient amount of 0.9% sodium chloride solution. The duration of the infusion is 15-30 minutes.

The recommended dosage of Rabelok for adults: 20 mg once a day.

Side effects

Since taking proton pump inhibitors can increase the risk of bone fractures, this should be taken into account when prescribing Rabelok.

Enteric-coated tablets

• on the part of the hematopoietic organs: rarely - thrombocytopenia, neutropenia, leukopenia, leukocytosis;
• from the digestive system: often - abdominal pain, nausea, vomiting, diarrhea, flatulence, constipation; infrequently - belching, dyspepsia, dry mouth; rarely - a disorder of taste, gastritis, stomatitis, anorexia, hepatitis, jaundice;
• allergic reactions: rarely - acute systemic reactions, hypersensitivity reactions in the form of facial edema, erythema;
• from the urinary system: infrequently - urinary tract infections; rarely - interstitial nephritis;
• from the nervous system: often - insomnia; infrequently - increased excitability; rarely - drowsiness, headache, weakness, dizziness, depression; frequency not established - confusion;
• dermatological reactions: infrequently - erythema, rash; rarely - increased sweating, pruritus, bullous skin reactions; very rarely - polymorphic erythema, Steven-Johnson syndrome, toxic epidermal necrolysis;
• others: often - flu-like syndrome, back pain, nonspecific pain, asthenia; infrequently - chills, chest pain, myalgia, arthralgia, cramps of the calf muscles, fever, increased activity of hepatic transaminases; rarely - blurred vision, increased body weight; the frequency is unknown - peripheral edema, hyponatremia, gynecomastia, with prolonged use - hypomagnesemia.

Lyophilisate for preparation of solution for intravenous administration

In clinical studies of the lyophilisate, adverse events were recorded in the form of pain (localization not specified), constipation, pharyngitis, flatulence, infections. A causal relationship between the appearance of abdominal pain, dry mouth, diarrhea, headache, dizziness, myalgia, arthralgia, peripheral edema, increased activity of liver enzymes, hepatic encephalopathy, hepatitis and the use of rabeprazole has not been established.

Overdose

Symptoms: symptoms of overdose have not been established. There are reports of minimal side effects after a single oral intake of 160 mg rabeprazole, which did not require medical intervention.

Treatment: there is no specific antidote, so symptomatic therapy is recommended. Dialysis is impractical due to the high degree of binding of rabeprazole to plasma proteins.

special instructions

Before starting treatment with Rabelok and after it, the patient should definitely carry out an endoscopic examination to exclude a malignant neoplasm, since the use of rabeprazole can mask symptoms and delay the period of correct diagnosis.

The action of the drug does not affect the blood level of parathyroid hormone, estrogen, testosterone, cortisol, prolactin, cholecystokinin, glucagon, secretin, follicle-stimulating and luteinizing hormones, renin, growth hormone and aldosterone. The use of Rabelok does not cause dysfunction of the thyroid gland, carbohydrate metabolism.

Studies have confirmed an increased risk of fractures of the wrist, spine, and hip associated with osteoporosis with proton pump inhibitor therapy. Fractures are more likely to occur in patients on therapy at high doses and for a long period (a year or more).

Influence on the ability to drive vehicles and complex mechanisms

During the period of application of Rabelok, it is recommended to avoid potentially hazardous activities, the implementation of which requires an increased concentration of attention and speed of psychomotor reactions, including driving.

Application during pregnancy and lactation

The use of Rabelok during gestation and lactation is contraindicated.

If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

Pediatric use

The use of Rabelok in the form of tablets is contraindicated in children under the age of 12 years, lyophilisate - under the age of 18 years.

The use of tablets for the treatment of children aged 12 years and older is indicated only for gastroesophageal reflux disease in a dose of 20 mg once a day. The duration of the course of therapy is no more than 8 weeks. There is no information on the safety and efficacy of rabeprazole in pediatric patients for other indications.

With impaired renal function

Rabelok tablets are used with caution in severe renal failure.

If liver function is impaired

According to the instructions, Rabelok should be prescribed with caution in severe liver failure.

In mild to moderate liver failure, blood levels of rabeprazole are generally higher than in patients with normal liver function.

Use in the elderly

Elderly patients do not need to adjust the dosage regimen of Rabelok.

Drug interactions

With simultaneous use with Rabelok:

• indirect anticoagulants, diazepam, phenytoin (drugs, the metabolism of which occurs by microsomal oxidation in the liver): slow down their excretion;
• sodium ketoconazole, itraconazole: can significantly reduce the level of its concentration in blood plasma;
• atazanavir: significantly reduces its effect, therefore it is not recommended to combine it with rabeprazole;
• cyclosporine: slows down your metabolism;
• methotrexate: may increase the concentration and / or its metabolite and increase the half-life;
• warfarin: may increase the risk of bleeding;
• antacids: contribute to a significant decrease in the plasma concentration of Rabelok;
• digoxin: lowers its bioavailability;
• clarithromycin: no clinically significant interaction;
• theophylline, warfarin, diazepam, phenytoin (drugs, the metabolism of which is carried out by cytochrome P450 isoenzymes): after a single use, their pharmacological properties do not change.

Analogs

The analogues of Rabelok are Pariet, Zulbeks, Zolispan, Razo, Noflux, Khairabezol, Lancid, Ontime, Bereta.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C in a dark place.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Rabelok

Most of the few reviews about Rabelok are positive. Patients indicate its rapid action after the start of use in exacerbation of gastric ulcer, pancreatitis. The drug relieves stomach pain and discomfort in the form of nausea, bitterness, heartburn, a feeling of heaviness in the stomach. Has a long-lasting effect of therapy. When compared with the analogue of the drug (Pariet), the authors of the reviews note the advantages of Rabelok, starting with its lower cost and a significant treatment result. Patients are advised to follow a strict diet while using the drug.

Price for Rabelok in pharmacies

The price of Rabelok for 1 bottle of lyophilisate for the preparation of a solution for intravenous administration can range from 518 rubles, for a package of tablets (14 pcs.) 10 mg each - 322 rubles, 20 mg - 524 rubles.

Rabelok: prices in online pharmacies

Drug name Price Pharmacy

Rabelok 20 mg enteric coated tablets 14 pcs. 208 RUB Buy

Rabelok 20 mg enteric-coated tablets 28 pcs. 332 RUB Buy

Rabelok 20 mg lyophilisate for preparation of solution for intravenous administration 85 g 1 pc. 364 RUB Buy

Rabelok tablets p.o intestinal. 20mg 28 pcs. 667 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!