Instructions for use ORTANOL® (ORTANOL)

Analogs

Level 4 ATC code matches: Khairabesol
Noflux

Lancid

Barol

Beret

Ontime

Gastrozol

Omeprazole

Pantoprazole

Proxium

Lansoprazole

Zulbex

Ultop

Epicurus

Pariet

Losek MAPS

Losek

Sanpraz

Emanera

Omez Insta

Ortanol analogues: Omez , Gasec , Loseprazole , Omelik .

Many people are interested in Orthanol or Omez - which is better? It all depends on the human body.

Instructions for use ORTANOL® (ORTANOL)

Adults

For duodenal ulcer

the standard dose is 20 mg 1 time/day for 2 weeks. If necessary, the course of treatment can be increased to 4 weeks. In some cases, the dose of omeprazole can be increased to 40 mg 1 time / day.

To prevent relapse of duodenal ulcer

the standard dose is 20 mg/day. If necessary, the dose can be increased to 40 mg 1 time / day.

For benign gastric ulcer

the standard dose is 20 mg 1 time / day for 4 weeks. If necessary, the course of treatment can be increased to 6-8 weeks. In some cases, the dose of omeprazole can be increased to 40 mg 1 time / day.

To prevent relapse in gastric ulcers

the standard dose is 20 mg/day. If necessary, the dose can be increased to 40 mg 1 time / day.

For reflux esophagitis

the standard dose is 20 mg 1 time / day for 4 weeks. If necessary, the course of treatment can be increased to 8 weeks. In some cases, with reflux esophagitis, the dose of omeprazole can be increased to 40 mg 1 time / day.

For maintenance therapy of reflux esophagitis to prevent relapse

the standard dose is 20 mg. If necessary, the dose of omeprazole can be increased to 40 mg 1 time / day.

For Zollinger-Ellison syndrome

The dose is recommended to be selected individually with continued therapy under the supervision of a specialist. The duration of therapy depends on clinical indications. The recommended starting dose is 60 mg/day. If the dose of the drug exceeds 80 mg/day, it should be divided into 2 doses. In patients with Zollinger-Ellison syndrome, treatment is not limited in time.

For the treatment of gastric and duodenal ulcers associated with the use of NSAIDs

the standard dose is 20 mg 1 time / day for 4 weeks. If necessary, the course of treatment can be increased to 8 weeks.

Prevention of relapse in gastric and duodenal ulcers caused by the use of NSAIDs:

in the risk group (patients over 60 years of age, a history of gastric or duodenal ulcer, a history of gastrointestinal bleeding), it is recommended to take omeprazole at a dose of 20 mg 1 time/day.

Symptomatic treatment of gastroesophageal reflux disease:

the standard dose is 20 mg depending on response to treatment. Duration of treatment is from 2 to 4 weeks.

If the patient does not notice improvement after 2 weeks of therapy, a more thorough examination should be performed.

Eradication of Helicobacter pylori

Patients with peptic ulcer associated with Helicobacter pylori infection

, should receive eradication therapy using appropriate combinations of antibiotics and adequate dosing regimens. The choice of the appropriate regimen should be based on individual patient tolerance and therapeutic guidelines. The following combinations were tested:

• omeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, 2 times a day each drug;
• omeprazole 20 mg, clarithromycin 250-500 mg, metronidazole 400-500 mg, 2 times a day each drug;
• omeprazole 40 mg 1 time/day, amoxicillin 500 mg, metronidazole 400-500 mg 3 times/day.

The duration of eradication therapy is 1 week. To avoid the development of resistance to therapy, it is not recommended to reduce the duration of treatment.

In patients with active peptic ulcers, treatment can be continued with omeprazole as monotherapy in accordance with the principles of dose selection and duration of therapy described above.

Due to the carcinogenic potential of metronidazole, combination therapy including metronidazole should not be the first option on the list of possible treatments. The period of treatment with metronidazole should not exceed 10 days.

Children

Clinical experience with the drug in children is limited. Omeprazole should be prescribed to children only in cases of severe reflux esophagitis

resistant to other types of therapy. Treatment should be started by a pediatrician in the clinic.

Continuous pH measurement and genotyping (for CYP2C19 status) can be performed to obtain an optimal therapeutic response.

Children over 1 year of age weighing > 10 kg

For the treatment of reflux esophagitis and symptomatic treatment of gastroesophageal reflux disease

The recommended dose of the drug is 1 mg/kg/day:

• with body weight more than 20 kg
  - 20 mg/day;
• if necessary, the dose can be increased to 40 mg 1 time / day.

Duration of therapy for reflux esophagitis

usually ranges from 4 to 8 weeks, for
gastroesophageal reflux disease
- 2-4 weeks and should not exceed 12 weeks, because There are no data on long-term use of the drug in this age group.

Children over 4 years old and teenagers

Combination therapy in accordance with antibacterial therapy regimens for the treatment of duodenal ulcer associated with Helicobacter pylori

With body weight from 31 to 40 kg

- omeprazole 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg, 2 times a day for one week.

With body weight >40 kg

- omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg, 2 times a day for one week.

Special patient groups

In elderly patients and in patients with impaired renal function

no dose adjustment is required.

In patients with impaired liver function

the bioavailability and T1/2 of omeprazole may increase, so the maximum dose of the drug is 20 mg/day.

Rules for using the drug

The capsules are swallowed with a sufficient amount of liquid (for example, a glass of water) before meals (for example, before breakfast or lunch) or on an empty stomach. Capsules should not be crushed or chewed.

When using the drug in children and adult patients who have difficulty swallowing, you can open the capsule and take its contents with half a glass of water or mix the contents with fruit juice, applesauce or still water. The resulting solution should be taken immediately after preparation or within 30 minutes, stirred before use and washed down with half a glass of water. The granules should not be chewed.

Orthanol price, where to buy

The average price of a heartburn remedy in Russia is 145 rubles.

The price of Orthanol in Ukraine is 95 UAH.

• Online pharmacies in RussiaRussia

ZdravCity

• Orthanol capsules 20 mg 14 pcs. Lek dd
  99 RUR order
• Orthanol capsules 20 mg 28 pcs. Lek dd

  RUB 133 order

• Orthanol capsules 10 mg 28 pcs. Lek dd

  RUB 173 order

Orthanol

Orthanol ®

(lat.
Ortanol ®
) is an antiulcer drug, a proton pump inhibitor, which reduces gastric acidity.

Dosage forms of Orthanol

The active ingredient is Orthanol omeprazole (Latin omeprazole
). Three variants of Orthanol are available in Russia:

• Orthanol in capsules containing 10 mg of omeprazole (the body and cap of the capsules are light pinkish-brown, with the black inscription “OME 10” on the body and cap)
• Orthanol in capsules containing 20 mg of omeprazole (the body and cap of the capsules are white, on the body and cap there is a black inscription “OME 20”)
• Orthanol in capsules containing 40 mg of omeprazole (white cap, light pinkish-brown body, black inscription “OME 40” on the body and cap)

Previously, a dosage form of “capsules soluble in the intestines” was also produced; each such capsule contained 20 mg of omeprazole.

Pharmacological properties of Orthanol

Orthanol (omeprazole) is an antisecretory drug that suppresses gastric secretion. Orthanol inhibits the proton pump H+-K+-ATPase in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid secretion. This leads to a decrease in the level of basal and stimulated secretion. After oral administration of Orthanol, the antisecretory effect occurs within the first hour and persists for 24 hours, the maximum effect is achieved after two hours. When the intake of Orthanol is stopped, secretory activity is completely restored after 3-5 days.

Professional medical publications concerning the treatment of gastrointestinal diseases with Orthanol

• Khavkin A.I., Zhikhareva N.S. Clinical experience with the use of omeprazoles from different manufacturers // Application of Consulium Medicum. Gastroenterology. 2012. No. 2. pp. 72–75.
• Morozov S.V., Kucheryavyi Yu.A. Treatment of patients with non-erosive form of gastroesophageal reflux disease. Modern view of the problem // Attending Physician. 2013. No. 7. pp. 32–41.

On the website gastroscan.ru in the literature catalog there is a section “Omeprazole”, containing articles relating to the treatment of diseases of the gastrointestinal tract with omeprazole.

Pharmacokinetics and pharmacodynamics of Orthanol

Pharmacokinetics and pharmacodynamics, as well as the interaction with other drugs of orthanol and the occurring effect of “omeprazole resistance” are determined by the active substance - omeprazole and are described in the article “Omepraloz”.

Indications for use of Orthanol

• exacerbation of gastric and duodenal ulcers
• erosive-ulcerative esophagitis
• peptic ulcers that developed while taking non-steroidal anti-inflammatory drugs
• stress ulcers
• Zollinger-Ellison syndrome, systemic mastocytosis
• erosive and ulcerative changes in the upper gastrointestinal tract that developed in patients with liver cirrhosis
• eradication of Helicobacter pylori
  as part of complex therapy
• anti-relapse treatment of patients with duodenal and gastric ulcers, prone to frequent exacerbations and the development of complications
• anti-relapse treatment of gastroesophageal reflux disease.

The dosage form of Orthanol - capsules containing 10 mg of omeprazole, is intended for the systematic treatment of heartburn that occurs at least twice a week, other manifestations of gastroesophageal reflux, and flatulence.

Method of administration of Orthanol and dose

Orthanol capsules are recommended to be taken in the morning (regardless of meals); the capsule should be swallowed whole, without chewing or dissolving, with liquid. In the absence of special prescriptions from a doctor, the following approximate doses are recommended:

• Duodenal ulcer - 20 mg of Orthanol (hereinafter calculated by the amount of omeprazole) per day for 2-4 weeks (in resistant cases up to 40 mg of Orthanol per day)
• Stomach ulcer - 20 mg Orthanol per day for 4-6 weeks (in resistant cases up to 40 mg Orthanol per day).
• Erosive-ulcerative esophagitis - 20-40 mg of Orthanol per day for 4 weeks; in case of severe disease, the course is extended to 6-8 weeks.
• Anti-relapse treatment of duodenal and gastric ulcers - 20 mg of Orthanol per day. Anti-relapse treatment of gastroesophageal reflux disease - 20 mg Orthanol capsule per day for a long time (up to 6 months).
• Zollinger-Ellison syndrome - the dose of Orthanol is selected individually depending on the initial level of gastric secretion, usually starting from 60-80 mg per day, a dose of 80 mg or more is divided into two doses. Treatment is effective if it is possible to achieve a reduction in the level of gastric secretion to 10 mmol/hour and below.
• Eradication of Helicobacter pylori
  as part of regimens with antibiotics or bismuth-containing drugs.

Self-treatment of heartburn and other symptoms of gastroesophageal reflux disease with 10 mg capsules

The over-the-counter dosage form - capsules of 10 mg of omeprazole is intended for self-treatment of patients with systematic heartburn and other symptoms of GERD. It is important that one-time heartburn is not cured by orthanol. The initial dose of Orthanol in capsules of 10 mg is 2 capsules once a day. If symptoms disappear, the dose can be reduced to one capsule per day. The maximum daily dose of Orthanol is two capsules. The lowest effective dose should always be used. The maximum course of treatment is two weeks. If symptoms do not improve during this time or if they worsen, you should consult a doctor. The capsule should be swallowed whole with sufficient liquid. Orthanol in daily doses of up to 20 mg fully meets the requirements for over-the-counter drugs. It is well tolerated and has a low risk of serious adverse events in its patient population. Isolated adverse events that occur during treatment with omeprazole in low doses are moderate in severity. The use of the drug Ortanol does not cause undesirable effects, the possibility of which has been described with long-term use of PPIs in high daily doses, for example, in the treatment of erosive GERD. The release form of the drug Ortanol provides a different number of 10 mg capsules per package. This was done to allow maximum individualization of heartburn treatment depending on the degree of its manifestations in a particular patient. People with severe heartburn, who may require a starting dose of 20 mg per day, will therefore need more capsules per pack. When symptoms begin to subside, the dose used for treatment can be reduced to 10 mg per day, which requires fewer capsules. It should be noted that the patient should not take Orthanol on his own for more than 14 days and that a new 14-day course of treatment can be carried out no earlier than after 4 months. If heartburn persists within 14 days of using the drug Ortanol or recurs a few days after stopping its use, the patient should consult a doctor for advice on further treatment and the need for examination, so as not to miss organic pathology (Pchelintsev M.V.).

Contraindications to Orthanol therapy

• hypersensitivity to omeprazole.

Use of Orthanol by pregnant women, breastfeeding and children

Before using Orthanol during pregnancy, it is recommended to consult a doctor.
Omeprazole passes into breast milk. If Ortanol therapy is necessary for a nursing mother, breastfeeding should be stopped.

Orthanol is not recommended for children under 18 years of age.

Cautions when using Orthanol

In the presence of any alarming symptoms (for example, significant spontaneous weight loss, frequent vomiting, dysphagia, hematemesis, or melena), as well as in the presence of a gastric ulcer (or suspected gastric ulcer), the possibility of malignancy should be excluded, therefore in these cases before the start and after the end of treatment, endoscopic monitoring is required to exclude malignant neoplasms, because
treatment with Orthanol may mask symptoms and delay correct diagnosis. In patients with severe liver failure, the dose of Orthanol should not exceed 20 mg. There is information about an increased risk of hip, wrist and spine fractures with long-term use or high doses of proton pump inhibitors, which include Orthanol (“FDA warning”).

In the countries of the former republics of the USSR, omeprazole is widely represented by generics, the prices of which are much lower than the prices of original drugs, and this often determines the patient’s choice of drug, especially for long-term use. Due to possible differences in the quality of drugs, an objective assessment of their effectiveness is required. Currently, an objective and accessible method for testing antisecretory agents in clinical practice is 24-hour intragastric pH-metry (Alekseenko S.A.).

Side effects of Orthanol

Orthanol is well tolerated by patients. When treated with Ortanol, in rare cases, the following, usually reversible, side effects may occur:

• from the digestive system: diarrhea or constipation, abdominal pain, dry mouth, taste disturbances, stomatitis, transient increase in the activity of liver enzymes in plasma
• from the nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, in predisposed patients - depression and hallucinations
• from the musculoskeletal system: muscle weakness, myalgia, arthralgia.
• skin reaction: skin rash, urticaria, erythema multiforme
• other: visual disturbances, peripheral edema, increased sweating, fever

General information

Orthanol in capsules containing 10 mg of omeprazole is available without a prescription, 20 and 40 mg - with a prescription.
Orthanol does not affect driving. According to the pharmacological index, Orthanol belongs to the group “Proton pump inhibitors”. For ATC - to the group “Proton pump inhibitors”, code A02BC01.

Manufacturer Orthanol:

Lek, Slovenia, a division of the multinational company Sandoz, specializing in the production of generics, whose headquarters are located in Germany and Switzerland, in turn a subsidiary of Novartis, Switzerland.

Other medicines containing the active ingredient omeprazole

. The following drugs are or were previously registered in Russia: Bioprazole, Vero-Omeprazole, Gastrozole, Demeprazole, Zhelkizol, Zolser, Chrismel, Lomak, Losek, Losek MAPS, Omegast, Omez, Omez Insta, Omecaps, Omepar, Omeprazole, Omeprazole pellets, Omeprazole -AKOS, Omeprazole-Acri, Omeprazole-E.K., Omeprazole-Richter, Omeprazole Sandoz, Omeprazole-FPO, Omeprazole-OBL, Omeprazole-Teva, Omeprol, Omeprus, Omefez, Omizak, Omipix, Omitox, Ortanol, Otsid, Pepticum , Pleom-20, Promez, Risek, Romesek, Sopral, Ulzol, Ulkozol, Ultop, Helitsid, Helol, Cisagast.

Orthanol has contraindications, side effects and application features; consultation with a specialist is necessary. Back to section

Ortanol®

Use in adults

Inside, preferably before meals (usually in the morning before breakfast).

The capsule should be swallowed whole with sufficient liquid. If the patient cannot swallow the Ortanol® capsule whole, you can dissolve its contents in a small amount of water, fruit juice (for example, apple or orange) or yogurt and use the resulting suspension within 30 minutes. Do not use the drug with milk or sparkling water. If you missed taking the drug, you must take the drug as soon as you remember. If it is time to take the next dose of Ortanol®, take it without doubling it.

Duodenal ulcer

The recommended dose for the treatment of patients with duodenal ulcers in the acute stage is 20 mg once daily for 2 weeks. If, after the first course of use of the drug, complete healing of the ulcer does not occur, a second two-week course of therapy is prescribed.

For patients with an insufficient response to treatment, the drug Ortanol® capsules 40 mg is prescribed 1 time per day. In this case, the ulcer usually heals within four weeks.

To prevent relapses, patients with duodenal ulcers are recommended to take Ortanol® 20 mg once a day. If necessary, the dose can be increased to 40 mg 1 time per day.

Stomach ulcer

The recommended dose for the treatment of patients with gastric ulcers in the acute stage is 20 mg once a day for 4 weeks. If complete healing does not occur after the first course of using the drug, a repeat four-week course of therapy is prescribed.

For gastric ulcers resistant to therapy, use the drug Ortanol® capsules 40 mg 1 time per day. In this case, healing usually occurs within eight weeks.

To prevent relapses, patients with gastric ulcers are recommended to take Ortanol® 20 mg once a day; if necessary, it can be increased to 40 mg once a day.

Eradication of Helicobacter pylori as part of combination therapy

The drug Ortanol® capsules 20 mg twice a day before meals for 1-2 weeks in combination with antibacterial drugs. The choice of antibiotic should be based on the patient's individual sensitivity and national, regional and local recommendations.

The most commonly used combinations of a three-component treatment regimen are:

• omeprazole 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg 2 times a day, morning and evening;
• omeprazole 20 mg + metronidazole 400 mg (or 500 mg) + clarithromycin 250 mg (or 500 mg) 2 times a day, morning and evening;
• omeprazole 20 mg + tinidazole 500 mg + clarithromycin 500 mg 2 times a day, morning and evening;
• omeprazole 20 mg + amoxicillin 1000 mg + levofloxacin 500 mg 2 times a day, morning and evening.

It is also possible to use the following combinations of a four-component treatment regimen:

• omeprazole 20 mg 2 times a day + metronidazole 400 (or 500) mg 2 times a day + tetracycline 500 mg 4 times a day + tripotassium bismuth dicitrate 120 mg 4 times a day;
• omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1000 mg + metronidazole 500 mg 2 times a day, morning and evening.

The use of a sequential treatment regimen is also effective:

• 5 days - omeprazole 20 mg + amoxicillin 1000 mg 2 times a day;
• then 5 days - omeprazole 20 mg + clarithromycin 500 mg 2 times a day + tinidazole 500 mg 2 times a day.

In cases where, after completing a course of treatment, the test for Helicobacter pylori remains positive, the course of treatment can be repeated.

Treatment of reflux esophagitis

The drug Ortanol® capsules is prescribed 20 mg once a day for 4 weeks. If after the first course of use of the drug there is no complete cure, a repeat four-week course of therapy is prescribed. In severe forms of reflux esophagitis, the dose can be increased to 40 mg per day, recovery usually occurs within 8 weeks.

Maintenance treatment of patients with reflux esophagitis in remission

The recommended dose for long-term maintenance treatment of patients with reflux esophagitis in remission is 20 mg per day. If necessary, it is possible to increase the dose of Ortanol® to 40 mg 1 time per day.

Symptomatic gastroesophageal reflux disease

The dosage regimen is set individually. The drug is used at 20 mg/day. The course of treatment (Ortanol® 20 mg once a day) is 4 weeks. If symptoms do not disappear at the end of therapy, additional examination of the patient is recommended.

For pain, heartburn or discomfort in the epigastric region associated with acid-dependent dyspepsia, the dosage regimen is set individually. The drug is prescribed at 20 mg/day. The course of treatment is 4 weeks. If after 4 weeks of using the drug Ortanol® 20 mg per day, symptoms do not disappear, additional examination of the patient is recommended.

Hypersecretory conditions

The dose of Ortanol® and the duration of treatment for patients with Zollinger-Ellison syndrome are selected individually.

The recommended starting dose for adults is 60 mg once daily, with a maximum of 120 mg daily. When a dose exceeding 80 mg/day is prescribed, it is divided into several doses.

Prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs))

Prevention - 1 capsule of Ortanol® 20 mg daily before breakfast during the entire course of NSAID treatment.

Treatment: 20 mg per day for 4-8 weeks.

Use in children

Treatment of reflux esophagitis

Symptomatic treatment of heartburn and sour belching in gastroesophageal reflux disease

In children over 2 years old and weighing more than 20 kg, it is recommended to use the drug Ortanol® capsules 20 mg 1 time per day. If necessary, the dose can be increased to 40 mg 1 time per day.

The duration of treatment is 4-8 weeks.

Symptomatic treatment of heartburn and sour belching in gastroesophageal reflux disease

The duration of treatment is 2-4 weeks. If the symptoms of the disease do not disappear after using omeprazole for 2-4 weeks, further examination is recommended.

Children over 4 years old (or weighing more than 31 kg) and adolescents

Treatment of duodenal ulcers caused by Helicobacter pylori

When choosing an antibiotic for appropriate combination therapy, it is necessary to take into account the patient's individual tolerance to the drugs.

Drugs should be used in accordance with the pattern of resistance and treatment guidelines adopted in the country, at the regional level, and at the local level, taking into account the duration of treatment (most often 7 days, sometimes 14 days) and the appropriate use of antibacterial drugs.

Treatment should be carried out under the supervision of a specialist.

The following doses are recommended:

In patients with impaired liver function, the daily dose should not exceed 20 mg.

In patients with impaired renal function, no dose adjustment is required.

In elderly patients (over 65 years of age), no dose adjustment is required.

ORTHANOL (capsules)

Hi all.
I have long wanted to write about Sandoz “Orthanol” Heartburn Capsules. I suffer from a fairly rare form of heartburn, it’s not an ulcer, but if I drink alcohol and then eat something, I get hellish heartburn, such that I can’t stand up or sit down. At the same time, after some time everything returns to normal, but some foods cause very severe attacks. I tried a huge number of tablets such as: Reni, Ranitidine, cough tablets Mucaltin, ash, various suspensions such as Maalox, but all of them did not help for long and only delayed the attack.

Perhaps the problem was in me, I thought, and decided to undergo fibrogastroscopy, but it did not show anything serious, only gastritis, well, this is of course serious, but the strangeness in the action of the above-mentioned medications somehow confused me. br> Once I saw an advertisement on TV for these capsules, which guaranteed 24 hours without heartburn, I took the plunge and bought them. Orthanol has 2 configurations - the active substance contained in the capsules is called “omeprazole”, 1 option. Packaging with capsules containing 10 mg of active ingredient. Option 2. Packaging with capsules containing 20 mg of active ingredient. In the first case, you need to take two capsules at a time. The most interesting thing is that in the pharmacy where I was they cost exactly the same, so it’s not difficult to guess what I chose. After drinking the capsule, and they are taken strictly on an empty stomach, I actually forgot about heartburn for two days. Not just as it says on the package. This surprised me very much because the problem with heartburn was over. After that, I thought about it and decided to study the contraindications; I won’t describe in detail what I saw, but there is something to look at. The most interesting thing is that I did not feel any of the symptoms described there. I drank these capsules every morning on an empty stomach, the attacks stopped completely, after drinking one course, that is, one package, I wondered if I needed a second one. But the heartburn never started. I drank what I wanted, ate what I wanted, but she never came. So I lived happily for 3 months, until again my hard life forced me to become corporate at work, and to corporate thoroughly and efficiently. In the morning I woke up again with a strange, familiar slight burning sensation, but it was much less. Which made me happy and sad at the same time.

The biggest disadvantage is that I convinced myself that heartburn would not return, but Orthanol met all my expectations, moreover, if you follow all the recommendations, it has a restorative therapeutic effect, I drank it for half a month, and lived without heartburn for three whole , isn't this the result.

I recommend it to anyone who suffers from a similar burden.