Nexium 20 mg tablets 28 (Esomeprazole)
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Active ingredient: esomeprazole magnesium trihydrate 22.3 mg, which corresponds to the content of esomeprazole 20 mg
Excipients: glyceryl monostearate 40-55 - 1.7 mg, hyprolose - 8.1 mg, hypromellose - 17 mg, iron oxide red dye (E172) - 60 μg, iron oxide yellow dye (E172) - 20 μg, magnesium stearate - 1.2 mg, copolymer of methacrylic and ethacrylic acid (1: 1) - 35 mg, microcrystalline cellulose - 273 mg, paraffin - 200 μg, macrogol - 3 mg, polysorbate 80 - 620 μg, crospovidone - 5.7 mg, sodium stearyl fumarate - 570 μg, sucrose spherical granules (sugar, spherical granules) (size 0.250-0.355 mm) - 28 mg, titanium dioxide (E171) - 2.9 mg, talc - 14 mg, triethyl citrate - 10 mg.
Esomeprazole is the S-isomer of omeprazole and reduces the secretion of hydrochloric acid in the stomach by specific inhibition of the proton pump in the parietal cells of the stomach. The S- and R-isomer of omeprazole have similar pharmacodynamic activity.
Indications for use
- treatment of erosive reflux esophagitis;
- long-term maintenance treatment after healing of erosive reflux esophagitis to prevent relapse;
- symptomatic treatment of GERD.
Peptic ulcer of the stomach and duodenum
As part of combination therapy:
- treatment of duodenal ulcer associated with Helicobacter pylori;
- prevention of recurrence of peptic ulcers associated with Helicobacter pylori.
Long-term acid-suppressing therapy in patients who have undergone bleeding from a peptic ulcer (after intravenous use of drugs that lower the secretion of the glands of the stomach, for prevention relapse).
Patients taking NSAIDs for a long time:
- healing of stomach ulcers associated with taking NSAIDs;
- prevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk;
Zollinger-Ellison syndrome or other conditions characterized by pathological hypersecretion of the glands of the stomach, incl. idiopathic hypersecretion.
- hypersensitivity to esomeprazole, substituted benzimidazoles or other ingredients that make up the drug;
- hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency;
- children's age up to 1 year or body weight less than 10 kg (due to the lack of data on the efficacy and safety of the drug in this group of patients), children's age 1-11 years (for other indications, except for treatment of erosive esophagitis and symptomatic treatment of GERD) and children over 12 years of age for indications other than GERD;
- esomeprazole should not be taken in conjunction with atazanavir and nelfinavir
With caution: severe renal failure (experience of use is limited).
Use in pregnancy and lactation
Currently, there is not enough data on the use of Nexium ® during pregnancy. The results of epidemiological studies of omeprazole, which is a racemic mixture, showed the absence of a fetotoxic effect or impaired fetal development.
When esomeprazole is administered to animals, no direct or indirect adverse effects on the development of the embryo or fetus were detected. The introduction of a racemic mixture of the drug also did not have any negative effect on animals during pregnancy, childbirth, and also in the period of postnatal development.
The drug should be prescribed to pregnant women only when the expected benefit to the mother exceeds the possible risk to the fetus.
It is not known whether esomeprazole is excreted in breast milk, so Nexium should not be prescribed ® during breastfeeding.
Use in case of impaired liver function
With mild to moderate liver failure, dose adjustment of the drug is not required. For patients with severe hepatic insufficiency, the maximum daily dose should not be exceeded - 10 mg for patients aged 1 -11 years and 20 mg for patients older than 12 years.
Use in renal dysfunction
Dose adjustment of the drug is not required. However, the experience of using the drug Nexium ® in patients with severe renal failure is limited; in this regard, when prescribing the drug to such patients, caution should be exercised.
Use in children
Due to the lack of data on efficacy and safety, Nexium should not be used ® in children under the age of 1 year or with a body weight of less than 10 kg.
Use in elderly patients
Dose adjustment of the drug is not required.
In the presence of any alarming symptoms (for example, such as significant spontaneous weight loss, repeated vomiting, dysphagia, vomiting with an admixture of blood or melena), as well as in the presence of a stomach ulcer (or if a stomach ulcer is suspected), the presence of a malignant neoplasm should be excluded, since treatment with Nexium ® can lead to smoothing of symptoms and delay the diagnosis.
In rare cases, in patients who took omeprazole for a long time, atrophic gastritis was detected during histological examination of biopsy specimens of the gastric mucosa.
Patients taking the drug for a long period (especially more than a year), should be under regular medical supervision.
Long-term use of the drug is not indicated for children and adolescents under the age of 12 years.
Patients taking Nexium ® "as needed", should be instructed to contact your doctor if the nature of the symptoms changes. Taking into account fluctuations in the concentration of esomeprazole in plasma when prescribing therapy "as necessary", the interaction of the drug with other drugs should be taken into account. When prescribing the drug Nexium ® for the eradication of Helicobacter pylori, the possibility of drug interactions for all components of triple therapy should be considered. Clarithromycin is a potent inhibitor of the CYP3A4 isoenzyme, therefore, when prescribing eradication therapy to patients receiving other drugs metabolized with the participation of the CYP3A4 isoenzyme (for example, cisapride), it is necessary to take into account possible contraindications and interactions of clarithromycin with these drugs.
Drug Nexium ® contains sucrose and dextrose, so it is contraindicated in patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
According to the results of the studies, pharmacokinetic / pharmacodynamic interaction between clopidogrel (loading dose of 300 mg and maintenance dose of 75 mg / day) and esomeprazole (40 mg / day inside) was noted, which leads to a decrease in exposure to the active metabolite of clopidogrel by an average of 40% and a decrease in the maximum inhibition of ADP-induced platelet aggregation by an average of 14%. Therefore, simultaneous use of esomeprazole and clopidogrel should be avoided.
Separate observational studies indicate that proton pump inhibitor therapy may slightly increase the risk. osteoporosis-related fractures, but other similar studies have not shown an increased risk.
In randomized, double-blind, controlled clinical trials of omeprazole and esomeprazole, including two open-label studies of long-term therapy (more than 12 years), the association of fractures against the background of osteoporosis with the use of proton pump inhibitors has not been confirmed. Although the causal relationship of the use of omeprazole / esomeprazole with fractures on the background of osteoporosis has not been established, patients at risk of developing osteoporosis or fractures on its background should be under appropriate clinical supervision.
Influence on the ability to drive vehicles and control mechanisms
Due to the fact that during therapy with Nexium ® dizziness, blurred vision and drowsiness may be observed, caution should be exercised when driving vehicles and other mechanisms.
Way Applications and Doses
Nexium ® in the dosage form of enteric-coated pellets and granules for the preparation of a suspension for oral administration, it is intended mainly for pediatric patients and those with difficulty swallowing.
Inwards. For taking 10 mg of Nexium ® pour the contents of one packet into a glass containing 15 ml of water. For taking 20 mg of Nexium ® pour the contents of 2 packets into a glass containing 30 ml of water. To take 40 mg of Nexium ® pour the contents of 4 packets into a glass containing 60 ml of water. The contents of the glass should be mixed and wait a few minutes for a suspension to form. The suspension can be taken orally immediately or within 30 minutes after cooking, stirring again before use. Then you should again add 15 ml of water to a glass, stir the remains and take inside. Do not use carbonated water. Pellets and granules should not be chewed or crushed.
The suspension can be administered through a nasogastric tube. Instructions for the preparation and administration of the drug through a nasogastric probe are given in the section "Administration of the drug through a nasogastric tube".
Children 1-11 years old with a body weight of > 10 kg
Treatment of erosive reflux esophagitis: for patients weighing more than 10 kg, but less than 20 kg - 10 mg once a day for 8 weeks. For patients weighing 20 kg or more - 10 mg or 20 mg once a day for 8 weeks.
Symptomatic treatment of GERD: 10 mg once a day for up to 8 weeks. The use of esomeprazole in doses greater than 1 mg / kg / day has not been studied.
Adults and children from 12 years
Treatment of erosive reflux esophagitis: 40 mg once a day for 4 weeks.
An additional 4-week course of treatment is recommended in cases when, after the first course, healing of esophagitis does not occur or symptoms persist.
Long-term supportive treatment after healing of erosive reflux esophagitis to prevent relapse: 20 mg once a day.
Symptomatic treatment of GERD: 20 mg once a day - patients without esophagitis. If after 4 weeks of treatment the symptoms do not disappear, an additional examination of the patient should be carried out. After eliminating the symptoms, you can switch to the regimen of taking the drug "if necessary", i.e. take Nexium ® 20 mg once a day with the resumption of symptoms. For patients taking NSAIDs who are at risk of developing a stomach or duodenal ulcer, treatment in the "if necessary" mode is not recommended.
Peptic ulcer of the stomach and duodenum
As part of a combination therapy for eradication with Helicobacter pylori:
- Treatment duodenal ulcers associated with Helicobacter pylori: Nexium® 20 mg, amoxicillin 1 g and clarithromycin 500 mg. All drugs are taken twice a day for 1 week.
- prevention of recurrence of peptic ulcers associated with Helicobacter pylori: Nexium® 20 mg, amoxicillin 1 g and clarithromycin 500 mg. All drugs are taken twice a day for 1 week.
Long-term acid-suppressing therapy in patients who have undergone bleeding from a peptic ulcer (after intravenous use of drugs that lower the secretion of the glands of the stomach to prevent relapse)
Nexium ® 40 mg 1 time per day for 4 weeks after the end of intravenous therapy with drugs that lower the secretion of the glands of the stomach.
Patients taking NSAIDs for a long time:
- Healing of stomach ulcers associated with NSAIDs: Nexium ® 20 mg or 40 mg once a day. Duration of treatment is 4-8 weeks.
- Prevention of gastric and duodenal ulcers associated with NSAIDs: Nexium ® 20 mg or 40 mg once a day.
Conditions associated with pathological hypersecretion of the glands of the stomach, including Zollinger-Ellison syndrome and idiopathic hypersecretion:
Recommended Starting Dose - Nexium ® 40 mg twice a day. In the future, the dose is selected individually, the duration of treatment is determined by the clinical picture of the disease. There is experience in using the drug in doses up to 120 mg 2 times a day.
Children under 1 year of age or weighing less than 10 kg: due to lack of efficacy and safety data, Nexium should not be used ® in children under the age of 1 year or with a body weight of less than 10 kg.
Renal failure: dose adjustment of the drug is not required. However, the experience of using the drug Nexium ® in patients with severe renal failure is limited; in this regard, when prescribing the drug to such patients, caution should be exercised.
Hepatic insufficiency: with mild to moderate liver failure, dose adjustment of the drug is not required. For patients with severe hepatic insufficiency, the maximum daily dose should not be exceeded - 10 mg for patients aged 1 -11 years and 20 mg for patients older than 12 years.
Elderly patients: dose adjustment of the drug is not required.
At the moment, extremely rare cases of intentional overdose are described. Oral administration of esomeprazole at a dose of 280 mg was accompanied by general weakness and symptoms from the gastrointestinal tract. Single dose of 80 mg of Nexium ® did not cause any negative consequences.
The antidote of esomeprazole is unknown. Esomeprazole binds well to plasma proteins, so dialysis is ineffective. In case of overdose, it is necessary to carry out symptomatic and general supportive treatment.
The following are side effects that dos not depend on the dosage regimen of the drug, noted when using the drug Nexium ® , both in clinical trials and in post-marketing studies. The frequency of side effects is given in the form of the following gradation: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1/10000, <1/1000); very rarely (<1/10000).
From the skin and subcutaneous tissues
Infrequently: dermatitis, itching, rash, urticaria;
Rarely: alopecia, photosensitivity;
Very rarely: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the musculoskeletal and connective tissue side
Rarely: arthralgia, myalgia;
Very rare: muscle weakness.
From the nervous system
Infrequently: dizziness, paresthesia, drowsiness;
Rarely: a violation of taste.
Rarely: depression, agitation, confusion;
Very rarely: hallucinations, aggressive behavior.
From the gastrointestinal tract
Often: abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting;
Infrequently: dry mouth;
Rarely: stomatitis, candidiasis of the gastrointestinal tract;
Very rare: microscopic colitis.
From the liver and biliary tract
Infrequently: increased activity of "liver" enzymes;
Rarely: hepatitis (with or without jaundice);
Very rarely: liver failure, encephalopathy in patients with liver disease.
From the genitals and mammary gland
Very much rarely: gynecomastia.
From the blood and lymphatic system
Rarely: leukopenia, thrombocytopenia;
Very rarely: agranulocytosis, pancytopenia.
From the immune system
Rarely: hypersensitivity reactions (e.g., fever, angioedema, anaphylactic reaction/anaphylactic shock).
From the respiratory system, chest organs and mediastinum
From the kidneys and urinary tract
Very rare: interstitial nephritis.
From the side of the organ of vision
Rarely: blurred vision.
From the side of metabolism and nutrition
Infrequently: peripheral edema;
Very rare: hypomagnesemia; hypocalcemia due to severe hypomagnesemia, hypokalemia due to hypomagnesemia.
Rarely: malaise, sweating.
Store at a temperature not exceeding 30 ° C.
Store in its original packaging. Shelf life: 3 years.
Keep out of reach of children.
- Dosage form
- 20 mg
- Number of tablets
- INN Russian
- Russian title