Esomeprazole (Tablets, Capsules, Lyophilisate) Instructions for Use

Instructions
Dosage forms

ATC Code

A02BC05 (Esomeprazole)

Active Substance

Esomeprazole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

H⁺-K⁺-ATPase inhibitor

Pharmacotherapeutic Group

Drugs for the treatment of diseases associated with acidity disorders; drugs for the treatment of gastric and duodenal ulcer disease and gastroesophageal reflux disease (GERD); proton pump inhibitors

Pharmacological Action

H⁺-K⁺-ATPase inhibitor, the dextrorotatory isomer of omeprazole. It reduces the secretion of hydrochloric acid in the stomach by specifically inhibiting the proton pump in parietal cells.

Being a weak base and converting to the active form in the acidic environment of the secretory tubules of the gastric mucosal parietal cells, it is activated and inhibits the proton pump – the enzyme H⁺-K⁺-ATPase. It inhibits both basal and stimulated secretion of hydrochloric acid.

The effect begins 1 hour after oral administration of 20 mg or 40 mg.

With daily use for 5 days at a dose of 20 mg once a day, the average maximum concentration of hydrochloric acid after stimulation with pentagastrin decreases by 90%.

Pharmacokinetics

After oral administration, Esomeprazole is rapidly absorbed. C_max in blood plasma is reached in 1-2 hours.

The absolute bioavailability of esomeprazole after a single dose of 40 mg is 64% and increases to 89% with daily administration once a day.

For a dose of 20 mg of esomeprazole, these figures are 50% and 68%, respectively. Plasma protein binding is 97%.

Esomeprazole is metabolized by the cytochrome P450 system. The main part is metabolized with the participation of the specific polymorphic isoenzyme CYP2C19, resulting in the formation of hydroxylated and demethylated metabolites of esomeprazole.

The metabolism of the remaining part is carried out by the isoenzyme CYP3A4; this produces the sulfo derivative of esomeprazole, which is the main metabolite determined in plasma.

The total clearance is approximately 17 L/h after a single dose of esomeprazole and 9 L/h after multiple doses. T_1/2 is 1.3 hours with systematic administration in a dosing regimen of once a day.

AUC increases with multiple doses (non-linear dose and AUC relationship with systematic administration, which is a consequence of reduced first-pass metabolism through the liver, as well as reduced systemic clearance caused by inhibition of the CYP2C19 enzyme by esomeprazole and/or its sulfonated metabolite).

It does not accumulate. Up to 80% of the dose is excreted by the kidneys as metabolites (less than 1% unchanged), the rest is excreted in the bile.

With daily IV administration once a day, Esomeprazole is completely eliminated from the blood plasma in the interval between administrations, and no tendency for esomeprazole accumulation is noted.

With repeated IV administration of esomeprazole at a dose of 40 mg, the average C_max in blood plasma is approximately 13.6 µmol/L.

The overall exposure increases somewhat less (by approximately 30%) with IV administration of esomeprazole compared to oral administration.

With IV administration of esomeprazole in doses of 40 mg, 80 mg, and 120 mg over 30 minutes followed by IV administration at a dose of 4 mg/h or 8 mg/h for 23.5 hours, a linear dependence of AUC on the administered dose was shown.

Indications

Gastroesophageal reflux disease: erosive reflux esophagitis (treatment), prevention of relapses in patients with healed esophagitis, symptomatic treatment of GERD.

As part of combination therapy: eradication of Helicobacter pylori, duodenal ulcer associated with Helicobacter pylori, prevention of recurrence of peptic ulcers in patients with peptic ulcer disease associated with Helicobacter pylori.

Long-term acid-suppressive therapy in patients who have had bleeding from a peptic ulcer (after IV use of drugs that reduce gastric gland secretion, to prevent recurrence).

For healing of gastric ulcer associated with NSAID use.

Prevention of gastric and duodenal ulcer associated with NSAID use in patients at risk.

Zollinger-Ellison syndrome or other conditions characterized by pathological hypersecretion of gastric glands, including idiopathic hypersecretion.

For the prevention of recurrence of bleeding from a peptic ulcer after endoscopic hemostasis (for IV administration).

In children (aged 1 year to 18 years) as an alternative to oral therapy when it is not possible to administer it – for gastroesophageal reflux disease in patients with erosive reflux esophagitis and/or severe symptoms of reflux disease (for IV administration).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
B98.0	Helicobacter pylori as the cause of diseases classified elsewhere
E16.4	Disorder of gastrin secretion (hypergastrinemia, Zollinger-Ellison syndrome)
E16.8	Other specified disorders of pancreatic internal secretion
K21.0	Gastro-esophageal reflux disease with esophagitis
K21.9	Gastro-esophageal reflux disease without esophagitis
K25	Gastric ulcer
K26	Duodenal ulcer
K27	Peptic ulcer
Y45	Analgesics, antipyretics and anti-inflammatory drugs

ICD-11 code	Indication
5A43.Z	Gastrin secretion disorder, unspecified
5A4Z	Disorders of glucose regulation or pancreatic internal secretion, unspecified
DA22.Z	Gastro-esophageal reflux disease, unspecified
DA24.Z	Unspecified esophagitis
DA60.Z	Gastric ulcer, unspecified
DA61	Peptic ulcer of unspecified site
DA63.Z	Duodenal ulcer, unspecified
PL00	Drugs, medicaments or biological substances causing injury or harm in therapeutic use
XN3DY	Helicobacter pylori (H. pylori)

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally or intravenously. Set the dosage regimen individually based on indication, clinical condition, and patient age.

For erosive reflux esophagitis treatment, take 40 mg orally once daily for 4-8 weeks. For long-term prevention of relapse in healed esophagitis, take 20 mg orally once daily.

For symptomatic GERD without esophagitis, take 20 mg orally once daily for 4 weeks. If symptoms persist after 4 weeks, conduct further investigation.

For Helicobacter pylori eradication, use as part of combination therapy. Administer esomeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, all taken orally twice daily for 7 days.

For healing of gastric ulcers associated with NSAIDs, take 20 mg orally once daily for 4-8 weeks.

For prevention of gastric and duodenal ulcers associated with NSAIDs in at-risk patients, take 20 mg orally once daily.

For Zollinger-Ellison syndrome, the recommended initial dose is 40 mg orally twice daily. Adjust the dose individually; continue treatment as long as clinically indicated. Doses up to 240 mg daily have been used.

For intravenous administration in patients where oral therapy is not appropriate, administer 20 mg or 40 mg once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10-30 minutes).

For prevention of recurrent peptic ulcer bleeding after endoscopic hemostasis, administer an 80 mg intravenous bolus over 30 minutes, followed by a continuous infusion of 8 mg per hour for 72 hours.

For children aged 1-11 years with GERD, the recommended oral dose is 10 mg once daily for up to 8 weeks. For children weighing more than 20 kg, a dose of 10 mg or 20 mg once daily can be used.

For adolescents aged 12-18 years with erosive esophagitis, take 40 mg orally once daily for 4-8 weeks. For symptomatic GERD, take 20 mg orally once daily for 4 weeks.

For patients with severe liver impairment, a maximum daily dose of 20 mg should not be exceeded.

No dose adjustment is required for patients with renal impairment or for elderly patients.

Take oral formulations at least one hour before meals. Swallow tablets and capsules whole with water; do not chew or crush.

Adverse Reactions

Skin and subcutaneous tissue disorders uncommon – dermatitis, pruritus, rash, urticaria; rare – alopecia, photosensitivity; very rare – erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders rare – arthralgia, myalgia; very rare – muscle weakness.

Nervous system disorders common – headache; uncommon – dizziness, paresthesia, somnolence, disorientation; rare – taste disturbance.

Psychiatric disorders uncommon – insomnia; rare – depression, agitation, confusion; very rare – hallucinations, aggressive behavior.

Gastrointestinal disorders common – abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting; uncommon – dry mouth; rare – stomatitis, gastrointestinal candidiasis; very rare – microscopic colitis (confirmed histologically).

Hepatobiliary disorders uncommon – increased activity of liver enzymes; rare – hepatitis; very rare – hepatic failure, encephalopathy in patients with liver disease.

Reproductive system and breast disorders very rare – gynecomastia.

Blood and lymphatic system disorders: rare – leukopenia, thrombocytopenia; very rare – agranulocytosis, pancytopenia.

Immune system disorders rare – hypersensitivity reactions (including fever, angioedema, anaphylactic reactions/anaphylactic shock).

Respiratory, thoracic and mediastinal disorders rare – bronchospasm.

Renal and urinary disorders very rare – interstitial nephritis.

Eye disorders rare – blurred vision.

Metabolism and nutrition disorders uncommon – peripheral edema; rare – hyponatremia; very rare – hypomagnesemia; hypocalcemia due to severe hypomagnesemia, hypokalemia due to hypomagnesemia.

General disorders and administration site conditions rare – malaise, sweating.

Contraindications

Hypersensitivity to esomeprazole; children under 12 years of age and children over 12 years of age for indications other than gastroesophageal reflux disease (for oral administration); children under 1 year of age and children under 18 years of age for indications other than gastroesophageal reflux disease (for IV administration); breastfeeding period.

Concomitant use of esomeprazole with atazanavir and nelfinavir is contraindicated.

With caution

Severe renal impairment.

Use in Pregnancy and Lactation

Use during pregnancy is possible only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus. Contraindicated for use during breastfeeding.

Use in Hepatic Impairment

Should be used with caution in severe hepatic impairment. Dose adjustment may be required.

Use in Renal Impairment

Should be used with caution in severe renal impairment. Dose adjustment may be required.

Pediatric Use

Contraindicated for use in children under 12 years of age and children over 12 years of age for indications other than gastroesophageal reflux disease (for oral administration); in children under 1 year of age and children under 18 years of age for indications other than gastroesophageal reflux disease (for IV administration).

Geriatric Use

When using proton pump inhibitors, especially when used in high doses and for a prolonged period (>1 year), the risk of fractures of the hip, wrist, and vertebrae increases, especially in elderly patients.

Special Precautions

In the presence of symptoms such as significant spontaneous weight loss, frequent vomiting, dysphagia, vomiting blood or melena, as well as in the presence (or suspicion) of a gastric ulcer, the possibility of a malignant neoplasm should be excluded, since treatment with esomeprazole may alleviate symptoms and thus delay the correct diagnosis.

During long-term therapy, the patient’s condition should be regularly monitored.

During treatment with proton pump inhibitors, the level of gastrin in the plasma increases as a result of reduced intragastric secretion of hydrochloric acid. In patients taking proton pump inhibitors for a long time, the formation of glandular cysts in the stomach is more often noted. These phenomena are due to physiological changes resulting from the inhibition of hydrochloric acid secretion.

Esomeprazole, like all drugs that reduce acidity, can lead to reduced absorption of vitamin B₁₂ due to hypo- or achlorhydria. This should be taken into account in patients with risk factors for reduced vitamin B₁₂ absorption during long-term therapy.

When using proton pump inhibitors, especially when used in high doses and for a prolonged period (>1 year), the risk of fractures of the hip, wrist, and vertebrae increases (especially in elderly patients).

Esomeprazole can cause an increase in the level of chromogranin A, which may distort the results of examinations for neuroendocrine tumors. Treatment with esomeprazole should be temporarily suspended at least 5 days before the determination of chromogranin A.

Influence on the ability to drive vehicles and mechanisms

During the use of esomeprazole, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

It is believed that with simultaneous use, an increase in plasma concentrations and enhancement of the effects of imipramine, clomipramine, and citalopram is possible.

It is believed that with simultaneous use, a decrease in plasma concentrations and clinical efficacy of itraconazole and ketoconazole is possible.

With simultaneous use with clarithromycin, a case of a significant increase in the AUC of esomeprazole due to inhibition of its metabolism under the influence of clarithromycin has been described.

With simultaneous use, an increase in plasma concentrations of diazepam and phenytoin is possible, which apparently has no clinical significance.

A decrease in the secretion of hydrochloric acid in the stomach during treatment with esomeprazole and other proton pump inhibitors may lead to a decrease or increase in the absorption of drugs whose absorption depends on environmental acidity.

With simultaneous use of omeprazole and saquinavir, an increase in the plasma concentration of saquinavir was noted.

With simultaneous use of esomeprazole and tacrolimus, an increase in the plasma concentration of tacrolimus was noted.

In some patients, an increase in the concentration of methotrexate was noted with concomitant use with proton pump inhibitors. When using high doses of methotrexate, the possibility of temporary withdrawal of esomeprazole should be considered.

Studies evaluating the short-term concomitant use of esomeprazole and naproxen or rofecoxib did not reveal a clinically significant pharmacokinetic interaction.

There is evidence that concomitant use of esomeprazole with clarithromycin, which inhibits the CYP3A4 isoenzyme, leads to a 2-fold increase in the AUC value of esomeprazole. Concomitant use of esomeprazole and a combined inhibitor of CYP3A4 and CYP2C19 isoenzymes, for example, voriconazole, may lead to a more than 2-fold increase in the AUC value for esomeprazole.

Drugs that induce CYP2C19 and CYP3A4 isoenzymes, such as rifampicin and St. John’s wort preparations, when used concomitantly with esomeprazole, may lead to a decrease in the plasma concentration of esomeprazole due to accelerated metabolism.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Esomeprazole [AlTro, LLC (Russia)]
Lyophilisate for preparation of solution for intravenous administration 40 mg: vial. 1, 10 or 50 pcs.

Marketing Authorization Holder

AlTro, LLC (Russia)

Manufactured By

Reyoung Pharmaceutical, Co., Ltd. (China)

Dosage Form

Esomeprazole

Lyophilisate for preparation of solution for intravenous administration 40 mg: vial. 1, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration in the form of a lyophilized powder or porous mass of white or almost white color; the reconstituted solution is a clear liquid from colorless to pale yellow.

	1 vial
Esomeprazole	40 mg

Excipients : disodium edetate, sodium hydroxide.

Glass vials (1) – cardboard packs.
Glass vials (10) – contour cell packs (1) – cardboard packs.
Glass vials (50) – contour cell packs (1) – cardboard packs.

Esomeprazole [B-PHARM, LLC (Russia)]
Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 5 or 10 pcs.

Marketing Authorization Holder

B-PHARM, LLC (Russia)

Manufactured By

Vifitech, CJSC (Russia)

Dosage Form

Esomeprazole

Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration in the form of a porous mass from white or almost white with a yellowish tint to light yellow.

	1 vial
Esomeprazole sodium	42.5 mg,
Equivalent to Esomeprazole content	40 mg

Excipients : disodium edetate dihydrate – 1.5 mg, sodium hydroxide solution 1 M q.s. to pH 9 – 11.

Vials – cardboard packs.
Vials (5) – cardboard packs.
Vials (10) – cardboard packs.

Esomeprazole [Izvarino Pharma LLC (Russia)]
Enteric-coated tablets, 20 mg: 10, 14, 20, 28, 30, 40, 42, 56, or 80 pcs.
Enteric-coated tablets, 40 mg: 10, 14, 20, 28, 30, 40, 42, 56, or 80 pcs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Forms

	Esomeprazole	Enteric-coated tablets, 20 mg: 10, 14, 20, 28, 30, 40, 42, 56, or 80 pcs.
		Enteric-coated tablets, 40 mg: 10, 14, 20, 28, 30, 40, 42, 56, or 80 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets from yellow to grayish-yellow in color, round in shape, biconvex, with a score on one side.

	1 tab.
Esomeprazole magnesium dihydrate	21.7 mg,
Equivalent to esomeprazole content	20 mg

Excipients: hypromellose (hydroxypropylcellulose) low-substituted, corn starch pregelatinized, colloidal silicon dioxide, mannitol, sodium stearyl fumarate, microcrystalline cellulose type 200, sodium carboxymethyl starch.

Shell composition hypromellose, macrogol-6000, acryl-eze II yellow 493Z220000 (methacrylic acid and ethyl acrylate copolymer (1:1), talc, titanium dioxide, poloxamer 407, calcium silicate, sodium bicarbonate, yellow iron oxide dye, sodium lauryl sulfate).

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.
80 pcs. – polyethylene jars (1) – cardboard packs.

Enteric-coated tablets, film-coated from yellow to grayish-yellow, oval, biconvex, with a score on one side and an engraved symbol “f” on the other.

	1 tab.
Esomeprazole magnesium dihydrate	43.4 mg,
Equivalent to esomeprazole content	40 mg

Esomeprazole [Kraspharma, PJSC (Russia)]
Lyophilizate for preparation of solution for intravenous administration 20 mg: vial 1 or 10 pcs.
Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 1 or 10 pcs.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Forms

	Esomeprazole	Lyophilizate for preparation of solution for intravenous administration 20 mg: vial 1 or 10 pcs.
		Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration in the form of a powder or porous mass, from white to white with a yellowish tint.

	1 vial
Esomeprazole	20 mg

Excipients: disodium edetate dihydrate, sodium hydroxide solution 1M.

20 mg – vials with a capacity of 10 ml (1) – cardboard packs.
20 mg – vials with a capacity of 10 ml (10) – cardboard boxes.

Lyophilizate for preparation of solution for intravenous administration in the form of a powder or porous mass, from white to white with a yellowish tint.

	1 vial
Esomeprazole	40 mg

Excipients: disodium edetate dihydrate, sodium hydroxide solution 1M.

40 mg – vials with a capacity of 10 ml (1) – cardboard packs.
40 mg – vials with a capacity of 10 ml (10) – cardboard boxes.

Esomeprazole [Pharmpotrebsoyuz, LLC (Russia)]
Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 1 or 10 pcs.

Marketing Authorization Holder

Pharmpotrebsoyuz, LLC (Russia)

Manufactured By

Bryntsalov-A, JSC (Russia)

Dosage Form

Esomeprazole

Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration in the form of a lyophilized powder or mass, white or almost white; the reconstituted solution is a clear liquid from colorless to pale yellow.

	1 vial
Esomeprazole	40 mg

Excipients: disodium edetate, sodium hydroxide.

Colorless neutral glass vials (1) – cardboard packs.
Colorless neutral glass vials (5) – contour cell packs (2) – cardboard packs.

Esomeprazole [Pharmproekt, JSC (Russia)]
Enteric-coated capsules, 20 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100, or 140 pcs.
Enteric-coated capsules, 40 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100, or 140 pcs.

Marketing Authorization Holder

Pharmproekt, JSC (Russia)

Dosage Forms

	Esomeprazole	Enteric-coated capsules, 20 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100, or 140 pcs.
		Enteric-coated capsules, 40 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 70, 100, or 140 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules hard gelatin No. 3, white body with a pink cap; capsule contents – spherical pellets coated with a white or almost white shell.

	1 caps.
Esomeprazole (as magnesium salt trihydrate)	20 mg

Excipients:
Pellet core sugar spheres (sucrose, starch syrup), sodium carbonate, sodium hydrogen phosphate anhydrous, povidone K30, sodium lauryl sulfate.
Pellet coating hypromellose phthalate, hypromellose (5 cps), titanium dioxide, talc, cetyl alcohol.
Capsule composition gelatin, titanium dioxide (E171), quinoline yellow dye (E104), azorubine dye (E122).

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (5) – cardboard packs.
14 pcs. – contour cell packs (10) – cardboard packs.

Enteric-coated capsules hard gelatin No. 1, white body with a pink cap; capsule contents – spherical pellets coated with a white or almost white shell.

	1 caps.
Esomeprazole (as magnesium salt trihydrate)	40 mg

Esomeprazole [Pharmstandard-UfaVITA OJSC (Russia)]
Lyophilizate for preparation of solution for intravenous administration 40 mg: fl. 10 pcs.

Marketing Authorization Holder

Pharmstandard-UfaVITA OJSC (Russia)

Dosage Form

Esomeprazole

Lyophilizate for preparation of solution for intravenous administration 40 mg: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration in the form of a porous mass, white or almost white, clumping is allowed.

	1 vial*
Esomeprazole sodium	42.5 mg,
Equivalent to esomeprazole content	40 mg

* the vial contains a 4% excess of the declared amount.

Excipients: disodium edetate dihydrate – 1.5 mg, sodium hydroxide solution 1 M – to pH 10.0-10.4.

Colorless glass vials (5) – contour cell packs (2) – cardboard packs.
Colorless glass vials (10) – cardboard packs.

Esomeprazole Canon [Canonpharma Production, CJS (Russia)]
Lyophilizate for preparation of solution for intravenous administration 40 mg: fl. 10 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Manufactured By

Ferment Firm, LLC (Russia)

Dosage Form

Esomeprazole Canon

Lyophilizate for preparation of solution for intravenous administration 40 mg: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration in the form of a porous mass, white or almost white.

	1 vial
Esomeprazole sodium	42.5 mg,
Equivalent to esomeprazole content	40 mg

Excipients: sodium edetate – 1.5 mg, sodium hydroxide 0.2 – 1 mg.

46 mg – vials with a volume of 5 ml (10) – cardboard packs.

Esomeprazole Canon [Canonpharma Production, CJS (Russia)]
Enteric-coated capsules, 10 mg: 14, 28, or 56 pcs.
Enteric-coated capsules, 20 mg: 14, 28, or 56 pcs.
Enteric-coated capsules, 40 mg: 14, 28, or 56 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Forms

	Esomeprazole Canon	Enteric-coated capsules, 10 mg: 14, 28, or 56 pcs.
		Enteric-coated capsules, 20 mg: 14, 28, or 56 pcs.
		Enteric-coated capsules, 40 mg: 14, 28, or 56 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules hard gelatin No. 3, white body, green cap; capsule contents – white or almost white spherical pellets.

	1 caps.
Esomeprazole pellets 15%*	66.67 mg,
Equivalent to esomeprazole content	10 mg

* esomeprazole magnesium trihydrate – 11.2 mg (in pellet composition)

Excipients: sugar spheres – 14.014 mg, hypromellose 5cps – 11.894 mg, hypromellose phthalate – 0.654 mg, disodium hydrogen phosphate – 1.933 mg, crospovidone (polyplasdone XL-10) – 0.06 mg, magnesium oxide light – 1.62 mg, mannitol – 0.753 mg, methacrylic acid and ethyl acrylate copolymer [1:1] dispersion 30% – 17.468 mg, mono- and diglycerides [Imwitor 900K] – 1.093 mg, sodium hydroxide – 0.133 mg, sodium carbonate – 0.753 mg, sodium lauryl sulfate – 0.013 mg, polysorbate 80 – 1.007 mg, talc – 1.48 mg, titanium dioxide – 0.773 mg, triethyl citrate – 1.82 mg, magnesium stearate – 0.25 mg, talc – 0.25 mg.

Hard gelatin capsule – 48 mg, incl.:
body: gelatin – 28.224 mg, titanium dioxide – 0.576 mg;
cap gelatin – 18.8049 mg, titanium dioxide – 0.384 mg, patent blue V dye – 0.0055 mg, quinoline yellow dye – 0.0048 mg, brilliant black PN dye – 0.0008 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (8) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.

Enteric-coated capsules hard gelatin No. 3, green body and cap; capsule contents – white or almost white spherical pellets.

	1 caps.
Esomeprazole pellets 15%*	133.33 mg,
Equivalent to esomeprazole content	20 mg

* esomeprazole magnesium trihydrate – 22.4 mg (in pellet composition)

Excipients: sugar spheres – 28.026 mg, hypromellose 5cps – 23.786 mg, hypromellose phthalate – 1.307 mg, disodium hydrogen phosphate – 3.867 mg, crospovidone (polyplasdone XL-10) – 0.12 mg, magnesium oxide light – 3.24 mg, mannitol – 1.507 mg, methacrylic acid and ethyl acrylate copolymer [1:1] dispersion 30% – 34.932 mg, mono- and diglycerides [Imwitor 900K] – 2.187 mg, sodium hydroxide – 0.267 mg, sodium carbonate – 1.507 mg, sodium lauryl sulfate – 0.027 mg, polysorbate 80 – 2.013 mg, talc – 2.96 mg, titanium dioxide – 1.547 mg, triethyl citrate – 3.64 mg, magnesium stearate – 0.5 mg, talc – 0.5 mg.

Hard gelatin capsule – 48 mg, incl.:
body: gelatin – 28.2074 mg, titanium dioxide – 0.576 mg, patent blue V dye – 0.0082 mg, quinoline yellow dye – 0.0072 mg, brilliant black PN dye – 0.0013 mg;
cap gelatin – 18.8049 mg, titanium dioxide – 0.384 mg, patent blue V dye – 0.0055 mg, quinoline yellow dye – 0.0048 mg, brilliant black PN dye – 0.0008 mg.

Enteric-coated capsules hard gelatin No. 1, green body and cap; capsule contents – white or almost white spherical pellets.

	1 caps.
Esomeprazole pellets 15%*	266.67 mg,
Equivalent to esomeprazole content	40 mg

* esomeprazole magnesium trihydrate – 44.8 mg (in pellet composition)

Excipients: sugar spheres – 56.054 mg, hypromellose 5cps – 47.547 mg, hypromellose phthalate – 2.613 mg, disodium hydrogen phosphate – 7.733 mg, crospovidone (polyplasdone XL-10) – 0.24 mg, magnesium oxide light – 6.48 mg, mannitol – 3.013 mg, methacrylic acid and ethyl acrylate copolymer [1:1] dispersion 30% – 69.868 mg, mono- and diglycerides [Imwitor 900K] – 4.373 mg, sodium hydroxide – 0.533 mg, sodium carbonate – 3.013 mg, sodium lauryl sulfate – 0.053 mg, polysorbate 80 – 4.027 mg, talc – 5.92 mg, titanium dioxide – 3.093 mg, triethyl citrate – 7.28 mg, magnesium stearate – 1 mg, talc – 1 mg.

Hard gelatin capsule – 76 mg, including:
body: gelatin – 44.6616 mg, titanium dioxide – 0.912 mg, patent blue V dye – 0.013 mg, quinoline yellow dye – 0.0114 mg, brilliant black PN dye – 0.002 mg;
cap gelatin – 29.7744 mg, titanium dioxide – 0.608 mg, patent blue V dye – 0.0087 mg, quinoline yellow dye – 0.0076 mg, brilliant black PN dye – 0.0013 mg.

7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
7 pcs. – contour cell blisters (8) – cardboard packs.
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (4) – cardboard packs.

Esomeprazole J [Jodas Expoim, LLC (Russia)]
Lyophilizate for preparation of solution for intravenous administration 20 mg: fl. 1 pc.
Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 1 pcs.

Marketing Authorization Holder

Jodas Expoim, LLC (Russia)

Manufactured By

Jodas Expoim, Pvt. Ltd. (India)

Dosage Forms

	Esomeprazole J	Lyophilizate for preparation of solution for intravenous administration 20 mg: fl. 1 pc.
		Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration as a porous mass in the form of a tablet or powder, white or almost white in color.

	1 vial
Esomeprazole sodium	21.3 mg,
Equivalent to esomeprazole content	20 mg

Excipients: disodium edetate dihydrate – 1.5 mg, sodium hydroxide – q.s. to adjust pH to 9.0-11.0.

20 mg – vials (1) – cardboard packs.

Esomeprazole PSK [PSK Pharma, LLC (Russia)]
Lyophilizate for preparation of solution for intravenous administration 40 mg: fl. 10 pcs.

Marketing Authorization Holder

PSK Pharma, LLC (Russia)

Dosage Form

Esomeprazole PSK

Lyophilizate for preparation of solution for intravenous administration 40 mg: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration white or almost white in color; caking is allowed.

	1 vial
Esomeprazole sodium	42.5 mg,
Equivalent to esomeprazole content	40 mg

Excipients: disodium edetate dihydrate – 1.5 mg, sodium hydroxide – q.s. to pH 9.0-11.0.

40 mg – colorless glass vials (10) – cardboard packs^x.

^x a first-opening control label may be applied.

Esomeprazole Zentiva [Zentiva, k.s. (Czech Republic)]
Enteric-coated tablets, 20 mg: 7, 10, 14, 15, 28, 30, 50, or 60 pcs.
Tablets, enteric-coated, 40 mg: 7, 10, 14, 15, 28, 30, 50 or 60 pcs.

Marketing Authorization Holder

Zentiva, k.s. (Czech Republic)

Manufactured By

Ethypharm (France)

Dosage Forms

	Esomeprazole Zentiva	Enteric-coated tablets, 20 mg: 7, 10, 14, 15, 28, 30, 50, or 60 pcs.
		Tablets, enteric-coated, 40 mg: 7, 10, 14, 15, 28, 30, 50 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets, enteric-coated light pink in color, biconvex, oval, engraved with “20” on one side.

	1 tab.
Esomeprazole magnesium dihydrate	21.7 mg,
Equivalent to esomeprazole content	20 mg

Excipients: sugar spheres (sucrose – 8.1 mg, corn starch – 0.7 mg) – 8.8 mg, hypromellose 3cP – 8.7 mg, hyprolose – 6.6 mg, polysorbate 80 – 1.9 mg, talc – 10.9 mg.

Coating composition magnesium stearate – 0.9 mg, methacrylic acid and ethyl acrylate copolymer [1:1] 30% dispersion – 28.5 mg, triethyl citrate – 8.5 mg, glyceryl monostearate – 4.3 mg, stearoyl macrogolglycerides – 0.3 mg, microcrystalline cellulose (180 µm) – 209.1 mg, microcrystalline cellulose (100 µm) – 108.7 mg, sodium stearyl fumarate – 1.1 mg, Opadry^® pink 5B94241 (hypromellose – 60%, titanium dioxide – 31.29%, macrogol – 8%, iron oxide red dye – 0.4%, iron oxide yellow dye – 0.31%) – 21 mg.

5 pcs. – blisters (3) – cardboard packs.
7 pcs. – blisters (1) – cardboard packs.
7 pcs. – blisters (2) – cardboard packs.
7 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.

Tablets, enteric-coated pink in color, biconvex, oval, engraved with “40” on one side.

	1 tab.
Esomeprazole magnesium dihydrate	43.4 mg,
Equivalent to esomeprazole content	40 mg

Excipients: sugar spheres (sucrose – 16.1 mg, corn starch – 1.4 mg) – 17.5 mg, hypromellose 3cP – 17.3 mg, hyprolose – 13.1 mg, polysorbate 80 – 3.9 mg, talc – 21.8 mg.

Coating composition magnesium stearate – 1.9 mg, methacrylic acid and ethyl acrylate copolymer [1:1] 30% dispersion – 57 mg, triethyl citrate – 17.1 mg, glyceryl monostearate – 8.6 mg, stearoyl macrogolglycerides – 0.6 mg, microcrystalline cellulose (180 µm) – 257.1 mg, microcrystalline cellulose (100 µm) – 139.2 mg, sodium stearyl fumarate – 1.5 mg, Opadry^® pink 5B94241 (hypromellose – 60%, titanium dioxide – 29.83%, macrogol – 8%, iron oxide red dye – 2.13%, iron oxide black dye – 0.04%) – 24 mg.

Esomeprazole-Belmed [Belmedpreparaty RUP (Republic of Belarus)]
Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 1 or 10 pcs.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Esomeprazole-Belmed

Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration as a porous mass from white to almost white in color, with a yellowish tint.

	1 vial
Esomeprazole sodium	42.5 mg,
Equivalent to esomeprazole content	40 mg

Excipients: disodium edetate dihydrate – 1.5 mg, sodium hydroxide 1M solution – to pH 11.0.

40 mg – vials (1) – cardboard packs.
40 mg – vials (10) – cardboard pack.

Esomeprazole-GEN [Gen İlaç Ve Sağlık Ürünleri San. Ve Tic., A.Ş. (Turkey)]
Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 1 pcs.

Marketing Authorization Holder

Gen İlaç Ve Sağlık Ürünleri San. Ve Tic., A.Ş. (Turkey)

Dosage Form

Esomeprazole-GEN

Lyophilizate for preparation of solution for intravenous administration 40 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration as a lyophilized powder or compacted mass, white or almost white in color.

	1 vial
Esomeprazole (as esomeprazole sodium)	40 mg

Excipients: disodium edetate, sodium hydroxide (for pH adjustment).

Colorless glass vials with a volume of 6 ml (1) – cardboard packs.

Esomeprazole-nativ [PharmCompany, LLC (Russia)]
Lyophilizate for preparation of solution for intravenous administration 40 mg: fl. 10 pcs.

Marketing Authorization Holder

PharmCompany, LLC (Russia)

Manufactured By

Nativa, LLC (Russia)

Dosage Form

Esomeprazole-nativ

Lyophilizate for preparation of solution for intravenous administration 40 mg: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration as a porous mass, white or almost white in color, caking is allowed.

	1 vial*
Esomeprazole sodium	42.5 mg,
Equivalent to esomeprazole content	40 mg

* the vial contains a 4% excess of the declared amount.

Excipients: disodium edetate dihydrate – 1.5 mg, sodium hydroxide 1 M solution – to pH 10.0-10.4.

40 mg – colorless glass vials (10) – cardboard packs.

Esomeprazole-SZ [Severnaya Zvezda NAO (Russia)]
Enteric-coated capsules 20 mg: 14, 20, 28, 30, 56, or 60 pcs.
Enteric-coated capsules 40 mg: 14, 20, 28, 30, 56, or 60 pcs.

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Dosage Forms

	Esomeprazole-SZ	Enteric-coated capsules 20 mg: 14, 20, 28, 30, 56, or 60 pcs.
		Enteric-coated capsules 40 mg: 14, 20, 28, 30, 56, or 60 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules hard gelatin size No. 3 with a white body and a dark red cap; capsule contents – spherical pellets white or almost white in color.

	1 caps.
Esomeprazole pellet substance	89 mg,
Including esomeprazole magnesium trihydrate	22.306 mg,
Equivalent to esomeprazole content	20 mg

[ pellet core sugar spheres (sucrose, starch syrup) – 26.388 mg, sodium carbonate – 2.374 mg, povidone K30 – 0.594 mg, sodium phosphate dibasic – 2.374 mg, sodium lauryl sulfate – 0.445 mg;
pellet coating hypromellose 5 cps – 10.905 mg, titanium dioxide – 4.45 mg, talc – 3.856 mg, hypromellose phthalate – 13.913 mg, cetyl alcohol – 1.395 mg].

Excipients:
Capsule body: titanium dioxide – 2%, gelatin – up to 100%;
Capsule cap: azorubine dye – 0.6619%, indigo carmine – 0.0286%, titanium dioxide – 0.6666%, gelatin – up to 100%.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (4) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.

Enteric-coated capsules hard gelatin size No. 1 with a yellow body and a brown cap; capsule contents – spherical pellets white or almost white in color.

	1 caps.
Esomeprazole pellet substance	178 mg,
Including esomeprazole magnesium trihydrate	44.612 mg,
Equivalent to esomeprazole content	40 mg

[ pellet core sugar spheres (sucrose, starch syrup) – 52.776 mg, sodium carbonate – 4.748 mg, povidone K30 – 1.188 mg, sodium phosphate dibasic – 4.748 mg, sodium lauryl sulfate – 0.89 mg;
pellet coating hypromellose 5 cps – 21.81 mg, titanium dioxide – 8.9 mg, talc – 7.712 mg, hypromellose phthalate – 27.826 mg, cetyl alcohol – 2.79 mg].

Excipients:
Capsule body: titanium dioxide – 1%, iron oxide yellow – 0.192%, gelatin – up to 100%;
Capsule cap: iron oxide black – 0.53%, iron oxide red – 0.93%, titanium dioxide – 0.3333%, iron oxide yellow – 0.2%, gelatin – up to 100%.

Medixlife (Author)

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