Pantoprazole (Tablets, Lyophilisate) Instructions for Use

Instructions
Dosage forms

ATC Code

A02BC02 (Pantoprazole)

Active Substance

Pantoprazole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

H⁺-K⁺-ATPase inhibitor. Antiulcer drug

Pharmacotherapeutic Group

Acid-related disorder treatment agents; antiulcer agents and agents for the treatment of gastroesophageal reflux disease (GERD); proton pump inhibitors

Pharmacological Action

Pantoprazole is an H⁺-K⁺-ATPase inhibitor. It blocks the final stage of hydrochloric acid secretion, reducing the level of both basal and stimulated (regardless of the type of stimulus) hydrochloric acid secretion in the stomach.

In duodenal ulcer disease associated with Helicobacter pylori, this reduction in gastric secretion increases the microorganism’s sensitivity to antibiotics. Pantoprazole also possesses its own antimicrobial activity against Helicobacter pylori.

Pharmacokinetics

Pantoprazole is rapidly absorbed after oral administration. The C_max after the first 20 mg dose is approximately 1.0-1.5 µg/ml.

The pharmacokinetics of pantoprazole after single and multiple administration are identical. In the dose range of 10-80 mg, the pharmacokinetics of pantoprazole in plasma remain linear for both oral and intravenous administration.

The absolute bioavailability of pantoprazole after oral administration is about 77%. Plasma protein binding is 98%. The V_d is 0.15 l/kg.

It is metabolized mainly in the liver. The main metabolic pathway is demethylation via CYP2C19 followed by sulfate conjugation. Other metabolic pathways include oxidation via CYP3A4.

The terminal T_1/2 is approximately 1 hour, and clearance is about 0.1 l/h/kg.

The main route of excretion is via the kidneys (about 80%) as pantoprazole metabolites, with the remainder excreted in the feces.

Indications

Exacerbation of gastric and duodenal ulcer disease, erosive gastritis (including that associated with NSAID use), stress ulcers and their complications (bleeding, perforation, penetration); Zollinger-Ellison syndrome; Helicobacter pylori eradication (in combination with antibacterial therapy); gastroesophageal reflux disease; erosive reflux esophagitis.

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)
K21	Gastro-esophageal reflux
K21.0	Gastro-esophageal reflux disease with esophagitis
K25	Gastric ulcer
K26	Duodenal ulcer
K27	Peptic ulcer
K29	Gastritis and duodenitis

ICD-11 code	Indication
5A43.Z	Gastrin secretion disorder, unspecified
DA22.Z	Gastro-esophageal reflux disease, unspecified
DA24.Z	Unspecified esophagitis
DA42.Z	Gastritis, unspecified
DA51.Z	Duodenitis, unspecified
DA60.Z	Gastric ulcer, unspecified
DA61	Peptic ulcer of unspecified site
DA63.Z	Duodenal ulcer, unspecified
DA7Z	Diseases of stomach or duodenum, unspecified
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 pantoprazole tablets orally with water before a meal. Do not chew or crush the tablets.

For erosive reflux esophagitis, the standard adult dose is 40 mg once daily for 4 to 8 weeks. For long-term management, use 20 mg once daily.

For gastric and duodenal ulcer treatment, use 40 mg once daily for 4 weeks (duodenal ulcer) or 8 weeks (gastric ulcer).

For Helicobacter pylori eradication, use 40 mg twice daily in combination with two appropriate antibiotics for 7 to 14 days.

For Zollinger-Ellison syndrome, initiate therapy with 80 mg twice daily. Adjust the dose individually; daily doses up to 240 mg may be used.

In patients with severe hepatic impairment, do not exceed a daily dose of 20 mg. Monitor liver enzyme levels regularly.

In patients with renal impairment and in the elderly, do not exceed a daily dose of 40 mg.

For intravenous administration, use the lyophilisate only when oral intake is not possible. The recommended intravenous dose is 40 mg once daily.

The duration of therapy is determined by the treating physician based on the clinical indication and patient response.

Adverse Reactions

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

Nervous system disorders: uncommon – headache, dizziness; rarely – taste disturbances; frequency unknown – paresthesia.

Psychiatric disorders: uncommon – sleep disorders; rarely – depression (including exacerbation of existing disorders); very rarely – disorientation (including exacerbation of existing disorders); frequency unknown – hallucinations, confusion (especially in predisposed patients), as well as possible exacerbation of symptoms if they existed prior to therapy initiation.

Eye disorders: rarely – blurred vision.

Gastrointestinal disorders: common – gastric fundic gland polyps (benign); uncommon – diarrhea, nausea, vomiting, abdominal distension, flatulence, constipation, dry mouth, abdominal discomfort and pain.

Hepatobiliary disorders: uncommon – increased liver enzyme activity (transaminases, γ-glutamyltransferase); rarely – increased bilirubin level; frequency unknown – hepatocellular damage, jaundice, hepatocellular insufficiency.

Renal and urinary disorders: frequency unknown – interstitial nephritis.

Musculoskeletal and connective tissue disorders: uncommon – fractures of the wrist, hip, spine; rarely – arthralgia, myalgia.

Metabolism and nutrition disorders: rarely – hyperlipidemia, change in body weight; frequency unknown – hyponatremia, hypomagnesemia.

Immune system disorders: rarely – hypersensitivity reactions (including anaphylactic reactions and anaphylactic shock), angioedema.

Reproductive system and breast disorders: rarely – gynecomastia.

Skin and subcutaneous tissue disorders: uncommon – exanthema/rash, pruritus, dermatitis; rarely – urticaria; frequency unknown – malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity, subacute cutaneous lupus erythematosus.

General disorders and administration site conditions: uncommon – asthenia, fatigue, malaise; rarely – increased body temperature, peripheral edema.

Contraindications

Hypersensitivity to pantoprazole; neurogenic dyspepsia, malignant gastrointestinal diseases, severe hepatic insufficiency; pregnancy, lactation (breastfeeding); childhood; use of HIV protease inhibitors such as atazanavir and nelfinavir, whose absorption depends on gastric juice pH (for oral administration).

With caution in hepatic insufficiency.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Use in Hepatic Impairment

Contraindicated for use in severe hepatic insufficiency. When used in patients with impaired liver function, plasma liver enzyme activity should be monitored regularly and Pantoprazole should be discontinued if it increases.

Use in Renal Impairment

In case of impaired renal function, it is not recommended to exceed the dose of 40 mg/day.

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated.

Geriatric Use

Proton pump inhibitors, especially when used in high doses and for long-term therapy (more than 1 year), may moderately increase the risk of fractures of the hip, wrist, and spine, predominantly in elderly people. In elderly patients, it is not recommended to exceed the dose of 40 mg/day.

Special Precautions

Intravenous use of pantoprazole is recommended only if oral administration is not possible.

Before starting therapy, the possibility of a malignant neoplasm in the stomach and esophagus should be excluded, because the use of pantoprazole reduces the severity of symptoms and may delay the establishment of a correct diagnosis. The diagnosis of reflux esophagitis requires mandatory endoscopic confirmation.

In elderly patients and in patients with impaired renal function, it is not recommended to exceed the dose of 40 mg/day.

When used in patients with impaired liver function, plasma liver enzyme activity should be monitored regularly and Pantoprazole should be discontinued if it increases.

Effect on ability to drive vehicles and operate machinery

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

Drug Interactions

With simultaneous use, Pantoprazole may alter the absorption of drugs whose absorption depends on the pH of the gastric contents (e.g., ketoconazole, itraconazole, posaconazole, and other drugs such as erlotinib).

Concomitant use of pantoprazole and HIV protease inhibitors, whose absorption depends on the acidity (pH) of gastric juice, such as atazanavir, nelfinavir, significantly reduces their bioavailability.

Since Pantoprazole is metabolized in the liver by the cytochrome P450 enzyme system, the possibility of drug interactions with drugs metabolized by the same enzyme system cannot be excluded.

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

Over-the-Counter

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

Pantoprazole [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

Pantoprazole

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 compacted mass of white or almost white color.

	1 vial
Pantoprazole (in the form of pantoprazole sodium monohydrate)	40 mg

Excipients: sodium hydroxide.

Glass vials with a capacity of 10 ml (1) – cardboard packs.
Glass vials with a capacity of 10 ml (10) – contour packs (1) – cardboard packs.
Glass vials with a capacity of 10 ml (50) – contour packs (1) – cardboard packs.

Pantoprazole [Atoll LLC (Russia)]
Enteric-coated tablets, 20 mg: 10, 14, 20, 25, 28, 30, 40, 42, 50, 56, 60, 70, 75, 90, 100, 120, 150, 200 or 250 pcs.
Enteric-coated tablets, 40 mg: 10, 14, 20, 25, 28, 30, 40, 42, 50, 56, 60, 70, 75, 90, 100, 120, 150, 200 or 250 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

	Pantoprazole	Enteric-coated tablets, 20 mg: 10, 14, 20, 25, 28, 30, 40, 42, 50, 56, 60, 70, 75, 90, 100, 120, 150, 200 or 250 pcs.
		Enteric-coated tablets, 40 mg: 10, 14, 20, 25, 28, 30, 40, 42, 50, 56, 60, 70, 75, 90, 100, 120, 150, 200 or 250 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets, film-coated white or almost white, round, biconvex; a cross-section shows two layers: a core of white or white with a yellowish tint and a coating.

	1 tab.
Pantoprazole sodium sesquihydrate	22.56 mg,
Equivalent to pantoprazole content	20 mg

Excipients: mannitol – 26.84 mg, crospovidone type B – 22 mg, anhydrous sodium carbonate – 5 mg, povidone K-25 – 4 mg, crospovidone type A – 3 mg, calcium stearate – 1.6 mg.

Coating composition hypromellose – 7.125 mg, propylene glycol – 1.593 mg, povidone K-25 – 0.143 mg, titanium dioxide – 0.128 mg, iron oxide yellow dye – 0.011 mg, Acryl-EZE White 93A – 8.1 mg, incl.: methacrylic acid and ethyl acrylate copolymer [1:1] – 5.346 mg: talc – 1.3365 mg, titanium dioxide – 1.215 mg, colloidal silicon dioxide – 0.081 mg, sodium bicarbonate – 0.081 mg, sodium lauryl sulfate – 0.0405 mg, triethyl citrate – 0.9 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (4) – cardboard packs.
14 pcs. – blister packs (5) – cardboard packs.
25 pcs. – blister packs (1) – cardboard packs.
25 pcs. – blister packs (2) – cardboard packs.
25 pcs. – blister packs (3) – cardboard packs.
25 pcs. – blister packs (4) – cardboard packs.
25 pcs. – blister packs (5) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (2) – cardboard packs.
30 pcs. – blister packs (3) – cardboard packs.
30 pcs. – blister packs (4) – cardboard packs.
30 pcs. – blister packs (5) – cardboard packs.
50 pcs. – blister packs (1) – cardboard packs.
50 pcs. – blister packs (2) – cardboard packs.
50 pcs. – blister packs (3) – cardboard packs.
50 pcs. – blister packs (4) – cardboard packs.
50 pcs. – blister packs (5) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
14 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
42 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
56 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Enteric-coated tablets, film-coated white or almost white, round, biconvex; a cross-section shows two layers: a core of white or white with a yellowish tint and a coating.

	1 tab.
Pantoprazole sodium sesquihydrate	45.12 mg,
Equivalent to pantoprazole content	40 mg

Excipients: mannitol – 53.68 mg, crospovidone type B – 44 mg, anhydrous sodium carbonate – 10 mg, povidone K-25 – 8 mg, crospovidone type A – 6 mg, calcium stearate – 3.2 mg.

Coating composition hypromellose – 14.25 mg, propylene glycol – 3.186 mg, povidone K-25 – 0.286 mg, titanium dioxide – 0.256 mg, iron oxide yellow dye – 0.022 mg, Acryl-EZE White 93A – 16.2 mg, incl.: methacrylic acid and ethyl acrylate copolymer [1:1] – 10.692 mg: talc – 2.673 mg, titanium dioxide – 2.43 mg, colloidal silicon dioxide – 0.162 mg, sodium bicarbonate – 0.162 mg, sodium lauryl sulfate – 0.081 mg, triethyl citrate – 1.8 mg.

Pantoprazole [Lekvalis, LLC (Russia)]
Enteric-coated film-coated tablets, 20 mg: 14, 28 or 56 pcs.
Enteric-coated film-coated tablets, 40 mg: 14, 28 or 56 pcs.

Marketing Authorization Holder

Lekvalis, LLC (Russia)

Manufactured By

Interpharma, LLC (Russia)

Dosage Forms

Pantoprazole		Enteric-coated film-coated tablets, 20 mg: 14, 28 or 56 pcs.
Pantoprazole		Enteric-coated film-coated tablets, 40 mg: 14, 28 or 56 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets from light green to green in color, round, biconvex.

	1 tab.
Pantoprazole sodium sesquihydrate	22.57 mg,
Equivalent to pantoprazole content	20 mg

Excipients: magnesium hydrogen carbonate – 7.53 mg, macrogol (polyethylene glycol) – 1.2 mg, mannitol – 63 mg, calcium stearate – 1.2 mg, colloidal silicon dioxide – 1 mg, crospovidone – 20 mg, povidone K30 – 3.5 mg.

Enteric coating composition: Vinkout WT-NAQ-03058 green – 9.36 mg, incl.: methacrylic acid and ethyl acrylate – 5.9 mg, colloidal silicon dioxide – 0.12 mg, triethyl citrate – 0.65 mg, titanium dioxide – 1.96 mg, talc – 0.57 mg, brilliant blue dye – 0.001 mg, indigo carmine – 0.065 mg, sodium lauryl sulfate – 0.094 mg.
Film coating composition Vinkout WT-TR-5002 – 2.64 mg, incl.: hypromellose – 2.27 mg, macrogol-400 (polyethylene glycol-400) – 0.37 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 film-coated tablets from light green to green in color, round, biconvex.

	1 tab.
Pantoprazole sodium sesquihydrate	45.14 mg,
Equivalent to pantoprazole content	40 mg

Excipients: magnesium hydrogen carbonate – 15.06 mg, macrogol (polyethylene glycol) – 2.4 mg, mannitol – 126 mg, calcium stearate – 2.4 mg, colloidal silicon dioxide – 2 mg, crospovidone – 40 mg, povidone K30 – 7 mg.

Enteric coating composition: Vinkout WT-NAQ-03058 green – 18.72 mg, incl.: methacrylic acid and ethyl acrylate – 11.8 mg, colloidal silicon dioxide – 0.24 mg, triethyl citrate – 1.3 mg, titanium dioxide – 3.92 mg, talc – 1.14 mg, brilliant blue dye – 0.002 mg, indigo carmine – 0.13 mg, sodium lauryl sulfate – 0.188 mg.
Film coating composition Vinkout WT-TR-5002 – 5.28 mg, incl.: hypromellose – 4.54 mg, macrogol-400 (polyethylene glycol-400) – 0.74 mg.

Pantoprazole [Rif LLC (Russia)]
Lyophilisate for preparation of solution for intravenous administration 40 mg: vial 1 or 5 pcs. in set with solvent

Marketing Authorization Holder

Rif LLC (Russia)

Manufactured By

Ozon Pharm, LLC (Russia)

Dosage Form

Pantoprazole

Lyophilisate for preparation of solution for intravenous administration 40 mg: vial 1 or 5 pcs. in set with solvent

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 clear, colorless or brownish in color.

	1 vial
Pantoprazole sodium sesquihydrate	45.1 mg,
Equivalent to pantoprazole content	40 mg

Excipients: sodium hydroxide, disodium edetate.

Solvent sodium chloride solution 0.9% – 10 ml (ampoules).

40 mg – vials of colorless glass with a capacity of 13.5 ml (1) in a set with a solvent (amp. 10 ml 1 pc.) – contour cell packs (1) – cardboard packs.
40 mg – vials of colorless glass with a capacity of 13.5 ml (1) – contour cell packs (1) in a set with a solvent (amp. 10 ml 1 pc.) – contour cell packs (1) – cardboard packs.
40 mg – vials of colorless glass with a capacity of 13.5 ml (5) – contour cell packs (1) in a set with a solvent (amp. 10 ml 5 pcs.) – contour cell packs (1) – cardboard packs.

Pantoprazole [Pharmpotrebsoyuz, LLC (Russia)]
Lyophilisate for preparation of solution for intravenous administration 40 mg: vial 1, 5 or 10 pcs.

Marketing Authorization Holder

Pharmpotrebsoyuz, LLC (Russia)

Manufactured By

Bryntsalov-A, JSC (Russia)

Dosage Form

Pantoprazole

Lyophilisate for preparation of solution for intravenous administration 40 mg: vial 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration in the form of a powder or compacted mass of white or almost white color; reconstituted solution – a clear yellowish solution.

	1 vial
Pantoprazole sodium sesquihydrate	45.1 mg,
Equivalent to pantoprazole content	40 mg

Excipients: disodium edetate – 1 mg, sodium hydroxide solution 1M – to pH 9.0 – 10.5.

40 mg – vials with a capacity of 10 ml (1) – cardboard packs.
40 mg – vials with a capacity of 10 ml (5) – contour cell packs (1) – cardboard packs.
40 mg – vials with a capacity of 10 ml (5) – contour cell packs (2) – cardboard packs.

Pantoprazole Avexima [Avexima JSC (Russia)]
Enteric-coated film-coated tablets, 20 mg: 10, 20, 30, or 40 pcs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Avexima Siberia LLC (Russia)

Dosage Form

Pantoprazole Avexima

Enteric-coated film-coated tablets, 20 mg: 10, 20, 30, or 40 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets light yellow in color, round, biconvex, with beveled edges, smooth on both sides.

	1 tab.
Pantoprazole sodium sesquihydrate	22.55 mg,
In terms of Pantoprazole	20 mg

Excipients: mannitol, anhydrous sodium carbonate, crospovidone, povidone K-30, calcium stearate.

Coating: Opadry II 85G280000 white*, sodium hydroxide**; enteric coating: ready mixture “Acryl-Ease” yellow 93092052***, simethicone emulsion 30%****.

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. – polyethylene jars (1) – cardboard packs.
20 pcs. – polyethylene jars (1) – cardboard packs.

* Opadry II 85G280000 white: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), macrogol (E1521), soy lecithin (E322).
** 1M sodium hydroxide solution is used to adjust the pH of the coating solution.
*** ready mixture “Acryl-Ease” yellow 93092052: methacrylic acid and ethyl acrylate copolymer [1:1], talc (E553b), titanium dioxide (E171), triethyl citrate, colloidal silicon dioxide, sodium bicarbonate (E500 (ii)), iron oxide yellow dye (E172), sodium lauryl sulfate.
**** simethicone emulsion 30% in terms of 100% polydimethylsiloxane: polydimethylsiloxane – 25.5-33%; purified water – up to 100%.

Pantoprazole Canon [Canonpharma Production, CJS (Russia)]
Enteric-coated film-coated tablets, 20 mg: 7, 10, 14, 20, 28, 30, 40, or 56 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Pantoprazole Canon

Enteric-coated film-coated tablets, 20 mg: 7, 10, 14, 20, 28, 30, 40, or 56 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets light green or green with a bluish tint in color, round, biconvex; on the cross-section – almost white in color.

	1 tab.
Pantoprazole sodium sesquihydrate	22.57 mg,
Equivalent to pantoprazole content	20 mg

Excipients: calcium stearate – 1.2 mg, colloidal silicon dioxide – 1 mg, crospovidone – 20 mg, heavy magnesium hydrogen carbonate – 7.53 mg, magnesium stearate – 0.66 mg, macrogol (polyethylene glycol) – 1.2 mg, mannitol – 62.34 mg, povidone K-30 – 3.5 mg.

Film coating composition Opadry clear – 2.4 mg, incl.: [hypromellose (hydroxypropyl methylcellulose) – 1.92 mg, macrogol (polyethylene glycol) – 0.48 mg]; Acryl-Ease green – 8.6 mg, incl.: [iron oxide yellow – 0.06 mg, brilliant blue dye – 0.026 mg, indigo carmine dye – 0.069 mg, colloidal silicon dioxide – 0.086 mg, methacrylic acid and ethyl acrylate copolymer [1:1] – 5.676 mg, sodium bicarbonate – 0.086 mg, sodium lauryl sulfate – 0.043 mg, talc – 1.419 mg, titanium dioxide – 1.135 mg]; triethyl citrate – 1.00 mg.

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

Pantoprazole Canon [Canonpharma Production, CJS (Russia)]
Enteric-coated film-coated tablets, 40 mg: 7, 10, 14, 20, 28, 30, 40, or 56 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Pantoprazole Canon

Enteric-coated film-coated tablets, 40 mg: 7, 10, 14, 20, 28, 30, 40, or 56 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets light green or green with a bluish tint in color, round, biconvex; on the cross-section – almost white in color.

	1 tab.
Pantoprazole sodium sesquihydrate	45.14 mg,
Equivalent to pantoprazole content	40 mg

Excipients: calcium stearate – 2.4 mg, colloidal silicon dioxide – 2 mg, crospovidone – 40 mg, heavy magnesium hydrogen carbonate – 15.06 mg, magnesium stearate – 1.32 mg, macrogol (polyethylene glycol) – 2.4 mg, mannitol – 124.68 mg, povidone K-30 – 7 mg.

Film coating composition Opadry clear – 4.8 mg, incl.: [hypromellose (hydroxypropyl methylcellulose) – 3.84 mg, macrogol (polyethylene glycol) – 0.96 mg]; Acryl-Ease green – 17.2 mg, incl.: [iron oxide yellow – 0.12 mg, brilliant blue dye – 0.052 mg, indigo carmine dye – 0.138 mg, colloidal silicon dioxide – 0.172 mg, methacrylic acid and ethyl acrylate copolymer [1:1] – 11.352 mg, sodium bicarbonate – 0.172 mg, sodium lauryl sulfate – 0.086 mg, talc – 2.838 mg, titanium dioxide – 2.27 mg]; triethyl citrate – 2 mg.

Pantoprazole-Acryhin [Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)]
Enteric-coated film-coated tablets, 20 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Pantoprazole-Akrikhin

Enteric-coated film-coated tablets, 20 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets yellow in color, round, biconvex; on the cross-section the core is from white to white with a grayish or yellowish tint.

	1 tab.
Pantoprazole sodium sesquihydrate	22.57 mg,
Equivalent to pantoprazole content	20 mg

Excipients: anhydrous sodium carbonate, mannitol, crospovidone, povidone K-90, calcium stearate.

Protective coating: ready mixture “OPADRY” colorless (hypromellose-2910, triacetin, talc);
Enteric coating: ready mixture “ACRYL-EASE” yellow (methacrylic acid and ethyl acrylate copolymer (1:1), talc, titanium dioxide, iron oxide yellow, anhydrous colloidal silicon dioxide, sodium bicarbonate, sodium lauryl sulfate), triethyl citrate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Pantoprazole-Acryhin [Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)]
Enteric-coated film-coated tablets, 40 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Pantoprazole-Akrikhin

Enteric-coated film-coated tablets, 40 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets yellow in color, round, biconvex; on the cross-section the core is from white to white with a grayish or yellowish tint.

	1 tab.
Pantoprazole sodium sesquihydrate	45.1 mg,
Equivalent to pantoprazole content	40 mg

Excipients: anhydrous sodium carbonate, mannitol, crospovidone, povidone K-90, calcium stearate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Pantoprazole-Advanced [Advanced Pharma, LLC (Russia)]
Enteric-coated film-coated tablets, 20 mg: 10, 20, or 30 pcs.
Enteric-coated film-coated tablets, 40 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Advanced Pharma, LLC (Russia)

Dosage Forms

	Pantoprazole-Advanced	Enteric-coated film-coated tablets, 20 mg: 10, 20, or 30 pcs.
		Enteric-coated film-coated tablets, 40 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets yellow in color, round, biconvex; on the cross-section the core is from white to almost white in color.

	1 tab.
Pantoprazole sodium sesquihydrate	22.57 mg,
Equivalent to pantoprazole content	20 mg

Excipients: sodium carbonate – 5 mg, mannitol – 25.83 mg, crospovidone – 25 mg, povidone K-90 – 2 mg, calcium stearate – 1.6 mg.

Shell composition: ready coating WT-TR-5002 clear – 9.84 mg (hypromellose 86.2%, macrogol 400 13.8%); enteric coating ACRYL-EZE^® 93A220026 yellow – 12.873 mg (methacrylic acid and ethyl acrylate copolymer 66%, talc 16.5%, titanium dioxide 12.7%, yellow iron oxide dye 2.3%, colloidal silicon dioxide 1%, sodium bicarbonate 1%, sodium lauryl sulfate 0.5%); triethyl citrate 1.287 mg.

10 pcs. – blisters (1) – carton packs.
10 pcs. – blisters (2) – carton packs.
10 pcs. – blisters (3) – carton packs.
10 pcs. – jars (1) – carton packs.
20 pcs. – jars (1) – carton packs.
30 pcs. – jars (1) – carton packs.

Enteric-coated film-coated tablets yellow, round, biconvex; the core is from white to almost white on the cross-section.

	1 tab.
Pantoprazole sodium sesquihydrate	45.1 mg,
Equivalent to pantoprazole content	40 mg

Excipients: sodium carbonate – 10 mg, mannitol – 51.7 mg, crospovidone – 50 mg, povidone K-90 – 4 mg, calcium stearate – 3.2 mg.

Shell composition: ready coating WT-TR-5002 clear – 19.68 mg (hypromellose 86.2%, macrogol 400 13.8%); enteric coating ACRYL-EZE^® 93A220026 yellow – 16.65 mg (methacrylic acid and ethyl acrylate copolymer 66%, talc 16.5%, titanium dioxide 12.7%, yellow iron oxide dye 2.3%, colloidal silicon dioxide 1%, sodium bicarbonate 1%, sodium lauryl sulfate 0.5%); triethyl citrate 1.67 mg.

Pantoprazole-Belmed [Belmedpreparaty RUP (Republic of Belarus)]
Lyophilisate for preparation of solution for intravenous administration 40 mg

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Pantoprazole-Belmed

Lyophilisate for preparation of solution for intravenous administration 40 mg

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration

	1 vial.
Pantoprazole (as pantoprazole sodium sesquihydrate)	40 mg

40 mg – vials – carton packs – By prescription
40 mg – vials (5 pcs.) – carton packs – By prescription

Pantoprazole-Teva [Pliva Hrvatska, d.o.o. (Croatia)]
Enteric-coated tablets, 20 mg: 28 pcs.
Tablets, enteric-coated, 40 mg: 28 pcs.

Marketing Authorization Holder

Pliva Hrvatska, d.o.o. (Croatia)

Dosage Forms

	Pantoprazole-Teva	Enteric-coated tablets, 20 mg: 28 pcs.
		Tablets, enteric-coated, 40 mg: 28 pcs.

Dosage Form, Packaging, and Composition

Tablets, enteric-coated from light yellow to yellow, round, biconvex, with the inscription “PA 783” in black on one side.

	1 tab.
Pantoprazole sodium sesquihydrate	22.555 mg,
Equivalent to pantoprazole content	20 mg

Excipients: mannitol – 78.645 mg, crospovidone – 2.2 mg, low-substituted hypromellose – 2.2 mg, sodium lauryl sulfate – 1.1 mg, colloidal silicon dioxide – 0.55 mg, talc – 1.65 mg, magnesium stearate – 1.1 mg.

Film coating composition Opadry AMB yellow 80W32009 – 8.8 mg (partially hydrolyzed polyvinyl alcohol – 4.006 mg, titanium dioxide – 2.193 mg, talc – 1.76 mg, yellow iron oxide dye – 0.382 mg, quinoline yellow aluminum lake dye – 0.241 mg, soy lecithin – 0.176 mg, xanthan gum – 0.042 mg.
Enteric coating composition methacrylic acid and ethyl acrylate copolymer [1:1] (Eudragit L30 D-55*) – 13.45 mg, glyceryl monostearate – 0.67 mg, triethyl citrate – 1.34 mg, polysorbate 80 – 0.34 mg.
Composition of black ink Opacode S-1-17860, used for applying the inscription on the tablets pharmaceutical glaze [shellac solution in ethanol] 55%, black iron oxide dye 25%, isopropanol 18%, aqueous ammonia 1%, butanol 0.5%, propylene glycol 0.5%.

14 pcs. – blisters (2) – carton packs.

* is a 30% aqueous dispersion of methacrylic acid and ethyl acrylate copolymer [1:1], containing 0.7% sodium lauryl sulfate and 2.3% polysorbate 80.

Tablets, enteric-coated from light yellow to yellow, round, biconvex, with the inscription “PA 784” in black on one side.

	1 tab.
Pantoprazole sodium sesquihydrate	45.11 mg,
Equivalent to pantoprazole content	40 mg

Excipients: mannitol – 157.29 mg, crospovidone – 4.4 mg, low-substituted hypromellose – 4.4 mg, sodium lauryl sulfate – 2.2 mg, colloidal silicon dioxide – 1.1 mg, talc – 3.3 mg, magnesium stearate – 2.2 mg.

Film coating composition Opadry AMB yellow 80W32009 – 17.6 mg (partially hydrolyzed polyvinyl alcohol – 8.012 mg, titanium dioxide – 4.386 mg, talc – 3.52 mg, yellow iron oxide dye – 0.764 mg, quinoline yellow aluminum lake dye – 0.482 mg, soy lecithin – 0.352 mg, xanthan gum – 0.084 mg.
Enteric coating composition methacrylic acid and ethyl acrylate copolymer [1:1] (Eudragit L30 D-55*) – 25.28 mg, glyceryl monostearate – 1.26 mg, triethyl citrate – 2.53 mg, polysorbate 80 – 0.63 mg.
Composition of black ink Opacode S-1-17860, used for applying the inscription on the tablets pharmaceutical glaze [shellac solution in ethanol] 55%, black iron oxide dye 25%, isopropanol 18%, aqueous ammonia 1%, butanol 0.5%, propylene glycol 0.5%.

14 pcs. – blisters (2) – carton packs.

* is a 30% aqueous dispersion of methacrylic acid and ethyl acrylate copolymer [1:1], containing 0.7% sodium lauryl sulfate and 2.3% polysorbate 80.

Pantoprazole-Vertex [Vertex, JSC (Russia)]
Enteric-coated film-coated tablets, 20 mg: 14, 15, 28, 30, 56, or 60 pcs.
Enteric-coated film-coated tablets, 40 mg: 14, 15, 28, 30, 56, or 60 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Forms

	Pantoprazole-Vertex	Enteric-coated film-coated tablets, 20 mg: 14, 15, 28, 30, 56, or 60 pcs.
		Enteric-coated film-coated tablets, 40 mg: 14, 15, 28, 30, 56, or 60 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated film-coated tablets yellow, round, biconvex; the core is white or almost white on the cross-section.

	1 tab.
Pantoprazole sodium sesquihydrate	22.55 mg,
Equivalent to pantoprazole content	20 mg

Excipients: crospovidone, mannitol, sodium carbonate, povidone K90, calcium stearate.

Film coating No.1:[hypromellose, talc, titanium dioxide, macrogol 4000 (polyethylene glycol 4000)] or [dry mix for film coating containing hypromellose, talc, titanium dioxide, macrogol 4000 (polyethylene glycol 4000)];
Film coating No.2 dry mix containing methacrylic acid and ethyl acrylate copolymer [1:1], talc, titanium dioxide, poloxamer 407, calcium silicate, sodium bicarbonate, yellow iron oxide dye, sodium lauryl sulfate.

14 pcs. – jars – carton packs.
14 pcs. – contour cell blisters – carton packs.
14 pcs. – contour cell blisters (2) – carton packs.
14 pcs. – contour cell blisters (4) – carton packs.
15 pcs. – jars – carton packs.
15 pcs. – contour cell blisters – carton packs.
15 pcs. – contour cell blisters (2) – carton packs.
15 pcs. – contour cell blisters (4) – carton packs.
28 pcs. – jars – carton packs.
30 pcs. – jars – carton packs.
56 pcs. – jars – carton packs.
60 pcs. – jars – carton packs.

Enteric-coated film-coated tablets yellow, round, biconvex; the core is white or almost white on the cross-section.

	1 tab.
Pantoprazole sodium sesquihydrate	45.1 mg,
Equivalent to pantoprazole content	40 mg

Excipients: crospovidone, mannitol, sodium carbonate, povidone K90, calcium stearate.

Medixlife (Author)

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