Itopride (Tablets) Instructions for Use
ATC Code
A03FA (Gastrointestinal motility stimulants)
Active Substance
Itopride (Rec.INN registered by WHO)
Clinical-Pharmacological Group
A drug that increases the tone and motility of the gastrointestinal tract. Acetylcholine release stimulant
Pharmacotherapeutic Group
Drugs for the treatment of functional gastrointestinal disorders; gastrointestinal motility stimulants
Pharmacological Action
A drug that stimulates gastrointestinal motility. Itopride enhances propulsive gastrointestinal motility due to antagonism of dopamine D2 receptors and dose-dependent inhibition of acetylcholinesterase activity. Itopride activates the release of acetylcholine and suppresses its degradation.
Itopride has a specific effect on the upper gastrointestinal tract, accelerates gastric transit, and improves gastric emptying.
It also has an antiemetic effect due to interaction with D2 receptors located in the trigger zone. Itopride caused dose-dependent suppression of apomorphine-induced vomiting.
It does not affect the serum gastrin level.
Indications
Relief of symptoms of functional non-ulcer dyspepsia (chronic gastritis), including: abdominal bloating; feeling of rapid satiety; pain or discomfort in the upper abdomen; anorexia; heartburn; nausea; vomiting.
ICD codes
| ICD-10 code | Indication |
| K29 | Gastritis and duodenitis |
| K30 | Functional dyspepsia (digestive disorder) |
| R10.1 | Pain localized to the upper abdomen |
| R11 | Nausea and vomiting |
| R12 | Heartburn |
| R14 | Flatulence and related conditions (including abdominal bloating, belching) |
| R63.0 | Anorexia |
| ICD-11 code | Indication |
| DA42.Z | Gastritis, unspecified |
| DA51.Z | Duodenitis, unspecified |
| DA7Z | Diseases of stomach or duodenum, unspecified |
| DD90.0 | Globus sensation |
| DD90.1 | Functional dysphagia |
| DD90.3 | Functional dyspepsia |
| DD90.Z | Functional disorders of esophagus or gastroduodenal system, unspecified |
| MD81.10 | Pain localized in the upper abdomen |
| MD90 | Nausea or vomiting |
| MD95 | Heartburn |
| ME08 | Flatulence and related conditions |
| MG43.7 | Anorexia |
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 as 50 mg tablets.
Take three times daily, typically before meals.
The total recommended daily dose is 150 mg.
Adjust the dosage for elderly patients based on their response and tolerance.
For patients with renal impairment, reduce the dose or increase the dosing interval.
Do not exceed the maximum daily dose of 150 mg without medical supervision.
The duration of treatment is determined by the prescribing physician based on symptom relief.
Discontinue use if symptoms persist or worsen despite therapy.
Adverse Reactions
From the hematopoietic system: leukopenia, thrombocytopenia.
From the endocrine system: increased prolactin level, gynecomastia.
From the CNS: dizziness, headache, tremor.
From the digestive system: diarrhea, constipation, abdominal pain, increased salivation, nausea, jaundice.
Allergic reactions: skin hyperemia, skin itching, rash, anaphylaxis.
Changes in laboratory parameters: increased activity of AST and ALT, GGT, ALP and bilirubin level.
Contraindications
Gastrointestinal bleeding, mechanical obstruction or perforation of the gastrointestinal tract; pregnancy; lactation (breastfeeding); children under 16 years of age; hypersensitivity to itopride.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and lactation (breastfeeding).
Special Precautions
Itopride should be used with caution in patients for whom the occurrence of cholinergic adverse reactions (associated with the enhancement of acetylcholine action under the influence of itopride) may worsen the course of the underlying disease.
Drug Interactions
Itopride enhances gastric motility, so it may affect the absorption of other orally administered drugs used simultaneously.
Use with particular caution simultaneously with drugs with a low therapeutic index, as well as in dosage forms with delayed release of the active substance or drugs with an enteric coating.
Anticholinergic agents may weaken the effect of itopride.
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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Film-coated tablets 50 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 70, 98, or 140 pcs.
Marketing Authorization Holder
Biocom, JSC (Russia)
Dosage Form
 |
Itopride | Film-coated tablets 50 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 70, 98, or 140 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, with a score on one side; slight surface roughness is acceptable; the core on the cross-section is white or almost white.
| 1 tab. | |
| Itopride hydrochloride | 50 mg |
Excipients : lactose monohydrate – 45.5 mg, corn starch – 19.5 mg, carmellose sodium – 0.7 mg, crospovidone – 4.3 mg, colloidal silicon dioxide (aerosil) – 4 mg, magnesium stearate – 1 mg.
Shell composition Opadry white – 5 mg (hypromellose (hydroxypropyl methylcellulose) – 60%, titanium dioxide (E171) – 25%, macrogol (polyethylene glycol) – 15%).
7 pcs. – blisters (1) – carton packs.
7 pcs. – blisters (2) – carton packs.
7 pcs. – blisters (3) – carton packs.
7 pcs. – blisters (4) – carton packs.
7 pcs. – blisters (5) – carton packs.
7 pcs. – blisters (7) – carton packs.
7 pcs. – blisters (10) – carton packs.
10 pcs. – blisters (1) – carton packs.
10 pcs. – blisters (2) – carton packs.
10 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (4) – carton packs.
10 pcs. – blisters (5) – carton packs.
10 pcs. – blisters (7) – carton packs.
10 pcs. – blisters (10) – carton packs.
14 pcs. – blisters (1) – carton packs.
14 pcs. – blisters (2) – carton packs.
14 pcs. – blisters (3) – carton packs.
14 pcs. – blisters (4) – carton packs.
14 pcs. – blisters (5) – carton packs.
14 pcs. – blisters (7) – carton packs.
14 pcs. – blisters (10) – carton packs.
Film-coated tablets 50 mg
Marketing Authorization Holder
PFKO-1, LLC (Russia)
Manufactured By
Obnovlenie Pfc, JSC (Russia)
Dosage Form
|
Itopride | Film-coated tablets 50 mg |
Dosage Form, Packaging, and Composition
Film-coated tablets
| 1 tab. | |
| Itopride | 50 mg |
10 pcs. – contour cell packs – carton packs (10 pcs.) – By prescription
10 pcs. – contour cell packs (12 pcs.) – carton packs (120 pcs.) – By prescription
10 pcs. – contour cell packs (18 pcs.) – carton packs (180 pcs.) – By prescription
10 pcs. – contour cell packs (2 pcs.) – carton packs (20 pcs.) – By prescription
10 pcs. – contour cell packs (3 pcs.) – carton packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (4 pcs.) – carton packs (40 pcs.) – By prescription
10 pcs. – contour cell packs (6 pcs.) – carton packs (60 pcs.) – By prescription
10 pcs. – contour cell packs (8 pcs.) – carton packs (80 pcs.) – By prescription
10 pcs. – contour cell packs (9 pcs.) – carton packs (90 pcs.) – By prescription
15 pcs. – contour cell packs – carton packs (15 pcs.) – By prescription
15 pcs. – contour cell packs (12 pcs.) – carton packs (180 pcs.) – By prescription
15 pcs. – contour cell packs (2 pcs.) – carton packs (30 pcs.) – By prescription
15 pcs. – contour cell packs (4 pcs.) – carton packs (60 pcs.) – By prescription
15 pcs. – contour cell packs (6 pcs.) – carton packs (90 pcs.) – By prescription
15 pcs. – contour cell packs (8 pcs.) – carton packs (120 pcs.) – By prescription
20 pcs. – contour cell packs – carton packs (20 pcs.) – By prescription
20 pcs. – contour cell packs (2 pcs.) – carton packs (40 pcs.) – By prescription
20 pcs. – contour cell packs (3 pcs.) – carton packs (60 pcs.) – By prescription
20 pcs. – contour cell packs (4 pcs.) – carton packs (80 pcs.) – By prescription
20 pcs. – contour cell packs (6 pcs.) – carton packs (120 pcs.) – By prescription
20 pcs. – contour cell packs (9 pcs.) – carton packs (180 pcs.) – By prescription
Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, 70, or 100 pcs.
Marketing Authorization Holder
Pharmproekt, JSC (Russia)
Dosage Form
|
Itopride | Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, 70, or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round biconvex; the core on the cross-section is from white to almost white.
| 1 tab. | |
| Itopride hydrochloride | 50 mg |
Excipients : lactose monohydrate, croscarmellose sodium, corn starch, colloidal silicon dioxide, magnesium stearate.
Film coating composition Opadry white (03F280075) [hypromellose (hydroxypropyl methylcellulose), macrogol (polyethylene glycol), titanium dioxide].
10 pcs. – contour cell packs (1) – carton packs.
10 pcs. – contour cell packs (2) – carton packs.
10 pcs. – contour cell packs (3) – carton packs.
10 pcs. – contour cell packs (4) – carton packs.
10 pcs. – contour cell packs (5) – carton packs.
10 pcs. – contour cell packs (6) – carton packs.
10 pcs. – contour cell packs (7) – carton packs.
10 pcs. – contour cell packs (10) – carton packs.
Film-coated tablets, 50 mg: 7, 10, 14, 20, 21, 30, 35, 40, 42, 49, 50, 56, 70, 84, 98, 100, 105, 126, or 140 pcs.
Marketing Authorization Holder
Elzapharm, LLC (Russia)
Manufactured By
Velpharm, LLC (Russia)
Dosage Form
|
Itopride | Film-coated tablets, 50 mg: 7, 10, 14, 20, 21, 30, 35, 40, 42, 49, 50, 56, 70, 84, 98, 100, 105, 126, or 140 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Itopride (in the form of hydrochloride) | 50 mg |
Excipients : lactose monohydrate, pregelatinized corn starch, croscarmellose sodium (primellose), colloidal silicon dioxide (aerosil), magnesium stearate; dry mixture for film coating containing hypromellose, titanium dioxide, macrogol 6000 or hypromellose, titanium dioxide, macrogol 6000 (polyethylene glycol 6000, polyethylene oxide 6000).
10 pcs. – contour cell packs – carton packs (10 pcs.) – By prescription
10 pcs. – contour cell packs (10 pcs.) – carton packs (100 pcs.) – By prescription
10 pcs. – contour cell packs (2 pcs.) – carton packs (20 pcs.) – By prescription
10 pcs. – contour cell packs (3 pcs.) – carton packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (4 pcs.) – carton packs (40 pcs.) – By prescription
10 pcs. – contour cell packs (5 pcs.) – carton packs (50 pcs.) – By prescription
10 pcs. – contour cell packs (7 pcs.) – carton packs (70 pcs.) – By prescription
10 pcs. – jars – carton packs (10 pcs.) – By prescription
100 pcs. – jars – carton packs (100 pcs.) – By prescription
105 pcs. – jars – carton packs (105 pcs.) – By prescription
126 pcs. – jars – carton packs (126 pcs.) – By prescription
14 pcs. – jars – carton packs (14 pcs.) – By prescription
14 pcs. – contour cell packs – carton packs (14 pcs.) – By prescription
14 pcs. – contour cell packs (10 pcs.) – carton packs (140 pcs.) – By prescription
14 pcs. – contour cell packs (2 pcs.) – carton packs (28 pcs.) – By prescription
14 pcs. – contour cell packs (3 pcs.) – carton packs (42 pcs.) – By prescription
14 pcs. – contour cell packs (4 pcs.) – carton packs (56 pcs.) – By prescription
14 pcs. – contour cell packs (5 pcs.) – carton packs (70 pcs.) – By prescription
14 pcs. – contour cell packs (7 pcs.) – carton packs (98 pcs.) – By prescription
20 pcs. – jars – carton packs (20 pcs.) – By prescription
21 pcs. – jars – carton packs (21 pcs.) – By prescription
30 pcs. – jars – carton packs (30 pcs.) – By prescription
40 pcs. – jars – carton packs (40 pcs.) – By prescription
42 pcs. – jars – carton packs (42 pcs.) – By prescription
63 pcs. – jars – carton packs (63 pcs.) – By prescription
7 pcs. – contour cell packs – carton packs (7 pcs.) – By prescription
7 pcs. – contour cell packs (10 pcs.) – carton packs (70 pcs.) – By prescription
7 pcs. – contour cell packs (2 pcs.) – carton packs (14 pcs.) – By prescription
7 pcs. – contour cell packs (3 pcs.) – carton packs (21 pcs.) – By prescription
7 pcs. – contour cell packs (4 pcs.) – carton packs (28 pcs.) – By prescription
7 pcs. – contour cell packs (5 pcs.) – carton packs (35 pcs.) – By prescription
7 pcs. – contour cell packs (7 pcs.) – carton packs (49 pcs.) – By prescription
70 pcs. – jars – carton packs (70 pcs.) – By prescription
84 pcs. – jars – carton packs (84 pcs.) – By prescription
Film-coated tablets, 50 mg: 28, 35, 49, 50, 56, 60, 70, 90, 98, 100, or 120 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Form
|
Itopride Canon | Film-coated tablets, 50 mg: 28, 35, 49, 50, 56, 60, 70, 90, 98, 100, or 120 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, cylindrical biconvex, with a score on one side; on the cross-section – almost white.
| 1 tab. | |
| Itopride hydrochloride | 50 mg |
Excipients : low-substituted hypromellose (hydroxypropylcellulose) – 12.5 mg, pregelatinized corn starch – 15 mg, colloidal silicon dioxide – 2.5 mg, croscarmellose sodium – 6.5 mg, lactose monohydrate – 35 mg, magnesium stearate – 1 mg, povidone K30 – 2.5 mg.
Film coating composition Opadry 20A28380 white – 4 mg, incl.: hypromellose (hydroxypropyl methylcellulose) – 1.35 mg, hypromellose (hydroxypropylcellulose) – 1.35 mg, talc – 0.8 mg, titanium dioxide – 0.5 mg.
7 pcs. – contour cell packs (4) – carton packs.
7 pcs. – contour cell packs (5) – carton packs.
7 pcs. – contour cell packs (7) – carton packs.
10 pcs. – contour cell packs (4) – carton packs.
10 pcs. – contour cell packs (5) – carton packs.
10 pcs. – contour cell packs (7) – carton packs.
14 pcs. – contour cell packs (4) – carton packs.
14 pcs. – contour cell packs (5) – carton packs.
14 pcs. – contour cell packs (7) – carton packs.
40 pcs. – polymer jars (1) – carton packs.
60 pcs. – polymer jars (1) – carton packs.
70 pcs. – polymer jars (1) – carton packs.
90 pcs. – polymer jars (1) – carton packs.
100 pcs. – polymer jars (1) – carton packs.
120 pcs. – polymer jars (1) – carton packs.
Film-coated tablets 50 mg
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Form
|
Itopride Reneval | Film-coated tablets 50 mg |
Dosage Form, Packaging, and Composition
Film-coated tablets
| 1 tab. | |
| Itopride hydrochloride | 50 mg |
10 pcs. – contour cell packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell packs (12) – cardboard packs (120 pcs.) – By prescription
10 pcs. – contour cell packs (18) – cardboard packs (180 pcs.) – By prescription
10 pcs. – contour cell packs (2) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell packs (3) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (4) – cardboard packs (40 pcs.) – By prescription
10 pcs. – contour cell packs (6) – cardboard packs (60 pcs.) – By prescription
10 pcs. – contour cell packs (8) – cardboard packs (80 pcs.) – By prescription
10 pcs. – contour cell packs (9) – cardboard packs (90 pcs.) – By prescription
15 pcs. – contour cell packs – cardboard packs (15 pcs.) – By prescription
15 pcs. – contour cell packs (12) – cardboard packs (180 pcs.) – By prescription
15 pcs. – contour cell packs (2) – cardboard packs (30 pcs.) – By prescription
15 pcs. – contour cell packs (4) – cardboard packs (60 pcs.) – By prescription
15 pcs. – contour cell packs (6) – cardboard packs (90 pcs.) – By prescription
15 pcs. – contour cell packs (8) – cardboard packs (120 pcs.) – By prescription
20 pcs. – contour cell packs – cardboard packs (20 pcs.) – By prescription
20 pcs. – contour cell packs (2) – cardboard packs (40 pcs.) – By prescription
20 pcs. – contour cell packs (3) – cardboard packs (60 pcs.) – By prescription
20 pcs. – contour cell packs (4) – cardboard packs (80 pcs.) – By prescription
20 pcs. – contour cell packs (6) – cardboard packs (120 pcs.) – By prescription
20 pcs. – contour cell packs (9) – cardboard packs (180 pcs.) – By prescription
Film-coated tablets, 50 mg: 14, 40, 70, 80, or 100 pcs.
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
|
Itopride-Vertex | Film-coated tablets, 50 mg: 14, 40, 70, 80, or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, with a score; the core on the cross-section is white or almost white.
| 1 tab. | |
| Itopride hydrochloride | 50 mg |
Excipients: corn starch pregelatinized, magnesium stearate, croscarmellose sodium, colloidal silicon dioxide.
Shell composition [hypromellose, hypromellose (hydroxypropylcellulose), talc, titanium dioxide] or [dry mix for film coating containing hypromellose, hypromellose (hydroxypropylcellulose), talc, titanium dioxide].
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (5) – cardboard packs.
14 pcs. – jars (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
![Itopride [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Itopride [Tablets] 2")