Metoclopramide (Tablets, Solution) Instructions for Use
ATC Code
A03FA01 (Metoclopramide)
Active Substance
Metoclopramide (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Centrally acting antiemetic drug blocking dopamine receptors
Pharmacotherapeutic Group
Means for the treatment of functional disorders of the gastrointestinal tract; gastrointestinal motility stimulants
Pharmacological Action
Antiemetic agent, helps reduce nausea, hiccups; stimulates gastrointestinal peristalsis.
The antiemetic effect is due to the blockade of dopamine D2 receptors and an increase in the threshold of chemoreceptors in the trigger zone; it is also a serotonin receptor blocker.
It is believed that Metoclopramide inhibits the relaxation of gastric smooth muscle induced by dopamine, thereby enhancing cholinergic responses of the gastrointestinal smooth muscle.
It helps accelerate gastric emptying by preventing relaxation of the gastric body and increasing the activity of the gastric antrum and upper small intestine.
It reduces the reflux of contents into the esophagus by increasing the pressure of the lower esophageal sphincter at rest and increases acid clearance from the esophagus due to an increase in the amplitude of its peristaltic contractions.
Metoclopramide stimulates the secretion of prolactin and causes a transient increase in the level of circulating aldosterone, which may be accompanied by short-term fluid retention.
Pharmacokinetics
After oral administration, it is rapidly absorbed from the gastrointestinal tract.
Plasma protein binding is about 30%.
It is biotransformed in the liver.
It is excreted mainly by the kidneys, both unchanged and in the form of metabolites.
T1/2 is from 4 to 6 hours.
Indications
Vomiting, nausea, hiccups of various origins. Atony and hypotension of the stomach and intestines (including postoperative); biliary dyskinesia; reflux esophagitis; flatulence; as part of complex therapy for exacerbations of gastric and duodenal ulcers; acceleration of peristalsis during X-ray contrast studies of the gastrointestinal tract.
ICD codes
| ICD-10 code | Indication |
| K21.0 | Gastro-esophageal reflux disease with esophagitis |
| K25 | Gastric ulcer |
| K26 | Duodenal ulcer |
| K27 | Peptic ulcer |
| K59.8 | Other specified functional intestinal disorders |
| K82.8 | Other specified diseases of gallbladder and cystic duct (including dyskinesia) |
| R06.6 | Hiccough |
| R11 | Nausea and vomiting |
| R14 | Flatulence and related conditions (including abdominal bloating, belching) |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| 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 |
| DB32.3 | Acquired hypoganglionosis of the colon |
| DB32.Z | Colonic motility disorders, unspecified |
| DC1Z | Diseases of gallbladder and biliary tract, unspecified |
| DD90.2 | Functional heartburn |
| DD91.Y | Other specified irritable bowel syndrome or functional bowel disorders |
| DD93.Y | Other specified functional gastrointestinal disorders in infants, toddlers and school-age children |
| DD94 | Functional disorder of the gallbladder |
| MD11.6 | Hiccough |
| MD90 | Nausea or vomiting |
| ME08 | Flatulence and related conditions |
| QB9A | Preparatory procedures for subsequent treatment |
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. |
Tablets
Adults: orally – 5-10 mg 3-4 times/day. For vomiting, severe nausea, Metoclopramide is administered intramuscularly or intravenously at a dose of 10 mg. Intranasally – 10-20 mg into each nostril 2-3 times/day.
Maximum doses: single dose when taken orally – 20 mg; daily – 60 mg (for all routes of administration).
The average single dose for children over 6 years of age is 5 mg 1-3 times/day orally or parenterally. For children under 6 years of age, the daily dose for parenteral administration is 0.5-1 mg/kg, frequency of administration – 1-3 times/day.
Solution
Intravenous or intramuscular.
Adults at a dose of 10-20 mg 1-3 times/day (maximum daily dose – 60 mg). Children over 6 years 5 mg 1-3 times/day.
For the prevention and treatment of nausea and vomiting caused by cytostatics or radiation therapy, administer intravenously at a dose of 2 mg/kg body weight 30 minutes before the use of cytostatics or irradiation; if necessary, the administration is repeated after 2-3 hours.
Before X-ray examination, adults are administered 10-20 mg intravenously 5-15 minutes before the start of the examination.
In patients with clinically significant hepatic and/or renal impairment, use at a dose half the usual dose; subsequent dose depends on the individual patient’s response to Metoclopramide.
Adverse Reactions
From the digestive system: at the beginning of treatment, constipation, diarrhea are possible; rarely – dry mouth.
From the central nervous system: at the beginning of treatment, feeling of fatigue, drowsiness, dizziness, headache, depression, akathisia are possible. The occurrence of extrapyramidal symptoms is possible in children and young adults (even after a single use of metoclopramide): spasm of facial muscles, hyperkinesis, spasmodic torticollis (as a rule, they disappear immediately after discontinuation of metoclopramide). With prolonged use, more often in elderly patients, manifestations of parkinsonism, dyskinesia are possible.
From the hematopoietic system: at the beginning of treatment, agranulocytosis is possible.
From the endocrine system: rarely, with prolonged use in high doses – galactorrhea, gynecomastia, menstrual cycle disorders.
Allergic reactions: rarely – skin rash.
Contraindications
Gastrointestinal bleeding, mechanical intestinal obstruction, perforation of the stomach or intestines, pheochromocytoma, extrapyramidal disorders, epilepsy, prolactin-dependent tumors, glaucoma, pregnancy, lactation, simultaneous use of anticholinergic drugs, hypersensitivity to metoclopramide.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy.
When used during lactation (breastfeeding), it should be taken into account that Metoclopramide passes into breast milk.
Experimental studies have not established an adverse effect of metoclopramide on the fetus.
Use in Hepatic Impairment
Use with caution in patients with impaired liver function.
Use in Renal Impairment
Use with caution in patients with impaired renal function.
Pediatric Use
Should be used with particular caution in children, especially young children, because they have a significantly higher risk of dyskinetic syndrome.
Geriatric Use
When used in elderly patients, it must be borne in mind that with long-term use of metoclopramide in high or medium doses, the most common side effect is extrapyramidal disorders, especially parkinsonism and tardive dyskinesia.
Special Precautions
Use with caution in patients with bronchial asthma, arterial hypertension, impaired liver and/or kidney function, and Parkinson’s disease.
Should be used with particular caution in children, especially young children, because they have a significantly higher risk of dyskinetic syndrome. Metoclopramide in some cases may be effective for vomiting caused by cytostatics.
When used in elderly patients, it must be borne in mind that with long-term use of metoclopramide in high or medium doses, the most common side effect is extrapyramidal disorders, especially parkinsonism and tardive dyskinesia.
During the use of metoclopramide, distortions of laboratory data on liver function and determination of aldosterone and prolactin concentrations in blood plasma are possible.
Effect on the ability to drive vehicles and machinery
During the treatment period, potentially hazardous activities requiring increased attention and rapid psychomotor reactions should be avoided.
Drug Interactions
With simultaneous use with anticholinergic agents, mutual weakening of effects is possible.
With simultaneous use with neuroleptics (especially phenothiazine derivatives and butyrophenone derivatives), the risk of extrapyramidal reactions increases.
With simultaneous use, the absorption of acetylsalicylic acid, paracetamol, and ethanol is enhanced.
Metoclopramide, when administered intravenously, increases the rate of absorption of diazepam and increases its maximum plasma concentration.
With simultaneous use with a slow-release dosage form of digoxin, a decrease in the concentration of digoxin in the blood serum by 1/3 is possible. No interaction was observed with simultaneous use with digoxin in a liquid dosage form or in the form of a rapidly soluble dosage form.
With simultaneous use with zopiclone, the absorption of zopiclone is accelerated; with cabergoline – a decrease in the effectiveness of cabergoline is possible; with ketoprofen – the bioavailability of ketoprofen decreases.
Due to antagonism towards dopamine receptors, Metoclopramide may reduce the antiparkinsonian effect of levodopa, while an increase in the bioavailability of levodopa is possible due to the acceleration of its evacuation from the stomach under the influence of metoclopramide. The results of the interaction are ambiguous.
With simultaneous use with mexiletine, the absorption of mexiletine is accelerated; with mefloquine – the rate of absorption of mefloquine and its plasma concentration increase, while a decrease in its side effects is possible.
With simultaneous use with morphine, the absorption of morphine when taken orally is accelerated and its sedative effect is enhanced.
With simultaneous use with hymecromone, mutual weakening of effects is observed.
With simultaneous use with nitrofurantoin, the absorption of nitrofurantoin is reduced.
When metoclopramide is used immediately before the administration of propofol or thiopental, a reduction in their induction doses may be required.
In patients receiving Metoclopramide, the effects of suxamethonium chloride are enhanced and prolonged.
With simultaneous use with tolterodine, the effectiveness of metoclopramide is reduced; with fluvoxamine – a case of development of extrapyramidal disorders has been described; with fluoxetine – there is a risk of developing extrapyramidal disorders; with cyclosporine – the absorption of cyclosporine is increased and its plasma concentration is increased.
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
Tablets 10 mg: 50 pcs.
Marketing Authorization Holder
Polpharma Pharmaceutical Works, Sa (Poland)
Dosage Form
 |
Metoclopramide | Tablets 10 mg: 50 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Metoclopramide hydrochloride | 10 mg |
50 pcs. – blisters (1) – cardboard packs.
Solution for intravenous and intramuscular administration 5 mg/1 ml: amp. 2 ml 5 pcs.
Marketing Authorization Holder
Polpharma Pharmaceutical Works, Sa (Poland)
Dosage Form
|
Metoclopramide | Solution for intravenous and intramuscular administration 5 mg/1 ml: amp. 2 ml 5 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous and intramuscular administration colorless, transparent.
| 1 ml | 1 amp. | |
| Metoclopramide hydrochloride | 5 mg | 10 mg |
Excipients: sodium pyrosulfite – 2 mg, sodium chloride – 14 mg, water for injection – up to 2 ml.
2 ml – ampoules made of colorless glass (5) – contour cell packaging (1) – cardboard packs.
Solution for intravenous and intramuscular administration 5 mg/ml: 2 ml amp. 5 or 10 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Metoclopramide | Solution for intravenous and intramuscular administration 5 mg/ml: 2 ml amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous and intramuscular administration transparent, colorless.
| 1 ml | |
| Metoclopramide hydrochloride | 5 mg |
Excipients: anhydrous sodium sulfite – 0.125 mg, sodium chloride – 9 mg, disodium edetate – 0.5 mg, water for injection – up to 1 ml.
2 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
2 ml – ampoules (5) – cardboard trays (1) – cardboard packs.
2 ml – ampoules (5) – cardboard trays (2) – cardboard packs.
2 ml – ampoules (5) – contour cell packaging (20) – cardboard boxes (for hospitals).
2 ml – ampoules (5) – contour cell packaging (50) – cardboard boxes (for hospitals).
2 ml – ampoules (5) – contour cell packaging (100) – cardboard boxes (for hospitals).
Solution for intravenous and intramuscular administration 5 mg/ml: 2 ml amp. 5 or 10 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Metoclopramide | Solution for intravenous and intramuscular administration 5 mg/ml: 2 ml amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous and intramuscular administration transparent, colorless.
| 1 amp. | |
| Metoclopramide hydrochloride monohydrate (calculated as metoclopramide hydrochloride) | 5 mg |
Excipients: anhydrous sodium sulfite – 0.125 mg, disodium edetate – 0.4 mg, sodium chloride – 8 mg, water for injection – up to 1 ml.
2 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
Tablets 10 mg: 50 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
Metoclopramide | Tablets 10 mg: 50 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical, with a bevel, marbling is allowed.
| 1 tab. | |
| Metoclopramide hydrochloride (in the form of monohydrate) | 10 mg |
Excipients: lactose monohydrate, potato starch, povidone K-17, calcium stearate.
10 pcs. – contour cell packaging (5) – cardboard packs.
Solution for intravenous and intramuscular administration 5 mg/ml: amp. 2 ml 10 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
Metoclopramide | Solution for intravenous and intramuscular administration 5 mg/ml: amp. 2 ml 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid.
| 1 amp. | |
| Metoclopramide hydrochloride | 10 mg |
Excipients: sodium chloride – 16 mg, sodium sulfite anhydrous – 0.5 mg, disodium edetate (disodium salt of ethylenediaminetetraacetic acid) – 0.8 mg, propylene glycol – 200 mg, 0.1M hydrochloric acid solution – to pH 4.5, water for injections – to 2 ml.
2 ml – glass ampoules (10) with a knife or scarifier – cardboard boxes.
2 ml – glass ampoules (10) – blister packs (1) with a knife or scarifier – cardboard packs.
Solution for intravenous and intramuscular administration 5 mg/1 ml: amp. 2 ml 5 or 10 pcs.
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
|
Metoclopramide | Solution for intravenous and intramuscular administration 5 mg/1 ml: amp. 2 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous and intramuscular administration in the form of a transparent, colorless liquid.
| 1 ml | |
| Metoclopramide hydrochloride monohydrate (calculated as the anhydrous substance) | 5 mg |
Excipients: sodium sulfite anhydrous – 0.125 mg, sodium chloride – 9 mg, disodium edetate – 0.5 mg, water for injections – to 1 ml.
2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
Tablets 10 mg: 10, 20 or 50 pcs.
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
|
Metoclopramide | Tablets 10 mg: 10, 20 or 50 pcs. |
Dosage Form, Packaging, and Composition
Tablets from white with a creamy tint to white with a cream tint, round, flat-cylindrical in shape, with a bevel and a score; slight marbling is allowed.
| 1 tab. | |
| Metoclopramide hydrochloride monohydrate (calculated as the anhydrous substance) | 10 mg |
Excipients: lactose monohydrate – 80 mg, corn starch – 32.3 mg, gelatin – 1.7 mg, calcium stearate monohydrate – 1 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
Solution for intravenous and intramuscular administration 10 mg/2 ml: amp. 5, 10 or 20 pcs.
Marketing Authorization Holder
Novosibkhimpharm, JSC (Russia)
Dosage Form
|
Metoclopramide | Solution for intravenous and intramuscular administration 10 mg/2 ml: amp. 5, 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intravenous and intramuscular administration | 1 ml | 1 amp. |
| Metoclopramide hydrochloride | 5 mg | 10 mg |
2 ml – ampoules (5) – contour plastic packs (1) – cardboard packs.
2 ml – ampoules (10) – contour plastic packs (1) – cardboard packs.
2 ml – ampoules (5) – contour plastic packs (2) – cardboard packs.
2 ml – ampoules (10) – contour plastic packs (2) – cardboard packs.
Tablets 10 mg: 50, 56, or 100 pcs.
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Form
|
Metoclopramide | Tablets 10 mg: 50, 56, or 100 pcs. |
Dosage Form, Packaging, and Composition
Tablets from white to white with a yellowish or creamy tint, flat-cylindrical, with a bevel, with marking “R” on one side or without it.
| 1 tab. | |
| Metoclopramide hydrochloride monohydrate | 10.5 mg, |
| Which corresponds to the content of metoclopramide hydrochloride | 10 mg |
Excipients: lactose monohydrate (milk sugar) – 66 mg, potato starch – 20 mg, calcium stearate – 1 mg, povidone K30 – 2 mg, colloidal silicon dioxide (aerosil) – 0.5 mg.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
Solution for intravenous and intramuscular administration 5 mg/1 ml: amp. 2 ml 5 or 10 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Metoclopramide | Solution for intravenous and intramuscular administration 5 mg/1 ml: amp. 2 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous and intramuscular administration in the form of a transparent, colorless or slightly colored liquid.
| 1 l | |
| Metoclopramide hydrochloride (in the form of a hydrate) | 5 g |
Excipients: sodium metabisulfite (sodium disulfite) – 0.075 g, sodium chloride – 8 g, disodium salt of ethylenediaminetetraacetic acid (Trilon B) – 0.25 g, water for injections – to 1 l.
2 ml – glass ampoules (5) – contour plastic packs (1) – cardboard packs.
2 ml – glass ampoules (5) – contour plastic packs (2) – cardboard packs.
2 ml – glass ampoules (10) – cardboard boxes.
Solution for intravenous and intramuscular administration 10 mg/2 ml: amp. 5 or 10 pcs.
Marketing Authorization Holder
Pharmfirma Sotex, CJSC (Russia)
Dosage Form
|
Metoclopramide | Solution for intravenous and intramuscular administration 10 mg/2 ml: amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intravenous and intramuscular administration | 1 ml | 1 amp. |
| Metoclopramide hydrochloride | 5 mg | 10 mg |
2 ml – ampoules (5) – contour plastic packs (1) – cardboard packs.
2 ml – ampoules (10) – contour plastic packs (1) – cardboard packs.
2 ml – ampoules (5) – contour plastic packs (2) – cardboard packs.
2 ml – ampoules (10) – contour plastic packs (2) – cardboard packs.
Solution for intravenous and intramuscular administration 5 mg/1 ml: amp. 5 or 10 pcs.
Marketing Authorization Holder
Ellara, LLC (Russia)
Dosage Form
|
Metoclopramide | Solution for intravenous and intramuscular administration 5 mg/1 ml: amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous and intramuscular administration transparent, colorless.
| 1 ml | |
| Metoclopramide hydrochloride monohydrate (calculated as metoclopramide hydrochloride) | 5 mg |
Excipients: disodium edetate dihydrate – 0.1 mg, sodium sulfite anhydrous – 0.125 mg, sodium chloride – 9 mg, sodium acetate trihydrate – 0.54 mg, acetic acid – 0.00066 mg, water for injections – to 1 ml.
2 ml – neutral glass ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – neutral glass ampoules (5) – contour cell packs (2) – cardboard packs.
![Metoclopramide [Tablets, Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Metoclopramide [Tablets, Solution] 2")