BRAND NAMES
 MECHANISM OF ACTION
Clebopride is a dopamine antagonist at D2 receptors, with antiemetic and prokinetic properties. Chemically, it is a substituted benzamide, closely related to metoclopramide.
- Symptomatic treatment of nausea and vomiting.
- Symptomatic treatment of dyspepsia.
- To facilitate radiological and endoscopic exploration of the gastrointestinal tract.
Adults: 0,5 mg 3 times a day (before meals).
Adolescents (12 to 20 years): 0,25 mg 3 times a day (before meals).
Children from 3 months to 12 years old: as a general rule 15 mcg per kg of body weight per day, divided into 3 doses
- Known hypersensitivity to cleborpride or any excipients.
- Patients in whom stimulation of gastrointestinal motility constitutes a risk (gastrointestinal haemorrhage, obstruction or perforation).
- History of neuroleptic-induced tardive dyskinesia.
- Parkinson disease and other extrapyramidal disturbances.
 WARNINGS AND PRECAUTIONS
- Doses higher than recommended may increase the likelihood of extrapyramidal reactions especially in children and adolescents.
- Clebopride should be used with caution in patients with severe hepatic or renal insufficiency in which plasmatic concentration of clebopride may be increased or prolonged.
- Caution should be observed to increased prolactin levels, especially in patients with sinus tumours or prolactin secreting hypophysary adenocarcinoma.
- Cases of acquired metahaemoglobinaemia due to ortopramides (benzamides) have been reported in new borns.
- Patients treated with clebopride should avoid situations that require a high state of alertness such as driving or use of dangerous machinery.
- Clebopride potentiates the effects on the central nervous system of phenotiazines and other antidopaminergics.
- Anticholinergics and narcotic analgesics neutralise the effects of clebopride on the gastrointestinal motility.
- The presence of clebopride decreases the effects of digoxin and cimetidine.
- Clebopride may potentiate the sedative effects of alcohol, hypnotics, anxiolytics and narcotics.
- The concomitant administration of IMAO may increase the risk of adverse reactions.
 PREGNANCY AND LACTATION
Pregnancy: There are limited amount of data from the use of clebopride in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of clebopride during pregnancy, especially during the first three months of pregnancy.
Lactation: It is not known whether clebopride is excreted in human milk and if it could have any repercussions on new born. As a precautionary measure, it is preferable to avoid the use of clebopride during lactation.
 SIDE EFFECTS
The table below lists the adverse reactions from clinical trials and post-marketing experience following the convention: very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000) and very rare (< 1/10,000).
|Endocrine disorders||Very rare: Hyperprolactinemia|
|Nervous system disorders||Rare: Extrapyramidal disorders, dystonias*, dyskinesia, tardive diskinesia**, sedation, tremor, somnolence|
|Reproductive system and breast disorders***||Very rare: Galactorrhea, gynecomastia, erectile dysfunction, amenorrhea|
*Dystonias are more commonly reported in neck, tongue or face.
**Tardive dyskinesia has been reported in elderly patients after long-term treatment.
***Hyperprolactinemia, galactorrhea, amenorrhea, gynecomastia and erectile dysfunction have been reported in patients after long-term treatment.
 RELATED LINKS
|5-HT3 receptor antagonists||Dolasetron • Granisetron • Ondansetron • Palonosetron • Tropisetron|
|Dopamine antagonists||Alizapride • Bromopride • Clebopride • Domperidone • Metoclopramide • Prochlorperazine • Thiethylperazine|
|H1 antagonists||Dimenhydrinate • Meclizine|
|NK1 receptor antagonists||Aprepitant • Fosaprepitant • Maropitant|
|Motion sickness||Cinnarizine • Dimenhydrinate • Meclizine • Meclizine/Pyridoxine • Scopolamine (Patch)|
|Pregnancy||Meclizine/Pyridoxine • Ondansetron|
|Drugs for constipation (laxatives and Prokinetic agents)|
|Softeners, emollients||Liquid paraffin|
|Contact laxatives||Bisacodyl (Dulcolax) • Senna • Cascara • Sodium picosulfate|
|Osmotically acting laxatives||Glycerin suppositories • Magnesium salts • Lactulose (Duphalac) • Macrogol • Mannitol • Sorbitol • Sodium phosphate|
|Prokinetic agents||Clebopride • Prucalopride (Resolor)|
|Others (irritable bowel syndrome accompanied by constipation)||Linaclotide (Constella, Linzess)|