Clebopride

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[edit] BRAND NAMES

[edit] STRUCTURE

Clebopride.jpg

[edit] 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.

[edit] INDICATIONS

  • Symptomatic treatment of nausea and vomiting.
  • Symptomatic treatment of dyspepsia.
  • To facilitate radiological and endoscopic exploration of the gastrointestinal tract.

[edit] DOSAGE

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

[edit] CONTRAINDICATIONS

  • 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.
  • Epilepsy.
  • Parkinson disease and other extrapyramidal disturbances.

[edit] 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.

[edit] INTERACTIONS

  • 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.

[edit] 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.

[edit] 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.

[edit] RELATED LINKS

[edit] BIBLIOGRAPHY

[edit] REFERENCES

Antiemetics
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
Veterinary Maropitant
Drugs for constipation (laxatives and Prokinetic agents)
Softeners, emollients Liquid paraffin
Contact laxatives Bisacodyl (Dulcolax)   Senna   Cascara   Sodium picosulfate
Bulk-forming laxatives Ispaghula
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)