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Metozolv ODT (metoclopramide hydrochloride)

Company: Salix Pharmaceuticals
Approval Status: Approved September of 2009
Treatment for: gastroesophageal reflux and diabetic gastroparesis
Areas: Gastrointestinal

| General Information | Side Effects | Mechanism of Action | Literature References |


General Information

Metozolv ODT is an orally disintegrating tablet formulation of metoclopramide hydrochloride. Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. While its mode of action is unclear, it appears to sensitize tissues to the action of acetylcholine.

Metozolv ODT is specifically indicated 1) as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy and 2) for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults.

Metozolv ODT is supplied as tablets designed for oral administration. Metozolv ODT should be taken on an empty stomach at least 30 minutes before eating. The recommended initial dose is as follows:

Symptomatic GERD
10 mg to 15 mg up to four times daily (e.g., at least 30 minutes before each meal and at bedtime). If symptoms only occur intermittently or at specific times of the day, metoclopramide may be used in single doses up to 20 mg prior to the symptoms rather than continuous treatment. Therapy should not exceed 12 weeks in duration.

Diabetic Gastroparesis
10 mg dose up to four times a day (e.g., at least 30 minutes before each meal and at bedtime). Therapy for two to eight weeks is recommended. Therapy should not exceed 12 weeks in duration.


Side Effects

Treatment with metoclopramide can cause tardive dyskinesia. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Therefore treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

Additional adverse events associated with the use of Metozolv ODT may include, but are not limited to, the following:

  • Nausea
  • Vomiting
  • Fatigue
  • Somnolence
  • Headache


Mechanism of Action

Metozolv ODT is an orally disintegrating tablet formulation of metoclopramide hydrochloride. Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. While its mode of action is unclear, it appears to sensitize tissues to the action of acetylcholine. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter. The antiemetic properties of metoclopramide appear to be a result of its antagonism of central and peripheral dopamine receptors. Dopamine produces nausea and vomiting by stimulation of the medullary chemoreceptor trigger zone (CTZ), and metoclopramide blocks stimulation of the CTZ by agents like l-dopa or apomorphine, which are known to increase dopamine levels or to possess dopamine-like effects. Metoclopramide also abolishes the slowing of gastric emptying caused by apomorphine, induces release of prolactin, and causes a transient increase in circulating aldosterone levels, which may be associated with transient fluid retention.


Literature References

Banani SJ, Lankarani KB, Taghavi A, Bagheri MH, Sefidbakht S, Geramizadeh B Comparison of metoclopramide oral tablets and solution in treatment of dysmotility-like dyspepsia. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists 2008 Jun 1;65(11):1057-61

Singh S, Singh J, Muthu MS, Balasubramaniam J, Mishra B Gastroretentive drug delivery system of metoclopramide hydrochloride: formulation and in vitro evaluation. Current Drug Delivery 2007 Oct;4(4):269-75

Patterson D, Abell T, Rothstein R, Koch K, Barnett J A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis. American Journal of Gastroenterology 1999 May;94(5):1230-4

McLoughlin J, Miller AJ Metoclopramide in the treatment of reflux oesophagitis: a comparison of normal and controlled-release formulations. Current Medical Research and Opinion 1993;13(3):145-53




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Metozolv ODT Drug Information

The Metozolv Odt drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.





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