Metozolv ODT (metoclopramide hydrochloride)

Company
Salix Pharmaceuticals

Approval Status
Approved September of 2009

Treatment for
gastroesophageal reflux and diabetic gastroparesis

Areas
Gastrointestinal

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.

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

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.

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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