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Pramigel (Metoclopramide, Aluminum, Magnesium, Simethicone)

Active Ingredient: Metoclopramide, Aluminum, Magnesium, Simethicone
Dosage: 10 mg/200 mg/200 mg/50 mg
Route of Administration: Oral
Dosage Form: Tablets
Quantity per package: 20 tablets per pack
Availability: Out of Stock

Reasons Pramigel Isn’t Used in the USA

  • Regulatory Differences: Metoclopramide has a black-box warning in the USA due to the risk of tardive dyskinesia from prolonged use.
  • Combination Formulation: The combination of specific antacid compounds isn’t standardized according to FDA guidelines.
  • Over-the-Counter Alternatives: Alternatives like antacids and proton pump inhibitors (PPIs) are widely available.

Alternative Drugs Sold in the USA

For Gastritis and GERD:

For Gas and Bloating:

What is Pramigel?

Pramigel is a combination of metoclopramide, aluminum, magnesium and simethicone. The drug has gastroprokinetic, antiemetic, demulcent and antiflatulent activity. It is indicated in acute and chronic gastritis, esophagitis due to gastroesophageal reflux, gastroduodenal ulcer, hiatal hernia, dyspepsia, aerophagia, meteorism, aerocolia, excess of food accompanied by gastric hyperacidity and in hyperchlorhydria and other disorders that respond favorably to the administration of a gastroprokinetic associated with a combined antacid and an antiflatulent. It is also indicated in the treatment of nonspecific dyspepsia in children and adults; migraine and headache.

Indications

This drug is indicated in acute and chronic gastritis, gastroesophageal reflux esophagitis, gastroduodenal ulcer, hiatal hernia, dyspepsia, aerophagia, meteorism, aerocolia accompanied by gastric hyperacidity and hyperchlorhydria and other disorders that respond favorably to the administration of a gastroprokinetic associated with a combined antacid and an antiflatulent. It is also indicated in the treatment of nonspecific dyspepsias in children and adults. It is useful in the treatment of migraines and headaches.

See also  Kinestase (Cisapride)

Countries Where Pramigel Is Popular and Why

Pramigel is popular in several Latin American countries due to its comprehensive approach to addressing a wide range of gastrointestinal issues, from reflux to indigestion. The inclusion of multiple active ingredients makes it convenient and effective for patients experiencing complex gastrointestinal symptoms.

Dosage and administration

The drug is taken orally. Children from 6 to 12 years: ½ tablet every 8 hours. Children over 12 years and adults: 1 tablet every 8 hours.

Contraindications

  • Hypersensitivity to any of the formula’s components;
  • Active gastrointestinal bleeding;
  • Intestinal occlusion;
  • Pancreatitis or acute appendicitis;
  • Renal or hepatic impairment;
  • Hypersensitivity to any of the compounds of the formula.

Side effects

Sensitive patients can experience drowsiness and laxity, insomnia, dizziness, mild extrapyramidal symptoms, gynecomastia and hives. These symptoms disappear when the dose is adjusted or when the administration is suspended.

Overdose

When accidental Pramigel overdose occurs, patients may experience sedation, dizziness, extrapyramidal reactions such as torticollis, trismus, oculogyric crises, constipation or diarrhea. These adverse effects are reversible when the dose is reduced or the medication is canceled.

Interaction

When metoclopramide is concomitantly administered with psychotropic, antihistamines, barbiturates or alcohol, it produces additional depressive effects on the CNS. Chloramphenicol, acetylsalicylic acid, desipramine, doxorubicin and propantheline decrease the absorption rate of metoclopramide. Do not administer the drug with digitalis, phenothiazines, propranolol.