RIOPAN ® Magaldrato

RIOPAN ® is a drug based on anhydrous magaldrate.

THERAPEUTIC GROUP: Antacids - antiulcera

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications RIOPAN ® Magaldrato

RIOPAN ® is indicated in the treatment of all those pathological manifestations of the gastro-intestinal tract associated with gastric hyperacidity such as duodenal and gastric ulcers, reflux esophagitis, gastritis and gastro-duodenitis.

Mechanism of action RIOPAN ® Magaldrato

The magaldrate contained in RIOPAN ® is a monohydrate compound consisting of magnesium and aluminum, and as such characterized by an antacid and buffer action which is expressed through the neutralization of protons contained in gastric juice.

In fact, this compound is not absorbed by the systemic circulation, thus carrying out its therapeutic action directly in the intragastric lumen, where it is able to maintain the gastric pH in a range of values between 3 and 5, which are perfectly suited to the therapeutic objectives.

In addition to the antacid action, very important in preventing damage to the gastric and esophageal mucous membranes, magaldrate has proved particularly useful in adsorbing lysolecithin and bile acids, protecting the gastric mucosa from the damaging action induced by these components present in the contents of the bile reflux.

The metabolites derived from the active ingredient are usually eliminated in the faeces in the form of insoluble aluminum salts.

Studies carried out and clinical efficacy

1. EFFECTIVENESS OF THE MAGALDRATE

Administration of RIOPAN GEL, containing magaldrate in healthy volunteers, has proved to be particularly rapid in ensuring an increase in intragastric pH. In fact, in these individuals the administration of 800 mg of magaldrate guaranteed an increase in the intragastric pH to values above 3 in just 10 minutes, although the buffering effect was then maintained for a limited period of time.

2. GASTROESOFAGEO and MAGALDRATO REFLUX

The administration of anhydrous magaldrate in adult patients suffering from gastro-oesophageal reflux, guaranteed a total remission of the symptomatology in 74% of the treated patients. Despite the good result obtained, the alginate proved to be more effective, allowing the improvement of symptoms in 82% of treated patients, and characterized by a more rapid timing of action.

3. ACTION ANTILUCERA DEL MAGALDRATO, MECHANISM OF ACTION

This interesting study carried out on animal models of gastric ulcer has shown how the intake of anhydrous magaldrate can guarantee a regression of the symptoms associated with gastric ulcer, facilitating healing, not only reducing the intragastric acidity, but also resulting in a reduction of the lipidic oxidation of gastric mucosa cells.

Method of use and dosage

RIOPAN ® chewable tablets of 800 mg of anhydrous magaldrate and orosoluble gel of 80 mg / mL:

in most cases the recommended dosage is 3.2 gr of magaldrate taken in four 800 mg doses immediately after the main meals and before going to bed.

The duration of treatment should last for at least 4 weeks even when the symptoms tend to regress in the early stages of the disease, while it should not extend beyond 6 weeks without a prescription.

The dosage could be changed by the doctor, based on the clinical situation of the patient, his therapeutic goals and the effectiveness of the therapy itself.

Warnings RIOPAN ® Magaldrato

It is very important to monitor renal function before and during therapy with magaldrate, and if this is compromised, avoid taking RIOPAN ® but continue under strict medical supervision with continuous monitoring of serum magnesium and aluminum levels.

It should also be remembered that prolonged use of compounds containing aluminum could compromise normal phosphate absorption, contributing to the appearance of hypophosphoremia.

The chewable tablets contain sorbitol, therefore, they could cause unpleasant side effects in patients with hereditary sorbitol intolerance.

RIOPAN ® should not be used in patients under the age of 12 years.

PREGNANCY AND BREASTFEEDING

Although there are no detailed studies to clarify the safety profile of RIOPAN ® when taken during pregnancy on the health of the unborn child, the presence of experimental models showing a potential harmful effect on the health of the fetus following the intake of aluminum salts, Magaldrate intake during pregnancy should be avoided or at most used for limited time and under strict medical supervision.

Interactions

The pharmacological interactions described for RIOPAN ® are essentially due to the antacid action of magaldrate, which, by maintaining the intragastric pH in a range of values between 3 and 5, could reduce the absorption of drugs such as tetracycline, quinolone derivatives, preparations based on iron, chlorpromazine and isionazide.

Possible pharmacokinetic alterations have also been described following the concomitant intake of coumarinic and benziodiazepine derivatives.

It would therefore be important to modulate the dosage of the aforementioned compounds or to spend at least two hours between the intake of RIOPAN ® and other medicines.

Contraindications RIOPAN ® Magaldrato

RIOPAN ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, in the case of porphyria, hypophosphataemia, severe kidney failure, cachexia and in pediatric patients.