GASTROFRENAL ® Chromoglicic acid

GASTROFRENAL ® is a drug based on cromoglicic acid sodium salt

THERAPEUTIC GROUP: Non-steroidal intestinal anti-inflammatory

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

Indications GASTROFRENAL ® Chromoglicic acid

GASTROFRENAL ® is useful in the treatment and prevention of food allergies and chronic inflammatory bowel diseases.

Mechanism of action GASTROFRENAL ® Chromoglicic acid

GASTROFRENAL ® is a drug based on sodium cromoglicate, which taken orally passes the gastric barrier, accumulating at the intestinal level where it acts.

Of the total amount assumed, only 1% is absorbed and subsequently excreted via the kidneys, while the remainder is concentrated in the intestinal lumen, where it acts as an anti-inflammatory.

Although not yet fully characterized, the main activity of sodium cromoglycate seems to materialize in the reduction of leukotriene production on one side, powerful mediators of inflammation, and in the inhibition of histamine production by tissue mast cells on the other.

These two different but complementary actions justify the anti-inflammatory activity of the drug in chronic intestinal inflammatory diseases and the antiallergic action against food antigens, respectively.

This last capacity, perhaps the most characterized, is always realized when the drug is taken before the potential allergen, even if the most probable mechanism of action is not that of inhibiting the antibody antigen binding, but that of blocking the molecular mechanisms that lead to the release of histamine.

Studies carried out and clinical efficacy

1. CROMOGLICATED SODIUM AND IRRITABLE COLON SYNDROME

Irritable bowel syndrome is one of those complex and multifactorial diseases, for which it has not yet been possible to identify a unique pathogenic mechanism. In this work, attention is given to the role that the increase in intestinal permeability has in mediating a significant inflammation of the colon, which contributes to the establishment of this pathology. At the same time, the intake of sodium cromoglycate appears to be useful in reducing the symptoms, probably acting on one of the mechanisms involved in the genesis of this disease.

2. HOW THE SODIUM CROMOGLICATED IN FOOD ALLERGIES ACTS

This important study has shown that among the possible mechanisms of action of sodium chromoglycate, there is that related to the ability to reduce the permeability of the intestinal mucosa to the passage of antigens potentially involved in the degranulation of mast cells and in the appearance of the related intestinal symptoms.

3. THE CORRECT APPROACH TO FOOD ALLERGIES

Food allergies are adverse reactions to common antigens introduced through the IgE mediated diet, which affect part of the population. The correct approach to treatment, should first include a careful diagnosis and an exclusion of potentially harmful foods, and possibly also a pharmacological treatment. Among the available options, sodium cromoglycate does not yet seem to have a therapeutic role, while it seems more suitable for the prophylaxis of these pathologies.

Method of use and dosage

GASTROFRENAL ® 100 mg sodium cromoglicate or granulated capsules for oral suspension 250/500 mg sodium cromoglicate: the most commonly used dose in adults is 250 mg 4 times a day or 500 mg twice a day concurrently with meals.

In most cases good control of symptoms is achieved in 2-3 weeks of treatment, at the end of which one-time use of GASTROFRENAL ® can be taken, 15 minutes before meals containing potentially allergenic foods.

To protect the oral and buccal mucous membranes, it is advisable to shake the contents of the oral suspension in the oral cavity and then swallow it.

Dosages for pediatric patients are significantly reduced.

In any case the correct dosage formulation should be formulated by the doctor after a careful evaluation of the patient's clinical picture and his therapeutic response to the drug.

Warnings GASTROFRENAL ® Chromoglicic acid

Although GASTROFRENAL ® acts by reducing the susceptibility to the development of intestinal allergic reactions, it is necessary to consider that a correct therapeutic approach should be based on the identification and elimination of all possible allergens.

Therefore patients with a personal history of anaphylactic shock and similar reactions to the ingestion of food allergens should not rely solely on the therapeutic capabilities of this medicine.

PREGNANCY AND BREASTFEEDING

The administration of GASTROFRENAL ® in pregnancy and lactation is not recommended, given the absence of experimental studies and clinical trials able to clarify the effective safety of the drug on the health of the unborn child and of the infant.

Interactions

The low systemic absorption of the cromoglycated salt minimizes the possible interactions with other drugs and molecules, making the use of GASTROFRENAL ® safe.

Contraindications GASTROFRENAL ® Chromoglicic acid

GASTROFRENAL ® is contraindicated only in patients with known hypersensitivity to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

GASTROFRENAL ® therapy has proved to be particularly safe and well tolerated, with the appearance of rare side effects such as nausea, rash and joint pain, all of modest magnitude and readily regressable once therapy is suspended.