GASTROFRENAL ® is a drug based on cromolyn sodium salt
THERAPEUTIC GROUP: Non-steroidal intestinal anti-inflammatory
Indications GASTROFRENAL ® Chromoglycic acid
GASTROFRENAL ® is useful in the treatment and prevention of food allergies and chronic inflammatory diseases of the intestine.
Mechanism of action GASTROFRENAL ® Chromoglycic acid
GASTROFRENAL ® is a sodium cromoglycate-based drug which, taken orally, passes the gastric barrier unscathed, accumulating in the intestine where it acts.
Of the total portion taken, 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 the production of leukotrienes on the one hand, powerful mediators of inflammation, and in the inhibition of the production of histamine by the tissue mast cells on the other.
These two different but complementary actions justify respectively the anti-inflammatory activity of the drug in chronic intestinal inflammatory diseases and the antiallergic action against food antigens.
This last capacity, perhaps the most characterized, always occurs 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. SODIUM CHROMOGLICATE AND IRRITABLE COLON SYNDROME
Nutr Clin Pract. 2008 Jun-Jul; 23: 284-92.
Behavioral and complementary approaches for the treatment of irritable bowel syndrome.
Wald A, Rakel D.
Irritable bowel syndrome is one of those complex and multifactorial pathologies, for which it has not yet been possible to identify a unique pathogenic mechanism. In this work, attention is paid to the role that the increase in intestinal permeability has in mediating a significant inflammation of the colon, which contributes to the onset of this pathology. At the same time the intake of cromolyn sodium seems to be useful in reducing the symptoms, probably acting on one of the mechanisms involved in the genesis of this disease.
2. HOW CHROMOGLICATED SODIUM WORKS IN FOOD ALLERGIES
J Nutr. 2006 Nov; 136: 2874-80.
Sodium cromoglycate inhibits absorption of the major soybean allergen, Gly m Bd 30K, in mice and human intestinal Caco-2 cells.
Weangsripanaval T, Murota K, Murakami Y, Kominami M, Kusudo T, Moriyama T, Ogawa T, Kawada T.
This important study has shown that among the possible mechanisms of action of cromolyn sodium, there is the one 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
Intern Emerg Med. 2009 Feb; 4: 11-24.
Food allergy and food intolerance: diagnosis and treatment.
Patriarca G, Schiavino D, Pecora V, Lombardo C, Pollastrini E, Aruanno A, Sabato V, Colagiovanni A, Rizzi A, De Pasquale T, Roncallo C, Decinti M, Musumeci S, Gasbarrini G, Buonomo A, Nucera E.
Food allergies are adverse reactions to common IgE-mediated antigens introduced through the diet, affecting part of the population. The correct approach to treatment should first envisage a careful diagnosis and exclusion of potentially harmful foods, and possibly also pharmacological treatment. Sodium cromoglycate still does not seem to have a therapeutic role among the available options, while it seems more suitable for the prophylaxis of such pathologies.
Method of use and dosage
GASTROFRENAL ® capsules of 100 mg of sodium cromoglycate or granules for oral suspension of 250/500 mg of sodium cromoglycate: the most used dose in adults is 250 mg 4 times a day or 500 mg twice a day in conjunction with meals.
In most cases, a good control of symptoms is achieved in 2-3 weeks of treatment, at the end of which it is possible to take GASTROFRENAL ® once, 15 minutes before meals containing potentially allergenic foods.
To protect the oral and buccal mucous membranes, it is recommended to shake the contents of the oral suspension in the mouth 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 ® Chromoglycic 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 ingestion of food allergens should not rely solely on the therapeutic capabilities of this medicine.
PREGNANCY AND BREASTFEEDING
The administration of GASTROFRENAL ® during pregnancy and breastfeeding is not recommended, given the absence of experimental studies and clinical trials capable of clarifying the actual safety of the drug on the health of the unborn child and infant.
Interactions
The low systemic absorption of the cromolyn salt minimizes the possible interactions with other drugs and molecules, making the intake of GASTROFRENAL ® as safe as possible.
Contraindications GASTROFRENAL ® Chromoglycic acid
GASTROFRENAL ® is contraindicated only in patients with known hypersensitivity to the active substance or to one of its excipients.
Undesirable Effects - Side Effects
Therapy with GASTROFRENAL ® proved to be particularly safe and well tolerated, with the appearance of rare side effects such as nausea, skin rashes and joint pain, all of a modest entity and promptly regressed once the therapy was suspended.
Note
GASTROFRENAL ® is a prescription drug.
The information on GASTROFRENAL ® Chromoglycic acid published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
