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Country of origin : Jordan

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sodium cromoglicate

Eye drops 2%, 4%

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Jordan
GMP approvals
Jordan
Registered in
Jordan
Manufacturer #6980
It was established in the late 1980s. It is one of the first pharmaceutical companies in the MENA region to pioneer the production of niche branded generics in the therapeutic areas of ophthalmology, ear, nose & throat, respiratory, and dermatology. After many years of success, the company is still focused on its differentiator and is proud to be one of the leaders in the MENA region having expanded into more than 5 production lines producing 140+ registered products, and exporting to 30+ markets globally.

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SODIUM CROMOGLICATE

Sodium Cromoglicate is most effective as a prophylaxis for allergic and exercise-induced asthma but not as a treatment for acute attacks. In patients suffering from Bronchial asthma, it is a long-term prophylactic in mild-to-moderate asthma. It decreases the frequency and severity of attacks and is more likely in extrinsic and exercise-induced asthma, especially in younger patients. Patients start feeling the relief within 2 – 4 weeks and continue for 1-2 weeks after the course of medication has been stopped. Allergic rhinitis is treated using a nasal decongestant and provides relief in 4–6 weeks, reducing the dependent on nasal decongestants, and curing Allergic conjunctivitis is used like regular eye drops and also provides relief in chronic cases. Cromoglicic acid, Cromoglycate, or Cromoglicate is traditionally described as a mast cell stabilizer and is commonly marketed as the sodium salt sodium Cromoglicate or Cromolyn sodium. It is used to prevent the release of inflammatory chemicals like histamine from mast cells. Sodium Cromoglicate has been the non-corticosteroid treatment of choice for asthma. However, it has now been replaced by leukotriene receptor antagonists because of their convenience and perceived safety. Cromoglicic acid requires administration four times daily and does not provide additive benefit in combination with inhaled corticosteroids. There are 2 classes namely Mast Cell Stabilizers & Ophthalmic. Sodium Cromoglicate is sold under the brand names Gastrocrom among others. Roger Altounyan, discovered it in 1965. It a breakthrough drug in the management of asthma, as the patients find freedom from steroids. Altounyan was investigating certain plants and herbs which have bronchodilation properties.

DOSAGE AND ADMINISTATION

It is sold as tablets, inhalers, and eye drops. For treating allergic conjunctivitis, in both Adults and Children are instilled One or two drops into each eye, up to four times a day or as need. In the treatment of allergies, the usual starting dose for adults and children over 14 years of age is 200 mg, taken four times daily. The starting dose for kids age 2-13 years is 100 mg, four times a day. for Inflammatory Bowel Disease (Off-label), the dose is 200 mg, orally, four times daily, and doubled if satisfactory results not achieved in the first 2 weeks of the treatment.

The PRICE of Sodium Cromoglicate

In the UK, A supply of 30 doses unit dose with Sodium Cromoglicate, 20 mg per 1 ml is £9.66. In India, the eye drops of 10 ml costs around USD 0,30 and the inhaler for 2 mg costs around USD 1.6 to USD 2.

How does it work?

Its actions prevent the release of mediators that attract inflammatory cells, as it stabilizes the inflammatory cells. MCT mast cells are stabilized in the mucosa area. However, the working mechanism not been fully understood. These work by inhibiting the response of sensory C fibers to the irritant capsaicin, inhibiting local axon reflexes involved in asthma. This results in inhibition in the release of preformed T cell cytokines and mediators involved in asthma.

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