Sodium Cromoglycate

Sodium Cromoglycate belongs to the pharmacological class of Mast cell stabilizers. Sodium Cromoglycate appears to have anti-allergy and antiasthmatic properties.

Sodium Cromoglycate had been approved for relieving symptoms as well as also for the treatment and maintenance of episodes of allergic rhinitis, food allergy, conjunctivitis, and asthma.

Sodium Cromoglycate is poorly absorbed in the gastrointestinal tract after oral administration.As a result of poor absorption of about 1% the remainder of the drug is excreted in the feces.

The common side effects associated with Sodium Cromoglycate are irregular nausea, headache, dizziness, joint pain, unpleasant taste.

Sodium Cromoglycate is found to be available in the form of Oral Solution, eye drops, capsules, nebulization solution , nasal spray. Sodium Cromoglycate is available in the U.S., Canada,E.U. , India, Australia, Japan.

Sodium Cromoglycate belongs to the pharmacological class of Mast cell stabilizers. Sodium Cromoglycate appears to have anti-allergy and antiasthmatic properties.

Sodium Cromoglycate binds to the glucocorticoid receptor which mediates changes in gene expression that might lead to multiple downstream effects over hours to days.

Cromoglycate is said to inhibit degradation of mast cells, followed by preventing the release of histamine as well as slow-reacting substance of anaphylaxis (SRS-A), mediators of type I allergic reactions. Cromoglicate also might reduce the release of inflammatory leukotrienes. Cromoglicate might act by inhibiting calcium influx.

Sodium Cromoglycate had been approved for relieving symptoms as well as also for the treatment and maintenance of episodes of allergic rhinitis, food allergy, conjunctivitis, and asthma.

The duration of action of Sodium Cromoglycate is about 6 hrs and the half- life is achieved is about 80-90 minutes.

Sodium Cromoglycate is available in oral tablets and solutions.

Sodium Cromoglycate can be used in the treatment of the following conditions:

• Allergic rhinitis
• Food allergy
• Conjunctivitis
• Asthma

Sodium Cromoglycate can help to relieve symptoms and also for the treatment and maintenance of allergic rhinitis, food allergy, conjunctivitis, asthma.

Sodium Cromoglycate is approved for use in the following clinical indications/conditions:

• Allergic rhinitis
• Food allergy
• Conjunctivitis
• Asthma

Food allergy

Oral:To be swallowed with the water as a whole as per the physician's prescription.

Conjunctivitis

Ophthalmic drops: 1 or 2 drops to be installed in the eye

Allergic Rhinitis and Asthma

Inhaler: The liquid is to be poured into the nebulizer device for inhalation.

Conjunctivitis

Ophthalmic drops : 2% or 5ml

Allergic Rhinitis and Asthma

Inhaler: 5mg/1MDI

Capsules: 10mg or 2 ml repulses

Food allergy

Oral: 100mg or 200mg dose 4 times a day

Oral Solution, eye drops, capsules, nebulization solution , nasal spray.

Smoking cessation and maintaining health is a must.

Caffeine should be avoided or limited to use as it might lead to the risk of nausea, palpitations, nervousness, rapid heartbeat, etc.

Alcohol intake should be avoided in the patients, especially with an underlying liver disorder or liver dysfunction.

Diet containing food with high sugar content and carbohydrates should be restricted.This includes pies, cakes, honey,cookies, jams, candies,chips and bread. It is also advised to reduce or limit the intake of cholesterol and saturated fat and instead choose poultry, lean meat or fish.

The dietary restrictions need to be individualized as per the patient's requirements.

Sodium Cromoglycate may be contraindicated under the following conditions:

• Hypersensitivity to the ingredients of the medication.

The adverse reactions related to Sodium Cromoglycate can be categorized as:

• Headache
• Mouth and throat irritation
• Skin rash
• Joint pain
• Dizziness
• Unpleasant taste
• Blurred vision
• Stinging or burning sensation of eyes

The common side effects of Sodium Cromoglycate include the following:

• Headache
• Mouth and throat irritation
• Skin rash
• Joint pain
• Dizziness
• Unpleasant taste
• Blurred vision
• Stinging or burning sensation of eyes

Pregnancy

Pregnancy Category B.

In reproductive studies such as in mice, rats, and rabbits, cromolyn sodium is said to had produced no evidence of the fetal malformations at subcutaneous doses which are up to 540 mg/kg in mice i.e. approximately equal to the MRDID in adults on mg/m2 basis and 164 mg/kg in rats which is less than the MRDID in adults on a mg/m2 basis or at an intravenous doses up to 485 mg/kg in rabbits which is approximately four times the MRDID in adults on a mg/m2 basis. There are, however, found to be, no adequate and well-controlled studies in pregnant women; hence sodium cromoglycate should be used during pregnancy only if clearly needed.

Nursing Mothers

It is unknown whether Sodium Cromoglycate is excreted in the human milk. As many drugs are found to be excreted in human milk, hence caution should be exercised when Cromolyn Sodium Oral Solution, Concentrate is being administered to a nursing woman.

Pediatric Use

In adult rats, there was found to be no adverse effects of cromolyn sodium had been observed at oral doses up to 6144 mg/kg which is approximately twenty five times the MRDID in adults on mg/m2 basis. In some neonatal rats, cromolyn sodium increased mortality at oral doses of 1000 mg/kg or greater which is approximately nine times the MRDID in infants on a mg/m2 basis but not at doses of 300 mg/kg or less approximately three times the MRDID in infants on a mg/m2 basis. Kidney and Plasma concentrations of cromolyn after oral administration to neonatal rats were up to twenty times greater than those in older rats. In terms of infants up to 6 months of age, which is available in clinical data suggest that the doses should not exceed twenty 20 mg/kg/day. The use of this product in pediatric patients who are less than 2 years of age should be reserved for the patients with severe disease in which the potential benefits outweigh the risks associated.

Geriatric Use

Clinical studies using Cromolyn Sodium Oral Solution, Concentrate did not include sufficient numbers of subjects who were aged 65 and over to determine whether they responded any differently from the younger subjects. The other reported clinical experience had not identified differences in responses between the older and younger patients. In general, dose selection for an older patient should be cautiously, usually starting at the low dosing range, reflecting the greater frequency of decreased renal, hepatic or cardiac function, and of concomitant disease or other drug therapy.

As Sodium Cromoglycate is absorbed only to a very limited extent, no action other than medical observation should be necessary alone or with symptomatic treatment if any symptoms appear.

Pharmacodynamics

In vitro and in vivo animal studies had shown that cromolyn sodium inhibits the release of mediators from the sensitized mast cells. The drug Cromolyn sodium acts by inhibiting the release of leukotrienes (SRS-A) and histamines from the mast cells. Cromolyn sodium had no intrinsic antihistamine, vasoconstrictor, or glucocorticoid activity

Pharmacokinetics

Cromolyn sodium is said to be poorly absorbed from the gastrointestinal tract. No more than about 1% of an administered dose is said to be absorbed by humans after the oral administration, the remainder being excreted in the feces. Very little absorption of cromolyn sodium had been seen after oral administration of about 500 mg by mouth to each of twelve volunteers. From 0.28 to 0.50% of the administered dose had been recovered in the first 24 hours of urinary excretion in three subjects. The mean urinary excretion of an administered dose over twenty four hours in the remaining nine subjects was 0.45%.

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