Nedocromil

Nedocromil belongs to the pharmacological class of Mast cell stabilizers. Nedocromil appears to have anti-inflammatory effects.

Nedocromil has been approved for relieving symptoms as well as for the treatment and maintenance of episodes of allergic conjunctivitis and asthma maintenance

Nedocromil exhibits low systemic absorption. When it is administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose is found to be systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. Nedocromil is not metabolized and is found to be eliminated primarily in the unchanged form in the urine, about 70%, and in the feces, about 30%.

The common side effects associated with Nedocromil are irregular nausea, dysmenorrhea, bronchitis, chest pain, cold/flu, and fever.

Nedocromil is found to be available in the form of Ophthalmic solution and oral inhalation Nedocromil is available in the U.S., Canada, E.U., India, Australia, and Japan.

Nedocromil belongs to the pharmacological class of Mast cell stabilizers. Nedocromil appears to have anti-allergy and anti-asthmatic properties.

Inhibits the activation of and mediator release from a variety of inflammatory cell types associated with hypersensitivity reactions, including eosinophils, neutrophils, macrophages, mast cells, monocytes, and platelets; it inhibits the release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis.

Nedocromil had been approved for relieving symptoms as well as also for the treatment and maintenance of episodes of allergic conjunctivitis and asthma maintenance.

The onset of action of Nedocromil is said to be within a few days, and the duration of action is about 2 hours.

Nedocromil is available in ophthalmic solutions and oral inhalations.

Nedocromil can be used in the treatment of the following conditions:

• Allergic conjunctivitis
• Asthma maintenance

Nedocromil can help to relieve symptoms and also for the treatment and maintenance of allergic conjunctivitis and asthma maintenance.

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

• Allergic conjunctivitis
• Asthma maintenance

Ophthalmic solutions

1 or 2 drops to be installed in the eye four times a day.

Oral Inhalation

1. Hold the inhaler in an upright position.
2. Cover the mouthpiece of the inhaler.
3. Shake the inhaler three or four times
4. Now breathe out all the air from the lungs.
5. Now breathe in the puff through the mouthpiece
6. Hold your breath for a second and breathe out.

Ophthalmic solutions

2% Nedocromil ophthalmic drops

1 or 2 drops of Nedocromil twice daily

Oral Inhalation

Asthma maintenance therapy

14 mcg per day inhalation, i.e., two actuations per day

one canister contains 210 mcg nedocromil

Ophthalmic solution and Inhalation.

• Dosage Adjustments in Kidney Patients:

No dosage adjustments are found to be needed for renal Impairment.

• Dosage Adjustments in Hepatic Impairment Patients:

No dosage adjustments are needed for hepatic Impairment.

• Dosage Adjustments in Pediatric Patients:

Not recommended in patients less than three years of age.

Smoking cessation and maintaining health are 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 patients, especially those with an underlying liver disorder or liver dysfunction.

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

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

Nedocromil may be contraindicated under the following conditions:

• Hypersensitivity to the ingredients of the medication.

Nedocromil Inhalation should not be used for acute asthma conditions as it might elevate the symptoms.

Avoid alcohol usage while on Nedocromil medication, as alcohol can worsen the effects of any underlying disease condition, including conditions such as dizziness, blurred vision, etc.

After the intravenous administration to the lactating rats, Nedocromil was found to be excreted in the milk. It is not known whether the drug nedocromil is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Nedocromil is administered to a nursing patient.

Pregnancy Category B

Reproduction studies performed in the mice rats and rabbits using a subcutaneous dose of 100mg/kg/day, i.e., more than 1600 times the maximum human daily ocular dose on an mg/kg basis, had revealed no evidence of teratogenicity or harm to the fetus due to the nedocromil sodium. There are, however, no adequate well-controlled studies on pregnant women. Because animal reproduction studies are not always predictive of human response, Nedocromil should be used during pregnancy only if needed.

No sufficient scientific evidence is traceable regarding the use and safety of Nedocromil in concurrent use with any particular food.

The adverse reactions related to Nedocromil can be categorized as follows:

• Headache
• Fever
• Chest Pain
• Fatigue
• Bronchitis
• Nausea
• Vomiting
• Coughing
• Pharyngitis

The common side effects of Nedocromil include the following:

• Headache
• Fever
• Chest Pain
• Fatigue
• Bronchitis
• Nausea
• Vomiting
• Coughing
• Pharyngitis

Pregnancy

Pregnancy Category B

Reproduction studies performed in the mice rats and rabbits using a subcutaneous dose of 100mg/kg/day, i.e., more than 1600 times the maximum human daily ocular dose on an mg/kg basis, had revealed no evidence of teratogenicity or harm to the fetus due to the nedocromil sodium. There are, however, no adequate well-controlled studies on pregnant women. Because animal reproduction studies are not always predictive of human response, Nedocromil should be used during pregnancy only if clearly needed.

• Nursing Mothers

After the intravenous administration to the lactating rats, Nedocromil was found to be excreted in the milk. It is not known whether the drug nedocromil is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Nedocromil is administered to a nursing patient.

• Pediatric Use

Safety and efficacy in the children below the age of 3 years of age has not been established.

• Geriatric Use

There is no overall difference in the efficacy and safety that has been observed between the older and the younger patients.

No reports of overdose had been reported in the human studies.

Pharmacodynamics

Nedocromil is an anti-inflammatory agent and can be administered directly to the bronchial mucosa. It has a significant inhibitory effect on allergen-induced early and late asthmatic reactions and on bronchial hyperresponsiveness.

Pharmacokinetics

Nedocromil exhibits low systemic absorption. When it is administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose is found to be systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. Nedocromil is not metabolized and is found to be eliminated primarily in the unchanged form in the urine, about 70%, and in the feces, about 30%.

1. https://reference.medscape.com/drug/alocril-nedocromil-ophthalmic-999594
2. https://go.drugbank.com/drugs/DB00716
3. https://www.rxlist.com/tilade-drug.htm#description
4. https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21009lbl.pdf