nedocromil ophthalmic

Action and Spectrum

Actions and Spectrum: 

The mechanism of action of nedocromil involves its ability to stabilize mast cells. Mast cells play a crucial role in the immune response to allergies by releasing various substances, including histamine, in response to allergens. Histamine is responsible for the symptoms of allergic reactions, such as itching, redness, and swelling. 

nedocromil prevents the release of histamine and other allergic mediators from mast cells in the conjunctiva. It does this by inhibiting the influx of calcium ions into the mast cells, which is necessary to release these substances. By blocking the release of histamine, nedocromil helps to reduce the allergic response and alleviate the associated symptoms. 

The spectrum of activity of nedocromil ophthalmic is primarily focused on allergic conjunctivitis. It is effective against allergic reactions triggered by various allergens, including pollen, animal dander, dust mites, and certain environmental irritants.

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

Ocular burning/stinging (10-30%) 

Nasal congestion (10-30%) 

Headache (40%) 

Unpleasant taste (10-30%)  

1-10% 

Conjunctivitis (<10%) 

Photophobia (<10%) 

Rhinitis (<10%) 

Asthma (<10%) 

Eye redness (<10%) 

Black Box Warning

Black box warning: 

None 

Contraindication / Caution

Contraindications/caution: 

Contraindications: 

Hypersensitivity 

Caution: 

• Allergic reactions: Some individuals may experience an allergic reaction to nedocromil or its components 
• Contact lenses: The medication may contain preservatives that can be absorbed by soft contact lenses, leading to irritation or discoloration of the lenses. Before reinserting your contact lenses, you should wait 10 to 15 minutes after using the eye drops. 

Pregnancy / Lactation

Pregnancy consideration: There is no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women 

Pregnancy category: C 

Lactation: Excretion of the drug in human breast milk is unknown 

Pregnancy category: 

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

The pharmacology of nedocromil ophthalmic involves its effects on various cell types and inflammatory mediators in the eye.  

• Mast Cell Stabilization: nedocromil ophthalmic exerts its therapeutic effects by stabilizing mast cells in the conjunctiva. Mast cells are immune cells that are central to the allergic response. nedocromil prevents the release of these mediators by inhibiting the influx of calcium ions into the mast cells, stabilizing them, and reducing the allergic response. 
• Anti-inflammatory Effects: Besides mast cell stabilization, nedocromil also possesses anti-inflammatory properties. It inhibits the production and release of inflammatory mediators, such as leukotrienes and prostaglandins, by various cell types in the conjunctiva. 

Pharmacodynamics:  

• Inhibition of Calcium Influx:  One of the mechanisms by which nedocromil stabilizes mast cells is by inhibiting the influx of calcium ions into the cells. Calcium influx is necessary for the release of mediators from mast cells. By blocking calcium channels, nedocromil reduces the activation and degranulation of mast cells, thereby preventing the release of histamine and other inflammatory substances. 

Pharmacokinetics: 

Absorption 

nedocromil ophthalmic is administered topically as eye drops. When applied to the eye, the conjunctival tissues and cornea absorb the medication locally. It has limited systemic absorption. 

Distribution 

Since nedocromil ophthalmic is intended for local ocular use, it remains primarily concentrated within the eye tissues. It does not have extensive distribution to other parts of the body. 

Metabolism 

nedocromil ophthalmic undergoes metabolism primarily in the liver. The exact metabolic pathways and metabolites formed have yet to be extensively characterized.  

Elimination and Excretion 

The elimination of nedocromil and its metabolites occurs predominantly through renal excretion. After metabolism in the liver, the resulting inactive metabolites are eliminated from the body via the kidneys. The elimination half-life of nedocromil is relatively short, typically within a few hours. 

Adminstartion

Administration: 

• Wash your hands thoroughly with soap and water before handling the eye drops to maintain cleanliness and reduce the risk of contamination. 
• Tilt your head slightly and pull down your lower eyelid to create a small pocket. 
• Hold the dropper bottle upside down and squeeze it gently to instill the prescribed number of drops into the pocket created by the lower eyelid.  
• After instilling the drops, gently release the lower eyelid and close your eye. You can gently press your finger against the inner corner of your eye near the nose for about one to two minutes. This helps to prevent the medication from draining into the tear duct and being absorbed systemically. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: nedocromil ophthalmic 

Why do we use nedocromil ophthalmic? 

nedocromil ophthalmic is primarily used to treat allergic conjunctivitis, a condition characterized by inflammation of the conjunctiva due to an allergic response. The main uses of nedocromil ophthalmic: 

• Allergic conjunctivitis: nedocromil ophthalmic is effective in relieving the symptoms of allergic conjunctivitis, including redness, itching, watering, and swelling of the eyes. It helps to reduce the allergic response by stabilizing mast cells, preventing the release of inflammatory substances such as histamine and leukotrienes.