Croma Eye Drops 10 ml is a combination sterile ophthalmic solution indicated for the symptomatic relief and management of ocular allergic conditions, including allergic conjunctivitis, vernal keratoconjunctivitis, and environmental ocular irritation.
Formulated with two active pharmaceutical ingredients—Sodium Cromoglicate and Tetrahydrozoline Hydrochloride—Croma Eye Drops offer a dual-action therapeutic approach. The solution stabilizes ocular mast cells to inhibit allergic mediator release while simultaneously inducing local vasoconstriction to rapidly diminish hyperemic redness and edema.
Active Ingredients & Dual-Action Mechanism
The therapeutic efficacy of Croma Eye Drops relies on the complementary pharmacodynamics of its two active components:
Sodium Cromoglicate (40 mg/ml or 2% w/v): Acts as a mast cell stabilizer. It inhibits the degranulation of sensitized ocular mast cells that occurs after exposure to specific antigens (such as pollen, dust mites, or pet dander). By preventing mast cell breakdown, it stops the release of histamine, leukotrienes, and other inflammatory mediators responsible for ocular itching, lacrimation, and swelling.
Tetrahydrozoline Hydrochloride (0.5 mg/ml or 0.05% w/v): Serves as an imidazoline derivative sympathomimetic agent with predominant alpha-adrenergic activity. It acts directly on the alpha-adrenergic receptors of the conjunctival vascular smooth muscle, causing local vasoconstriction. This rapidly reduces conjunctival vascular congestion, ocular redness, and minor mucosal irritation.
Combined Therapeutic Effect
Immediate Symptom Relief: Tetrahydrozoline provides rapid clearing of ocular hyperemia (redness) and discomfort within minutes of instillation.
Long-Term Allergic Control: Sodium Cromoglicate provides sustained protection against ongoing allergic cascades, reducing the frequency and severity of recurrent allergic flare-ups with continuous prophylactic use.
Key Medical Indications & Clinical Benefits
Allergic Conjunctivitis Management: Effective in alleviating acute and seasonal allergic conjunctivitis triggered by airborne allergens.
Rapid Redness Reduction: Clears conjunctival redness caused by environmental irritants such as smoke, smog, wind, chlorinated water, or prolonged screen fatigue.
Alleviation of Pruritus and Irritation: Directly targets histamine-induced itching (pruritus), burning sensations, and excessive tearing (lacrimation).
Dual Action Formulation: Combines long-acting preventive allergic control with immediate vascular decongestion in a single, convenient ophthalmic drop.
Usage Instructions & Administration Protocol
Important Note: Croma Eye Drops should be administered in accordance with healthcare provider guidance or package instructions to avoid rebound congestion or contamination.
Recommended Adult and Pediatric Dosage: Instill 1 to 2 drops into the affected eye(s) 3 to 4 times daily, or as directed by a physician.
Administration Procedure:
Wash hands thoroughly with soap and water prior to handling the bottle.
Tilt the head backward slightly and gently pull down the lower eyelid to form a small pocket.
Hold the dropper bottle vertically above the eye, ensuring the tip does not touch the eye, eyelid, hands, or any external surface to preserve sterility.
Instill the prescribed number of drops into the conjunctival sac.
Close the eye gently for 1 to 2 minutes and press lightly on the inner corner (nasolacrimal occlusion) to minimize systemic absorption.
Replace and tighten the bottle cap immediately after use.
Safety Precautions, Warnings & Contraindications
Contraindications
Hypersensitivity: Contraindicated in individuals with known hypersensitivity to Sodium Cromoglicate, Tetrahydrozoline Hydrochloride, or any inactive excipient in the formulation.
Narrow-Angle Glaucoma: Contraindicated in patients with narrow-angle (angle-closure) glaucoma due to the sympathomimetic risks of intraocular pressure elevation.
General Warnings & Clinical Considerations
Contact Lens Wearers: Contact lenses must be removed prior to instillation. The formulation may contain preservatives (such as benzalkonium chloride) that can be absorbed by soft contact lenses. Lenses may be reinserted 15 minutes following administration.
Rebound Hyperemia Risk: Prolonged or excessive use of sympathomimetic decongestants like Tetrahydrozoline can lead to "rebound" conjunctival hyperemic congestion (rhinitis/conjunctivitis medicamentosa). Do not exceed 3 to 5 consecutive days of continuous use without medical supervision.
Cardiovascular & Systemic Precautions: Patients with severe cardiovascular disease, hypertension, hyperthyroidism, or diabetes mellitus should use alpha-adrenergic decongestants under medical advisement.
Transient Visual Disturbances: Mild, temporary stinging or blurred vision may occur immediately following instillation. Avoid driving or operating machinery until vision clears completely.
Pregnancy & Lactation: Use during pregnancy or breastfeeding should be evaluated by a healthcare professional to weigh clinical benefits against potential risks.
Product Specifications & Storage
Dosage Form: Sterile Ophthalmic Solution (Eye Drops).
Volume: 10 ml dropper bottle.
Storage Temperature: Store below 25°C in a dry place protected from direct heat and sunlight.
Post-Opening Shelf Life: Discard any remaining solution 30 days after opening the bottle to ensure microbiological safety and prevent ocular infection. Keep out of reach of children.