Cromohexal® (Solution, Spray, Drops) Instructions for Use
ATC Code
S01GX01 (Cromoglicic acid)
Active Substance
Cromoglicic acid (Rec.INN registered by WHO)
Clinical-Pharmacological Group
An antiallergic drug for topical use in ophthalmology
Pharmacotherapeutic Group
Antiallergic agent – mast cell membrane stabilizer
Pharmacological Action
Antiallergic agent, mast cell membrane stabilizer. It inhibits the release of histamine, leukotrienes, and other biologically active substances from mast cells.
It is believed that the delay in the release of mediators occurs as a result of an indirect blockade of the penetration of calcium ions into the cells.
It has been established that Cromoglicic acid suppresses the migration of neutrophils, eosinophils, and monocytes.
Pharmacokinetics
Absorption through the mucous membrane of the eye is insignificant. Systemic bioavailability is less than 0.03%.
Half-life (T1/2) is 5-10 minutes. Plasma protein binding is 65%.
It is not metabolized. It is excreted unchanged in the urine and through the intestine in approximately equal amounts.
Indications
Prevention and treatment: allergic conjunctivitis, allergic keratitis, keratoconjunctivitis, irritation of the ocular mucosa caused by allergic reactions (environmental factors, occupational hazards, household chemicals, cosmetics, ophthalmic dosage forms, plants, and pets).
ICD codes
| ICD-10 code | Indication |
| H10.1 | Acute atopic (allergic) conjunctivitis |
| H16.2 | Keratoconjunctivitis (including that caused by external influence) |
| ICD-11 code | Indication |
| 9A60.01 | Acute atopic conjunctivitis |
| 9A60.02 | Allergic conjunctivitis |
| 9A60.0Y | Other specified papillary conjunctivitis |
| 9A60.0Z | Papillary conjunctivitis, unspecified |
| 9A60.5 | Vernal keratoconjunctivitis |
| 9A73 | Exposure keratitis |
| 9A74 | Neurotrophic keratitis |
| 9A7Y | Other specified diseases of cornea |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Spray
Apply intranasally 4-6 times/day. The course of treatment is 4 weeks. Discontinuation should be carried out gradually, over 1 week.
Solution
Unless otherwise prescribed, adults and children are recommended to inhale the contents of one vial (20 mg/2 ml) 4 times/day, at equal time intervals if possible.
The recommended dose can be doubled, and the frequency of use can be increased to 6 times/day if necessary.
After achieving the therapeutic effect, the drug can be inhaled as needed.
Cromohexal®, with its regular use, prevents the development of asthmatic manifestations, but is not intended for the treatment of acute attacks.
The initial course of therapy should be at least 4 weeks. The full effect is usually achieved after 2-4 weeks. Dose reduction is recommended to be carried out gradually, over 1 week.
To open the vial, break off the upper marked part of the single-use vial. For inhalation, use special inhalers, for example, an ultrasonic one.
The duration of therapy is determined by the attending physician.
Drops
When used in ophthalmology, the dose is set individually depending on the indications and the dosage form used.
Adverse Reactions
From the organ of vision: temporary impairment of visual acuity, sensation of heat in the eye, conjunctival edema, sensation of a foreign body in the eye, dry eyes, lacrimation, meibomitis, superficial lesion of the corneal epithelium.
Contraindications
Hypersensitivity to cromoglicic acid, children under 2 years of age.
With caution
Children under 4 years of age, pregnancy, breastfeeding period.
Use in Pregnancy and Lactation
Use with caution during pregnancy and breastfeeding.
Use in Hepatic Impairment
The drug is approved for use in hepatic impairment.
Use in Renal Impairment
The drug is approved for use in renal impairment.
Pediatric Use
Contraindicated in children under 2 years of age. In children over 2 years of age, use in dosage forms intended for this category of patients.
Geriatric Use
The drug is approved for use in elderly patients.
Special Precautions
For some time after instillation into the eyes, refrain from performing work requiring increased attention and good vision.
Drug Interactions
With topical use in ophthalmic practice, Cromoglicic acid reduces the need for the use of ophthalmic drugs containing corticosteroids.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Metered nasal spray 2.8 mg/1 dose: bottle 85 doses or 170 doses with dosing device
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH (Germany)
Dosage Form
 |
Cromohexal® | Metered nasal spray 2.8 mg/1 dose: bottle 85 doses or 170 doses with dosing device |
Dosage Form, Packaging, and Composition
Metered nasal spray in the form of a clear solution, from colorless to slightly yellowish, without mechanical inclusions.
| 1 dose | |
| Sodium cromoglicate | 2.8 mg |
Excipients : benzalkonium chloride, sodium chloride, disodium edetate, liquid non-crystallizing sorbitol, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, water for injections.
85 doses (15 ml) – plastic bottles with a dosing device (1) – cardboard packs.
170 doses (30 ml) – plastic bottles with a dosing device (1) – cardboard packs.
Inhalation solution 20 mg/2 ml: amp. 50 or 100 pcs.
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
Pharma Stulln, GmbH (Germany)
Dosage Form
 |
Cromohexal® | Inhalation solution 20 mg/2 ml: amp. 50 or 100 pcs. |
Dosage Form, Packaging, and Composition
Inhalation solution clear, colorless or slightly yellowish, without mechanical inclusions.
| 1 amp. | |
| Sodium cromoglicate | 20 mg |
Excipients : purified water.
2 ml – polyethylene ampoules (10) – strips (5) – cardboard packs.
2 ml – polyethylene ampoules (10) – strips (10) – cardboard packs.
Eye drops 2%: dropper bottle 10 ml
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH (Germany)
Dosage Form
|
Cromohexal® | Eye drops 2%: dropper bottle 10 ml |
Dosage Form, Packaging, and Composition
Eye drops 2% in the form of a clear, colorless to slightly yellowish solution without mechanical inclusions.
| 1 ml | |
| Sodium cromoglicate | 20 mg |
Excipients : benzalkonium chloride – 0.1 mg, sodium chloride – 4 mg, disodium edetate – 1.5 mg, liquid non-crystallizing sorbitol – 20 mg, sodium dihydrogen phosphate dihydrate – 1 mg, disodium hydrogen phosphate dodecahydrate – 5 mg, sodium hydroxide – to pH 7.0, water for injections – 0.9661 mg.
10 ml – polyethylene dropper bottles (1) – cardboard packs.
Eye drops 2%: dropper bottle 10 ml
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
Aeropharm GmbH (Germany)
Dosage Form
|
Cromohexal® | Eye drops 2%: dropper bottle 10 ml |
Dosage Form, Packaging, and Composition
Eye drops 2% in the form of a clear, colorless to slightly yellowish solution without mechanical inclusions.
| 1 ml | |
| Sodium cromoglicate | 20 mg |
Excipients : benzalkonium chloride – 0.1 mg, sodium chloride – 4 mg, disodium edetate – 1.5 mg, liquid non-crystallizing sorbitol – 20 mg, sodium dihydrogen phosphate dihydrate – 1 mg, disodium hydrogen phosphate dodecahydrate – 5 mg, sodium hydroxide – to pH 7.0, water for injections – 0.9661 mg.
10 ml – polyethylene dropper bottles (1) – cardboard packs.
![Cromohexal® [Solution, Spray, Drops] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Cromohexal® [Solution, Spray, Drops] 2")