Registered Kenya · PPB

EPICROM 2 % STERILE OPHTHALMIC SOLUTION

SODIUM CROMOGLICATE

H2025/CTD12221/25049 2% OR 20 MG PER 1 ML GENERIC/BIOSIMILARS

What it does

Cromoglicate is a medicine used to help prevent allergic reactions and asthma symptoms.

Commonly used for: asthma, allergic rhinitis (hay fever), conjunctivitis (eye allergy)

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2025/CTD12221/25049
Registration date
-
Expiry date
2030 July 14
Status
Registered
Active ingredient
SODIUM CROMOGLICATE
Dosage form
2% OR 20 MG PER 1 ML
Strength
-
Pack size
CARTON BOX CONTAINING 1 DROPPER OF OPAQUE LDPE PLASTIC BOTTLE FILLED WITH 10 ML OF STERILE OPHTHALMIC SOLUTION & TRANSPARENT LDPE NOZZLE COVERED WITH HDPE TAMPER PROOF CAP WITH INSERT LEAFLET
Therapeutic class
GENERIC/BIOSIMILARS
RxNorm RxCUI
2921
Manufacturer / MAH
Zadchem Healthcare
Country of origin
FOREIGN
Manufacturer location
Jabavu House, Jabavu Lane, off Argwings Kodhek Rd, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:20:11 · updated 2026-09-18 02:14:06

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Cromoglicate is a medicine used to help prevent allergic reactions and asthma symptoms.

What it treats

  • asthma
  • allergic rhinitis (hay fever)
  • conjunctivitis (eye allergy)

How it works

Cromoglicate works by preventing the release of substances in the body that cause allergic symptoms.

Who it's for

This medicine is suitable for people with asthma and those suffering from allergies.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: cromoglicate

BNF-referenced

Cromoglicate, also known as cromolyn, is a synthetic compound primarily used in the treatment of asthma, allergic rhinitis, conjunctivitis, systemic mastocytosis, and ulcerative colitis. It functions as a mast cell stabilizer, inhibiting the release of mediators involved in allergic reactions. The drug is available in various formulations, including inhalers and ophthalmic solutions.

Indications

  • Asthma
  • Allergic rhinitis
  • Conjunctivitis
  • Systemic mastocytosis
  • Ulcerative colitis

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidelines for paediatric patients.

Adults: Refer to the BNF for specific dosing recommendations based on the condition being treated.

Mechanism of action

Cromoglicate inhibits degranulation of mast cells, preventing the release of histamine and slow-reacting substance of anaphylaxis (SRS-A), which are mediators of type I allergic reactions. It may also reduce the release of inflammatory leukotrienes and is proposed to inhibit calcium influx, which is critical for mast cell degranulation in response to allergens.

Pharmacodynamics

Cromoglicate works by inhibiting antigen-induced bronchospasms and stabilizing mast cells, which helps prevent asthma attacks and alleviates symptoms of allergic rhinitis. It demonstrates efficacy in treating conjunctivitis through its action on mast cells in the conjunctival tissue and is used for systemic conditions like mastocytosis and ulcerative colitis due to its ability to modulate inflammatory responses.

Pharmacokinetics

Cromoglicate is poorly absorbed from the gastrointestinal tract when taken orally, which limits its systemic effects. It is primarily local-acting, and its effects are mainly observed in the respiratory and ocular systems. The half-life and specific metabolic pathways of cromoglicate are not well-defined, but it is known to act rapidly upon administration.

Adverse effects

  • Local irritation
  • Cough
  • Nausea
  • Headache

Precautions

  • Use with caution in patients with known hypersensitivity to cromoglicate or any of its ingredients
  • Monitor for efficacy and adverse effects in patients with asthma or other allergic conditions

Pregnancy

Cromoglicate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult relevant guidelines.

Breast-feeding

Cromoglicate is excreted in breast milk, caution should be exercised when administering to nursing mothers.

Storage

Store below 25°C, protect from light. Do not freeze.

Formulations

  • Ophthalmic solution
  • Oral capsules
  • Inhalation solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: cromoglicate

PubChem CID 2882

Molecular formula: C23H16O11

Mechanism of action

Cromoglicate inhibits degranulation of mast cells, subsequently preventing the release of histamine and slow-reacting substance of anaphylaxis (SRS-A), mediators of type I allergic reactions. Cromoglicate also may reduce the release of inflammatory leukotrienes. Cromoglicate may act by inhibiting calcium influx. One important action of cromolyn is believed to be the inhibition of pulmonary mast cell degranulation in response to a variety of stimuli, including the interaction between cell-bound IgE and specific antigen. ... The release of histamine and other granular contents, as well as the production of leukotrienes, can be shown to be markedly reduced in vitro by cromolyn. However, its efficacy and potency are highly dependent on the source of the mast cells. ... Attention has been focused on the ability of cromolyn to reverse various functional changes in leukocytes obtained from the blood of asthmatic subjects undergoing allergen challenge, such as increased expression of membrane-bound receptors. ... Low concentrations (100 nM) of cromolyn can suppress completely the activation effects of chemoattractant peptides of human neutrophils, eosinophils, or monocytes. The mechanisms of action of cromolyn remain relatively poorly defined. Most attention has been focused on the ability of cromolyn to reduce the accumulation of intracellular Ca +2 induced by antigen in sensitized mast cells. One biochemical correlate of the reduction of histamine release from mast cells by cromolyn is the enhanced phosphorylation of a 78,000-dalton protein. Unfortunately, these observations have been made using rather high concn of cromolyn (50 to 200 uM), and their relationship to therapeutic response has yet to be established. For more Mechanism of Action (Complete) data for CROMOLYN (6 total), please visit the HSDB record page.

Pharmacodynamics

Cromoglicate or cromolyn (USAN), a synthetic compound, inhibits antigen-induced bronchospasms and, hence, is used to treat asthma and allergic rhinitis. Cromoglicate is used as an ophthalmic solution to treat conjunctivitis and is taken orally to treat systemic mastocytosis and ulcerative colitis.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.