Registered Rwanda · Rwanda FDA

AUROCROME

Cromolyn sodium ophthalmic solution 2%w/v

Rwanda FDA-HMP-MA-0900 Ophthalmic Eye Drop 2%w/v alimentary tract and metabolism INN generic

What it does

Cromolyn is a medication used to prevent allergic reactions and asthma attacks by stabilizing mast cells and preventing the release of substances that cause inflammation.

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

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

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-0900
Registration date
22/02/2024
Expiry date
21/02/2029
Status
Registered
Active ingredient
Cromolyn sodium ophthalmic solution 2%w/v
Dosage form
Ophthalmic Eye Drop
Strength
2%w/v
Pack size
5ml Bottle
Therapeutic class
-
ATC class (WHO)
A07EB - Antiallergic agents, excl. corticosteroids
RxNorm RxCUI
42612
Manufacturer / MAH
Aurolab
Applicant / LTR
AUROLAB, INDIA
Country of origin
INDIA
Manufacturer location
No 1, Sivaganga Rd, Veerapanjan, Madurai, Tamil Nadu 625020, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:20 · updated 2026-09-21 02:30:20

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Cromolyn is a medication used to prevent allergic reactions and asthma attacks by stabilizing mast cells and preventing the release of substances that cause inflammation.

What it treats

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

How it works

Cromolyn works by blocking the release of certain chemicals in the body that can cause allergic reactions and inflammation, helping to keep airways open and reduce allergy symptoms.

Who it's for

Cromolyn is for people who suffer from asthma or allergies and need help preventing symptoms.

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

Clinical monograph: cromolyn

BNF-referenced

Cromolyn, also known as cromoglicate, is a synthetic compound primarily utilized for its anti-allergic properties. It acts as a mast cell stabilizer, preventing the release of histamine and other mediators involved in type I hypersensitivity reactions. Cromolyn is employed in the management of asthma, allergic rhinitis, and other allergic conditions, including conjunctivitis and systemic mastocytosis. Its role as an anti-inflammatory agent makes it a valuable treatment option for patients with allergic disorders.

Indications

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

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidelines in 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, which prevents the release of histamine and slow-reacting substance of anaphylaxis (SRS-A). It may also reduce the release of inflammatory leukotrienes by inhibiting calcium influx into mast cells. Cromolyn has been shown to suppress the activation effects of chemoattractant peptides on human leukocytes, thereby mitigating allergic responses.

Pharmacodynamics

Cromoglicate effectively inhibits antigen-induced bronchospasms and is beneficial in treating conditions such as asthma and allergic rhinitis. It is also used ophthalmically to treat conjunctivitis and orally for systemic mastocytosis and ulcerative colitis. The compound's efficacy relies on its ability to stabilize mast cells and prevent the release of pro-inflammatory mediators.

Pharmacokinetics

Cromolyn is poorly absorbed systemically when administered orally; hence, its effects are primarily localized to the site of administration. It is metabolized in the liver and excreted in urine. Pharmacokinetic properties may vary based on the route of administration, with inhaled forms providing targeted delivery to the respiratory tract.

Adverse effects

  • Cough
  • Throat irritation
  • Nausea
  • Headache

Precautions

  • Use with caution in patients with known hypersensitivity to cromolyn.
  • Monitor patients for worsening asthma symptoms.

Pregnancy

Cromolyn is classified as category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women.

Breast-feeding

Cromolyn is excreted in breast milk, but the effects on the nursing infant are unknown. Caution should be exercised when administering to a nursing mother.

Storage

Store below 25 degrees Celsius. Protect from light and moisture.

Formulations

  • Inhalation solution
  • Ophthalmic solution
  • Oral 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: cromolyn

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.