Sodium Cromoglicate + Xylometazoline Hydrochloride

Approved Indications:

• Allergic Rhinitis (Seasonal or Perennial): Indicated for the symptomatic relief of nasal congestion, sneezing, nasal itching, and rhinorrhea.
• Vasomotor Rhinitis (Non-Allergic Rhinitis): Used to manage nasal hyperreactivity with congestion and rhinorrhea.
• Nasal Congestion due to Common Cold or Sinusitis: Provides decongestant effect in upper respiratory tract infections.
• Preventive Management of Nasal Allergy: Sodium cromoglicate prevents recurrence of symptoms with regular use.

Clinically Accepted Off-Label Uses:

• Adjunctive treatment in mild nasal polyposis to reduce inflammation and allergic triggers.
• Post-surgical nasal inflammation to minimize recurrence of congestion and allergic irritation.

Route of Administration: Intranasal (nasal spray only)

Adults and Adolescents (≥12 years):

• 1 spray in each nostril, 2 to 4 times daily.
• Maximum: Do not exceed 3 sprays per nostril per day.
• Limit use of xylometazoline component to 7 consecutive days.

Children (6 to 11 years):

• 1 spray in each nostril, up to twice daily, under adult supervision.
• Duration: Do not exceed 5 to 7 days of continuous use.

Elderly Patients:

• Use cautiously due to the potential for systemic absorption of xylometazoline, which may affect blood pressure or cardiovascular function.

Renal or Hepatic Impairment:

• No dose adjustment required, but avoid prolonged use due to lack of long-term safety data.

Administration Tips:

• Gently blow nose before application.
• Shake bottle well before each use.
• Insert nozzle into nostril and spray while inhaling gently.
• Avoid tilting head backward.
• Do not share the bottle to avoid cross-infection.

Sodium Cromoglicate acts by stabilizing mast cells in the nasal mucosa, thereby inhibiting the release of histamine and other inflammatory mediators such as leukotrienes and prostaglandins. This prevents the early and late phases of allergic responses, reducing hypersensitivity and inflammation.
Xylometazoline Hydrochloride is a direct-acting alpha-adrenergic agonist. It induces vasoconstriction of the arterioles in the nasal mucosa, leading to decreased blood flow, reduced swelling, and relief from nasal congestion. The combination offers both preventive control (cromoglicate) and rapid symptom relief (xylometazoline).

Sodium Cromoglicate:

• Absorption: Minimal systemic absorption via intranasal route.
• Bioavailability: Very low (<5%)
• Distribution: Primarily local action on nasal mucosa.
• Metabolism: Not significantly metabolized.
• Excretion: Mostly unchanged via feces and urine.
• Half-life: Approximately 1.5 hours (if absorbed systemically)

Xylometazoline Hydrochloride:

• Absorption: Rapid local absorption; systemic absorption is possible with overuse.
• Onset of Action: Within 5 to 10 minutes.
• Duration of Action: Up to 10 hours.
• Metabolism: Partially metabolized in the liver.
• Half-life: 2 to 3 hours (systemic circulation).
• Excretion: Renal

Pregnancy:

• No official FDA category; use with caution.
• Sodium Cromoglicate: Considered safe due to poor systemic absorption.
• Xylometazoline Hydrochloride: Use only when benefits outweigh risks. Prolonged use may impair placental blood flow due to vasoconstriction.

Lactation:

• Likely safe during breastfeeding.
• Sodium Cromoglicate: Minimal to no excretion in breast milk.
• Xylometazoline Hydrochloride: Systemic exposure low, but caution is advised due to possible infant side effects (e.g., irritability).
• Short-term use preferred.

• Sodium Cromoglicate: Mast Cell Stabilizer / Anti-Allergic Agent
• Xylometazoline Hydrochloride: Nasal Decongestant / Sympathomimetic Alpha-Adrenergic Agonist

• Known hypersensitivity to sodium cromoglicate, xylometazoline, or any excipients.
• Narrow-angle glaucoma.
• Recent nasal surgery or trauma.
• Atrophic rhinitis (rhinitis sicca).
• Concurrent use or recent use (within 14 days) of monoamine oxidase inhibitors (MAOIs).
• Children under 6 years of age (formulation-specific restriction).

• Risk of rhinitis medicamentosa with prolonged use of xylometazoline (>7 days).
• Use with caution in:
• Hypertension
• Hyperthyroidism
• Diabetes mellitus
• Coronary artery disease
• Prostatic hypertrophy
• Monitor elderly patients closely due to higher cardiovascular sensitivity.
• Avoid eye exposure.
• Discontinue if symptoms worsen or persist beyond recommended duration.

Common Side Effects:

• Local (Nasal): Burning, dryness, irritation, sneezing, nasal discomfort
• Systemic: Headache, transient dizziness

Less Common or Serious Effects:

• Palpitations
• Hypertension
• Tachycardia
• Rebound congestion (with extended use of xylometazoline)
• Epistaxis (nosebleeds)
• Restlessness or insomnia (particularly in children)

• MAO Inhibitors (e.g., phenelzine, tranylcypromine): May lead to hypertensive crisis when combined with xylometazoline.
• Tricyclic Antidepressants (e.g., amitriptyline): Enhance vasoconstrictive action.
• Other Sympathomimetic Drugs: Additive cardiovascular stimulation.
• Antihypertensives (e.g., beta-blockers): May reduce the effectiveness of blood pressure control.
• CYP450 metabolism is minimal; however, avoid concurrent drugs affecting sympathetic tone.

• No major regulatory updates in indication or safety as of recent reviews.
• Guidelines from ENT and allergy associations recommend short-duration use of nasal decongestants.
• Sodium cromoglicate remains widely recommended as a preventive agent in allergic rhinitis, especially in pediatric and mild cases.
• Emphasis continues on avoiding prolonged use of topical vasoconstrictors due to rebound risks.

• Temperature: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C.
• Light: Protect from light.
• Humidity: Store in a dry place.
• Freezing: Do not freeze.
• Handling: Shake before use.
• Shelf-Life After Opening: Discard the bottle 4 weeks after opening, even if unused.