DECOZAL 0.1% NASAL SPRAY COLDS 10ML

Indications

Approved Uses

Short-term symptomatic relief of nasal congestion associated with the common cold, allergic rhinitis (including hay fever), and sinusitis.

Dosage & Administration

Dosing by Condition

Nasal congestion (adults and children ≥12 years for 0.1%): 1 spray in each nostril up to 2-3 times daily (about every 8-10 hours); do not exceed 3 doses in 24 hours and do not use >3-5 consecutive days.

Initial Dose

1 spray in each nostril.

Maintenance Dose

1 spray in each nostril every 8-10 hours as needed.

Maximum Dose

3 applications per nostril per day; maximum 5 consecutive days of use

Children's Dosage

0.1% concentration: Not recommended for children under 12 years. Children 12 years and older: 1 spray per nostril up to 3 times daily.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; do not use continuously for more than 3-5 days to reduce risk of rebound congestion.

Side Effects

Common Side Effects

Transient nasal burning/stinging, nasal dryness/irritation, sneezing; rebound congestion (rhinitis medicamentosa) with prolonged or excessive use.

Side Effect Frequency

Common (≥1% to <10%): nasal dryness/irritation (burning/stinging), sneezing; Uncommon (≥0.1% to <1%): epistaxis, hypersensitivity reactions; Frequency/likelihood increases with prolonged use: rebound congestion (rhinitis medicamentosa); Rare: systemic sympathomimetic effects such as palpitations/tachycardia, increased blood pressure, headache, nausea, insomnia.

Safety & Warnings

Contraindications

Hypersensitivity to xylometazoline/excipients; rhinitis sicca (dry rhinitis); narrow-angle/angle-closure glaucoma; concomitant use with MAO inhibitors or within 14 days of stopping; after trans-sphenoidal hypophysectomy or other nasal surgery exposing the dura mater.

Warnings & Precautions

Do not use longer than 5-7 consecutive days; use with caution in hypertension/cardiovascular disease, hyperthyroidism, diabetes, and prostatic hypertrophy; avoid eyes; do not share the bottle to reduce cross-infection risk.

Age Restriction

0.1% xylometazoline nasal spray: for adults and adolescents ≥12 years; not recommended for children <12 years (use pediatric 0.05% if appropriate).

Driving Warning

Safe

Drug Interactions

Drug Interactions

MAO inhibitors (and within 14 days of stopping) and tricyclic antidepressants (potentiated pressor effects); other sympathomimetics (additive cardiovascular effects).

Interaction Severity

MAJOR: Concomitant or recent (within 14 days) MAO inhibitors-risk of hypertensive reaction. MODERATE: Tricyclic antidepressants and other drugs that increase sympathetic tone (potential pressor effects). CAUTION: Other topical nasal decongestants (additive local/systemic sympathomimetic effects).

Food Interaction

No clinically relevant food interactions.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Children

0.1% concentration: Not recommended for children under 12 years. Children 12 years and older: 1 spray per nostril up to 3 times daily.

Elderly

Use with caution due to increased risk of cardiovascular effects and prostatic hypertrophy; standard adult dosing applies but use the lowest effective dose

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Stopping the Medicine

Can be stopped at any time; limit use to ≤5-7 days to prevent rebound congestion, and if rebound occurs after prolonged use, stop and consider saline/intranasal steroid support as needed.

Overdose

Overdose/accidental ingestion (especially in children) may cause CNS depression (somnolence/coma), respiratory depression, bradycardia or tachycardia, hypertension followed by hypotension, hypothermia; management is supportive and urgent medical evaluation is required.

Patient Counseling

Use 0.1% only as directed (typically 1 spray per nostril up to 2-3 times daily; max 3 doses/24 h). Do not use longer than 3-5 consecutive days to avoid rebound congestion. Do not share the bottle; clean the nozzle after use. Seek medical advice before use if you have uncontrolled hypertension/heart disease, hyperthyroidism, diabetes, glaucoma, or are taking MAOIs/TCAs; stop and seek care if palpitations, severe headache, dizziness, or persistent/worsening symptoms occur.

Monitoring Requirements

No routine monitoring

Pharmacology

Mechanism of Action

Stimulates alpha-adrenergic receptors in the nasal mucosa causing vasoconstriction, which reduces mucosal edema and nasal congestion.

Onset of Action

Within about 5-10 minutes.

Duration of Effect

Approximately 6-10 hours (often cited up to ~10 hours).

Bioavailability

Low/minimal systemic absorption after intranasal use at recommended doses (primarily local effect).

Metabolism

Not well characterized/limited data; any absorbed fraction is expected to undergo typical systemic metabolism, but clinically the effect is mainly local.

Product Information

Available Dosage Forms

Nasal spray, nasal drops

Generic Availability

Yes

OTC Alternatives

Saline nasal spray/irrigation; intranasal oxymetazoline; intranasal phenylephrine; (where appropriate) oral pseudoephedrine.

Symptom Target

Congestion

Sedating

No

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