Antazol Plus

Antazol Plus is a combination nasal spray that pairs a mast cell stabilizer with a topical decongestant for the management of allergic rhinitis (hay fever), combining rapid symptomatic relief with prophylactic control of the underlying allergic response.

Established / labeled uses

• Symptomatic and prophylactic treatment of seasonal and perennial allergic rhinitis, including sneezing, nasal itching, rhinorrhea (runny nose), and nasal congestion.
• Short-term relief of nasal blockage associated with allergic rhinitis where rapid decongestion is needed alongside regular anti-allergic (mast-cell stabilizing) therapy.

Adjunct / combination-dependent use

Antazol Plus is generally used as a short course at the start of an allergic rhinitis flare, or intermittently alongside other maintenance anti-allergic therapy (e.g., intranasal corticosteroids or oral antihistamines) when a physician determines additional short-term decongestion is required. It is not intended as a substitute for first-line, long-term allergic rhinitis therapy.

This product is not indicated for the common cold, sinusitis, or nasal congestion unrelated to allergy, and is not recommended for continuous long-term use because of its decongestant component (see Duration of Treatment and Precautions and Warnings).

Sodium Cromoglicate + Xylometazoline Hydrochloride nasal spray typically contains Sodium Cromoglicate 2% w/v (20 mg/mL) and Xylometazoline Hydrochloride 0.025% w/v (0.25 mg/mL) as the active ingredients in an aqueous nasal spray base, along with pharmaceutically acceptable preservatives and excipients. Exact strengths may vary slightly by manufacturer; refer to the product label/pack insert for the specific formulation dispensed.

Antazol Plus is a fixed-dose combination nasal spray formulated for allergic rhinitis. It brings together two complementary mechanisms in a single delivery device: Sodium Cromoglicate, a mast cell stabilizer that reduces the release of histamine and other inflammatory mediators when used regularly, and Xylometazoline Hydrochloride, a fast-acting topical alpha-adrenergic decongestant that shrinks swollen nasal blood vessels to relieve congestion within minutes.

The combination is designed to give patients rapid symptomatic relief from nasal blockage while the mast cell stabilizer component works over subsequent days to dampen the allergic inflammatory response, thereby reducing overall symptom burden with continued, regular, but time-limited use.

Antazol Plus belongs to a combination therapeutic class of anti-allergic mast cell stabilizers (Sodium Cromoglicate) and topical nasal decongestants (imidazoline-derivative alpha-adrenergic agonists) (Xylometazoline Hydrochloride), formulated together for allergic rhinitis.

Sodium Cromoglicate + Xylometazoline Hydrochloride combines two active ingredients with distinct and complementary mechanisms of action:

Sodium Cromoglicate (mast cell stabilizer)

Sodium Cromoglicate inhibits degranulation of sensitized mast cells following exposure to allergens, preventing the release of histamine, leukotrienes, and other inflammatory mediators that trigger allergic rhinitis symptoms. Its effect is prophylactic rather than immediate; maximal benefit generally requires regular, sustained use, and it does not reverse congestion or symptoms that have already developed.

Xylometazoline Hydrochloride (topical decongestant)

Xylometazoline Hydrochloride is a direct-acting alpha-adrenergic agonist that constricts dilated arterioles in the nasal mucosa, reducing mucosal blood flow and oedema. This produces rapid (within minutes) but temporary relief of nasal congestion. Its effect is purely symptomatic and does not address the underlying allergic process.

Used together, the combination provides fast decongestant relief alongside slower-onset prophylactic control of allergic nasal inflammation.

Antazol Plus is for intranasal use only.

• Blow the nose gently to clear the nasal passages before use.
• Shake the bottle and prime the pump (spray into the air away from the face) before the first use or after a period of non-use, per the pack insert.
• Tilt the head slightly forward, insert the nozzle tip into one nostril, and close the other nostril with a finger.
• Spray while breathing in gently through the nose; avoid tilting the head back to reduce swallowing of the drug into the throat.
• Repeat in the other nostril as directed.
• Wipe the nozzle clean after use and keep it capped. Do not share the nasal spray bottle with other people, to avoid spreading infection.

Clinically significant interactions with Antazol Plus relate mainly to its xylometazoline (decongestant) component; sodium cromoglicate has minimal systemic absorption and few known clinically significant drug interactions.

• Monoamine oxidase inhibitors (MAOIs): Concurrent use, or use within about 2 weeks of stopping an MAOI, can precipitate a hypertensive crisis due to enhanced sympathomimetic effect; this combination should be avoided (see Contraindications).
• Other sympathomimetic agents/decongestants (oral or nasal, e.g., pseudoephedrine, other imidazoline decongestants): Concurrent use may have additive cardiovascular effects (raised blood pressure, increased heart rate); avoid combining unless advised by a physician.
• Tricyclic antidepressants and other agents that potentiate pressor (blood-pressure-raising) effects: May enhance the cardiovascular effects of the xylometazoline component; use with caution.

Most side effects of Antazol Plus relate to local nasal irritation or to systemic absorption of the decongestant component with prolonged/excessive use.

Prolonged use beyond the recommended duration can cause rhinitis medicamentosa (rebound congestion); see Precautions and Warnings and Duration of Treatment.

Data on the use of Antazol Plus during pregnancy and lactation are limited. As a precaution, Antazol Plus should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should be consulted before use. Similarly, breastfeeding mothers should consult a physician before using Antazol Plus, and if use is advised, it should be limited to the lowest effective dose for the shortest necessary duration, since systemic absorption of the decongestant component may occur.

Antazol Plus should be used with the following precautions:

• Duration of use: Do not use continuously for more than 5–7 days, as this can cause rebound nasal congestion (rhinitis medicamentosa) that worsens on stopping the spray (see Duration of Treatment).
• Cardiovascular disease/hypertension: Use with caution in patients with heart disease, high blood pressure, or arrhythmias, as systemic absorption of the decongestant component can raise blood pressure and heart rate.
• Hyperthyroidism and diabetes mellitus: Use with caution, as sympathomimetic effects may be exaggerated.
• Prostatic hypertrophy: Use with caution due to potential effects on urinary retention from sympathomimetic activity.
• Avoid concurrent use of other nasal or oral decongestants unless directed by a physician (see Interactions).
• Discontinue and consult a physician if symptoms do not improve within the recommended treatment period, or if irritation, nosebleeds, or worsening congestion occur.
• For nasal use only; avoid contact with the eyes.
• Do not share the nasal spray bottle with other people.

Overdose of Antazol Plus, particularly from swallowing the contents of the bottle (especially in children), can cause exaggerated sympathomimetic effects such as marked drowsiness or, paradoxically, central nervous system stimulation, rapid or irregular heartbeat, significant changes in blood pressure, sweating, and, in severe cases, seizures or coma. If overdose is suspected, seek immediate medical attention or contact a poison control center/emergency services right away; do not attempt to manage a suspected overdose at home without professional medical guidance. Keep the product out of the reach of children at all times.

Store at room temperature (below 30°C), away from light and moisture. Keep the bottle tightly closed when not in use. Keep out of reach of children.

• Pregnancy and lactation: Use only if clearly needed, under medical advice (see Pregnancy and Lactation).
• Pediatric patients: Not recommended below the minimum age stated on the product label; safety and efficacy of Antazol Plus have not been established in young children (see Pediatric Uses).
• Elderly: May be more sensitive to the cardiovascular effects of the decongestant component; use the lowest effective dose and monitor for side effects.
• Renal or hepatic impairment: Specific dose-adjustment data are not well established; use with caution and under medical supervision given the systemic sympathomimetic effects possible with the decongestant component.
• Cardiovascular disease, hyperthyroidism, diabetes, or prostatic hypertrophy: Use with caution (see Precautions and Warnings).

Antazol Plus should generally be used for short courses only, typically not exceeding 5–7 consecutive days, because of the risk of rebound congestion (rhinitis medicamentosa) from the decongestant component. If ongoing prophylactic control of allergic rhinitis is needed beyond this period, a physician should be consulted about continuing with a decongestant-free anti-allergic regimen (e.g., sodium cromoglicate alone, an intranasal corticosteroid, or an antihistamine) rather than prolonging use of the combination product.

Mast cell stabilizer (anti-allergic agent) combined with an imidazoline-derivative topical nasal decongestant (alpha-adrenergic agonist).

Sodium Cromoglicate + Xylometazoline Hydrochloride acts through two complementary mechanisms: Sodium Cromoglicate stabilizes mast cell membranes, preventing degranulation and release of histamine and other mediators that drive allergic rhinitis symptoms, providing prophylactic benefit with regular use. Xylometazoline Hydrochloride directly stimulates alpha-adrenergic receptors in nasal blood vessels, causing vasoconstriction that rapidly reduces mucosal swelling and nasal congestion. Together, they provide both quick symptomatic decongestion and longer-term reduction of the allergic inflammatory response.

The safety and efficacy of Antazol Plus have not been well established in young children, largely because of the systemic absorption risk of the xylometazoline (decongestant) component. Use in children is generally restricted to the minimum age stated on the specific product label, and Antazol Plus should not be used in infants or very young children. Where use is considered appropriate for an older child, it should be at the lowest effective dose, for the shortest necessary duration, and only under medical advice. Parents/caregivers should never exceed the recommended dose or frequency in children, given the risk of serious systemic decongestant toxicity with overdose (see Overdose Effects).