Azelastine Hydrochloride nasal spray is an H1-receptor antagonist indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children aged 5 years and above, as well as for vasomotor rhinitis in adults and adolescents aged 12 years and older.

Azelastine Hydrochloride eye drops are indicated for the treatment and prevention of symptoms of seasonal allergic conjunctivitis in adults and children aged 4 years and above, and for the treatment of perennial (non-seasonal) allergic conjunctivitis in adults and children aged 12 years and older.

Azelaic acid demonstrates antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. This effect is primarily due to inhibition of microbial protein synthesis. Additionally, azelaic acid helps normalize keratinization, producing an anticomedonal effect that contributes to its overall therapeutic action.

Azelastine eye drops contain azelastine hydrochloride, an antiallergic (antihistamine) agent. It works by blocking the effects of histamine, a substance released during allergic reactions, thereby reducing symptoms and inflammation in the eye. Azelastine is a phthalazinone derivative and acts as a potent, long-acting selective H1-receptor antagonist. In addition to its antihistamine effect, it also exhibits anti-inflammatory properties when applied topically.

Both in vitro and in vivo studies have demonstrated that azelastine inhibits the synthesis and release of various mediators involved in allergic responses, including histamine, leukotrienes, platelet-activating factor (PAF), and serotonin.

Nasal Spray

Seasonal Allergic Rhinitis: The recommended dosage of Azelastine Nasal Spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of Azelastine Nasal Spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.

Vasomotor Rhinitis: The recommended dosage of Azelastine Nasal Spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily. Administer Azelastine Nasal Spray by the intranasal route only.

Priming: Prime Azelastine Nasal Spray before initial use by releasing 4 sprays or until a fine mist appears. When Azelastine Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azelastine Nasal Spray into the eyes.

Eye drop-

Seasonal allergic conjunctivitis: The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. If allergen exposure is anticipated Azelastine hydrochloride Eye drops, solution should be administered prophylactically, prior to the exposure.

Non-seasonal (perennial) allergic conjunctivitis: The usual dosage in adults and children 12 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily.

As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks. Patients should be advised to contact their doctor if symptoms worsen or do not improve after 48 hours.

Administration
How to use the Nasal Spray

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as followsRemove the dust cover.

• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Caution is advised when using Azelastine nasal spray together with alcohol, central nervous system (CNS) depressants, cimetidine, or ketoconazole, as these combinations may alter its effects or increase side effects.

Azelastine is contraindicated in patients with known hypersensitivity to azelastine or any of its formulation ingredients.

Common adverse effects include headache, dizziness, sneezing, nasal bleeding, nausea, nasal irritation (stinging or itching), dry mouth, sore throat, and a bitter taste.

The safety of azelastine during pregnancy has not been fully established. It should be used only if the potential benefit outweighs the possible risk to the fetus. It is not known whether azelastine is excreted in human breast milk; therefore, caution is advised when used in breastfeeding mothers.

Some patients may experience drowsiness while using azelastine nasal spray. Therefore, caution should be taken when driving or operating machinery. Concurrent use with alcohol or other CNS depressants should be avoided, as it may further reduce alertness and impair CNS function.

Pediatric Use: The safety and effectiveness of azelastine nasal spray have not been established in children under 5 years of age.

Nasal antihistamine preparations.

Store in a cool and dry place, protected from light. Keep out of reach of children. Do not freeze.