When to use
Prophylaxis and treatment of allergic rhinitis including hay fever and that caused by other airborne allergens such as house dust mite and animal dander.
This medicine also provides symptomatic relief of sneezing, itchy and runny nose, itchy and watery eyes, nasal congestion and associated sinus discomfort.
Ingredients: Each spray contains: 50 micrograms of Fluticasone Propionate (0.05% w/w)
Other ingredients: Dextrose (anhydrous), Microcrystalline cellulose & Sodium carboxymethylcellulose, Phenylethyl alcohol, Benzalkonium chloride, Polysorbate 80, Dilute hydrochloric acid and Purified water.
Warnings & Precautions
• An abnormally heavy challenge of summer allergens may in certain instances require additional therapy.
• Local infection: Infections of nasal airways should be appropriately treated.
• Significant interactions between Fluticasone Propionate and potent inhibitors of the cytochrome P450 3A4 system
e.g : Ketoconazole and protease inhibitors such as ritonavir and cobicistat, may occur. This may result in increased systemic exposure to Fluticasone Propionate.
Before you take Otri-Allergy Aqueous Nasal spray:
a. Do not take Otri-Allergy Aqueous Nasal Spray in case of: Hypersensitivity to Fluticasone propionate or any other ingredients in this product.
b. Take special care with Otri-Allergy Aqueous Nasal Spray:
Treatment should be stopped, or the advice of a doctor sought if an improvement is not seen within 7 days.
This medicine should not be used for more than 3 months continuously without consulting a doctor..
• Care must be taken when withdrawing patients from systemic steroid treatment, and commencing therapy, if there is any reason to suspect that their adrenal function is impaired.
• Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression.
• Significant interactions between Fluticasone Propionate and potent inhibitors of the cytochrome P450 3A4 system e.g : Ketoconazole and protease inhibitors such as ritonavir and cobicistat, may occur.
This may result in increased systemic exposure to Fluticasone Propionate.
• Systemic effects of nasal corticosteroids have been reported particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Potential systemic effect may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (Particularly in children).
Medical advice should be sought before using this medicine in the case of:
1. concomitant use of other corticosteroid products, such as tablets, creams, ointments, asthma medications, similar nasal sprays or eye/nose drops
2. fever or an infection in the nasal passages or sinuses.
3. recent injury or surgery to the nose, or problems with ulceration in the nose.
• Visual disturbances may occur with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision, they should see an ophthalmologist. Possible causes may be cataract, glaucoma.
Warning about excipients:
This product contains Benzalkonium Chloride which may cause bronchospasm
c. Taking other medicines:
Low plasma concentrations of fluticasone propionate are achieved after intranasal dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4. Hence, significant drug interactions are unlikely.
• Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects.
• Other inhibitors of cytochrome P450 3A4 produce negligible (erythromycin) and minor (ketoconazole) increases in systemic exposure to fluticasone propionate without notable reductions in serum cortisol concentrations. Care is advised when co-administering potent inhibitors (e.g. ketoconazole).
• Ritonavir (a highly potent cytochrome P450 3A4 inhibitor) increased the fluticasone propionate plasma concentrations several hundred-fold, resulting in reduced serum cortisol concentrations. Cases of Cushing’s syndrome and adrenal suppression have been reported. The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.
d. Pregnancy and Breast feeding:
Medical opinion should be sought, before using this medicine, in the case of pregnancy or breast feeding.
• As with other drugs, the use of intranasal fluticasone propionate during pregnancy and lactation requires that the benefits be weighed against possible risks associated with the product or with any alternative therapy
e. Driving and using machines:
Unlikely to produce an effect.
Possible side effects:
System Organ |
Class Adverse Event |
Frequency |
| Immune system disorders |
Hypersensitivity reactions,
anaphylaxis/anaphylactic
reactions, bronchospasm,
skin rash, oedema
of the face or tongue |
Very rare |
| Nervous system, disorders |
Headache,
unpleasant taste,
unpleasant smell |
Common |
Eye disorders |
Glaucoma,
raised intraocular pressure,
cataract |
Very rare |
| Respiratory thoracic and mediastinal disorders |
Epistaxis |
Very common |
Nasal dryness,
nasal irritation,
throat dryness,
throat irritation |
Common |
Nasal septal perforation |
Very rare |
Overdose:
Administration of doses higher than those recommended over a long period of time may lead to temporary suppression of adrenal function.
In these patients, treatment with fluticasone propionate should be continued at a dose sufficient to control symptoms.
How to store OtriAllergy Aqueous Nasal Spray?
• Do not store above 30°C.
• Keep out of the reach and sight of children.
• Do not use this medicine after the expiry date, which is stated on the carton, inner label. The expiry date refers to the last day of that month.
