Composition :
Each spray contains: Triamcinolone Acetonide 55 mcg
Pharmacodynamic properties:
Triamcinolone acetonide is a Corticosteroid with potent anti-inflammatory properties; elicits effects on various cells, including mast cells and eosinophils; also elicits effects on inflammatory mediators (eg, histamine, eicosanoids, leukotrienes, cytokines).
Product does not have an immediate effect on allergic signs and symptoms. An improvement in some patient symptoms may be seen within the first day of treatment and relief may be expected in 3 to 4 days. When product is prematurely discontinued symptoms may not recur for several days.
In clinical studies performed in adults and children 6 years of age and above at doses up to 440 mcg/day intranasally, and in children 2 to 5 years of age at 110 μg/day intranasally, no suppression of the Hypothalamic-Pituitary-Adrenal (HPA axis has been observed).
Pharmacokinetics:
Absorption : Minimal systemic absorption occurs, mostly by small amount swallowed during nasal administration.
Indications:
It is indicated for the treatment of symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and over.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients.
Warnings and precautions:
- If there is any reason to suppose that adrenal function is impaired, care must be taken while transferring patients from systemic steroid treatment to intranasal .
- The development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. When such an infection develops it may require treatment with appropriate local therapy and temporary discontinuation of treatment with product.
- Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery or trauma, it should be used with caution until healing has occurred.
- Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects 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 behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
- Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence of using higher than recommended doses then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
- close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.
- If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
- product contains benzalkonium chloride, long term use may cause oedema of the nasal mucosa.
Pediatric population:
product is not recommended for use in children under 2 years of age.
Reduction in growth velocity has been reported in children receiving nasal corticosteroids.
It is recommended that the height of children receiving treatment with nasal corticosteroids is regularly monitored. Therapy should be managed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. The long-term effects of reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height are unknown. In addition, consideration should be given to referring the patient to a paediatric specialist, especially for children under the age of 6 years this is strongly recommended.
Adverse Reactions:
• Infections and infestations
Common: flu syndrome, pharyngitis, rhinitis
• Immune system disorders
Not known: hypersensitivity (including rash, urticaria, pruritus and facial oedema)
• Psychiatric disorders
Not known: insomnia
• Nervous system disorders
Common: headache
Not known: dizziness, alterations of taste and smell
• Eye disorders
Not known: chorioretinopathy, cataract, glaucoma, increased ocular pressure, blurred vision .
• Respiratory, thoracic and mediastinal disorders
Common: bronchitis, epistaxis, cough
Rare: nasal septum perforations
Not known: nasal irritation, dry mucous membrane, nasal congestion, sneezing, dyspnoea
• Gastrointestinal disorders
Common: dyspepsia, tooth disorder
Not known: nausea
• General disorders and administration site conditions
Not known: fatigue
• Investigations
Not known: decreased blood cortisol
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. Growth retardation has been reported in children receiving intranasal steroids.
Drug Interactions:
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Pregnancy & Breast-feeding:
Pregnancy Category: C
Clinical experience in pregnant women is limited. In animal studies, corticosteroids have been shown to induce teratogenic effects.
Triamcinolone acetonide may pass into human breast milk.
Triamcinolone acetonide should not be administered during pregnancy or lactation unless the therapeutic benefit to the mother is considered to outweigh the potential risk to the fetus/baby.
Dosage and method of administration:.
Adults:
The recommended starting dose is 220 micrograms as 2 sprays in each nostril once daily. Once symptoms are controlledpatients can be maintained on 110 micrograms (1 spray in each nostril once daily).
Paediatric population:
Children aged 12 years and over: The recommended starting dose is 220 micrograms as 2 sprays in each nostril once daily. Once symptoms are controlled patients can be maintained on 110 micrograms (1 spray in each nostril once daily).
Children aged 6 to 12 years: The recommended dose is 110 micrograms as 1 spray in each nostril once daily. In patients with more severe symptoms, a dose of 220 micrograms may be used. But once symptoms are controlled, patients should be maintained on the lowest effective dose.
Children aged 2 to 5 years: The recommended and maximum dose is 110 micrograms as 1 spray in each nostril once daily .
Continuous use beyond 3 months in children under 12 years is not recommended
Method of administration :
This product is for nasal use only.
Suspension; shake well before use
Before using for first time, prime pump by releasing 5 sprays into air away from face.
If not used for >2 weeks, repeat priming by releasing 1 spray into air before using.
Overdose:
Like any other nasally administered corticosteroid, acute overdosing is unlikely in view of the total amount of active ingredient present. In the event that the entire contents of the bottle were administered all at once, via either oral or nasal application, clinically significant systemic adverse events would most likely not result. The patient may experience some gastrointestinal upset if taken orally.
Don’t use after 4 weeks of first opening