Nasacort AQ

Nasacort AQ

triamcinolone acetonide

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Contents
Triamcinolone acetonide.
Description
Each actuation delivers 55 micrograms of triamcinolone acetonide. The active ingredient of Nasacort is triamcinolone acetonide. Bottles of Nasacort contain either 6.5g or 16.5g suspension (with 3.575 mg or 9.075 mg triamcinolone acetonide respectively).
The active ingredient is an anti-allergic corticosteroid.
Nasacort is supplied as an unscented, thixotropic suspension of microcrystalline triamcinolone acetonide in an aqueous medium, contained in a 20 ml high density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. Bottle of Nasacort contain either 6.5 g or 16.5 g of suspension, providing 30 or 120 actuations respectively.
Each actuation delivers 55 micrograms triamcinolone acetonide from the nosepiece to the patient after initial priming.
Excipients/Inactive Ingredients: The inactive ingredients are: microcrystalline cellulose, carmellose sodium, polysorbate 80, purified water, glucose anhydrous, benzalkonium chloride, edetate disodium and hydrochloric acid or sodium hydroxide (for adjustment of pH).
Action
Pharmacotherapeutic Group: nasal corticosteroid. ATC Code: R 01 AD.
Pharmacology: Pharmacodynamics: Mechanism of action: Triamcinolone acetonide is a more potent derivative of triamcinolone and is approximately 8 times more potent than prednisone. Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids are very effective in the treatment of allergic diseases in man.
Pharmacodynamic effects: Nasacort does not have any immediate effect on allergic signs and symptoms. An improvement in some patient symptoms may be seen within the first day of treatment with Nasacort and relief may be expected in 3 to 4 days. When Nasacort is prematurely discontinued symptoms may not recur for several days.
In clinical studies performed in adults and children at doses up to 440 mcg/day intranasally, no suppression of the Hypothalamic-Pituitary-Adrenal (HPA) axis has been observed.
In pediatric patients 2 to 5 years of age (n = 61) receiving triamcinolone acetonide 110 micrograms per day intranasally, HPA axis function was assessed by cosyntropin stimulation test; however, the results were inconclusive.
In a six-week placebo-controlled clinical study evaluating the effect of NASACORT (once-daily dose of 110 micrograms or 220 micrograms) on HPA axis function (as measured by 24-hour serum cortisol AUC) in 140 children (2 to 11 years of age), no statistically significant difference from placebo was observed.
An effect of NASACORT on adrenal function in children 2 to 5 years age group cannot be ruled out.
A one-year double-blind, placebo-controlled parallel group study in 298 treated pediatric patients (3 to 9 years of age) was conducted to assess the effect of NASACORT (once-daily dose of 110 micrograms) on growth velocity using stadiometry. From the primary analysis of evaluable patients (134 NASACORT and 133 placebo), the estimated growth velocity in the NASACORT group was 0.45 cm/year lower than that in the placebo group with 95% CI ranging between 0.11 to 0.78 cm/year lower than placebo. Difference between treatment groups started within 2 months of drug initiation. After stopping treatment during the 2-month follow-up period it was observed that the mean growth velocity in the treatment group returned to baseline (pre-treatment) values.
Pharmacokinetics: Single dose intranasal administration of 220 micrograms of Nasacort in normal adult subjects and in adult patients with allergic rhinitis demonstrated low absorption of triamcinolone acetonide. The mean peak plasma concentration was approximately 0.5 ng/ mL (range 0.1 to 1 ng/mL) and occurred at 1.5 hours post dose. The mean plasma drug concentration was less than 0.06 ng/mL at 12 hours and below the assay detection limit at 24 hours. The average terminal half-life was 3.1 hours. Dose proportionality was demonstrated in normal subjects and in patients following a single intranasal dose of 110 micrograms or 220 micrograms Nasacort. Following multiple doses in pediatric patients, plasma drug concentrations, AUC, Cmax and Tmax were similar to those values observed in adult patients.
Paediatric patients: Intranasal administration of NASACORT Aqueous nasal spray 110 mcg once daily in pediatric patients 2 to 5 years of age exhibited similar systemic exposure to that achieved in adult patients 20 to 49 years of age with an intranasal administration of NASACORT nasal spray at a dose of 220 mcg once daily. Based on the population pharmacokinetic modeling, the apparent clearance and volume of distribution following intranasal administration of NASACORT in pediatric patients 2 to 5 years of age were found to be approximately half of that in adults.
Toxicology: Preclinical Safety Data: In pre-clinical studies, only effects typical of glucocorticoids were observed. Like other corticosteroids, triamcinolone acetonide (administered by inhalation or other routes) has been shown to be teratogenic in rats and rabbits, resulting in cleft palate and/ or internal hydrocephaly and axial skeletal defects. Teratogenic effects, including CNS and cranial malformations, have also been observed in non-human primates.
No evidence of mutagenicity was detected in in-vitro gene mutation test. Carcinogenicity assays in rodents show no increase in the incidence of individual tumour types.
Indications/Uses
Nasacort AQ Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older.
Dosage/Direction for Use
Nasacort is for nasal use only.
Patients aged 12 years and older: the recommended starting dose is 220 mcg as 2 sprays in each nostril, once daily. Once symptoms are controlled patients can be maintained on 110 mcg (1 spray in each nostril, once daily).
Children aged 6-12 years: the recommended dose is 110 mcg as 1 spray in each nostril, once daily. In patients with more severe symptoms, a dose of 220 mcg may be used. But once symptoms are controlled, patients should be maintained on the lowest effective dose.
Children 2 to 5 years of age: The recommended and maximum dose is 110 mcg per day given as one spray in each nostril once daily.
An improvement in some patients symptoms may be seen within the first day of treatment, and generally, it takes one week of treatment to reach maximum benefit. Initial assessment for response should be made during this time frame and periodically until the patient's symptoms are stabilized. If adequate relief of symptoms has not been obtained after 3 weeks of treatment, Nasacort AQ Nasal Spray should be discontinued.
Nasacort AQ Nasal Spray is not recommended for children under 2 years of age.
Method of administration: Before using Nasacort blow the nose gently to clear the nostrils.
1. Remove the cap by pulling upwards. Shake bottle gently before use.
2. The first time the patient use the nasal spray, hold the bottle upright and fill the pump by pressing the nozzle downwards and releasing it 5 times, until a fine spray is produced. The pack is now ready to use.
3. Close one nostril with a finger. Hold the bottle upright and insert the nozzle into the nostril as far as is comfortable. Whilst breathing in gently through the nose with the mouth closed, press the bottle upwards once to deliver one spray.
4. Breathe out through the mouth.
5. Repeat steps 3 and 4 if the patient has to spray again in the same nostril and for the other nostril.
6. For patients aged 12 years and older, steps 3, 4 and 5 should be repeated once more to achieve the recommended dosage of 2 sprays into each nostril.
7. To keep the spray nozzle clean, wipe it with a tissue after each use. Replace the cap over the nozzle. If the nasal spray has not been used for 2 weeks or more than it needs to be sprayed once the air before use.
Also the bottle should be discarded after 30 actuations or within one month of starting treatment (6.5g pack), or after 120 actuations or within 2 months of starting treatment (16.5g pack). Do not transfer any remaining suspension to another bottle.
Always shake the bottle before use.
Overdosage
Like any other nasally administered corticosteroid, acute overdosing with Nasacort 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.
Contraindications
Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
Special Precautions
If there is any reason to suppose that adrenal function is impaired, care must be taken while transferring patients from systemic treatment to Nasacort.
In clinical studies with Nasacort administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. When such as infection develops in may require treatment with appropriate local therapy and temporary discontinuance of treatment with Nasacort.
Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery of trauma, Nasacort 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 behavioural 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 for higher than recommended doses being used than additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Glaucoma and/or cataracts have been reported in patients receiving nasal corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.
NASACORT contains benzalkonium chloride, an irritant, which may cause skin reactions.
Paediatric population: As experienced with Nasacort in children under 2 years of age is limited, use in this age group is not recommended.
Reduction in growth velocity has been reported in children receiving nasal corticosteroids, including NASACORT at licensed doses. 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. In addition, consideration should be given to referring the patient to a paediatric specialist.
The long-term effects of reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height are unknown.
Effects on Ability to Drive and Use Machines: Nasacort has no or negligible influence on the ability to drive and operate machines.
Use In Pregnancy & Lactation
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 be administered during pregnancy or lactation unless the therapeutic benefit to the mother is considered to outweigh the potential risk to the foetus/baby.
Adverse Reactions
The adverse events reported in clinical trials with NASACORT most commonly involved the mucous membranes of the nose and throat. The following terminologies have been used in order to classify the occurrence of adverse reactions: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥ 1/1,000 and < 1/100; Rare ≥ 1/10,000 and <1/1,000; Very rare < 1/10,000 and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The most frequent adverse reactions in adults and children 6 years of age and older were: 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: cataract, glaucoma, increased ocular pressure.
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.
Reduction of growth velocity has been observed in children during a post-marketing clinical trial with NASACORT.
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.
Additional Adverse Reactions for Children 2 to 5 years: Respiratory, thoracic and mediastinal disorders: Common: Pharyngolaryngeal pain.
Skin and subcutaneous tissue disorders: Common: Excoriation.
Gastrointestinal disorders: Common: Upper abdominal pain, diarrhea.
Drug Interactions
No interactions with other medicaments are known.
Storage
Store below 25°C.
Shelf-Life: The shelf life of Nasacort is 24 months.
The shelf-life after the bottle is first opened is 1 month for the 6.5g (30 actuation) pack, or 2 months for the 16.5g (120 actuation) pack.
ATC Classification
R01AD11 - triamcinolone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Presentation/Packing
Nasal spray 55 mcg/spray x 30 doses, 120 doses.
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