NASACORT 55 µg nasal powder spray bottle/15mL

VIDAL
Medicines
Update of 12/10/2026

NASACORT^®
triamcinolone acetonide

Forms and presentations

Nasal spray suspension at 55 µg/dose:  Spray bottle of 15 ml (120 sprays), with metering pump and nasal tip.

Composition

	p spray
Triamcinolone acetonide	55 µg

Excipients: disodium edetate, anhydrous glucose, microcrystalline cellulose and sodium carmellose (Avicel CL 611), polysorbate 80, benzalkonium chloride, dilute hydrochloric acid, sodium hydroxide, purified water.

1 spray of 100 mg delivers 1 dose of 55 µg of triamcinolone acetonide.

Excipient with known effect: benzalkonium chloride (15 µg per dose) (see Warnings and Precautions for Use).

Indications

Nasacort is indicated for the treatment of symptoms of seasonal and perennial allergic rhinitis in adults and children aged 2 years and older.

Dosage and administration

Dosage

Method of administration:

Nasal use.

• Shake the bottle gently before use.
  
• During first use, the pump must be primed with 5 sprays. When not in use, it remains correctly primed for approximately 2 weeks. Beyond that, it can be re-primed with 1 single spray.
  

Contraindications

• Hypersensitivity to triamcinolone or to any of the excipients mentioned in section Composition.
  
• Haemostasis disorders, in particular epistaxis.
  
• Oro-buccal-nasal and ophthalmic infection by herpes simplex virus.
  
• Child under 2 years of age, in the absence of clinical data.
  

Warnings and precautions

Warnings:

Paediatric population:

Nasacort must not be used in children under 2 years of age (see Contraindications).

The risk of systemic effects, adrenal suppression and impact on child growth is increased in case of concomitant administration of inhaled or a fortiori systemic corticosteroid therapy.

A slowing of growth has been reported in children receiving nasal corticosteroid therapy including Nasacort at therapeutic doses in long-term studies (1 year of treatment). See Pharmacodynamics.

Regular monitoring of children's height is recommended in children receiving nasal corticosteroid therapy. The effect of treatment should be monitored in order to reduce the nasal corticosteroid dose, if possible, to the lowest dose at which effective symptom control is achieved. The long-term effects of growth slowing associated with nasal corticosteroids, including the impact on final adult height, are not known. Furthermore, it is strongly recommended to refer the patient to a paediatrician, in particular for children under 6 years of age.

Visual disturbances: Visual disturbances may occur during systemic or local corticosteroid therapy. In case of blurred vision or the appearance of any other visual symptom during corticosteroid therapy, an ophthalmological examination is required to look for, in particular, cataract, glaucoma, or a rarer lesion such as central serous chorioretinopathy, described with the administration of systemic or local corticosteroids. Close monitoring is therefore justified in patients with visual disturbances or a history of elevated intraocular pressure, glaucoma and/or cataract.

Systemic effects may occur, in particular during long-term treatment with high doses of nasal corticosteroids. The risk of systemic repercussions nevertheless remains lower than with oral corticosteroids and may vary according to individual susceptibility and the composition of the corticosteroid product used (may vary according to the potency, dosage and pharmacokinetic properties (lipophilicity, volume of distribution and elimination half-life) of the steroid). Possible systemic effects are Cushing's syndrome or Cushingoid symptoms, skin thinning, subcutaneous haematomas, adrenal insufficiency, growth retardation in children and adolescents, decreased bone density, cataract and glaucoma and, more rarely, psychological and behavioural disorders including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggressiveness (particularly in children). Concomitant administration of nasal corticosteroids in patients on long-term oral corticosteroid therapy does not exempt from the necessary precautions when reducing oral corticosteroid doses. These will be decreased very gradually and withdrawal must be carried out under careful medical supervision (watching for signs of acute or subacute adrenal insufficiency), continuing beyond the cessation of systemic corticosteroid therapy.

Local intranasal administration of corticosteroids is not recommended in patients who have recently had an ulceration of the nasal septum, or who have undergone surgery or trauma to the nose, until healing is complete.

Risks associated with abrupt discontinuation of corticosteroids after prolonged use may include exacerbation or recurrence of the underlying disease, adrenocortical insufficiency or steroid withdrawal syndrome. However, these effects are extremely rare for nasal corticosteroids, and much less likely to occur with nasal corticosteroids than with oral corticosteroids.

Benzalkonium chloride:

This medicine contains 15 micrograms of benzalkonium chloride per dose.

Due to the presence of benzalkonium chloride, this medicine may cause oedema of the nasal mucosa, particularly in cases of long-term use, and respiratory discomfort.

Precautions for use

Nasal patency should be ensured to allow optimal distribution of the product. Advise the patient to dry the nasal passages by blowing the nose before instillation.

In case of major nasal obstruction, a detailed examination of the ENT area should be performed.

In case of prolonged treatment, repeated examinations of the nasal mucosa are recommended in order to assess any effect of corticosteroid therapy on the nasal mucosa. If atrophy of the nasal mucosa is observed, a reduction in local corticosteroid doses should be considered.

In cases of pulmonary tuberculosis or pulmonary fungal infection, the institution of close monitoring and appropriate treatment is required.

Advise the patient that this is a regular treatment and that several days of treatment may be needed before effects on rhinitis symptoms are observed.

Athletes should be made aware that this product contains an active substance that may induce a positive reaction in tests carried out during anti-doping controls.

Interactions

Combinations not recommended:

+ CYP3A inhibitors:

Concomitant administration of CYP3A inhibitors, including products containing cobicistat, is expected to increase the risk of systemic side effects. The combination should be avoided, unless the benefits outweigh the increased risk of systemic side effects of corticosteroids; in this case, patients should be monitored for possible systemic side effects of corticosteroids.

Fertility, pregnancy and breastfeeding

Pregnancy:

In animals, experimentation has demonstrated a teratogenic effect, which varies according to species.

In humans, epidemiological studies have detected no teratogenic risk associated with oral corticosteroid use during the first trimester.

During chronic diseases requiring treatment throughout pregnancy, a slight intrauterine growth retardation is possible. Neonatal adrenal insufficiency has been exceptionally observed after high-dose corticosteroid therapy.

A period of clinical (weight, diuresis) and biological (blood glucose) monitoring of the newborn may be justified.

Consequently, this medicine may be prescribed during pregnancy if needed.

Breastfeeding:

The passage of triamcinolone acetonide into milk has not been studied. Nevertheless, other corticosteroids are excreted into milk.

Available data appear to show good tolerance in children; however, the biological or clinical impact of long-term maternal treatment has not been evaluated to date.

Consequently, breastfeeding is possible during short-term treatment. During chronic treatment, as a precaution, breastfeeding should be avoided.

Adverse effects

The classification of adverse events according to their frequency is as follows: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10 000 and < 1/1000), very rare (< 1/10 000), frequency not known (cannot be estimated from the available data).

System organ classes
Frequency	Adverse effects
Immune system disorders
Frequency not known	Hypersensitivity including pruritus or rash
Endocrine disorders
Frequency not known	Steroid withdrawal syndrome (see Warnings and Precautions for Use)
Nervous system disorders
Common	Headache
Frequency not known	Dysgeusia, parosmia
Eye disorders
Very rare	Cataract, glaucoma
Frequency not known	Blurred vision (see Warnings and Precautions for Use), increased intraocular pressure*, chorioretinopathy
Respiratory, thoracic and mediastinal disorders
Common	Epistaxis, cough
Frequency not known	Nasal burning or irritation sensation, dryness of nasal and oropharyngeal mucous membranes, pharyngeal irritation, nasal congestion, sneezing, dyspnoea, nasal septum perforation*, atrophy of the nasal mucosa*
Infections and infestations
Common	Rhinitis, pharyngitis, flu-like syndrome
Frequency not known	Nasal and oropharyngeal candidiasis
Gastrointestinal disorders
Common	Dyspepsia, dental abnormalities
Frequency not known	Nausea
Psychiatric disorders
Frequency not known	Insomnia
General disorders and abnormalities at the site of administration
Frequency not known	Fatigue
Investigations
Frequency not known	Decreased blood cortisol level

^*  Rare cases of nasal septum perforation, ocular hypertension and atrophy of the nasal mucosa have been reported with long-term intranasal corticosteroid administration.


Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Overdose

It could cause hypothalamic-pituitary-adrenal suppression and, if prolonged, clinical signs of hypercorticism. These symptoms will disappear after discontinuation of treatment, which should be gradual.

Pharmacodynamics

Pharmacotherapeutic class: Topical glucocorticoid, ATC code: R01AD11 (R: respiratory system).

Triamcinolone acetonide is a glucocorticoid. It exerts a local anti-inflammatory activity. It is a more potent derivative than triamcinolone, its activity being approximately 8 times greater than that of prednisone.

In clinical studies conducted in adults and children aged 6 years and over, at intranasal doses up to 440 micrograms/day, and in children aged 2 to 5 years at intranasal doses of 110 micrograms/day, no suppression of the hypothalamic-pituitary-adrenal (HPA) axis was observed.

Pharmacokinetics

After intranasal administration of a dose of 220 micrograms of triamcinolone acetonide, the mean peak plasma concentration is approximately 0,5 ng/ml (between 0,1 and 1 ng/ml) and occurs 1 h 30 after administration.

The mean plasma concentration of the product is less than 0,06 ng/ml at 12^e hour, and below the detection threshold of the assay method at 24^e hour. The half-life is 3 to 3,3 hours.

Paediatric population:

After administration of multiple intranasal doses of Nasacort, the systemic exposure observed in paediatric patients aged 6 to 12 years was similar to that observed in adult patients.

Intranasal administration of Nasacort at doses of 110 micrograms/day in paediatric patients aged 2 to 5 years showed systemic exposure similar to that obtained in adult patients at doses of 220 micrograms/day.

The apparent clearance and volume of distribution in paediatric patients aged 2 to 5 years were approximately half of those obtained in adults.

Preclinical safety

In preclinical studies, only effects characteristic of glucocorticoids were observed.

No mutagenic effect was noted in the tests in vitro (reverse mutation test in Salmonella and forward mutation test in Chinese hamster ovary cells).

Studies in rodents did not show any carcinogenic effect related to administration of triamcinolone acetonide. Like other corticosteroids, triamcinolone acetonide is teratogenic in animals and induces (in rats and rabbits) cleft palate and/or internal hydrocephalus and skeletal abnormalities at the level of the spinal column. Other teratogenic effects such as central nervous system abnormalities and craniofacial malformations were observed in monkeys. Triamcinolone acetonide induces an increase in foetal resorptions, stillbirth and a decrease in the weight of newborns and in survival rate in rodents without change in the pregnancy rate.

Storage conditions

No special storage conditions.

HANDLING/DISPOSAL INSTRUCTIONS

Shake the bottle gently before use.

At first use, the pump must be primed with 5 sprays. When not in use, it remains correctly primed for approximately 2 weeks.

Beyond that, it can be re-primed with 1 single spray.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Prescription, supply and reimbursement

LIST I

Marketing authorisation (AMM)

3400934292293 (1997, SmPC rev 12.09.2022).

Price:	7,47 euros (bottle of 15 ml).
Social Security reimbursement at 30%. Collect.

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