Excess dosage or too-frequent administration of injections into the same site may cause local subcutaneous atrophy. If this occurs, recovery may take several months due to the long-term effect of the drug.
Like any other nasally administered corticosteroid, acute overdosing with Aftach Allergy or Triamcinolone Nasal Spray 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.
The use of solvents containing methylparaben, propylparaben, phenol, etc. should be avoided, since they may cause precipitation of the steroid.
None known.
For assessment of adverse reactions (ADRs) following terms regarding frequency are used:
| very common | (>1/10) |
| common | (>1/100 to <1/10) |
| uncommon | (>1/1,000 to <1/100) |
| rare | (>1/10,000 to 1</1,000) |
| very rare | (<1/10,000) |
not known (cannot be estimated from the available data)
Adverse effects depend on the dose and the duration of treatment. Systemic adverse effects are rare, but may occur as a result of repeated periarticular injection. As with other intraarticular steroid treatments, transient adrenocortical suppression has been observed during the first week after injection. This effect is enhanced if corticotropin or oral steroids are used concomitantly.
Immune system disorders
Very rare: anaphylaxis-type reactions
Not known: exacerbation or masking of infections
Endocrine disorders
Not known: menstrual irregularities, amenorrhoea and postmenopausal vaginal bleeding; hirsutism; development of a cushingoid state; secondary adrenocortical and pituitary unresponsiveness, particularly during periods of stress (e.g. trauma, surgery or illness); decreased carbohydrate tolerance; manifestation of latent diabetes mellitus
Psychiatric disorders
Not known: insomnia; exacerbation of existing psychiatric symptoms; depression (sometimes severe); euphoria; mood swings; psychotic symptoms
Nervous system disorders
Rare: vertigo
Not known: increased intracranial pressure with papilloedema (pseudotumor cerebri) usually after treatment; headache
Eye disorders
)
Cardiac disorders
Not known: cardiac failure; arrhythmias
Vascular disorders
Very rare: thromboembolism
Not known: hypertension
Gastrointestinal disorders
Not known: peptic ulcers with possibility of subsequent perforation and haemorrhage; pancreatitis
Skin and subcutaneous tissue disorders
Very rare: hyperpigmentation or hypopigmentation
Not known: impaired wound healing; thin and fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; purpurea; striae; acneiform eruptions; hives; rash
Musculoskeletal and connective tissue disorders
Very rare: calcinosis; tendon rupture
Not known: loss of muscle mass; osteoporosis; aseptic necrosis of the heads of the humerus and femur; spontaneous fractures; Charcot-like arthropathy
Renal and urinary disorders
Not known: negative nitrogen balance owing to protein catabolism
General disorders and administration site conditions
Common: Local reactions include sterile abscesses, post-injection erythema, pain, swelling and necrosis at the injection site.
Rare: Excess dosage or too-frequent administration of injections into the same site may cause local subcutaneous atrophy, which, due to the properties of the drug, will only return to normal after several months.
Paediatric population
Glucocorticoids may induce growth suppression in children.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
The adverse events reported in clinical trials with Aftach Allergy or Triamcinolone Nasal Spray most commonly involved the mucous membranes of the nose and throat.
The following frequency rating has been used, when applicable:
Very common > 10%; Common > 1 and < 10%; Uncommon > 0.1 and < 1%; Rare > 0.01 and < 0.1%; Very rare < 0.01% and not known (frequency cannot be estimated from available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The most frequent adverse reactions in adults 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 and 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
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Aftach hexacetonide is a potent teratogen in many animals. For example cleft palate has been reported in mice, rats, rabbits, and hamsters. CNS anomalies and cranial malformations have been observed in monkeys following gestational exposure. To date, however, no signs of teratogenicity of corticosteroids have been observed in humans.
Environmental Risk Assessment (ERA)
The environmental risk assessment has been performed according to European standards. From these results it is assumed that the medicinal product is unlikely to represent a risk for the environment following the recommended use in patients.
In pre-clinical studies, only the effects typical of glucocorticosteroids were observed
Like other corticosteroids, triamcinolone acetonide has been shown to be teratogenic in rats and rabbits. Teratogenic effects which occurred in the rat and in the rabbit included 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 tests
Carcinogenicity assays in rodents show no increase in the incidence of individual tumour types.
Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids
ATC code: H02AB08
Mechanism of action
The mode of action of glucocorticoids is not fully known, but local injections are thought to have an anti-inflammatory effect.
Pharmacodynamic effects
Aftach HEXACETONIDE is a synthetic glucocorticoid with pronounced anti-inflammatory activity. The product is a microcrystalline water suspension with a depot effect.
The anti-inflammatory potency of Aftach on a milligram by milligram comparison is approximately five times that of hydrocortisone. Triaminolone has practically no mineralocorticoid effect, so no sodium retention occurs.
Paediatric population
The efficacy and safety of Aftach hexacetonide in children and adolescents are based on the well-researched effects of glucocorticoids, which are the same in children and adults. Published studies and current therapeutic guidelines for treatment of Juvenile Idiopathic Arthritis (JIA) indicate efficacy and safety in children and adolescents for the treatment of JIA.
Pharmacotherapeutic group: nasal corticosteroid, ATC code: R 01 AD
Triamcinolone acetonide is a more potent derivative of triamcinolone and is approximately 8 times more potent than prednisone. Although the precise mechanism of corticosteroid anti-allergic action is unknown, corticosteroids are very effective in the treatment of allergic diseases in man.
Aftach Allergy or Triamcinolone Nasal Spray 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 with Aftach Allergy or Triamcinolone Nasal Spray and relief may be expected in 3 to 4 days. When Aftach Allergy or Triamcinolone Nasal Spray 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.
The hexacetonide ester is almost insoluble in water, so dissolution is slow and the effect in the tissue of the injection site lasts for a long time, from a few weeks to several months. Generally, the onset of effect after Aftach HEXACETONIDE administration occurs after 24 hours and normally lasts for 4 to 6 weeks.
Aftach hexacetonide is hydrolysed by human serum in vitro (43% hydrolysed after 24 hours), but following intra-articular injection, the substance does not disperse in situ.
Single dose intranasal administration of 220 micrograms of Aftach Allergy or Triamcinolone Nasal Spray in normal adult subjects and in adult patients with allergic rhinitis demonstrated minimal 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 Aftach Allergy or Triamcinolone Nasal Spray. Following multiple doses in paediatric patients, plasma drug concentrations, AUC, Cmax and Tmax were similar to those values observed in adult patients.
Aftach HEXACETONIDE has no or negligible influence on the ability to drive and use machines.
Aftach Allergy or Triamcinolone Nasal Spray has no known effect on the ability to drive and operate machines.
Aftach HEXACETONIDE ampoules must be inspected for discolouration of the contents prior to administration.
Shake gently before use.
If necessary, Aftach HEXACETONIDE may be mixed with 1% or 2% lidocaine hydrochloride or other similar local anaesthetics. Aftach HEXACETONIDE should be drawn into the syringe before drawing in the anaesthetic to prevent contamination of Aftach HEXACETONIDE. The syringe should then be shaken gently, and the resulting solution used immediately thereafter.
No special requirements.
