Product Dossier
SPRAY-TISH
Product Dossier for SPRAY-TISH (tramazoline hydrochloride, Sanofi Consumer Healthcare). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Sanofi Consumer Healthcare
- Active ingredient: tramazoline hydrochloride
- Therapeutic area: Respiratory
- Same area: NUCALA
- Same area: VENTOLIN
What it is
Spray-Tish is a nasal mist containing the active ingredient tramazoline hydrochloride in a strength of 1.18 mg/mL. Tramazoline hydrochloride is an alpha-sympathomimetic that has a vasoconstricting effect and rapidly reduces swelling of the nasal mucosa. This leads to rapid and long-lasting decongestion of the nasal passages, with local vasoconstriction usually occurring within 5 minutes and lasting for up to 8 hours after intranasal administration.
Approved indications
— Symptomatic relief of nasal congestion associated with common cold. — Symptomatic relief of nasal congestion associated with hayfever. — Symptomatic relief of nasal congestion associated with rhinitis.
Dosing overview
For adults and children six years of age and over, the recommended dose is 1 to 2 sprays into each nostril up to 4 times a day as required. Administration should not be continued longer than 3 days without medical advice.
Key safety warnings
The use of Spray-Tish for prolonged periods of time is not recommended, and if symptoms have not disappeared following use for 3 days, a physician should be consulted as to whether treatment should be continued. Frequent or prolonged use may cause nasal congestion to recur or worsen. Prolonged use of mucous membrane-decreasing cold remedies may lead to chronic inflammation and wasting of the nasal mucous membrane, and rebound congestion can occur on cessation of continuous treatment over long periods. Spray-Tish should be used with caution and on medical advice in patients with arterial hypertension, heart diseases, hyperthyroidism, diabetes mellitus, prostate hypertrophy, phaeochromocytoma and porphyria due to the potential risk of systemic absorption. If monoamine oxidase inhibitors, tricyclic antidepressants or vasopressor drugs are given simultaneously, effects on the cardiovascular system can lead to an increase in blood pressure, and combined use with tricyclic antidepressants can also lead to arrhythmias. Care should be taken that Spray-Tish does not enter the eyes as it may cause irritation.
Contraindications
Spray-Tish should not be used in patients with dry diseases of the nasal mucous membrane which form crusts and scabs (rhinitis sicca), patients after cranial surgery via the nasal cavity, patients with narrow-angle glaucoma, patients with hypersensitivity to tramazoline hydrochloride, benzalkonium chloride or any other excipient in Spray-Tish, or children under six years of age, as specific studies to establish safety are not available.
Regulatory history
Spray-Tish (tramazoline hydrochloride 1.18mg/mL spray solution) was first listed on the Australian Register of Therapeutic Goods (ARTG 42391) on 5 November 1992. The text was approved by the Therapeutic Goods Administration on 21 August 1998.