Flunisolide: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Nasal
Perennial allergic rhinitis, Seasonal allergic rhinitis

Adult: As 0.25 mg (0.025%) nasal solution: Initially, 2 sprays (0.05 mg) in each nostril bid (total of 0.2 mg daily); may increase to 2 sprays in each nostril tid (total of 0.3 mg daily). Max: 8 sprays in each nostril daily (total of 0.4 mg daily).
Child: 6-14 years Initially, 1 spray (0.025 mg) in each nostril tid or 2 sprays (0.05 mg) in each nostril bid (total 0.15-0.2 mg daily). Max: 4 sprays in each nostril daily (total of 0.2 mg daily). ≥15 years Same as adult dose. Once symptoms are controlled, reduce maintenance dose to the lowest effective dose (e.g. 1 spray in each nostril once daily; total of 0.05 mg daily).

Special Precautions

Patient with active or latent TB infection, untreated bacterial, fungal, or systemic viral infection or ocular herpes simplex; recurrent epistaxis; previous treatment with systemic corticosteroids for prolonged period; on alternate-day prednisone regimens for any disease. Avoid use in patient with recent nasal septal ulcers, nasal trauma or surgery until healing has occurred. Not for use in the presence of untreated localised infection involving the nasal mucosa. Avoid exposure to chickenpox or measles. May mask the signs of infection (including fungal infection). Avoid abrupt withdrawal. Children. Pregnancy and lactation.

Adverse Reactions

Significant: Growth retardation in children; suppression of hypothalamic-pituitary-adrenal (HPA) axis (especially in younger children or in patients receiving chronic high doses), immunosuppression (including increased incidence of secondary infection or prolongation or exacerbation of viral infection), nasal septal perforation, nasal ulceration, epistaxis. Rarely, development of localised Candida albicans infections of the nose and/or pharynx.
Eye disorders: Watery eyes.
Gastrointestinal disorders: Nausea, vomiting, temporary or permanent ageusia.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Transient nasal burning and stinging; nasal congestion, nasal irritation, sneezing, sore throat, temporary or permanent anosmia.

Pregnancy Category (US FDA)

Inhalation/Respiratory/Nasal: C

Monitoring Parameters

Monitor growth in paediatric patients (for prolonged treatment), signs and symptoms of HPA axis suppression or adrenal insufficiency, signs of nasal ulceration or septal perforation; candida infection with long term use.

Drug Interactions

Increase risk of HPA suppression with prednisone.

Action

Description:
Mechanism of Action: Flunisolide is a synthetic fluorinated corticosteroid which decreases inflammation by suppressing the polymorphonuclear leucocytes migration and reversal of increased capillary permeability.
Pharmacokinetics:
Absorption: Absorbed approximately 50%.

Chemical Structure

Storage

Store between 15-30°C.

MIMS Class

Antihistamines & Antiallergics

ATC Classification

R01AD04 - flunisolide ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.

References

Anon. Flunisolide (Nasal). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/09/2022.

Buckingham R (ed). Flunisolide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2022.

Flunisolide Solution (Ingenus Pharmaceuticals, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/09/2022.

Flunisolide. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 12/09/2022.

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