Fluticasone Furoate and Oxymetazoline Hydrochloride Nasal Spray | F2NASE OX

Dosage form and Strength Nasal Spray: 27.5 mcg/50 mcg

Clinical Particulars: Therapeutic Indication: Posology and method of Administration: The recommended dose is two spray actuations (27.5 micrograms of Fluticasone Furoate and 50 mcg of Oxymetazoline Hydrochloride per spray actuation) in each nostril once daily (total daily dose. 110 micrograms of Fluticasone Furoate and 200 mcg of Oxymetazoline Hydrochloride). Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril (total dailydose 55 micrograms of Fluticasone Furoate and 100 mcg of Oxymetazoline Hydrochloride) may be effective for maintenance. Fluticasone Furoate and Oxymetazoline Hydrochloride nasal spray is for administration by the intranasal route only. The intranasal device should be shaken before use. The device is primed by pressing the mist release button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright. Re-printing (approximately 6 sprays until a fine mist is seen) is only necessary if the cap is left off for 5 days or the intranasal device has not been used for 30 days or more.

Contraindications: Fluticasone Furoate and Oxymetazoline Hydrochloride nasal spray is contraindicated in the following conditions:

• Ae less than 12 years
• Hypersensitivity to Fluticasone Furoate. Oxymetazoline or any other ingredients of this medicine.
• In patients who have undergone recent trans-nasal surgery
• In patients with chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis)
• In patients with cardiovascular diseases, hyperthyroidism, angle closure glaucoma or prostatic enlargement

Special Warnings and Precautions for Use: Keep the spray away from the eyes

Systemic Corticosteroid Effects: Systemic effects of nasal corticosteroid may occur, particularly at high doses. These effects are much less likely to occur than with oral corticosteroids are may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may including cushing’s syndrome, cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety depression or aggression (particularly in children). Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroids cover should be considered during periods of stress or elective surgery.

Drug Interactions:

Interaction with CYP3A Inhibitors: Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P4503A4. Based on data with another glucocorticoid (fluticasone propionate), that is metabolized by CYP3A4, coadministration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate. Caution is recommended when co-administering fluticasone furoate with potent CYP3A inhibitors including cobicistat containing products as an increase in the risk of systemic side effects is expected. Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects. In a drug interaction study of intranasal fluticasone furoate with the potent CYP3A4 inhibitor ketoconazole there were more subjects with measurable fluticasone furoate concentrations in the ketoconazole group (6 of the 20 subjects) compared to placebo (1 out of 20 subjects). This small increase in exposure did not result in a statistically significant difference in 24 hour serum cortisol levels between the two groups. The enzyme induction and inhibition data suggest that there is no theoretical basis for anticipating metabolic interactions between fluticasone furoate and the cytochrome P450 mediated metabolism of other compounds at clinically relevant intranasal doses. Therefore, no clinical studies have been conducted to investigate interactions of fluticasone furoate on other drugs monoamine oxidase inhibitors (MAOIs) nonselective beta adrenergic antagonists or tricyclic antidepressants. Use of Oxymetazoline containing nasal spray in combination with monoamine oxidase inhibitors (MAOIs), nonselective beta adrenergic antagonists or tricyclic antidepressants may cause hypertension and is not recommended.

Use in Special Populations (Such as pregnant women, lactating women, paediatric patients, geriatric patients etc)

Children < 12 years of age: Fluticasone Furoate and Oxymetazoline Hydrochloride nasal spray should not be used in children less than 12 years of age

Elderly (> 65 years old): No dose adjustment is required in this population.

Renal Impairment: No dose adjustment is required in this population

Hepatic Impairment: No dose adjustment is required in this population

Pregnancy: There are no adequate data from the use of fluticasone furoate and Oxymetazoline containing nasal sprays in pregnant women.

In animal studies glucocorticoids have been shown to induce malformations including cleft palate and intra-uterine growth retardation. This is not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure.

Breast-feeding: It is unknown whether nasal administration fluticasone furoate or Oxymetazoline is excreted in human breast milk. Administration of Fluticasone furoate and Oxymetazoline hydrochloride nasal spray to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

Fertility: There are no fertility data in humans.

Presentation: F2Nase OX nasal spray contains 70 metered doses.