flunisolide intranasal (Rx)

>10%

Nasal burning/stinging (13-44%)

Aftertaste (8-17%)

1-10%

Nausea

Epistaxis

Nasal dryness

Pharyngitis

Cough increased

<1%

Hoarseness

Nasal ulceration

Abnormal sense of smell

Sinusitis

Vertical growth suppression

Contraindications

Hypersensitivity

Do not use with untreated local infection involving the nasal mucosa

Recent nasal surgery/injury

Cautions

Replacement of systemic corticosteroids with topical administration can be accompanied by signs of adrenal insufficiency: some patients may experience withdrawal symptoms

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients Rare reports of nasal septal perforation

Temporary or permanent loss of sense of smell or taste reported

Because of the inhibitory effect of corticosteroids on wound healing, a nasal corticosteroid should be used with caution in patients who have experienced recent nasal septal ulcers, recurrent epistaxis, nasal surgery or trauma, until healing has occurred

Systemic corticoid effects typical of Cushing's syndrome are minimal with recommended doses of topical steroids, this potential increases with excessive doses

Corticosteroids are known to cause immunosuppression resulting in increased susceptibility to infection

Pregnancy

There are no studies in pregnant women to inform a drug-associated risk for birth defects or miscarriage; there are clinical considerations with use in pregnant women to inform a drug-associated risk; in animal reproduction studies, flunisolide administered to pregnant rats and rabbits during of organogenesis produced fetal structural abnormalities; dose in rats and rabbits was approximately 3 and 1 times maximum recommended human daily dose, respectively

Lactation

There is no information on presence of flunisolide in human milk, or effects on breast fed child, or on milk production; because other corticosteroids are excreted in human milk, exercise caution when administering therapy to nursing women

The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Elicits potent glucocorticoid and weak mineralocorticoid effects; provides direct anti-inflammatory actions to nasal mucosa

Absorption

Bioavailability: 50% (intranasal); 20% (PO) due high first-pass liver metabolism

Metabolism

Converted by the liver to the much less active primary metabolite and to glucuronide and sulfate conjugates

Elimination

Half-life: 1-2 hr

Excretion: 50% feces; 50% urine