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flunisolide intranasal

 

Classes: Corticosteroids, Intranasal

Dosing and uses of Flunisolide intranasal

 

Adult dosage forms and strengths

nasal spray

  • 25mcg/actuation
  • 29mcg/actuation

 

Seasonal Allergic Rhinitis

2 sprays each nostril BID; may increase to TID/QId

 

Administration

Prime spray by actuating 5-6 times first before use, if it has not been used for >4 days, or if it has been disassembled for cleaning

 

Pediatric dosage forms and strengths

nasal spray

  • 25mcg/actuation
  • 29mcg/actuation

 

Seasonal Allergic Rhinitis

<6 years: Safety and efficacy not established

6-14 years: 1 spray each nostril TID, or 2 sprays each nostril BId

 

Administration

Prime spray by actuating 5-6 times first before use, if it has not been used for >4 days, or if it has been disassembled for cleaning

 

Flunisolide intranasal adverse (side) effects

>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

 

Warnings

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 and lactation

Pregnancy category: C

Lactation: Corticosteroids are known to be secreted in breast milk

 

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.

 

Pharmacology of Flunisolide intranasal

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