Professional Information

Corticosteroids (Nasal)

This monograph includes information on the following:

1) Beclomethasone
2) Budesonide
3) Dexamethasone ^{32} ^†
4) Flunisolide
5) Fluticasone
6) Mometasone
7) Triamcinolone

INN:
Beclomethasone—Beclometasone

VA CLASSIFICATION
Primary: NT201

Commonly used brand name(s): Beconase¹; Beconase AQ¹; Dexacort Turbinaire³; Flonase⁵; Nasacort⁷; Nasacort AQ⁷; Nasalide⁴; Nasarel⁴; Nasonex⁶; Rhinalar⁴; Rhinocort²; Rhinocort Aqua²; Rhinocort Turbuhaler²; Vancenase¹; Vancenase AQ 84 mcg¹; Vancenase pockethaler¹.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

^†Not commercially available in Canada.

Category:

Anti-inflammatory (steroidal), nasal—

corticosteroid (nasal)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Rhinitis, perennial allergic (treatment) ^{02} ^{12} ^{20} ^{21} ^{23} ^{24} ^{25} ^{66} ^{67} ^{68} ^{69} ^{76} ^{77} ^{78} ^{83} ^{84} ^{85} ^{86}
Rhinitis, seasonal allergic (treatment) ^{02} ^{20} ^{21} ^{23} ^{24} ^{66} ^{67} ^{68} ^{69} ^{73} ^{77} ^{78} ^{83} ^{85} ^{86} or
[Rhinitis, seasonal (prophylaxis) or]
[Rhinitis, vasomotor nonallergic (treatment) ^{25}]—Nasal corticosteroids are indicated in the treatment of seasonal or perennial allergic or vasomotor nonallergic ^{25} rhinitis in patients who have exhibited significant side effects from, or have exhibited poor response to, other therapies, such as antihistamines and decongestants. ^{14} ^{86} ^{75} ^{77} ^{97} Antihistamines and decongestants are generally considered primary therapies for these disorders. ^{38} ^{75} ^{101} However, some clinicians consider nasal corticosteroids primary therapy for perennial or seasonal rhinitis because they are more effective ^{14} ^{23} ^{33} ^{37} ^{46} ^{50} ^{51} ^{52} ^{53} ^{54} ^{55} ^{59} ^{60} ^{97} ^{98} if prophylaxis is started two to four weeks prior to exposure to allergens. ^{73} Nasal budesonide is indicated for use in [ children 4 to 6 years of age ]¹and older.^{103}
—[Nasal corticosteroids are used in some patients for prophylaxis of seasonal rhinitis. This form of therapy is generally reserved for patients who have consistently demonstrated a need for nasal corticosteroids to control seasonal rhinitis symptoms. ^{37} ^{39} ^{48} Antihistamines and decongestants are considered primary therapies for this disorder ^{38} ^{75} ^{97} ^{101} .]
—Dexamethasone nasal aerosol is less frequently used because its use results in a significantly higher incidence of systemic adverse effects with no additional benefit over other nasal corticosteroids. ^{36} ^{40} ^{52}

Allergic disorders, nasal (treatment)
Inflammatory conditions, noninfectious, nasal (treatment) or
Polyps, nasal (treatment)—Nasal corticosteroids are indicated in the treatment of allergic or inflammatory nasal conditions and nasal polyps. ^{12} ^{52} ^{54} ^{86}

Polyps, nasal, postsurgical recurrence of (prophylaxis)—Beclomethasone is indicated [and budesonide nasal solution, dexamethasone, flunisolide, and triamcinolone ^{97} are used ] to prevent recurrence of nasal polyps following their surgical removal and sufficient mucosal healing. ^{02} ^{12} ^{15} ^{25} ^{66} ^{67} ^{75} ^{76} ^{83} ^{84} ^{85}

[Rhinitis, vasomotor (treatment)]—Budesonide is used in the treatment of vasomotor rhinitis in patients who are unresponsive to conventional therapy. Antihistamines are generally considered the primary therapy for this disorder. ^{99}

Acceptance not established
Use of nasal budesonide in children younger than 4 years of age for the treatment of seasonal and perennial rhinitis has not been established.^{103}

¹ Not included in Canadian product labeling.

Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Beclomethasone dipropionate: 521.05 ^{01}
    Beclomethasone dipropionate monohydrate: 539.06 ^{25} ^{76}
    Budesonide: 430.54 ^{87}
    Dexamethasone sodium phosphate: 516.41 ^{88}
    Flunisolide: 443.52 ^{89}
    Fluticasone propionate: 500.58 ^{91}
    Mometasone furoate: 521.44 ^{90}
    Triamcinolone acetonide: 434.51 ^{92}

Mechanism of action/Effect:

In the treatment of nasal symptoms, the primary action of nasally applied corticosteroids is anti-inflammatory. ^{02} ^{12} ^{16} ^{25} ^{36} ^{40} ^{42} ^{66} ^{67} ^{68} ^{70} ^{77} ^{84} Nasal corticosteroids inhibit the IgE- and mast cell-mediated early-phase allergic reaction. ^{16} ^{23} ^{43} ^{44} ^{46} ^{49} ^{52} ^{70} They also inhibit the migration of inflammatory cells into the nasal tissue (the late-phase or late-onset allergic reaction) ^{86}, which may play a significant role in the pathology of chronic rhinitis. ^{16} ^{23} ^{24} ^{40} ^{42} ^{43} ^{44} ^{46} ^{49} ^{52} ^{70}

During the late-phase allergic reaction, eosinophils, neutrophils, basophils, and mononuclear cells produce inflammatory mediators, which cause a reappearance of nasal symptoms. ^{36} ^{43} ^{44} ^{47} ^{52} ^{97}

Absorption:

Beclomethasone dipropionate—Rapidly absorbed from the nasal mucosa; and from the gastrointestinal tract. ^{02} ^{25} ^{52} ^{66} ^{67} ^{75} ^{76} ^{83} ^{85}

Budesonide—Very little is absorbed from the nasal mucosa; 20% reaches the systemic circulation. ^{16} ^{70}

Dexamethasone sodium phosphate—Rapidly and extensively absorbed from the nasal mucosa; ^{52} ^{56} readily absorbed from the gastrointestinal mucosa.

Flunisolide—50% of dose is absorbed from the nasal mucosa. ^{20} ^{21} ^{52} ^{71} ^{72}

Fluticasone—Less than 2% from the nasal mucosa. ^{24}

Mometasone—Rapid and extensive absorption from esophagus, trachea, nasal passages and mouth after intranasal dose. ^{73}

Triamcinolone—Slow from the nasal mucosa. ^{68}

Distribution:

A portion of the drug administered nasally is swallowed. ^{25} ^{52} ^{56} ^{73} ^{75} ^{76}

Protein binding:

Beclomethasone—87%, to albumin and transcortin. ^{02} ^{25} ^{62} ^{63} ^{66} ^{67} ^{75} ^{76} ^{83} ^{85}

Budesonide—88%, to albumin. ^{16} ^{70}

Dexamethasone sodium phosphate—High (65–90%) to albumin and transcortin. ^{13} ^{62}

Flunisolide—Moderate, to albumin and transcortin. ^{62} ^{63}

Fluticasone—91%, to albumin; not significantly bound to transcortin. ^{24}

Biotransformation:

Beclomethasone—Hepatic to free beclomethasone and other inactive metabolites. ^{02} ^{25} ^{52} ^{56} ^{66} ^{67} ^{83} ^{85} The portion of the dose that is swallowed and absorbed from the gastrointestinal tract undergoes extensive first-pass metabolism to inactive compounds ^{56} ^{63}. Initially hydrolyzed to beclomethasone-17-propionate by fecal esterases ^{25} ^{83} ^{85}.

Budesonide—Rapid; hepatic to 16–alpha-hydroxyprednisolone and 6–beta-hydroxybudesonide ^{12} ^{16} ^{52} ^{70}

Flunisolide—Rapid; hepatic to a less active 6-beta-hydroxy metabolite and to glucuronide and sulfate conjugates ^{20}. The portion of the dose that is swallowed and absorbed from the gastrointestinal tract undergoes extensive first-pass metabolism to inactive compounds. ^{56} ^{63}

Fluticasone—Hepatic to an active 17–beta-carboxylic acid derivative; only 0.02% renal. ^{24}

Triamcinolone acetonide—Hepatic to 3 less active metabolites, 6-beta-hydroxytriamcinolone acetonide, 21-carboxytriamcinolone acetonide, and 21-carboxy-6-beta-hydroxytriamcinolone acetonide. ^{68} ^{69}

Half-life:

Beclomethasone dipropionate:

15 hours (plasma). ^{52}

Budesonide:

Approximately 2 hours (plasma). ^{16} ^{52} ^{70}

Dexamethasone sodium phosphate:

190 minutes (plasma). ^{62}

Flunisolide:

1 to 2 hours (plasma) ^{20} ^{21} ^{52}.

Fluticasone:

3 hours ^{24} ^{74}.

Triamcinolone acetonide:

Intravenous: Approximately 90 minutes (plasma). ^{68} ^{69}

Intranasal: Apparent half-life is 4 hours (plasma) (range, 1 to 7 hours); however, this value probably reflects lingering absorption ^{68} ^{97}; 3.1 hours with aqueous (AQ) formulation ^{69}.

Onset of action:

Beclomethasone and flunisolide—Usually 3 to 7 days; however, may rarely be as long as 2 to 3 weeks in some patients. ^{02} ^{17} ^{25} ^{40} ^{66} ^{67} ^{75}

Budesonide—As early as 24 hours; usually 2 to 3 days ^{12}.

Fluticasone—As early as 12 hours; usually 2 to 3 days ^{24}.

Triamcinolone acetonide—As early as 12 hours. ^{68}; usually 4 to 7 days ^{68} ^{69}.

Time to peak concentration:

Budesonide:

Oral, approximately 3 hours. ^{52}

Inhalation, within 1 hour. ^{12} ^{18} ^{52}

Flunisolide:

10 to 30 minutes.

Triamcinolone acetonide:

Average of 3.4 hours (range, 0.5 to 8 hours). ^{68}

Peak plasma concentration

Flunisolide—0.4 to 1.0 nanogram per mL.

Triamcinolone acetonide—Less than 1 nanogram per mL. ^{68}

Time to maximum benefit

Beclomethasone and flunisolide—Up to 3 weeks in some patients. ^{25} ^{75} ^{76} ^{83} ^{85}

Budesonide—Usually 3 to 7 days, but up to 3 weeks in some patients. ^{16} ^{70}

Fluticasone—usually 4 to 7 days. ^{24} ^{74}

Triamcinolone acetonide—Usually 4 to 7 days. ^{68}

Elimination:
    Beclomethasone—Fecal; renal, 12 to 15%. ^{02} ^{25} ^{66} ^{67} ^{75} ^{76} ^{83} ^{85}
    Budesonide—Renal, 67%; feces 33%. ^{16} ^{70}
    Dexamethasone sodium phosphate—Renal. ^{13}
    Flunisolide—Renal, 50% (65 to 75% primary metabolite); fecal, 50%. ^{20} ^{21}
    Fluticasone—Renal, less than 5% as metabolite; fecal, remaining dose as parent drug and metabolites. ^{24}

Precautions to Consider

Cross-sensitivity and/or related problems

Patients intolerant of benzalkonium chloride, disodium edetate, oleic acid or phenylethanol may be intolerant of some nasal corticosteroid preparations, since they may contain these substances as preservatives.

Beclomethasone dipropionate ^{02} ^{67} ^{83} ^{85}, dexamethasone ^{86}, budesonide ^{16} ^{70}, and triamcinolone ^{68} aerosols also contain fluorocarbon propellants; beclomethasone dipropionate monohydrate ^{05} ^{25}, budesonide ^{12} ^{18}, flunisolide ^{20} ^{21}, fluticasone propionate ^{24}, mometasone furoate ^{22} and triamcinolone ^{69} solution, suspension and powder dosage forms contain no fluorocarbon propellants.

Flunisolide solution contains propylene glycol and polyethylene glycols ^{20} ^{21}.

Carcinogenicity

Beclomethasone—No evidence of carcinogenicity was demonstrated in rats receiving beclomethasone for 95 weeks (13 weeks by inhalation and 82 weeks orally). ^{02} ^{25} ^{66} ^{67} ^{75} ^{76} ^{83} ^{85}

Budesonide—No evidence of carcinogenic effect was found in mice and rats given oral doses of up to 200 mcg/kg/day for 91 weeks. An increase in incidence of gliomas and hepatocellular tumors were observed in a 104-week study in male rats given doses of 50 mcg/kg/day orally. No such changes were seen in male rats at doses of 10 and 25 mcg/kg/day or at any dose in female rats. ^{16} ^{70}

Flunisolide—In long-term studies, flunisolide given orally caused an increase in the incidence of benign pulmonary adenomas in mice but not in rats. Also, as reported for other corticosteroids, flunisolide caused an increased incidence of mammary adenocarcinoma in female rats receiving the highest oral doses ^{20}.

Fluticasone—Tumorigenic potential was found in mice given oral doses of up to 1000 mcg/kg (20 times the maximum recommended daily (MRD) intranasal dose in adults and 10 times the MRD in children) for 78 weeks and in rats given inhalation doses up to 57 mcg/kg (2 times MRD intranasal dose in adults and equal to the MRD intranasal dose in children), for 104 weeks. ^{24}

Mometasone—No evidence of carcinogenicity was found in rats when given an inhalation dose of 67 mcg per kg body weight (mcg/kg) (approximately 3 times the MRD intranasal dose in adult humans on a mcg/m ² basis). No evidence of an increase in tumors was found in mice given an inhalation dose of 160 mcg/kg (approximately 4 times the MRD intranasal dose in adult humans on a mcg/m ² basis). ^{73}

Triamcinolone—No evidence of carcinogenicity was demonstrated in a 2-year study on male and female rats administered oral doses of 1 mcg per kg of body weight (mcg/kg) a day and male and female mice administered oral doses of 3 mcg/kg a day. ^{68} ^{69} ^{97}

Mutagenicity

Beclomethasone—Studies on mutagenicity have not been done. ^{02} ^{25} ^{66} ^{67} ^{75} ^{76} ^{83} ^{85}

Budesonide—No mutagenicity or clastogenic properties was found in any tests. ^{16} ^{70}

Fluticasone—No gene mutation induction was found in prokaryotic or eukaryotic cells in vitro . ^{24}

Triamcinolone—Studies on mutagenicity have not been done. ^{68} ^{69} ^{97}

Pregnancy/Reproduction
Fertility—
Beclomethasone: Female dogs administered beclomethasone orally showed impaired fertility (inhibition of the estrous cycle). However, this effect was not observed following administration of the medication via inhalation. ^{02} ^{25} ^{66} ^{67} ^{75} ^{76} ^{83} ^{85}

Dexamethasone: Dexamethasone may increase or decrease spermatozoa count or motility in some patients. ^{86}

Flunisolide: Studies in female rats showed some evidence of impaired fertility. ^{20} ^{63}

Fluticasone—No evidence of impairment of fertility was observed in studies of rats given subcutaneous doses of up to 50 mcg/kg (2 times the MRD intranasal dose in adult humans on a mcg/m ² basis). ^{24}

Mometasone—No impairment in fertility was observed in rats administered subcutaneous doses of 15 mcg/kg (approximately 3/4 the MRD intranasal dose in adult humans on a mcg/m ² basis). ^{70}

Triamcinolone: Male and female rats administered triamcinolone acetonide orally at doses of up to 15 mcg/kg per day (maternally toxic doses are 2.5 to 15 mcg/kg per day) exhibited no evidence of impaired fertility.

Pregnancy—
Corticosteroids cross the placenta. Adequate and well-controlled studies in humans have not been done with beclomethasone ^{25}, budesonide, dexamethasone ^{86}, flunisolide ^{20} ^{21} ^{27} ^{63}fluticasone, mometasone ^{23}or triamcinolone nasal formulations. Use during pregnancy should be considered only if the benefit to the mother outweighs the potential risk to the fetus ^{75}, especially during the first trimester ^{70} ^{77}.

Studies in animals have shown that corticosteroids are embryotoxic, fetotoxic, and/or teratogenic. ^{02} ^{25} ^{66} ^{67} ^{75} However, teratogenic effects have not been confirmed in humans receiving systemic corticosteroids.

Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism (anorexia, hypotension, weakness and weight loss). ^{35} ^{75} ^{86}

Beclomethasone

In one study of orally inhaled beclomethasone in humans, beclomethasone did not cause teratogenic or other adverse effects ^{63}.

Studies in mice and rabbits have shown that beclomethasone administered subcutaneously at 10 times the MRD adult human dose causes increased fetal resorptions and birth defects, including cleft palate, agnathia, microstomia, absence of tongue, delayed ossification, and partial agenesis of the thymus. ^{02} ^{63} ^{66} ^{67} ^{75} ^{83} ^{85} No teratogenic effects were observed in rats given an inhalation dose of 10 times the MRD adult human dose or an oral dose of 1000 times the MRD adult human dose. ^{75} ^{83} ^{85}

FDA Pregnancy Category C. ^{25} ^{75} ^{76} ^{83} ^{85}

Budesonide

Studies in rats, mice, and rabbits have shown that subcutaneously administered budesonide causes fetal malformations, primarily skeletal defects ^{16} ^{70}, decrease in pup weight, piloerection, decrease in peri- and post-natal viability. ^{12}

FDA Pregnancy Category C. ^{70}

Dexamethasone

Adequate and well-controlled studies in humans have not been done with dexamethasone nasal aerosol ^{86}.

Flunisolide

Adequate and well-controlled studies in humans have not been done. ^{20} ^{21}

Studies in rabbits and rats have shown that systemically administered flunisolide causes teratogenic and fetotoxic effects.

FDA Pregnancy Category C. ^{20} ^{21}

Fluticasone

Studies on mice and rats ^{24} ^{77} given subcutaneous doses of 45 and 100 mcg/kg, respectively, (equal to and 4 times, respectively, the MRD intranasal dose in adult humans on a mcg/m ² basis) revealed fetal toxicity including embryonic growth retardation, omphalocele, cleft palate and retarded cranial ossifications.

Studies on rabbits given a subcutaneous dose of 4 mcg/kg (less than the MRD in adult humans on a mcg/m ² basis), revealed decrease in fetal weight and cleft palate. No teratogenic effects were reported at oral doses of up to 300 mcg/kg (25 times the MRD intranasal dose in adult humans on a mcg/m ² basis). Fluticasone crossed the placenta following oral administration of 1000 mcg/kg given to rats and 300 mcg/kg given to rabbits (approximately 4 and 25 times the MRD intranasal dose in adult humans on a mcg/m ² basis).

FDA Pregnancy Category C. ^{24}

Mometasone

Reproductive studies in rats administered subcutaneous doses of 15 mcg/kg (approximately 3/4 the MRD intranasal dose in adult humans on a mcg/m ² basis), experienced prolonged gestation and labor, reduced offspring survival and reduced maternal weight gain.

Studies in mice given subcutaneous doses of 60 and 180 mcg/kg (approximately 2 and 4 times, respectively, the MRD intranasal dose in adult humans on a mcg/m ² basis) experienced cleft palate, reduced fetal body weight, delayed ossification and reduced maternal weight gain. Offspring survival was reduced in the 180 mcg/kg dosage group. Studies in mice given a subcutaneous dose of 20 mcg/kg (approximately 1/2 of the MRD intranasal dose in adults on a mcg/m ² basis) showed no teratogenic effects.

Rabbits given a dermal dose of 150 mcg/kg (approximately 14 times the MRD intranasal dose in adult humans on a mcg/m ² basis) experienced flexed front paws, reduced maternal weight gain, reduced fetal weight and delayed ossification.

Rats given a dermal dose of 600 mcg/kg and 1200 mcg/kg (approximately 30 and 60 times the MRD intranasal dose in adult humans on a mcg/m ² basis), experienced reduced maternal weight gain and passed on umbilical hernia, cleft palate, microphthalmia, reduced maternal weight gain, and delayed ossification to their rat pups. ^{70}

FDA Pregnancy Category C. ^{73}

Triamcinolone

A few female rats administered oral doses of 8 mcg/kg per day exhibited dystocia and prolonged delivery and at oral doses of 5 mcg/kg per day exhibited an increase in fetal resorptions, stillbirths, decrease in pup body weight and survival. ^{68} ^{69}

. Studies in rats and rabbits administered systemic doses of 20 to 80 mcg/kg per day have shown teratogenic effects, including a low incidence of cleft palate and/or internal hydrocephaly and axial skeletal defects. Studies in non-human primates administered systemic doses of 500 mcg/kg per day have shown teratogenic effects, including CNS and cranial malformations ^{68} ^{69} ^{77}. Administration of triamcinolone nasal aerosol to pregnant rats and rabbits resulted in embryotoxic and fetotoxic effects that were comparable to those produced by administration by other routes. ^{69}

FDA Pregnancy Category C. ^{68} ^{69}

Breast-feeding

Distribution of significant quantities of corticosteroids into breast milk may suppress growth, interfere with endogenous corticosteroid production, or cause other adverse effects in the nursing infant ^{63}.

Beclomethasone, budesonide, flunisolide, fluticasone, and triamcinolone—It is not known whether beclomethasone, budesonide, flunisolide, fluticasone, or triamcinolone is distributed into breast milk. ^{02} ^{12} ^{16} ^{20} ^{21} ^{24} ^{25} ^{63} ^{66} ^{67} ^{68} ^{69} ^{70} ^{75} ^{76} ^{77} ^{83} ^{85} However, systemic corticosteroids are distributed into breast milk ^{63}, and caution should be exercised when administering corticosteroids to nursing women. Use of corticosteroids while breast-feeding should be considered only if the benefit to the mother outweighs the potential risk to the infant. ^{02} ^{12} ^{16} ^{20} ^{21} ^{25} ^{66} ^{67} ^{68} ^{69} ^{70} ^{77} ^{83} ^{85}

Dexamethasone—It is distributed into breast milk. ^{63} ^{86} Nursing while receiving pharmacologic doses of dexamethasone is not recommended. ^{63} ^{86}

Mometasone—Plasma concentrations are not measurable in breast milk following the administration of the MRD intranasal adult human dose; thus fetal or breast milk exposure is expected to be negligible and toxicity low. Use of mometasone while breast-feeding should be considered if the benefit to the mother outweighs the risk to the infant. ^{23}

Pediatrics
^{54}
Significant suppression of growth has not been well documented ^{97} ^{102} with the use of usual doses of nasal beclomethasone and flunisolide ^{36} ^{40} ^{52} ^{63}. If significant systemic absorption of nasal corticosteroids occurs in pediatric patients, adrenal suppression and growth suppression may result ^{63}. Prolonged or high-dose therapy with these medications during pregnancy, especially dexamethasone, requires careful attention to dosage and close monitoring of growth and development of the infant. ^{02} ^{12} ^{16} ^{20} ^{21} ^{23} ^{24} ^{25} ^{66} ^{67} ^{68} ^{69} ^{70} ^{73} ^{75} ^{76} ^{83} ^{85}

Geriatrics

Appropriate studies with nasal corticosteroids have not been performed in the geriatric population. ^{63} However, geriatrics-specific problems that would limit the usefulness of this medication in the elderly are not expected. ^{24} ^{63} ^{76}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

Ephedrine or
Phenobarbital or
Rifampin    (induction of hepatic microsomal enzyme activity, by ephedrine, phenobarbital and rifampin, may result in increased metabolism, decreased serum concentration, decreased elimination half-life of dexamethasone and may warrant an increase in dexamethasone dosage ^{86}.)

Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
For dexamethasone
Nitroblue tetrazolium test for bacterial infection    (dexamethasone may produce false-negative results ^{86})

With physiology/laboratory test values
Adrenal function as assessed by corticotropin (ACTH) stimulation or measurement of plasma cortisol and
Hypothalamic-pituitary-adrenal (HPA) axis function    (may be decreased if significant absorption occurs, especially in children; most likely with dexamethasone ^{02} ^{16} ^{20} ^{21} ^{23} ^{24} ^{25} ^{66} ^{67} ^{68} ^{69} ^{70} ^{83} ^{85})

Glucose concentration, blood and urine    (may be increased if significant absorption occurs because of intrinsic hyperglycemic activity of glucocorticoids; most likely with dexamethasone)

Hematologic status    (should be monitored during long-term therapy)

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).

Risk-benefit should be considered when the following medical problems exist
Amebiasis, latent or active    (dexamethasone or other corticosteroids may activate latent amebiasis ^{86})

Asthma    (may exacerbate symptoms ^{20} ^{21} ^{25} ^{83} ^{85})

Diabetes mellitus    (dexamethasone may decrease carbohydrate tolerance and use may warrant an increase in insulin dosage ^{86})

Glaucoma    (may increase intraocular pressure ^{02} ^{24} ^{66} ^{67} ^{73} ^{75} ^{76} ^{86})

Hepatic function impairment^{12}^{77}
Hypothyroidism^{12}^{77}^{29}
» Left ventricular free wall rupture or
» Myocardial infarction, recent    (concurrent use with dexamethasone may exacerbate these conditions ^{86})

» Infections, fungal, bacterial, or systemic viral or^{12}^{16}^{20}^{21}^{23}^{24}^{25}^{68}^{69}^{73}^{75}^{76}^{77}^{83}^{85}^{86}
» Ocular herpes simplex^{16}^{23}^{68}^{69}^{70}^{73}^{75}^{76}^{86}    (corticosteroids may mask infection)

Nasal septal ulcers, recent or
Nasal surgery, recent or
Nasal trauma, recent    (corticosteroids inhibit wound healing ^{12} ^{16} ^{20} ^{21} ^{23} ^{68} ^{69} ^{70} ^{73} ^{75} ^{76} ^{77} ^{87} ^{100})

» Tuberculosis, latent or active, of respiratory tract^{12}^{16}^{20}^{21}^{23}^{24}^{68}^{69}^{73}^{75}^{76}^{77}^{86}
» Hypersensitivity to corticosteroids^{12}^{16}^{20}^{21}^{23}^{24}^{25}^{68}^{69}^{73}^{75}^{76}^{77}^{83}^{85}^{86}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Adrenal function assessment    (assessment of HPA axis function may be advisable at periodic intervals in patients receiving long-term nasal corticosteroid therapy; important in patients receiving usual doses of dexamethasone or greater-than-recommended doses of beclomethasone, budesonide, flunisolide, fluticasone, mometasone or triamcinolone ^{12} ^{15} ^{20} ^{21} ^{23} ^{24} ^{37} ^{38} ^{39} ^{56} ^{68} ^{69} ^{75} ^{77} ^{86})

» Otolaryngologic examination    (should be performed in patients on long-term therapy to monitor nasal mucosa and nasal passages for infection, nasal septal perforation, nasal membrane ulceration, or other histologic changes ^{37} ^{38}.)

Side/Adverse Effects

Note: The risk of systemic effects is minimal with usual doses of nasal beclomethasone and flunisolide. Side effects from usual doses of beclomethasone are generally limited to local effects ^{52} ^{55}.
Systemic effects including hypothalamic-pituitary-adrenal (HPA) axis suppression may occur with usual doses of nasal dexamethasone ^{86} greater-than-recommended doses of beclomethasone, budesonide flunisolide, fluticasone or triamcinolone ^{20} ^{21} ^{23} ^{24} ^{56} ^{75}. (Doses of 440 mcg of triamcinolone acetonide administered daily for 42 days did not measurably affect adrenal response to a 6-hour cosyntropin test. ^{97}) If the patient is particularly sensitive or has recently used systemic corticosteroids prior to using nasal corticosteroids, the patient may also be predisposed to hypercorticism (blurred vision, bone fractures, excess facial hair growth in females, fullness or rounding of face, neck, and trunk, hypertension, increased thirst and urination, impotence in males, lack of menstrual periods, muscle wasting or weakness). ^{24} ^{25} ^{41} ^{70} ^{75} ^{83} ^{85}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
For beclomethasone

Headache —incidence 34% ^{02} ^{66} ^{67} ^{76}

For triamcinolone

Headache —incidence 18% ^{68} ^{77}

Incidence less frequent
For all nasal corticosteroids

Crusting inside nose ^{52} ^{77} or epistaxis (bloody mucus or unexplained nosebleeds ^{02} ^{20} ^{21} ^{23} ^{24} ^{52} ^{66} ^{67} ^{68} ^{75} ^{76} ^{83} ^{85} ^{86} ^{90})—especially if spray is improperly aimed toward nasal septum, rather than onto the turbinates ^{52}

sore throat ^{24} ^{52}

ulceration of nasal mucosa (sores inside nose ^{02} ^{21} ^{52} ^{66} ^{67} ^{75} ^{76} ^{83} ^{85})

For dexamethasone ^{86}

Allergic reaction or bronchial asthma (shortness of breath, troubled breathing, tightness in chest, hives, or wheezing)

cataracts, glaucoma, optic nerve damage, or secondary ocular fungal or viral infection (blindness; blurred vision; discharge or redness of the eye; eye pain)

headache

For fluticasone ^{24}

Allergic reaction or bronchial asthma ^{24}(shortness of breath, troubled breathing, tightness in chest, hives, or wheezing)

cough

headache

nausea or vomiting

For beclomethasone (monohydrate), budesonide, dexamethasone ^{86}, and flunisolide

Cough ^{20} ^{21}

dizziness or light-headedness ^{86}

hoarseness —not reported for budesonide ^{20} ^{21}

lethargy (unusual tiredness or weakness)

loss of sense of taste or smell — reported for dexamethasone and flunisolide ^{02} ^{20} ^{21} ^{66} ^{67} ^{86}

nausea or vomiting ^{20} ^{21} ^{86}

rhinorrhea, continuing ^{75} ^{83} ^{85} (runny nose), stuffy nose, continuing ^{20} ^{21} ^{86}
watery eyes, continuing —not reported for budesonide

stomach pains —not reported for budesonide

For mometasone

Headache ^{73}

Incidence rare
For all nasal corticosteroids

Nasal candidiasis ^{02} ^{16} ^{20} ^{21} ^{24} ^{25} ^{66} ^{67} ^{68} ^{69} ^{70} ^{73} ^{75} ^{76} ^{83} ^{85} (white patches inside nose)

nasal septal perforation (bloody mucus or unexplained nosebleeds ^{02} ^{24} ^{25} ^{31} ^{52} ^{57} ^{58} ^{66} ^{67} ^{73} ^{75} ^{76} ^{83} ^{85} ^{86})

ocular hypertension ^{02} ^{24} ^{25} ^{66} ^{67} ^{73} ^{75} ^{76} ^{83} ^{85} (eye pain; nausea; vomiting; gradual loss of vision)

pharyngeal candidiasis ^{02} ^{16} ^{20} ^{21} ^{24} ^{25} ^{66} ^{67} ^{68} ^{69} ^{70} ^{73} ^{75} ^{76} ^{77} ^{83} ^{85} ^{86} (white patches in throat)

For beclomethasone

Cataracts, conjunctivitis, or glaucoma ^{02} ^{66} ^{67} ^{76} (blindness; blurred vision; discharge or redness in the eye, eyelid, or inner lining of the eyelid; eye pain)

myalgia ^{76} ( muscle pain)

hypersensitivity reaction, delayed or immediate ^{25} ^{75} ^{83} ^{85} (large hives; rash; shortness of breath or troubled breathing ^{02} ^{66} ^{67}; swelling of eyelids, face, or lips)

rhinitis, atrophic ^{77} (bad smell; dry or stuffy nose ; headache behind eye sockets)

tinnitus ^{76} ( ringing in the ears)

ulceration of nasal mucosa ^{25} (sores inside nose)

wheezing ^{25}

For budesonide

Dermatitis (rash)

urticaria (hives)

For fluticasone
^{24}^{74}
Abdominal pain (stomach pain)

bronchitis (cough)

diarrhea

dizziness

fever

flu-like symptoms

hypersensitivity reaction, delayed or immediate ^{75} (large hives; rash; shortness of breath or troubled breathing; swelling of eyelids, face, or lips)

ophthalmic changes (blindness; blurred vision; eye pain; dry and irritated eyes)

runny nose

For triamcinolone

Burning or stinging, continuing, after use of spray, irritation inside nose ^{68} ^{69}

Symptoms of chronic overdose

Acneiform lesions (acne)

Cushing"s syndrome ^{24} ^{25} ^{75} ^{76} ^{83} ^{84} ^{85} ^{86} ^{56}(blurred vision, increased thirst, and increased urination; bone fractures; excess facial hair growth in females; fullness or rounding of the face, neck, and trunk; high blood pressure ; impotence in males; muscle wasting and weakness)

menstrual changes ^{86}

Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
For all nasal corticosteroids

Burning, dryness, or other irritation inside the nose, mild and transient ^{16} ^{20} ^{21} ^{23} ^{24} ^{25} ^{52} ^{70} ^{75} ^{76} ^{77} ^{83} ^{85} ^{86}

For beclomethasone and flunisolide
^{61}
Irritation of throat —possibly due to vehicle in nasal spray

sneezing attacks —may be more common in children using beclomethasone aerosol or flunisolide spray ^{37} ^{38} ^{40} ^{52} ^{59} ^{60} ^{75} ^{83} ^{85}

Incidence less frequent
For all nasal corticosteroids

Sneezing ^{97}

For budesonide

Throat itching

For dexamethasone
^{86}
Cardiovascular changes (heart attack, high blood pressure, or weak heart )

dermatological changes (flushing; impaired wound healing; suppressed reaction to skin tests)

endocrine changes (suppressed growth in children)

fluid and electrolyte disturbances ( dehydration or extreme thirst; water retention)

gastrointestinal changes (lower abdominal or stomach pain and burning; stomach bloating)

hiccups

increased appetite and weight gain

malaise ( general unwell feeling)

musculoskeletal changes (bone fractures; muscle wasting and weakness)

neurological disturbances (headache; seizures)

thromboembolism (tingling or swelling in hands, lower legs, or feet)

urticaria (hives)

For triamcinolone

Sinus congestion (stuffy nose or headache)

stuffy nose

throat discomfort ^{68} ^{69}

Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
For acute overdose—Adverse effects due to acute overdose are unlikely with the small quantities of corticosteroid contained in each canister. ^{20} ^{21} ^{23} ^{25} ^{68} ^{69} ^{73} ^{75} ^{77} ^{78} ^{86}

For chronic overdose ^{02} ^{66} ^{67} ^{86} ^{87}—If symptoms of chronic overdose (hypercorticism ^{41}) occur, nasal corticosteroids should be discontinued slowly. ^{24} ^{25} ^{70} ^{75}

Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Corticosteroids (Nasal) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Intolerance ^{97} or sensitivity ^{86} to corticosteroids

Pregnancy—Risk-benefit must be considered, since systemic corticosteroids cross the placenta and have demonstrated embryotoxicity, fetotoxicity, and teratogenicity in animals; infants born to mothers who received substantial doses of corticosteroids during pregnancy should be observed for hypoadrenalism ^{35}

Breast-feeding—Risk-benefit must be considered, since systemic corticosteroids are distributed into breast milk and have demonstrated embryotoxicity, fetotoxicity, and teratogenicity in animals; infants breast-fed by mothers who received substantial doses of corticosteroids while breast-feeding should be observed for hypoadrenalism ^{35}

Use in children—Significant effect on growth by beclomethasone or flunisolide has not been documented; importance of monitoring growth and development with prolonged or high-dose therapy

Other medical problems, especially amebiasis, diabetes mellitus, fungal, bacterial, or systemic viral infections, glaucoma, hepatic function impairment, hypothyroidism, left ventricular free wall rupture, recent myocardial infarction, nasal ulcers, surgery, or trauma, ocular herpes simplex, or latent or active tuberculosis of respiratory tract

Proper use of this medication
» Proper administration technique; reading patient directions carefully before use ^{90}

Blowing nose to clear nasal passages before administration; aiming spray away from nasal septum (aiming towards the inner corner of eye) ^{77} ^{97}

» Compliance with therapy; may require up to 3 weeks for full benefit ^{77}

» Importance of not using more medication than the amount prescribed, because of potential enhanced absorption and increased severity of side effects

» Checking with physician before using medication for other nasal problems

Saving special inhaler used for beclomethasone or dexamethasone; refills may be available

» Proper dosing
Missed dose: Using as soon as possible if remembered within an hour or so; if remembered later, not using at all; not doubling doses

» Proper storage ^{65} ; not storing budesonide powder in damp places, especially if cap has not been tightly screwed on ^{97} ; decreased efficacy if aerosol canister is cold ^{65} ; not puncturing, breaking, or burning aerosol container; discarding unused portion of beclomethasone solution or flunisolide solution 3 months after opening package

Precautions while using this medication
Regular visits to physician to check progress during prolonged therapy

» Avoiding immunizations while taking nasal corticosteroids, unless approved by physician, due to a possible neurological hazard and lack of antibody response ^{86}

» Checking with physician if:    —signs of infection of nose, throat, or sinuses occur
   —no improvement within 7 days (for dexamethasone) ^{28}
   —no improvement within 3 weeks for other nasal corticosteroids ^{75} ^{76}
   —condition becomes worse

Side/adverse effects
Signs of potential side effects, especially acneiform lesions, allergic reaction or bronchial asthma, burning, stinging or irritation in nose after use of spray, cardiovascular changes, cough, crusting inside nose, Cushing's syndrome, dermatological changes, dizziness or light-headedness, endocrine changes, epistaxis, fluid or electrolyte disturbances, gastrointestinal changes, headache, hoarseness, hypersensitivity reaction, increased appetite and weight gain, lethargy, loss of sense of taste or smell, malaise, musculoskeletal changes, nasal candidiasis, nasal septal perforation, nausea or vomiting, ocular hypertension, pharyngeal candidiasis, rhinitis, rhinorrhea, sore throat, stomach pain, stuffy nose, thromboembolism, or urticaria

General Dosing Information
In patients with blocked nasal passages, a topical decongestant may be used just prior to use of the nasal corticosteroid. ^{02} ^{12} ^{23} ^{66} ^{67} ^{68} ^{69} ^{75} However, because prolonged use of topical nasal decongestants may cause congestive rebound, they should preferably be used for a maximum of 3 to 5 days. An oral decongestant is recommended for chronic nasal congestion.

The smallest dose of a nasal corticosteroid required to control symptoms should be used as a maintenance dose after the desired clinical response is achieved ^{02} ^{15} ^{18} ^{23} ^{24} ^{67} ^{68} ^{72} ^{78} ^{80}.

The dosage of other corticosteroids being administered concurrently by other routes of administration, including oral inhalation, should be taken into account when determining the usual adult prescribing limits of nasal corticosteroids. ^{90}

BECLOMETHASONE

Summary of Differences
Indications: Betamethasone dipropionate monohydrate is indicated for the treatment of vasomotor nonallergic rhinitis ^{25}.

Pharmacology/pharmacokinetics: See Pharmacology/Pharmacokinetics .

Precautions: Cross-sensitivity and/or related problems—Nasal suspension dosage form contains no fluorocarbon propellants. ^{05} ^{25}

Side/adverse effects: See Side/Adverse Effects .

Additional Dosing Information
Regular use is required to obtain full therapeutic benefit. Medication should be discontinued if improvement is not evident after 3 weeks. ^{02} ^{66} ^{67}

See also General Dosing Information .

Nasal Dosage Forms

BECLOMETHASONE DIPROPIONATE NASAL AEROSOL

Usual adult and adolescent dose
Anti-inflammatory (steroidal), nasal
Nasal, 42 or 50 mcg (0.042 or 0.05 mg) (1 metered spray) in each nostril two to four times a day (total daily dose, 168 to 400 mcg [0.168 to 0.4 mg]); then decrease the dose to amount needed to maintain effect. ^{02} ^{67} ^{75} ^{82} ^{83} ^{85}

Usual adult prescribing limits
Nasal, 1 mg per day. ^{82}

Note: If orally inhaled beclomethasone is used concurrently, the combined total daily dose should not exceed 1 mg. ^{82}

Usual pediatric dose
Anti-inflammatory (steroidal), nasal
Children up to 6 years of age: Safety and efficacy have not been established. ^{02} ^{67} ^{75} ^{82} ^{83} ^{85}

Children 6 to 12 years of age: Nasal, 42 (0.042mg) (1 metered spray) in each nostril three times a day (total daily dose, 252 mcg [0.252 mg]). ^{02} ^{67} ^{75} ^{83} ^{85}

Children 12 years of age and older (In Canada, children 6 years of age and older): See Usual adult and adolescent dose.

Usual pediatric prescribing limits
Nasal, 500 mcg (0.5 mg) per day. ^{82} If orally inhaled beclomethasone is used concurrently, the combined total daily dose should not exceed 500 mcg (0.5 mg). ^{82}

Strength(s) usually available
U.S.—

42 mcg (0.042 mg) per metered spray (Rx) [Beconase^{02}^{67} (fluorocarbons) ( oleic acid)] [Vancenase^{85} ( fluorocarbons) (oleic acid)] [Vancenase pockethaler^{75}^{83} (fluorocarbons ) (oleic acid)]

Canada—

50 mcg (0.05 mg) per metered spray (Rx) [Beconase] [Vancenase^{82} (fluorocarbons) (oleic acid)][Generic]^{27}

Packaging and storage:
Store between 2 and 30 °C (36 and 86 °F), unless otherwise specified by manufacturer. ^{02} ^{67} ^{75} ^{82} ^{83} ^{85}. Protect from moisture and unusual temperature changes. ^{75} ^{83}

Auxiliary labeling:
   • For the nose.
   • Shake well. ^{75} ^{83} ^{85}

Note: When dispensing, include patient instructions. ^{75} ^{83} ^{85}
Explain administration technique.

BECLOMETHASONE DIPROPIONATE MONOHYDRATE NASAL SUSPENSION

Usual adult and adolescent dose
Anti-inflammatory (steroidal), nasal
Nasal, 42 to 100 mcg (0.042 to 0.1 mg) (1 or 2 metered sprays) in each nostril one ^{25} or two times a day (total daily dose, 168 to 400 mcg [0.168 to 0.4 mg]). ^{05} ^{66} ^{76} ^{84}

Usual adult prescribing limits
Nasal, 600 mcg (0.6 mg) (12 metered sprays) per day. ^{84}

Note: If orally inhaled beclomethasone is used concurrently, the combined total daily dose should not exceed 1 mg. ^{84}

Usual pediatric dose
Anti-inflammatory (steroidal), nasal
Children up to 6 years of age: Safety and efficacy have not been established. ^{05} ^{25} ^{28} ^{66} ^{76} ^{84}

Children 6 years of age and older: See Usual adult and adolescent dose.
^{25}^{84}

Usual pediatric prescribing limits
Nasal, 400 mcg (0.4 mg) (8 metered sprays) per day. ^{84} If orally inhaled beclomethasone is used concurrently, the combined total daily dose should not exceed 500 mcg (0.5 mg). ^{84}

Strength(s) usually available
U.S.—

42 mcg (0.042 mg) per metered spray (Rx) [Beconase AQ^{05}^{66} (benzalkonium chloride) (carboxymethylcellulose sodium) (dextrose ) (hydrochloric acid) ( microcrystalline cellulose) (phenylethanol 0.25% ) (polysorbate 80)]

84 mcg (0.084 mg) per metered spray (Rx) [Vancenase AQ 84 mcg^{25}^{76} (benzalkonium chloride) (carboxymethylcellulose sodium) (dextrose ) (microcrystalline cellulose) ( phenylethyl alcohol) (polysorbate 80)]

Canada—

50 mcg (0.05 mg) per metered spray: Not commercially available. (Rx)
Note: Withdrawn from the Canadian market in March 2000.

Packaging and storage:
Store between 2 and 30 °C (36 and 86 °F), unless otherwise specified by manufacturer. ^{25} ^{66} ^{84}

Auxiliary labeling:
   • For the nose. ^{76}
   • Shake well. ^{25} ^{76}

Note: When dispensing, include patient instructions. ^{25} ^{66} ^{76} ^{84}
Explain administration technique.

BUDESONIDE

Summary of Differences
Pharmacology/pharmacokinetics: See Pharmacology/Pharmacokinetics.

Precautions: Cross-sensitivity and/or other related problems—Nasal powder and suspension dosage forms contain no fluorocarbon propellants ^{12} ^{18}

Side/adverse effects: See Side/Adverse Effects.

Additional Dosing Information
Regular use is required to obtain full therapeutic benefit. Treatment should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. ^{12} ^{70} ^{79}

See also General Dosing Information.

Nasal Dosage Forms

Note: Bracketed information in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

BUDESONIDE NASAL POWDER

Usual adult and adolescent dose
Anti-inflammatory (steroidal), nasal
Nasal inhalation, initially 200 mcg (0.2 mg) (2 metered inhalations) in each nostril once a day in the morning (total daily dose, 400 mcg [0.4 mg]), the dosage then being decreased to the lowest effective dose according to patient response. ^{18} ^{81}

Usual adult prescribing limits
Nasal inhalation, 800 mcg (0.8 mg) (8 metered inhalations) per day. ^{18}

Usual pediatric dose
Anti-inflammatory (steroidal), nasal inhalation
Children up to 6 years of age: Safety and efficacy have not been established. ^{18} ^{81}

Children 6 years of age and older: See Usual adult and adolescent dose. ^{18} ^{81}

Note: [Children 4 to 6 years of age]¹ have benefited from 100 mcg (1 metered inhalation) to 200 mcg (2 metered inhalations) in each nostril daily, up to 400 mcg (4 metered inhalations total) daily, followed by a dosage adjusted to the lowest effective dose as determined by the child's response.^{103}

Usual pediatric prescribing limits
Nasal inhalation, 400 mcg (0.4 mg) (4 metered inhalations) per day. ^{18}

Strength(s) usually available
U.S.—
Not commercially available.

Canada—

100 mcg (0.1 mg) per metered inhalation (Rx) [Rhinocort Turbuhaler^{18}^{81}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. ^{18}

Auxiliary labeling:
   • For the nose.

Note: When dispensing, include patient instructions. ^{81}
Explain administration technique.

BUDESONIDE NASAL SUSPENSION

Usual adult and adolescent dose
Anti-inflammatory (steroidal), nasal or
Rhinitis—Initial: Nasal, 128 mcg (0.128 mg) (2 metered sprays) in each nostril once a day in the morning or 64 mcg (0.064 mg) (1 metered spray) in each nostril twice a day (total daily dose, 256 mcg [0.256 mg]).). ^{12} ^{79}
Polyps—Initial: Nasal, 64 mcg (0.064 mg) (1 metered spray) in each nostril twice a day (total daily dose, 256 mcg [0.256 mg]). ^{12} ^{79}

Usual adult prescribing limits
Nasal, 800 mcg (0.8 mg) per day.

Usual pediatric dose
Anti-inflammatory (steroidal), nasal
Children up to 6 years of age: Safety and efficacy have not been established. ^{12} ^{79}

Children 6 years of age and older: See Usual adult and adolescent dose. ^{12} ^{79}

Note: [Children 4 to 6 years of age]¹ have benefited from 100 mcg (1 metered inhalation) to 200 mcg (2 metered inhalations) in each nostril daily, up to 400 mcg (4 metered inhalations total) daily, followed by a dosage adjusted to the lowest effective dose as determined by the child's response.^{103}

Usual pediatric prescribing limits
Nasal, 400 mcg (0.4 mg) per day.

Strength(s) usually available
U.S.—
Not commercially available.

Canada—

64 mcg (0.64 mg) per metered spray (Rx) [Rhinocort Aqua^{12}^{79} (carboxymethylcellulose sodium) (disodium edetate) (glucose (anhydrous) ) (hydrochloric acid) ( microcrystalline cellulose) (potassium sorbate) (purified water)][Generic]^{29}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing. ^{12}

Auxiliary labeling:
   • For the nose.
   • Shake well. ^{12} ^{79}

Note: When dispensing, include patient instructions. ^{92}
Explain administration technique.

BUDESONIDE NASAL AEROSOL

Usual adult and adolescent dose
Anti-Inflammatory (steroidal), nasal
Initial: Nasal, 64 mcg (0.064 mg) (2 metered sprays) in each nostril twice a day or 128 mcg (0.128 mg) (4 metered sprays) in each nostril once a day (total daily dose, 256 mcg [0.256 mg]). ^{16} ^{70}

Usual pediatric dose
Anti-inflammatory (steroidal), nasal
Children up to 6 years of age: Safety and efficacy have not been established. ^{16} ^{70}

Children 6 years of age and older: See Usual adult and adolescent dose ^{16} ^{70} .

Note: [Children 4 to 6 years of age]¹ have benefited from 100 mcg (1 metered inhalation) to 200 mcg (2 metered inhalations) in each nostril daily, up to 400 mcg (4 metered inhalations total) daily, followed by a dosage adjusted to the lowest effective dose as determined by the child's response.^{103}

Strength(s) usually available
U.S.—

32 mcg (0.032 mg) per metered spray (Rx) [Rhinocort^{16}^{70} (fluorocarbons)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40°C (104°F), preferably between 15 and 30°C (59 and 86°F), unless otherwise specified by manufacturer. ^{16}

Auxiliary labeling:
   • For the nose.
   • Shake well. ^{16} ^{70}

DEXAMETHASONE

Summary of Differences
Indications: Less frequently used to significantly increased incidence of adverse effects ^{40}.

Pharmacology/pharmacokinetics: See Pharmacology/Pharmacokinetics .

Precautions: Altered carbohydrate tolerance.

Cross-sensitivity and/or related problems—Nasal aerosol contains fluorocarbon propellants ^{86}.

Breast-feeding—Dexamethasone is distributed into breast milk. Use caution when administering to nursing women.

Laboratory value alterations—False-negative results may occur with nitroblue tetrazolium test for bacterial infections ^{86}.

Other medications—Concurrent use with ephedrine, phenobarbital and rifampin may warrant an increase in dexamethasone dosage.

Other medical conditions—Increased health risk if recent myocardial infarction or left ventricular free wall rupture.

Side/adverse effects:

HPA axis suppression or other systemic corticosteroid effects may occur with usual nasal inhalation doses ^{08} ^{09} ^{86}

See also Side/Adverse Effects .

Additional Dosing Information
When medication is to be discontinued, dosage usually should be reduced gradually according to the dose, frequency, and duration of therapy ^{86}.

Patients whose conditions do not improve within 7 days should be re-evaluated ^{86}. Use of dexamethasone should be limited to a maximum of 2 weeks.

See also General Dosing Information .

Nasal Dosage Forms

DEXAMETHASONE SODIUM PHOSPHATE NASAL AEROSOL

Usual adult and adolescent dose
Anti-inflammatory (steroidal), nasal
Nasal, 200 mcg (0.2 mg) (2 metered sprays) of dexamethasone phosphate in each nostril two or three times a day (total daily dose, 800 mcg [0.8 mg] to 1.2 mg or dexamethasone phosphate), the dosage then being decreased according to patient response ^{86}.

Note: Some patients may be maintained on 100 mcg (0.1 mg) (1 metered spray) of dexamethasone phosphate in each nostril two times a day. Therapy should be discontinued as soon as possible ^{86}. If symptoms recur, therapy may be reinstituted.

Usual adult prescribing limits
Nasal, 1.2 mg (12 metered sprays) of dexamethasone phosphate per day ^{86}.

Usual pediatric dose
Anti-inflammatory (steroidal), nasal
Children up to 6 years of age: Use is not recommended ^{86}.

Children 6 to 12 years of age: Nasal, 100 or 200 mcg (0.1 to 0.2 mg) (1 or 2 metered sprays) of dexamethasone phosphate in each nostril two times a day (total daily dose, 400 to 800 [0.4 to 0.8 mg] of dexamethasone phosphate ^{86}.

Usual pediatric prescribing limits
Nasal, 800 mcg (0.8 mg) (8 metered sprays) of dexamethasone phosphate per day ^{86}.

Strength(s) usually available
U.S.—

100 mcg (0.1 mg) as phosphate per metered spray (Rx) [Dexacort Turbinaire^{86} (alcohol 2%) ( chlorofluorocarbons)]

Canada—
Not commercially available.

Packaging and storage:
Store below 49 °C (120 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
• For the nose.
• Shake well.

Note: When dispensing, include patient instructions ^{86}.
Explain administration technique.

FLUNISOLIDE

Summary of Differences
Pharmacology/pharmacokinetics: See Pharmacology/Pharmacokinetics .

Precautions: Cross-sensitivity and/or related problems—Nasal solution dosage form contains no fluorocarbon propellants. ^{20} ^{21} ^{71}

Side/adverse effects: See Side/Adverse Effects .

Additional Dosing Information
Regular use is required to obtain full therapeutic benefit. Treatment should not be continued beyond 3 weeks in the absence of significant symptomatic improvement.

See also General Dosing Information .

Nasal Dosage Forms

FLUNISOLIDE NASAL SOLUTION USP

Usual adult dose
Anti-inflammatory (steroidal), nasal
Initial: Nasal, 50 mcg (0.05 mg) (2 metered sprays) in each nostril two times a day (total daily dose, 200 mcg [0.2 mg]); if necessary, dosing frequency may be increased to three times a day (total daily dose, 300 mcg [0.3 mg]). ^{20} ^{21} ^{71} ^{72} ^{80}

Maintenance: Nasal, as little as 25 mcg (0.025 mg) (1 metered spray) in each nostril once a day has been effective (total daily dose, 50 mcg [0.05 mg]). ^{72} ^{80}

Usual adult prescribing limits
Nasal, 400 mcg (0.4 mg) (16 metered sprays) per day. ^{20} ^{21} ^{71} ^{72}

Note: In Canada, adult prescribing limits are as follows: 300 mcg (0.3 mg) (12 metered sprays) per day ^{80}.

Usual pediatric dose
Anti-inflammatory (steroidal), nasal

Children up to 6 years of age:
Safety and efficacy have not been established. ^{20} ^{21} ^{71} ^{72}

Children 6 to 14 years of age:
Initial—Nasal, 25 mcg (0.025 mg) (1 metered spray) in each nostril three times a day ^{80}; or 50 mcg (0.05 mg) (2 metered sprays) in each nostril two times a day; (total daily dose, 150 or 200 mcg [0.15 or 0.2 mg]). ^{20} ^{21} ^{71} ^{72}

Maintenance—Nasal, as little as 25 mcg (0.025 mg) (1 metered spray) in each nostril once a day has been effective (total daily dose, 50 mcg [0.05 mg]). ^{72} ^{80}

Children 14 years of age and older:
See Usual adult dose.

Usual pediatric prescribing limits
Nasal, 200 mcg (0.2 mg) (8 metered sprays) per day. ^{20} ^{21} ^{71} ^{72}

Note: In Canada, pediatric dosing limits are as follows: 150 mcg (0.15 mg) (6 metered sprays) per day ^{80}.

Strength(s) usually available
U.S.—

25 mcg (0.025 mg) per metered spray (Rx) [Nasalide^{21}^{71} (benzalkonium chloride) (butylated hydroxyanisole) (citric acid) (disodium edetate) ( hydrochloric acid) (polyethylene glycol 3350) (propylene glycol) (purified water ) (sodium citrate) (sodium hydroxide)] [Nasarel^{20}^{72} (benzalkonium chloride) (butylated hydroxyanisole) (citric acid) ( disodium edetate) (hydrochloric acid) (polyethylene glycol 400) (polysorbate 20) (propylene glycol) ( sodium citrate dihydrate) (sodium hydroxide) (sorbitol)]

Canada—

25 mcg (0.025 mg) per metered spray (Rx) [Rhinalar^{19}^{80} (benzalkonium chloride) (citric acid) (polyethylene glycol ) (propylene glycol) ( sodium citrate)]

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F). ^{71} ^{72} ^{80} Store in a tight container and in an upright position. Protect from light.

Auxiliary labeling:
• For the nose.

Note: When dispensing, include patient instructions. ^{71} ^{72} ^{80}
Explain administration technique.

FLUTICASONE

Summary of Differences
Pharmacology/pharmacokinetics: See Pharmacology/Pharmacokinetics .

Precautions: Cross-sensitivity and/or other related problems—Nasal suspension dosage form contains no fluorocarbon propellants ^{24}.

Side/adverse effects: See also Side/Adverse Effects .

Additional Dosing Information
Regular use is required to obtain full therapeutic benefit. Treatment should not be continued beyond 3 weeks in the absence of significant symptomatic improvement.

See also General Dosing Information .

Nasal Dosage Forms

FLUTICASONE PROPIONATE NASAL SUSPENSION

Usual adult and adolescent dose
Anti-inflammatory (steroidal), nasal
Nasal, initially 100 mcg (0.1 mg) (2 metered sprays) in each nostril once a day or 50 mcg (0.05 mg) (1 metered spray) in each nostril twice a day (total daily dose, 200 mcg [0.2 mg]), the dosage then being decreased, to 50 mcg (0.05 mg) (1 metered spray) in each nostril once a day, according to patient response. ^{24} ^{74}

Note: In Canada, the dose may be increased to 100 mcg (0.1 mg) (2 metered sprays) in each nostril every twelve hours (total daily dose, 400 mcg [0.4 mg]), if no response at the usual and adolescent dose. ^{64}

Usual adult prescribing limits
Nasal, 0.2 mg (4 metered sprays) of fluticasone propionate per day. ^{74}

Note: In Canada, the maximum adult and adolescent dose is 400 mcg (0.4 mg) (8 metered sprays) of fluticasone propionate per day. ^{64}

Usual pediatric dose
Anti-inflammatory (steroidal), nasal
Children up to 4 years of age: Use is not recommended. ^{64} ^{74}

Children 4 to 11 years of age: Nasal, 5

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