No

Corticosteroid, Oral Inhaler; Corticosteroid, Nasal

Steroid-dependent asthma; nasal solution is used for seasonal or perennial rhinitis

C

Clinical effects on the fetus: No data on crossing the placenta or effects on the fetus

Breast-feeding/lactation: No data on crossing into breast milk or effects on the infant

Known hypersensitivity to flunisolide, acute status asthmaticus; viral, tuberculosis, fungal or bacterial respiratory infections, or infections of nasal mucosa

Use with caution in patients with hypothyroidism, cirrhosis, hypertension, congestive heart failure, ulcerative colitis, thromboembolic disorders; do not stop medication abruptly if on prolonged therapy; fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; several months may be required for recovery of this syndrome; during this period, aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery or infections. When consumed in excessive quantities, systemic hypercorticism and adrenal suppression may occur; withdrawal and discontinuation of the corticosteroid should be done carefully. Controlled clinical studies have shown that inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. Growth velocity provides a means of comparing the rate of growth among children of the same age.

FDA's Pulmonary and Allergy Drugs and Metabolic and Endocrine Drugs advisory committees discussed this issue at a July 1998 meeting. They recommended that the agency develop class-wide labeling to inform healthcare providers so they would understand this potential side effect and monitor growth routinely in pediatric patients who are treated with inhaled corticosteroids, intranasal corticosteroids or both.

Long-term effects of this reduction in growth velocity on final adult height are unknown. Likewise, it also has not yet been determined whether patients' growth will "catch up" if treatment in discontinued. Drug manufacturers will continue to monitor these drugs to learn more about long-term effects. Children are prescribed inhaled corticosteroids to treat asthma. Intranasal corticosteroids are generally used to prevent and treat allergy-related nasal symptoms.

Patients are advised not to stop using their inhaled or intranasal corticosteroids without first speaking to their healthcare providers about the benefits of these drugs compared to their risks.

>10%:

Cardiovascular: Pounding heartbeat

Central nervous system: Dizziness, headache, nervousness

Dermatologic: Itching, rash

Endocrine & metabolic: Adrenal suppression, menstrual problems

Gastrointestinal: GI irritation, anorexia, sore throat, bitter taste

Local: Nasal burning, Candida infections of the nose or pharynx, atrophic rhinitis

Respiratory: Sneezing, coughing, upper respiratory tract infection, bronchitis, nasal congestion, nasal dryness

Miscellaneous: Increased susceptibility to infections

1% to 10%:

Central nervous system: Insomnia, psychic changes

Dermatologic: Acne, urticaria

Gastrointestinal: Increase in appetite, xerostomia, dry throat, loss of taste perception

Ocular: Cataracts

Respiratory: Epistaxis

Miscellaneous: Diaphoresis, loss of smell

<1%: Abdominal fullness, bronchospasm, shortness of breath

When consumed in excessive quantities, systemic hypercorticism and adrenal suppression may occur; in those cases, discontinuation and withdrawal of the corticosteroid should be done judiciously

Expected interactions similar to other corticosteroids

Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; does not depress hypothalamus

Absorption: Nasal inhalation: ~50%

Metabolism: Rapidly in the liver to active metabolites

Half-life: 1.8 hours

Elimination: Equally in urine and feces

Children >6 years:

Oral inhalation: 2 inhalations twice daily (morning and evening) up to 4 inhalations/day

Nasal: 1 spray each nostril twice daily (morning and evening), not to exceed 4 sprays/day each nostril

Adults:

Oral inhalation: 2 inhalations twice daily (morning and evening) up to 8 inhalations/day maximum

Nasal: 2 sprays each nostril twice daily (morning and evening); maximum dose: 8 sprays/day in each nostril

Dizziness and nervousness are common; may cause insomnia

None reported

No information available to require special precautions

No effects or complications reported

Use as directed; do not use nasal preparations for oral inhalation. Do not increase dosage or discontinue abruptly without consulting prescriber. Review use of inhaler or spray with prescriber or follow package insert for directions. Keep oral inhaler clean and unobstructed. Always rinse mouth and throat after use of inhaler to prevent opportunistic infection. If you are also using an inhaled bronchodilator, wait 10 minutes before using this steroid aerosol. You may experience dizziness, anxiety, or blurred vision (rise slowly from sitting or lying position and use caution when driving or engaging in tasks requiring alertness until response to drug is known); or taste disturbance or aftertaste (frequent mouth care and mouth rinses may help). Report pounding heartbeat or chest pain; acute nervousness or inability to sleep; severe sneezing or nosebleed; difficulty breathing, sore throat, hoarseness, or bronchitis; respiratory difficulty or bronchospasms; disturbed menstrual pattern; vision changes; loss of taste or smell perception; or worsening of condition or lack of improvement. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Shake well before giving; do not use Nasalide® orally; throw out product after it has been opened for 3 months

Inhalant:

Nasal (Nasalide®, Nasarel™): 25 mcg/actuation [200 sprays] (25 mL)

Oral:

AeroBid®: 250 mcg/actuation [100 metered doses] (7 g)

AeroBid-M® (menthol flavor): 250 mcg/actuation [100 metered doses] (7 g)

Solution, spray: 0.025% [200 actuations] (25 mL)

Expert Panel Report 2, "Guidelines for the Diagnosis and Management of Asthma," Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 94-4051, April, 1997.

Expert Panel Report, National Asthma Education Program, "National Heart, Lung and Blood Institute: Guidelines for the Diagnosis and Management of Asthma," J Allergy Clin Immunol, 1991, 88(3 pt 2):425-534.