Data from FDA - Curated by EPG Health - Last updated 22 December 2016
(6.1) To report SUSPECTED
6.1 Clinical Trials Experience Because clinical trials are conducted under widely
The 7 trials included 536 subjects (57 girls and 108 boys aged 4 to 11 years, 137 female and 234 male adolescents and adults) treated with fluticasone propionate 200 mcg once daily over 2 to 4 weeks and 2 placebo-controlled clinical trials which included 246 subjects (119 female and 127 male adolescents and adults) treated with fluticasone propionate 200 mcg once daily over 6 months (Table 1).
Also included in
4 Years with
6.2 Postmarketing Experience In addition to
Because these reactions are reported voluntarily from
These events have been chosen for inclusion due to either their
Ear and Labyrinth
2 DOSAGE AND ADMINISTRATION Administer Fluticasone propionate nasal spray by the intranasal route only.
Prime fluticasone propionate nasal spray before using for the first time or after a period of non-use (1 week or more) by shaking the contents well and releasing 6 sprays into the air away from the face.
Patients should use fluticasone propionate nasal spray at regular intervals since its
Maximum effect may take several days and individual patients will experience a variable time to onset and different degree of symptom
For intranasal use only.
(2.1) Adolescents and children aged 4 years and older: 1 spray per nostril once daily (100 mcg per day).
The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also
After the first few days,
2.2 Adolescents and Children (
8 USE IN SPECIFIC POPULATIONS Hepatic
(8.6) 8.1 Pregnancy Teratogenic Effects Pregnancy Category C. There are
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at
Because animal reproduction studies are not always predictive of human response, fluticasone propionate nasal spray should be used during pregnancy only if the potential
Women should be advised to contact their physicians if they become pregnant while taking fluticasone propionate nasal spray.
In rabbits, fetal weight reduction and cleft palate were observed at a fluticasone propionate dose approximately 0.3 times the MRHDID for adults (on a mg/ m2 basis at a maternal subcutaneous dose of 4 mcg/ kg/day).
Fluticasone propionate crossed the placenta following subcutaneous administration to mice and
Experience with oral corticosteroids since their introduction in pharmacologic, as
In addition, because there is a natural
Nonteratogenic Effects Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy.
8.3 Nursing Mothers It is not known whether fluticasone propionate is excreted in human breast milk.
However, other corticosteroids have been detected in human milk.
Subcutaneous administration to lactating
Since there are
8.4 Pediatric Use The
This effect was observed in the
To minimize the systemic effects of intranasal corticosteroids, including fluticasone propionate nasal spray, each patient 's dosage should be titrated to
A 1-year placebo-controlled trial was conducted in 150 pediatric subjects (aged 3 to 9 years) to assess the effect of fluticasone propionate nasal spray (single daily dose of 200 mcg) on
From the primary population receiving fluticasone propionate nasal spray (n = 56) and placebo (n = 52), the point estimate for
Geriatric Use A
|Date Last Revised||21-01-2016|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||PureTek Corporation|