Ticanase

Name: Ticanase

Ticanase 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. Shake fluticasone propionate nasal spray gently before each use.

Patients should use fluticasone propionate nasal spray at regular intervals since its effectiveness depends on its regular use. Maximum effect may take several days and individual patients will experience a variable time to onset and different degree of symptom relief.

Adults

The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dose to 1 spray in each nostril once daily for maintenance therapy.

Maximum total daily doses should not exceed 2 sprays in each nostril (total dose, 200 mcg/day). There is no evidence that exceeding the recommended dose is more effective.

Adolescents and Children (Aged 4 Years and Older)

The recommended starting dosage in adolescents and children, aged 4 years and older is 1 spray in each nostril once daily (total daily dose, 100 mcg). Patients not adequately responding to 1 spray in each nostril may use 2 sprays in each nostril once daily (total daily dose, 200 mcg). Once adequate control is achieved, the dosage should be decreased to 1 spray in each nostril once daily.

The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). There is no evidence that exceeding the recommended dose is more effective.

PRINCIPAL DISPLAY PANEL - Ticanase™ (fluticasone propionate nasal spray & saline nasal spray) kit carton

Established Pharmacological Class
Substance Pharmacological Class
Saline Nasal Spraysteril Applicator, Ent
Ticanase 
fluticasone propionate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59088-392
Packaging
# Item Code Package Description
1 NDC:59088-392-00 1 KIT in 1 PACKAGE
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, SPRAY 120 
Part 2 1 BOTTLE, WITH APPLICATOR 177 mL
Part 1 of 2
FLUTICASONE PROPIONATE 
fluticasone propionate spray, metered
Product Information
Item Code (Source) NDC:60505-0829
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 50 ug
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
DEXTROSE  
CELLULOSE, MICROCRYSTALLINE  
CARBOXYMETHYLCELLULOSE SODIUM  
PHENYLETHYL ALCOHOL  
POLYSORBATE 80  
WATER  
Packaging
# Item Code Package Description
1 NDC:60505-0829-1 1 BOTTLE, SPRAY in 1 CARTON
1 120 SPRAY, METERED in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077538 09/19/2007
Part 2 of 2
SALINE NASAL SPRAY  STERIL
Product Information
Item Code (Source) GS1:705928051775
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg  in 1 mL
SODIUM BICARBONATE  
WATER  
Packaging
# Item Code Package Description
1 GS1:705928051775 1 BOTTLE, WITH APPLICATOR in 1 CARTON
1 177 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
exempt device KCJ
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077538 01/11/2016
Labeler - PureTek Corporation (785961046)
Registrant - PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Operations
Apotex Inc. 255092496 manufacture(60505-0829)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 785961046 pack(59088-392)
Revised: 01/2016   PureTek Corporation
(web3)