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