MedPath
HSA Approval

DYMISTA NASAL SPRAY

SIN15255P

DYMISTA NASAL SPRAY

DYMISTA NASAL SPRAY

June 5, 2017

PHARMLINE MARKETING PTE. LTD.

PHARMLINE MARKETING PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantPHARMLINE MARKETING PTE. LTD.
Licence HolderPHARMLINE MARKETING PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SPRAY, METERED

**DOSAGE AND ADMINISTRATION** **Dosage** Adults, adolescents and children (6 years and older) One spray in each nostril twice daily (morning and evening). Children below 6 years DYMISTA® nasal spray is not recommended for use in children below 6 years of age as safety and efficacy has not been established in this age group. Elderly No dose adjustment is required in this population (see _Pharmacokinetics_ under _Special Populations_ – _Age_ and _PRECAUTIONS_ – _Use in the Elderly_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Renal and hepatic impairment No dose adjustment is required in patients with renal impairment or mild to moderate hepatic impairment (see _Pharmacokinetics_ under _Special Populations_ – _Renal Impairment_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Caution is required when treating patients with severe hepatic impairment (see _Pharmacokinetics_ under _Special Populations_ – _Hepatic Impairment_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Duration of treatment** DYMISTA® nasal spray is suitable for long-term use. There is no restriction regarding duration of use. **Method of Administration** DYMISTA® Nasal Spray is for administration by the nasal route only. Preparing the spray: Shake the bottle gently before each use for about 5 seconds. Then, remove the protective cap. Prior to first use, DYMISTA® nasal spray must be primed by pressing down and releasing the pump 6 times until a fine mist appears. If DYMISTA® nasal spray has not been used for more than 7 days, reprime by pressing down and releasing the pump a number of times until a fine mist is produced. Do not prick the nozzle in case spray is not obtained. Clean the actuator with water. Using the spray: After blowing the nose, spray the suspension once into each nostril keeping the head tilted downward. After each use, wipe the spray tip and replace the protective cap.

NASAL

Medical Information

**INDICATIONS** Symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 6 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

**CONTRAINDICATIONS** Hypersensitivity to the active substance(s) or to any of the excipients.

R01AD58

fluticasone, combinations

Manufacturer Information

PHARMLINE MARKETING PTE. LTD.

Cipla Limited

Active Ingredients

Fluticasone propionate

0.0365 %w/w

Azelastine hydrochloride

0.1 %w/w

Azelastine

Documents

Package Inserts

Dymista PI.pdf

Approved: April 3, 2019

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DYMISTA NASAL SPRAY - HSA Approval | MedPath