- Approval Id
- 43bc9af5ed65a8d4
- Drug Name
- DYMISTA NASAL SPRAY
- Product Name
- DYMISTA NASAL SPRAY
- Approval Number
- SIN15255P
- Approval Date
- 2017-06-05
- Registrant
- PHARMLINE MARKETING PTE. LTD.
- Licence Holder
- PHARMLINE MARKETING PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SPRAY, METERED
- Dosage
- **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.
- Route Of Administration
- NASAL
- Indication Info
- **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
- **CONTRAINDICATIONS**
Hypersensitivity to the active substance(s) or to any of the excipients.
- Atc Code
- R01AD58
- Atc Item Name
- fluticasone, combinations
- Pharma Manufacturer Name
- PHARMLINE MARKETING PTE. LTD.
- Company Detail Path
- /organization/pharmline-marketing-pte-ltd
