[Indications]

Perennial allergic rhinitis

 

[Dosage and Administration]

Adults and children 12 years of age and older: The usual recommended dose is one spray in each nostril twice daily.

(Each spray delivers 100mg as suspension. This spray contains 0.05mg as mometasone furoate plus 0.14mg as azelastine HCl. Total daily dose is 0.2mg as mometasone furoate and 0.56mg as azelastine HCl.)

 

[Contraindications]

1) Patients with hypersensitivity to any ingredients of Nasaflex Nasal Spray

2) Patients with untreated localized infection involving the nasal mucosa

3) Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.

4) Pregnant or nursing women

5) Children 6 years of age and younger

 

 [Adverse Events]

1. The adverse events obtained from azelastine HCl are as follows.
   1. In rare cases, a mild, transient irritation of the inflamed nasal mucosa may occur, with symptoms such as stinging, itching, sneezing, and epistaxis.
   2. frequently than in the placebo group included: arthralgia, asthma, bronchitis, [Pregnancy and Nursing Mothers]

1. Nasaflex Nasal Spray should not be administered to pregnancy or nursing mothers because it has no data for pregnancy and nursing mothers.
2. Azelastine hydrochloride has been shown to cause developmental toxicity in mice, rats, and rabbits. In mice, azelastine hydrochloride caused embryo-fetal death, malformations (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at an oral dose approximately 280 times the maximum recommended daily intranasal dose (MRDID) in adults on a mg/m2 basis.
3. There are no adequate or well-controlled studies in pregnant women. As with other nasal corticosteroid preparations, mometasone furoate nasal spray should not be used in pregnancy or lactation unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.

 

[Pediatric Use]

1. Safety and effectiveness of Nasaflex Nasal Spray in pediatric patients below the age of 12 years have not been established.

 

 

[Special Precautions for Administration]

1. This drug should be used for nasal spray.
2. Prior to administration of the first dose, shake container well and actuate pump 10 times (until a uniform spray is obtained). If pump is not used for 14 days or longer, reprime the pump with 2 actuations until a uniform spray is observed. Shake container well before each use. The bottle should be discarded after the labelled number of actuations or within 2 months of first use.
3. Do not spray Nasaflex into your eyes or nasal septum directly.
4. Do not use Nasaflex together with other patients in order to prevent contamination all one can.

 

[Special Precautions for Disposal and Other Handling]

1. Keep out of the reach of children.
2. Do not use Nasaflex for over 2 months.
3. Do not put it the other containers for preventing misuse and preserving quality.

 

[Storage] 

Store at 1 to 30°C, tight container

International name- Nasaflex Nasal Spray

Manufactured by Hanlim pharma