Azelast Nasal Spray
Azelastine Hydrochloride Nasal prep
137mcg
Incepta Pharmaceuticals Ltd.
| Pack size | 120 dose (spray) unit |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 180.00 AED |
Indications
Azelast Nasal Spray is used for:
Allergic rhinitis, Vasomotor rhinitis
Adult Dose
Allergic Rhinitis, Vasomotor rhinitis
Adults: 2 sprays per nostril twice daily.
Child Dose
Allergic Rhinitis, Vasomotor Rhinitis: Children 5 years to 11 years of age: 1 spray into each nostril twice daily.
Children >12 years: 2 sprays per nostril twice daily.
Renal Dose
Administration
Intranasal Preparation
Prime with 4 sprays before initial use to obtain fine mist when sprayed; if idle for 3 days, reprime with 2 sprays
Intranasal Administration
For intranasal administration only
Avoid spraying into eyes
Keep head tilted downward when spraying into nostril
Breathe gently and do not tip head back after spraying avoid medicine from running down into throat
May experience bitter taste in mouth after administration
Contra Indications
Known hypersensitivity to Azelastine Hydrochloride or any of its components.
Precautions
May cause CNS depression/drowsiness; use caution when performing tasks requiring mental alertness eg, operating heavy machinery
Avoid administering concurrent CNS depressants that may add to somnolence
Caution in premature newborns and neonates
Pregnancy-Lactation
Pregnancy
Limited data from postmarketing experience over decades of use in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes
Animal data
In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose; oral administration to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than maximum recommended human daily intranasal dose of 1.096 mg; relevance of these findings in animals to pregnant women considered questionable based upon high animal to human dose multiple
Lactation
There are no data on presence in human milk, effects on breastfed infant, or on milk production; breastfed infants should be monitored for signs of milk rejection during use by lactating women; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Interactions
Contraindicated (2)
calcium/magnesium/potassium/sodium oxybates
sodium oxybate
Serious - Use Alternative (4)
clonidine
fedratinib
lonafarnib
stiripentol
Adverse Effects
Side effects of Azelastine Hydrochloride Nasal prep :
>10%
Bitter taste (8-19.7%),Headache (8-14.8%),Somnolence (1-11.5%),Cold symptoms/rhinitis (2-17%),Cough (11%)
1-10%
Nasal burning (4.1%),Sneezing (3.1%),Dry mouth (2.8%),Nausea (2.8%),Conjunctivitis (2-5%),Asthma (5%),Fatigue (2.3%),Rhinitis (2.3%),Pharyngitis (4%),Dizziness (2%),Weight increase (2%),Myalgia (<2%)
<1%
Amenorrhea,Breast pain,Constipation,Contact dermatitis,Eczema,Flushing,Glossitis,Hyperkinesia,Hypertension,Tachycardia,Vertigo,Vomiting
Mechanism of Action
Azelastine blocks histamine H1-receptor activity and inhibits release of inflammatory mediators from mast cells.
Note
Azelast 137mcg Nasal Spray manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Azelastine Hydrochloride Nasal prep. Azelast is availble in Bangladesh.
Farmaco BD drug index information on Azelast Nasal Spray is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.