Astelin Generic

Azelastine is an anti-histamine a chemical that blocks the effects of histamine another chemical that is responsible for some of the symptoms in allergic reactions. Azelastine is chemically different from other anti-histamines and is used only as a nasal inhaler for the treatment of symptoms of seasonal allergic rhinitis such as runny nose sneezing and nasal itching in adults and children 12 years of age and older. Azelastine was approved by the FDA in 1996.

Azelastine generally is used as 2 sprays in each nostril twice daily.

The most common side effect noted with azelastine is a bitter taste that develops in 1 of 5 persons using it. Tiredness occurs in 1 of 9. Weight gain has been reported in 1 of 50 and muscle pain in 1 of 75. Other reported side effects include headache nasal irritation sore throat dry mouth and sneezing.

Azelastine can promote the sedating effects of other medications that cause sedation. Such drugs include narcotic pain relievers e.g. Percocet barbiturates sedatives such as alprazolam Xanax or clonazepam Klonopin and ethanol.

There have been no reported overdosages with Astelin® Nasal Spray. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse events other than increased somnolence since one bottle of Astelin® Nasal Spray contains 17 mg of azelastine hydrochloride. Clinical studies in adults with single doses of the oral formulation of azelastine hydrochloride up to 16 mg have not resulted in increased incidence of serious adverse events. General supportive measures should be employed if overdosage occurs. There is no known antidote to Astelin® Nasal Spray. Oral ingestion of antihistamines has the potential to cause serious adverse effects in young children. Accordingly Astelin® Nasal Spray should be kept out of the reach of children. Oral doses of 120 mg/kg and greater approximately 460 times the maximum recommended daily intranasal dose in adults and children on a mg/m 2 basis were lethal in mice. Responses seen prior to death were tremor convulsions decreased muscle tone and salivation. In dogs single oral doses as high as 10 mg/kg approximately 260 times the maximum recommended daily intranasal dose in adults and children on a mg/m 2 basis were welltolerated but single oral doses of 20 mg/kg were lethal.

Azelastine is used to treat symptoms associated with allergic rhinitis such as runny nose sneezing and nasal itching.

The nasal spray should be stored at room temperature between 15 and 30°C 59-86°F.