Azelastine Ophthalmic Solution
Name: Azelastine Ophthalmic Solution
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Azelastine Ophthalmic Solution - Clinical Pharmacology
Azelastine hydrochloride is a relatively selective histamine H1 antagonist and an inhibitor of the release of histamine and other mediators from cells (e.g., mast cells) involved in the allergic response. Based on in-vitro studies using human cell lines, inhibition of other mediators involved in allergic reactions (e.g., leukotrienes and PAF) has been demonstrated with azelastine hydrochloride. Decreased chemotaxis and activation of eosinophils has also been demonstrated.
Pharmacokinetics and Metabolism
Absorption of azelastine following ocular administration was relatively low. A study in symptomatic patients receiving one drop of azelastine hydrochloride ophthalmic solution in each eye two to four times a day (0.06 to 0.12 mg azelastine hydrochloride) demonstrated plasma concentrations of azelastine hydrochloride to generally be between 0.02 and 0.25 ng/mL after 56 days of treatment. Three of nineteen patients had quantifiable amounts of N-desmethylazelastine that ranged from 0.25 to 0.87 ng/mL at Day 56.
Based on intravenous and oral administration, the elimination half-life, steady-state volume of distribution and plasma clearance were 22 hours, 14.5 L/kg and 0.5 L/h/kg, respectively. Approximately 75% of an oral dose of radiolabeled azelastine hydrochloride was excreted in the feces with less than 10% as unchanged azelastine. Azelastine hydrochloride is oxidatively metabolized to the principal metabolite, N-desmethylazelastine, by the cytochrome P450 enzyme system. In-vitro studies in human plasma indicate that the plasma protein binding of azelastine and N-desmethylazelastine are approximately 88% and 97%, respectively.
In a conjunctival antigen challenge study, azelastine hydrochloride ophthalmic solution was more effective than its vehicle in preventing itching associated with allergic conjunctivitis. Azelastine hydrochloride ophthalmic solution had a rapid (within 3 minutes) onset of effect and a duration of effect of approximately 8 hours for the prevention of itching.
In environmental studies, adult and pediatric, patients with seasonal allergic conjunctivitis were treated with azelastine hydrochloride ophthalmic solution for two to eight weeks. In these studies, azelastine hydrochloride ophthalmic solution was more effective than its vehicle in relieving itching associated with allergic conjunctivitis.
Azelastine hydrochloride ophthalmic solution is contraindicated in persons with known or suspected hypersensitivity to any of its components.
Azelastine hydrochloride ophthalmic solution is for ocular use only and not for injection or oral use.
Package label.principal display panel - carton
Azelastine Hydrochloride Ophthalmic Solution, 0.05%
6 mL - Sterile
For the Eye Only
|AZELASTINE HYDROCHLORIDE |
azelastine hydrochloride solution/ drops
|Labeler - Sun Pharma Global FZE (864347344)|
|Sun Pharmaceutical Industries Limited||725959238||ANALYSIS(47335-938), MANUFACTURE(47335-938)|
Azelastine Side Effects
More Common Side Effects
The more common side effects of azelastine eye drops can include:
burning or stinging in the eye(s)
bitter taste in the mouth
If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
How to Take azelastine (Dosage)
What are you taking this medication for?Allergic conjunctivitis (eye allergies)
Generic: azelastine eye dropsForm: Ophthalmic solution 0.5% Adult dosage (ages 18 years years and older)
Typical dosage: One drop of 0.05% eye drops in each affected eye, 2 times per day.Child dosage (ages 3–17 years)
Typical dosage: One drop of 0.05% eye drops in each affected eye, 2 times per day.Child dosage (ages 0–2 years)
It hasn’t been confirmed that azelastine eye drops are safe and effective for use in people younger than 3 years.Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you. Important considerations for taking azelastine