azelastine ophthalmic (Rx)

Brand and Other Names:Optivar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 0.05%

Allergic Conjunctivitis

Instill 1 gtt in affected eye(s) q12hr

Dosage Forms & Strengths

ophthalmic solution

  • 0.05%

Allergic Conjunctivitis

<3 years: Safety and efficacy not established

>3 years: As adults; instill 1 gtt in affected eye(s) q12hr

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Adverse Effects

>10%

Transient burning/stinging (30%)

Headache (15%)

Bitter taste (10%)

Frequency Not Defined

Asthma

Temporary blurring

Bitter taste

Conjunctivitis

Dyspnea

Eye pain

Fatigue

Influenza-like symptoms

Pharyngitis

Pruritus

Rhinitis

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Warnings

Contraindications

Hypersensitivity

Contact lens-related irritation

Cautions

Do not wear contact lenses if eyes are red; wait 10 min after azelastine to insert contacts

Take care not to touch any surface, the eyelids, or surrounding areas with the dropper tip of the bottle or single-use container to prevent contaminating the dropper tip and solution; discard single-use container immediately after use; product is sterile when packaged

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Excretion in milk unknown; use with caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Histamine H1 antagonist, inhibits vascular permeability and release of histamine and other mediators involved in allergic response

Pharmacokinetics

Half-Life: 22 hr

Onset of action: 3 min (peak effect)

Duration: 8 hr

Absorption: Extremely low systemic exposure

Protein Bound: 88-97%

Metabolism: Liver

Excretion: Feces

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
azelastine nasal
-
205.5 mcg (0.15 %) aerosol
azelastine nasal
-
137 mcg (0.1 %) aerosol
azelastine nasal
-
137 mcg (0.1 %) aerosol
azelastine nasal
-
137 mcg (0.1 %) aerosol
azelastine nasal
-
205.5 mcg (0.15 %) aerosol
azelastine nasal
-
205.5 mcg (0.15 %) aerosol
azelastine nasal
-
137 mcg (0.1 %) aerosol
azelastine nasal
-
137 mcg (0.1 %) aerosol
azelastine nasal
-
137 mcg (0.1 %) aerosol
azelastine nasal
-
205.5 mcg (0.15 %) aerosol
azelastine nasal
-
137 mcg (0.1 %) aerosol
azelastine nasal
-
205.5 mcg (0.15 %) aerosol
azelastine ophthalmic (eye)
-
0.05 % drops
azelastine ophthalmic (eye)
-
0.05 % drops
azelastine ophthalmic (eye)
-
0.05 % drops
azelastine ophthalmic (eye)
-
0.05 % drops
azelastine ophthalmic (eye)
-
0.05 % drops

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
azelastine nasal

AZELASTINE SPRAY - NASAL

(AY-ze-LAS-teen)

COMMON BRAND NAME(S): Astelin, Astepro

USES: This medication is used to relieve nasal symptoms such as runny/itching/stuffy nose, sneezing, and post-nasal drip caused by allergies or other conditions. Azelastine belongs to a class of drugs known as antihistamines. It works by blocking certain natural substances called histamines that are responsible for nasal symptoms.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, consult your doctor or pharmacist.Follow the instructions for test sprays in the air if you are using the spray pump for the first time or if you have not used it for 3 days or more. A fine mist is a sign that the spray pump is working properly.Gently blow your nose before using this medication. Use this medication in the nose as directed by your doctor, usually once or twice a day in both nostrils. Do not spray it in your eyes or mouth. The dosage is based on your medical condition, age, and response to treatment.To prevent a bitter taste in your mouth, breathe in gently and do not tilt your head back after using this medication.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Keep track of the number of sprays used from the spray pump. Discard the pump after you have used the number of sprays specified on the manufacturer's package.This medication usually begins to work within 3 hours of use.Tell your doctor if you do not get better or if you get worse.

SIDE EFFECTS: A bitter taste in the mouth, drowsiness, tiredness, nasal discomfort, sneezing fits, cough, nose bleeds, runny nose, dry mouth, headache, or red eyes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using azelastine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems.This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Ask your doctor for ways to reduce your exposure to substances (such as pollen, pet dander, dust mites, mold, smoke) that can worsen allergy symptoms.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Keep the bottle upright with the pump tightly closed. Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised July 2021. Copyright(c) 2022 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.