Azelastine Ophthalmic

Name: Azelastine Ophthalmic

What should I do if I forget a dose?

Instill the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not instill a double dose to make up for a missed one.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about azelastine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about azelastine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using azelastine.

Review Date: October 4, 2017

Contraindications

Hypersensitivity to azelastine or any component of the formulation

Dosing Adult

Allergic conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s) twice daily.

Dosing Pediatric

Allergic conjunctivitis: Children ≥3 years and Adolescents: Ophthalmic: Refer to adult dosing.

Dosing Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Administration

For topical ophthalmic use only. Wash hands prior to use. Do not touch tip of container to any surface, the eyelids, or surrounding areas. After instilling drops, wait at least 10 minutes before inserting contact lenses. Do not insert contacts if eyes are red.

Adverse Reactions

>10%:

Central nervous system: Headache (15%)

Ocular: Transient burning/stinging (30%)

1% to 10%:

Central nervous system: Fatigue

Dermatologic: Pruritus

Gastrointestinal: Bitter taste (10%)

Ocular: Conjunctivitis, eye pain, blurred vision (temporary)

Respiratory: Asthma, dyspnea, pharyngitis, rhinitis

Miscellaneous: Flu-like syndrome

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Azelastine ophthalmic side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, itching, or eye redness after using this medication;

  • eye pain;

  • trouble breathing; or

  • fever, chills, sore throat, flu symptoms.

Less serious side effects may include:

  • mild burning or stinging

  • mild itching, irritation or discomfort;

  • runny nose;

  • blurred vision (temporary);

  • headache; or

  • a bitter taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects

This medication may temporarily sting or burn your eyes for a minute or two after use. Temporary blurred vision, headache, or a bitter taste in your mouth may also 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 he or she 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.

Tell your doctor right away if you have any serious side effects, including: eye pain.

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.

List Azelastine HCL Drops side effects by likelihood and severity.

Renal Dose Adjustments

No adjustment recommended

Azelastine ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus AU TGA pregnancy category: B3 US FDA pregnancy category: C

Animal studies have revealed evidence of embryotoxicity, foetotoxicity, and teratogenicity with high oral doses (25,000 to 57,000 times the recommended human ocular dose). Systemic absorption is low after ocular administration (plasma concentration range: 0.02 to 0.25 ng/mL). There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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