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Olopatadine Nasal (PATANASE): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
665 mcg
Brand names:
Active ingredient:

Patient information: uses, side effects, how to take - Olopatadine Nasal

What is olopatadine hydrochloride nasal spray?

Olopatadine hydrochloride nasal spray is a prescription nasal spray that contains an antihistamine. Olopatadine hydrochloride nasal spray is used to treat seasonal allergy symptoms in adults and children 6 years of age and older. It is not known if olopatadine hydrochloride nasal spray is safe and effective in children under 6 years of age.

Before using olopatadine hydrochloride nasal spray, tell your healthcare provider about all of your medical conditions, including if you:

  • have nose problems, such as nose bleeds, or sores in the nose.
  • are pregnant or planning to become pregnant. It is not known if olopatadine hydrochloride nasal spray will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if olopatadine passes into your breast milk. You and your healthcare provider should decide if you will use olopatadine hydrochloride nasal spray if you plan to breastfeed.

are pregnant or planning to become pregnant. It is not known if olopatadine hydrochloride nasal spray will harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if olopatadine passes into your breast milk. You and your healthcare provider should decide if you will use olopatadine hydrochloride nasal spray if you plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Olopatadine hydrochloride nasal spray and other medicines may affect each other and cause side effects.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider or pharmacist when you get a new medicine.

How should I use olopatadine hydrochloride nasal spray?

  • See the “Instructions for Use” at the end of this Patient Information leaflet for information about the right way to use olopatadine hydrochloride nasal spray.
  • Olopatadine hydrochloride nasal spray is for use in your nose only. Do not spray it in your eyes or mouth.
  • Use olopatadine hydrochloride nasal spray exactly as your healthcare provider tells you to use it.
  • Do not use more than your healthcare provider tells you.
  • If you use too much olopatadine hydrochloride nasal spray, call your healthcare provider or pharmacist right away
  • Throw away olopatadine hydrochloride nasal spray after 240 sprays (about 30 days) after the first priming. Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it.

Olopatadine hydrochloride nasal spray is for use in your nose only. Do not spray it in your eyes or mouth.

Use olopatadine hydrochloride nasal spray exactly as your healthcare provider tells you to use it.

Do not use more than your healthcare provider tells you.

If you use too much olopatadine hydrochloride nasal spray, call your healthcare provider or pharmacist right away

Throw away olopatadine hydrochloride nasal spray after 240 sprays (about 30 days) after the first priming. Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it.

What should I avoid while using olopatadine hydrochloride nasal spray?

  • Olopatadine hydrochloride nasal spray can cause sleepiness or drowsiness.

    Do not drive, operate machinery, or do anything that needs you to be alert until you know how olopatadine hydrochloride nasal spray affects you.

  • Do not drink alcohol or take any medicines that may cause you to feel sleepy while using olopatadine hydrochloride nasal spray. It may make your sleepiness worse.

Do not drink alcohol or take any medicines that may cause you to feel sleepy while using olopatadine hydrochloride nasal spray. It may make your sleepiness worse.

What are the possible side effects of olopatadine hydrochloride nasal spray?

Olopatadine hydrochloride nasal spray may cause serious side effects, including:

  • nosebleeds.
  • sores in the nose.
  • hole in the cartilage between the nose (nasal septum perforation). A whistling sound when you breathe may be a symptom of nasal septum perforation.
  • sleepiness or drowsiness.

sores in the nose.

hole in the cartilage between the nose (nasal septum perforation). A whistling sound when you breathe may be a symptom of nasal septum perforation.

sleepiness or drowsiness.

The most common side effects of olopatadine hydrochloride nasal spray in people 12 years of age and older include:

  • bad or bitter taste
  • headache

headache

  • throat pain
  • nose congestion

nose congestion

  • cough
  • urinary tract infection

urinary tract infection

The most common side effects of olopatadine hydrochloride nasal spray in people 6 to

11 years of age include:

  • headache
  • upper respiratory tract infection

upper respiratory tract infection

  • bad or bitter taste
  • fever

fever

  • rash

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of olopatadine hydrochloride nasal spray.

For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store olopatadine hydrochloride nasal spray?

  • Store olopatadine hydrochloride nasal spray at room temperature between 39°F to 77°F (4°C to 25°C).
  • Do not use your olopatadine hydrochloride nasal spray after the expiration date on the label or box.

Do not use your olopatadine hydrochloride nasal spray after the expiration date on the label or box.

Keep olopatadine hydrochloride nasal spray and all medicines out of the reach of children.

General information about olopatadine hydrochloride nasal spray.

Medicines are sometimes prescribed for conditions that are not mentioned in the Patient Information leaflet. Do not use olopatadine hydrochloride nasal spray for a condition for which it was not prescribed. Do not give olopatadine hydrochloride nasal spray to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about olopatadine hydrochloride nasal spray that is written for health professionals.

What are the ingredients in olopatadine hydrochloride nasal spray?

Active ingredient: olopatadine hydrochloride 665 micrograms per spray.

Inactive ingredients: 0.01% benzalkonium chloride, dibasic sodium phosphate, edetate disodium, hydrochloric acid and/or sodium hydroxide, purified water and sodium chloride.

Manufactured by Padagis®

Yeruham, Israel

4S000 RC PH6

For more information, go to www.padagis.com or call 1-866-634-9120.

  1. This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: 09/2023

Instructions for Use

INSTRUCTIONS FOR USE

Olopatadine Hydrochloride (oh-loe-PA-ta-deen HYE-droe-KLOR-ide) Nasal spray, 665mcg/Spray

for intranasal use

This Instructions for Use contains information on how to use olopatadine hydrochloride nasal spray.

Read this Instructions for Use that comes with olopatadine hydrochloride nasal spray before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Olopatadine hydrochloride nasal spray is for use in your nose only.

Do not spray olopatadine hydrochloride nasal spray in your eyes or mouth.

Important information you need to know before using olopatadine hydrochloride nasal spray

  • Use olopatadine hydrochloride nasal spray exactly how your healthcare provider tells you to use it.
  • Your olopatadine hydrochloride nasal spray bottle must be shaken and primed before you use it for the first time and when you have not used it for more than 7 days.
  • Throw away olopatadine hydrochloride nasal spray after 240 sprays after the first priming. Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it.

Your olopatadine hydrochloride nasal spray bottle must be shaken and primed before you use it for the first time and when you have not used it for more than 7 days.

Throw away olopatadine hydrochloride nasal spray after 240 sprays after the first priming. Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it.

Using olopatadine hydrochloride nasal spray

Step 1. Remove the blue plastic cap and the blue clip (see Figure A).

Figure A

Step 2. Hold the bottle and press down on the shoulders of the nasal applicator with your forefinger and middle finger.

  • Support the bottom of the bottle with your thumb (see Figure B). Prime the bottle by pressing and releasing the shoulders of the bottle down firmly 5 times or until you see a fine mist come out of the nasal applicator.
  • Now your pump is primed and ready to use.
  • If you do not use olopatadine hydrochloride nasal spray for more than 7 days, you will need to prime the bottle again by pressing and releasing the shoulders of the bottle down firmly 2 times or until you see a fine mist come out of the nasal applicator.

Now your pump is primed and ready to use.

If you do not use olopatadine hydrochloride nasal spray for more than 7 days, you will need to prime the bottle again by pressing and releasing the shoulders of the bottle down firmly 2 times or until you see a fine mist come out of the nasal applicator.

Figure B

Step 3. Gently blow your nose to clear your nostrils. Hold 1 nostril closed with a finger. Tilt your head down (chin toward chest) and insert the nasal applicator into a nostril. Hold the bottle upright with the nasal applicator tip pointing away from the center of the nose (see Figure C).

Step 4. Breathe in gently through your nose. While breathing in, press firmly and quickly on the nasal applicator shoulders to release the spray into your nostril (see Figure C).

Step 5. Breathe out through your mouth. Do not tilt your head back or blow your nose right after using olopatadine hydrochloride nasal spray. This may cause you to get a bitter taste in your mouth.

Step 6. Repeat Steps 3 through 5 above to deliver a spray in your other nostril.

Step 7. If your healthcare provider tells you to use 2 sprays in each nostril, repeat Steps 3 through 5 for the second spray in each nostril.

Figure C

Step 8. Wipe the nasal applicator with a clean tissue and replace the plastic cap and clip (see Figure D).

Figure D

Cleaning the olopatadine hydrochloride nasal spray nasal applicator

Step 9. To clean the nasal applicator, remove the plastic cap and clip

(see Figure E).

If the nasal applicator becomes clogged, do not try to clear it using a

pointed object.

Figure E

Step 10. Gently pull the nasal applicator up to remove it from the bottle (see Figure F).

Figure F

Step 11. With the nasal applicator pointing downwards, wash it by running warm tap water into the nasal applicator for about 1 minute (see Figure G).

Step 12. Shake the nasal applicator to remove any water and put the nasal applicator back on the bottle.

Step 13. Prime the bottle again by pressing the shoulders of the bottle down firmly and releasing the shoulders 2 times or until you see a fine mist come out of the white nasal applicator.

Repeat Steps 11 and 12 above if the nasal applicator is still clogged.

Figure G

How should I store olopatadine hydrochloride nasal spray?

  • Store olopatadine hydrochloride nasal spray at room temperature between 39°F to 77°F (4°C to 25°C).
  • Do not use olopatadine hydrochloride nasal spray after the expiration date on the label or box.

Do not use olopatadine hydrochloride nasal spray after the expiration date on the label or box.

Keep olopatadine hydrochloride nasal spray and all medicines out of the reach of children.

Manufactured by Padagis®

Yeruham, Israel

4S000 RC PH6

  1. For more information, go to www.padagis.com or call 1-866-634-9120.
  1. This Instructions for Use has been approved by the U.S. Food and Drug Administration.Revised: 09/2023

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 202853 · View the label on DailyMed

Revision date stated in the text: September 2023

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Olopatadine Nasal

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Histamine-1 Receptor Antagonist, Histamine-1 Receptor Inhibitor, Mast Cell Stabilizer
Active ingredient Olopatadine hydrochloride 665 mcg
Dosage form Spray
Route Nasal
Marketing status listed in the FDA NDC Directory
Company (applicant) PADAGIS ISRAEL
FDA approval ANDA 202853Abbreviated New Drug Application (ANDA) – generic drug Approved January 31, 2017
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 3 labelers list this drug on DailyMed
Packages (NDC)
Package
665 mcg – 240 in 1 bottle / 1 in 1 carton NDC 45802-104-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.