Olopatadine

What is olopatadine?

Olopatadine is a prescription medicine that is used to ease allergy signs.

Description

Olopatadine Hydrochloride Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Spray, is a white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz [b,e]oxepin-2-acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3 • HCl with the following chemical structure:

Olopatadine Hydrochloride Nasal Spray contains 0.6% w/v olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) . Olopatadine Hydrochloride Nasal Spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.

Mechanism of Action

Olopatadine is a histamine H1 -receptor antagonist. The antihistaminic activity of olopatadine has been documented in isolated tissues, animal models, and humans.

Before taking olopatadine, tell your doctor:

• If you are allergic to olopatadine; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take olopatadine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take olopatadine?

• Tell all of your health care providers that you take olopatadine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how olopatadine affects you.
• If you have had any recent nose surgery, injury, ulcers, or sores, talk with your doctor.
• Avoid alcohol or other drugs and natural products that slow your actions.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using olopatadine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is olopatadine best taken?

Use olopatadine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take olopatadine by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
• Prime pump by spraying 5 times before first use or 2 sprays if the pump has not been used for 7 days.
• Blow your nose before use.
• Close 1 nostril.
• When using, tilt your head forward a little.
• Put nose spray tube into other nostril.
• While breathing in through the nose, press down once to release spray.
• Breathe out from your mouth.
• Spray up the nose only. Do not spray onto the wall joining the two nostrils.
• Follow how to clean carefully.
• Put the cap back on after you are done using your dose.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are the side effects of olopatadine that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Nose sores.
• Very bad nose irritation.
• Bad nosebleeds.
• Whistling sound when you breathe.

What are some other side effects of olopatadine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Bad taste in your mouth.
• Nosebleed.
• Headache.
• Throat pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out olopatadine?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Throw away any part not used after 240 sprays.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – CONTAINER LABEL – 30.5 G

• AKORN
• NDC 50383-943-23
• Olopatadine
• Hydrochloride Nasal
• Spray, 665 mcg
• FOR INTRANASAL USE ONLY
• 240 Metered Sprays
• Net Fill Weight 30.5 g
• Rx Only

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – CARTON LABEL – 30.5 G

• AKORN
• NDC 50383-943-23
• Olopataine
• Hydrochloride
• Nasal Spray,
• 665 mcg
• FOR INTRANASAL USE ONLY
• 240 Metered Sprays
• Net Fill Weight 30.5 g
• Rx Only

SRC: NLM .