Patanase Nasal Spray

DRUG DESCRIPTION

PATANASE (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of PATANASE (olopatadine hydrochloride nasal spray) 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:

PATANASE (olopatadine hydrochloride) Structural Formula Illustration

PATANASE (olopatadine hydrochloride nasal spray) 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) [see DOSAGE AND ADMINISTRATION]. PATANASE (olopatadine hydrochloride nasal spray) 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.

What are the possible side effects of olopatadine nasal (Patanase)?

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

Stop using olopatadine and call your doctor at once if you have any of these serious side effects:

  • nosebleed;
  • sores inside your nose; or
  • burning or pain when you urinate.

Less serious side effects may include:

  • drowsiness;
  • a bitter taste in your mouth;
  • headache;
  • dry mouth,...

Read All Potential Side Effects and See Pictures of Patanase Nasal Spray

What are the precautions when taking olopatadine hydrochloride nasal spray (Patanase Nasal Spray)?

Before using olopatadine, 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.

This drug may rarely make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Patanase Nasal Spray


Patanase Nasal Spray Consumer (continued)

SIDE EFFECTS: A bitter taste in the mouth, nosebleeds, or irritation/soreness in the nose may occur. Drowsiness may rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

The bitter taste can be reduced by sniffing gently through your nose after each spray, rather than breathing in through your nose so deeply that the medication goes to the back of your throat and gets into your mouth.

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 immediately if any of these rare but serious side effects occur: sores in your nose, hole in the nasal septum.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

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 olopatadine, 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.

This drug may rarely make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.


Patanase Nasal Spray Patient Information Including Side Effects

Brand Names: Patanase

Generic Name: olopatadine (nasal) (Pronunciation: OH loe PA ta deen)

  • What is olopatadine nasal (Patanase Nasal Spray)?
  • What are the possible side effects of olopatadine nasal (Patanase Nasal Spray)?
  • What is the most important information I should know about olopatadine nasal (Patanase Nasal Spray)?
  • What should I discuss with my healthcare provider before using olopatadine nasal (Patanase Nasal Spray)?
  • How should I use olopatadine nasal (Patanase Nasal Spray)?
  • What happens if I miss a dose (Patanase Nasal Spray)?
  • What happens if I overdose (Patanase Nasal Spray)?
  • What should I avoid while taking olopatadine nasal (Patanase Nasal Spray)?
  • What other drugs will affect olopatadine nasal (Patanase Nasal Spray)?
  • Where can I get more information?

What is olopatadine nasal (Patanase Nasal Spray)?

Olopatadine is an antihistamine. It blocks the effects of the chemical histamine in your body.

Olopatadine treats sneezing, itching, runny nose, and other nasal symptoms of allergies.

Olopatadine nasal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of olopatadine nasal (Patanase Nasal Spray)?

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

Stop using olopatadine and call your doctor at once if you have any of these serious side effects:

  • nosebleed;
  • sores inside your nose; or
  • burning or pain when you urinate.

Less serious side effects may include:

  • drowsiness;
  • a bitter taste in your mouth;
  • headache;
  • dry mouth, sore throat;
  • cough, sneezing, runny nose, cold symptoms;
  • weight gain; or
  • nausea, diarrhea, stomach pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about olopatadine nasal (Patanase Nasal Spray)?

Before using olopatadine nasal, tell your doctor if you have any non-allergic conditions affecting the inside of your nose, such as a deviated septum.

Olopatadine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of olopatadine nasal.

Talk with your doctor if your allergy symptoms do not improve or if they get worse.

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