Optivar

DRUG DESCRIPTION

OPTIVAR® (azelastine hydrochloride ophthalmic solution), 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H1 -receptor antagonist for topical administration to the eyes. Azelastine hydrochloride is a white crystalline powder with a molecular weight of 418.37. Azelastine hydrochloride is sparingly soluble in water, methanol and propylene glycol, and slightly soluble in ethanol, octanol, and glycerine. Azelastine hydrochloride is a racemic mixture with a melting point of 225°C. The chemical name for azelastine hydrochloride is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride and is represented by the following chemical structure:

Optivar ®  (azelastine hydrochloride)   Structural Formula Illustration

Empirical chemical structure: C22H24ClN3O•HCl

Each mL of OPTIVAR® contains: Active: 0.5 mg azelastine hydrochloride, equivalent to 0.457mg of azelastine base; Preservative: 0.125 mg benzalkonium chloride; Inactives: disodium edetate dihydrate, hypromellose, sorbitol solution, sodium hydroxide and water for injection. It has a pH of approximately 5.0 to 6.5 and an osmolarity of approximately 271 to 312 mOsmol/L.

What are the possible side effects of azelastine ophthalmic (Optivar)?

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 azelastine ophthalmic and call your doctor if you have a serious side effect such as:

  • severe burning, stinging, itching, or redness in your eyes;
  • eye pain;
  • trouble breathing; or
  • fever, chills, sore throat, flu symptoms.

Less serious side effects may include:

  • mild burning or...

Read All Potential Side Effects and See Pictures of Optivar »

What are the precautions when taking azelastine hydrochloride (Optivar)?

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 (such as preservatives like benzalkonium chloride), 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 cause temporary blurred or unstable vision after you apply it. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug...

Read All Potential Precautions of Optivar »


Optivar Consumer (continued)

SIDE EFFECTS: This medication may temporarily sting or burn your eyes for a minute or two when applied. Temporary blurred vision, headache, or a bitter taste in your mouth may also occur. If any of these effects persist or worsen, notify 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 immediately if any of these unlikely but serious side effects occur: trouble breathing, eye pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 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 (such as preservatives like benzalkonium chloride), 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 cause temporary blurred or unstable vision after you apply it. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

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


Optivar Patient Information Including Side Effects

Brand Names: Optivar

Generic Name: azelastine ophthalmic (Pronunciation: a ZEL as teen)

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

What is azelastine ophthalmic (Optivar)?

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

Azelastine ophthalmic is used to treat itchy eyes caused by allergies (hay fever).

Azelastine ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of azelastine ophthalmic (Optivar)?

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 azelastine ophthalmic and call your doctor if you have a serious side effect such as:

  • severe burning, stinging, itching, or redness in your eyes;
  • 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.

What is the most important information I should know about azelastine ophthalmic (Optivar)?

You should not use this medication if you are allergic to azelastine ophthalmic.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use azelastine ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 10 minutes after using azelastine ophthalmic before putting your contact lenses in.

Do not wear contact lenses while your eyes are red or irritated. Azelastine ophthalmic should not be used to treat minor contact lens irritation.

Stop using azelastine ophthalmic and call your doctor if you have a serious side effect such as eye pain, trouble breathing, severe burning, stinging, itching, or redness in your eyes.

Each bottle of this medicine is for a single use only. Throw away the bottle after one use, even if there is still some medicine left over.

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