Drugs Details

Drugs Info of Optivar
Drugs Details
  • Drugs Type  : Multum
  • Date : 26th Feb 2015 07:11 am
  • Brand Name : Optivar
  • Generic Name : azelastine ophthalmic (Pronunciation: a ZEL as teen
Descriptions

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 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...

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 »
This monograph has been modified to include the generic and brand name in many instances.

Indications

OPTIVAR (azelastine hydrochloride) ® is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

Dosage Administration

The recommended dose is one drop instilled into each affected eye twice a day.

How Supplied

OPTIVAR® (azelastine hydrochloride ophthalmic solution), 0.05% is supplied as follows:

OPTIVAR (azelastine hydrochloride) ® 6 mL (NDC#0037-7025-60) solution in a translucent 10 mL HDPE container with a LDPE dropper tip and a white HDPE screw cap.

OPTIVAR (azelastine hydrochloride) ® 0.2 mL (NDC#0037-7025-01) solution in a translucent 1 mL HDPE single-use container, packaged as 4 single-use containers in a foil pouch in a carton.

Attention

Once OPTIVAR (azelastine hydrochloride) ® 0.2 mL unit dose foil pouch is open, unopened containers can be used for one month, not to exceed the expiration date imprinted on the container. After one month they should be discarded. Use only if foil pouch is sealed and single container is intact. Discard each container immediately after use.

Storage

OPTIVAR (azelastine hydrochloride) ® 6 mL container: Store UPRIGHT between 2° and 25°C (36° and 77°F).
OPTIVAR (azelastine hydrochloride) ® 0.2 mL container: Store at controlled room temperature 20°-25°C (68° -77°F).

OPTIVAR (azelastine hydrochloride) ® 6 mL container Manufactured by: Patheon UK Ltd., Swindon, United Kingdom. OPTIVAR (azelastine hydrochloride) ® 0.2 mL container Manufactured by: Catalent Pharma Solutions, Woodstock, Illinois, USA. Distributed by: Meda Pharmaceuticals™, Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120. OPTIVAR (azelastine hydrochloride) ® 6 ml container Made in United Kingdom. OPTIVAR (azelastine hydrochloride) ® 0.2 mL Made in United States. Issued 06/2008. FDA revision date: 07/02/08
This monograph has been modified to include the generic and brand name in many instances.

Side Effects

In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild.

The following events were reported in 1-10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring. Some of these events were similar to the underlying disease being studied.

Read the Optivar (azelastine hydrochloride) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.

Read the Optivar Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

OPTIVAR (azelastine hydrochloride) ® is for ocular use only and not for injection or oral use.

Precautions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Azelastine hydrochloride administered orally for 24 months was not carcinogenic in rats and mice at doses up to 30 mg/kg/day and 25 mg/kg/day, respectively. Based on a 30 µL drop size, these doses were approximately 25,000 and 21,000 times higher than the maximum recommended ocular human use level of 0.001 mg/kg/day for a 50 kg adult.

Azelastine hydrochloride showed no genotoxic effects in the Ames test, DNA repair test, mouse lymphoma forward mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow. Reproduction and fertility studies in rats showed no effects on male or female fertility at oral doses of up to 25,000 times the maximum recommended ocular human use level. At 68.6 mg/kg/day (57,000 times the maximum recommended ocular human use level), the duration of the estrous cycle was prolonged and copulatory activity and the number of pregnancies were decreased. The numbers of corpora lutea and implantations were decreased; however, the implantation ratio was not affected.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Azelastine hydrochloride has been shown to be embryotoxic, fetotoxic, and teratogenic (external and skeletal abnormalities) in mice at an oral dose of 68.6 mg/kg/day (57,000 times the recommended ocular human use level). At an oral dose of 30 mg/kg/day (25,000 times the recommended ocular human use level), delayed ossification (undeveloped metacarpus) and the incidence of 14 th rib were increased in rats. At 68.6 mg/kg/day (57,000 times the maximum recommended ocular human use level) azelastine hydrochloride caused resorption and fetotoxic effects in rats. The relevance to humans of these skeletal findings noted at only high drug exposure levels is unknown.

There are no adequate and well-controlled studies in pregnant women. OPTIVAR (azelastine hydrochloride) ® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether azelastine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when OPTIVAR (azelastine hydrochloride) ® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

OPTIVAR (azelastine hydrochloride) ® is contraindicated in persons with known or suspected hypersensitivity to any of its components.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Azelastine hydrochloride is a relatively selective histamine H1 antagonist and an inhibitor of the release of histamine and other mediators from cells (e.g. mast cells) involved in the allergic response. Based on in-vitro studies using human cell lines, inhibition of other mediators involved in allergic reactions (e.g. leukotrienes and PAF) has been demonstrated with azelastine hydrochloride. Decreased chemotaxis and activation of eosinophils has also been demonstrated.

Pharmacokinetics and Metabolism

Absorption of azelastine following ocular administration was relatively low. A study in symptomatic patients receiving one drop of OPTIVAR (azelastine hydrochloride) ® in each eye two to four times a day (0.06 to 0.12 mg azelastine hydrochloride) demonstrated plasma concentrations of azelastine hydrochloride to generally be between 0.02 and 0.25 ng/mL after 56 days of treatment. Three of nineteen patients had quantifiable amounts of N-desmethylazelastine that ranged from 0.25-0.87 ng/mL at Day 56.

Based on intravenous and oral administration, the elimination half-life, steady-state volume of distribution and plasma clearance were 22 hours, 14.5 L/kg and 0.5 L/h/kg, respectively. Approximately 75% of an oral dose of radiolabeled azelastine hydrochloride was excreted in the feces with less than 10% as unchanged azelastine. Azelastine hydrochloride is oxidatively metabolized to the principal metabolite, N-desmethylazelastine, by the cytochrome P450 enzyme system. In-vitro studies in human plasma indicate that the plasma protein binding of azelastine and N-desmethylazelastine are approximately 88% and 97%, respectively.

Clinical Trials

In a conjunctival antigen challenge study, OPTIVAR (azelastine hydrochloride) ® was more effective than its vehicle in preventing itching associated with allergic conjunctivitis. OPTIVAR (azelastine hydrochloride) ® had a rapid (within 3 minutes) onset of effect and a duration of effect of approximately 8 hours for the prevention of itching.

In environmental studies, adult and pediatric patients with seasonal allergic conjunctivitis were treated with OPTIVAR (azelastine hydrochloride) ® for two to eight weeks. In these studies, OPTIVAR (azelastine hydrochloride) ® was more effective than its vehicle in relieving itching associated with allergic conjunctivitis.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

To prevent contaminating the dropper tip and solution, care should be taken not to touch any surface, the eyelids, or surrounding areas with the dropper tip of the bottle or single-use container. Keep bottle tightly closed when not in use. Discard single-use container immediately after use. This product is sterile when packaged.

Patients should be advised not to wear a contact lens if their eye is red. OPTIVAR (azelastine hydrochloride) ® should not be used to treat contact lens related irritation. The preservative in OPTIVAR (azelastine hydrochloride) ® , benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling OPTIVAR (azelastine hydrochloride) ® before they insert their contact lenses.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

AZELASTINE DROPS - OPHTHALMIC

 

(AY-zel-AS-teen)

 

COMMON BRAND NAME(S): Optivar

 

USES: Azelastine is used to treat itching eyes caused by allergies (allergic conjunctivitis). This medication is an antihistamine. It works by blocking certain natural substances (such as histamines) responsible for allergic symptoms.

Do not use this medication to treat redness and irritation due to wearing contact lenses.

 

HOW TO USE: To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

Remove contact lenses before using this medication because it contains a preservative that can be absorbed by them. Wait at least 10 minutes after using this medication before putting the lenses back in. Do not wear contact lenses if your eyes are red.

Use this medication usually twice a day or as directed by your doctor. Tilt your head back, look upward and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.

Inform your doctor if your condition persists or worsens.

Consumer Overview Side Effect

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.

 

Read the Optivar (azelastine hydrochloride) Side Effects Center for a complete guide to possible side effects

Learn More »

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.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Consult your doctor for additional ways to minimize and relieve your symptoms (e.g., avoiding irritants that trigger allergies, using cold compresses and lubricating eye drops).

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store upright and tightly closed between 36-77 degrees F (2-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

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 that reduces the natural chemical histamine in the body. Histamine can produce symptoms of itching or watery eyes.

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

Azelastine ophthalmic may also be used for 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 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.

Read the Optivar (azelastine hydrochloride) Side Effects Center for a complete guide to possible side effects

Learn More »

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.

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 this medication while wearing contact lenses. Azelastine ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using azelastine 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 severe eye pain, trouble breathing, or severe burning, stinging, itching, or redness in your eyes.

Side Effects Centers
  • Optivar

Patient Detailed How Take

What should I discuss with my healthcare provider before using azelastine ophthalmic (Optivar)?

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

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

FDA pregnancy category C. It is not known whether azelastine ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether azelastine ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 3 years old.

How should I use azelastine ophthalmic (Optivar)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use this medication while wearing contact lenses. Azelastine ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medication before putting your contact lenses in.

Wash your hands before using the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
  • Use only the number of drops your doctor has prescribed.
  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
  • 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.

The 0.2 milliliter (0.2 mL) container of azelastine is for one use only. Throw away after one use, even if there is still some medicine left in it. Each 0.2 mL container must be used within one month after you open the foil pouch.

Store at room temperature away from heat and moisture. Keep each single-use 0.2 mL container in the foil pouch until you are ready to use it.

Side Effects Centers
  • Optivar

Patient Detailed Avoid Taking

What happens if I miss a dose (Optivar)?

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.

What happens if I overdose (Optivar)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using azelastine ophthalmic (Optivar)?

Do not use other eye medications during treatment with azelastine unless your doctor tells you to.

What other drugs will affect azelastine ophthalmic (Optivar)?

It is not likely that other drugs you take orally or inject will have an effect on azelastine used in the eyes. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about azelastine ophthalmic.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 7.01. Revision date: 9/20/2011.

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Side Effects Centers
  • Optivar

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