olopatadine ophthalmic (Rx, OTC)

Brand and Other Names:Pataday, Patanol, more...Pazeo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 0.1% (Patanol [OTC])
  • 0.2% (Pataday [OTC])
  • 0.7% (Pazeo)

Allergic Conjunctivitis

Indicated for the treatment of ocular itching associated with allergic conjunctivitis

0.1% solution (Patanol): 1 gtt BID in affected eye(s) at an interval of 6-8 hr

0.2% solution (Pataday): 1 gtt in affected eye(s) qDay

0.7% solution (Pazeo): 1 gtt in affected eye(s) qDay

Dosage Forms & Strengths

ophthalmic solution

  • 0.1% (Patanol [OTC])
  • 0.2% (Pataday [OTC])
  • 0.7% (Pazeo)

Allergic Conjunctivitis

Indicated for the treatment of ocular itching associated with allergic conjunctivitis

<2 years (Pataday, Pazeo) or <3 years (Patanol): Safety and efficacy not established

0.1% solution (Patanol): 1-2 gtt BID in affected eye(s) at an interval of 6-8 hr

0.2% solution (Pataday): 1 gtt in affected eye(s) qDay

0.7% solution (Pazeo): 1 gtt in affected eye(s) qDay

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Adverse Effects

1-10%

Headache (7%)

Asthenia (<5%)

Blurred vision (<5%)

Burning or stinging (<5%)

Cold syndrome (<5%)

Dry eye (<5%)

Foreign body sensation (<5%)

Hyperemia (<5%)

Hypersensitivity (<5%)

Keratitis (<5%)

Lid edema (<5%)

Nausea (<5%)

Pharyngitis (<5%)

Pruritus (<5%)

Rhinitis (<5%)

Sinusitis (<5%)

Taste perversion (<5%)

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Warnings

Contraindications

Pataday and Pazeo: None

Patanol: Known hypersensitivity

Cautions

Do not wear a contact lens if their eye is red

Benzalkonium chloride, a preservative in ophthalmic solution, may be absorbed by soft contact lenses

For external use only; do not use if solution changes color or becomes cloudy, patient is sensitive to any ingredient in the product, or to treat contact lens irritation

Use caution when using product; to avoid contamination, do not touch tip of container to any surface; remove contact lenses before use; wait at least 10 min before reinserting lenses after use

Discontinue use and see healthcare practitioner if eye pain, changes in vision, increased redness of the eye or itching worsens or lasts for more than 72 hours

Keep product out of reach of children; if swallowed, contact Poison Control Center right away

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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women

Animal studies

  • Olopatadine was found not to be teratogenic in rats and rabbits
  • Rats treated at 600 mg/kg/day, or 150,000 times the MROHD and rabbits treated at 400 mg/kg/day, or ~100,000 times the MROHD, during organogenesis showed a decrease in live fetuses
  • In addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight
  • Further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight

Lactation

Olopatadine has been identified in the milk of nursing rats following oral administration

It is unknown whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk

Exercise caution when using olopatadine hydrochloride is administered to a nursing mother

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Antihistamine (H1 antagonist); inhibits release of histamine from mast cells and histamine induced effects on conjunctival epithelial cells.

Pharmacokinetics

Absorption: Limited systemic

Half-Life: 3 hr

Protein binding: ~55%

Metabolites: N-desmethyl olopatadine; olopatadine N-oxide

Half-life: 3 hr

Excretion: Urine (60-70%); feces (17%)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
olopatadine nasal
-
0.6 % aerosol
olopatadine nasal
-
0.6 % aerosol
olopatadine nasal
-
0.6 % aerosol
olopatadine nasal
-
0.6 % aerosol
Patanase nasal
-
0.6 % aerosol
olopatadine ophthalmic (eye)
-
0.2 % drops
olopatadine ophthalmic (eye)
-
0.1 % drops
olopatadine ophthalmic (eye)
-
0.1 % drops
olopatadine ophthalmic (eye)
-
0.1 % drops
olopatadine ophthalmic (eye)
-
0.2 % drops
olopatadine ophthalmic (eye)
-
0.1 % drops
olopatadine ophthalmic (eye)
-
0.2 % drops
olopatadine ophthalmic (eye)
-
0.1 % drops
olopatadine ophthalmic (eye)
-
0.1 % drops
olopatadine ophthalmic (eye)
-
0.1 % drops
olopatadine ophthalmic (eye)
-
0.2 % drops
olopatadine ophthalmic (eye)
-
0.2 % drops

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
olopatadine nasal

OLOPATADINE SPRAY - NASAL

(oh-low-PAT-uh-deen)

COMMON BRAND NAME(S): Patanase

USES: Olopatadine is used to relieve symptoms of seasonal allergies that occur in the nose, such as runny/itchy/stuffy nose, sneezing, and post-nasal drip. This medication is an antihistamine. It works by blocking certain natural substances called histamines that are responsible for allergic symptoms.Do not use this medication in children younger than 2 years unless specifically directed by the doctor. To decrease the risk for serious side effects, carefully follow all of the doctor's dosage directions. Do not give other cough and cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (such as saline nose drops/spray, using a humidifier or infant nasal suction bulb).

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using olopatadine and each time you get a refill. Follow the instructions on how to properly use this medication. If you have any questions, consult your doctor or pharmacist.Follow the instructions for properly priming the spray pump before using the bottle for the first time and if you have not used the medication for more than 7 days. Avoid spraying in your eyes or directly onto the nasal septum (the wall between the two nostrils).Use this medication in your nose as directed by your doctor, usually twice a day in both nostrils.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.Keep track of the number of sprays you use, including test sprays used to prime the bottle. Discard the bottle after you have used the labeled number of sprays on the product package, even if the bottle is not completely empty. By doing this, you can be sure that you get the correct amount of drug in each spray.Tell your doctor if your symptoms do not improve.

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 last or get worse, 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 this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: sores in your nose, hole in the nasal septum.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.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. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).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.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose in adults may include drowsiness. In children, overdose symptoms may include restlessness/agitation, and may be followed by drowsiness.

NOTES: Do not share this medication with others.

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. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature. Keep all medications 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.

Information last revised December 2022. Copyright(c) 2022 First Databank, Inc.

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.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.