olopatadine intranasal (Rx)

Brand and Other Names:Patanase
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

nasal spray

  • 6% (665mcg/100 microliters spray)

Seasonal Allergic Rhinitis

2 sprays per nostril q12hr

Dosage Forms & Strengths

nasal spray

  • 6% (665mcg/100 microliters spray)

Seasonal Allergic Rhinitis

<6 years: Safety and efficacy not established

6-12 years: 1 spray per nostril q12hr

>12 years: 2 sprays per nostril q12hr

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Adverse Effects

>10%

Bitter taste (12.8%; 1% pediatric)

Respiratory epistaxis (3-25%)

1-10%

Headache (4.4%)

Depression (2%)

Fatigue (1%)

Somnolence (1%)

Weight gain (1%)

Epistaxis (3.2%; 5.7% pediatric)

Upper respiratory tract infection (2.6% pediatric)

Pharyngolaryngeal pain (2.2%)

Postnasal drip (1.5%)

Cough (1.4%)

Urinary tract infection (1.2%)

Upper respiratory tract infection in children (3%)

<1%

CPK elevation

Dry mouth

Anosmia

Hyposmia

Nasopharyngitis

Throat irritation

Influenza

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Warnings

Contraindications

Hypersensitivity

Cautions

May cause epistaxis, nasal ulceration, or nasal septal perforation

Avoid with nasal disease other than allergic rhinitis

May impair mental/physical abilities required for hazardous tasks (eg, driving, operating machinery)

Avoid concurrent use of alcohol or other CNS depressants (possible additive sedation)

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Pregnancy & Lactation

Pregnancy

Published data from postmarketing experience with antihistamines, have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

However, there are no published human data specific to this drug

Animal data

  • In animal reproductive studies, oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in number of live fetuses at maternal doses approximately 110 and 1460 times the maximum recommended human daily intranasal dose (MRHDID) on a mg/m2 basis, respectively

Lactation

  • There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; although orally administered drug is present in rat milk, there is no information about nasally administered drug
  • It is not known whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk
  • The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breast fed infant from drug or from underlying maternal condition

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.

Pharmacokinetics

Half-Life: 8-12 hr

Onset of action: 30 min (seasonal allergy)

Absorption: Systemic 57%

Bioavailability 57%

Peak Plasma Time: 0.25-2 hr

Peak Plasma Concentration: 23.3 ng/mL

Protein Bound: 55% (predominantly albumin)

Metabolites: N-desmethyl olopatadine; olopatadine N-oxide

Metabolism: Liver; not extensive

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

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Administration

Intranasal Administration

Prime nasal spray before initial use and when not in use for >7 days

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
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)
-
0.2 % 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 nasal
-
0.6 % aerosol
olopatadine nasal
-
0.6 % aerosol
olopatadine nasal
-
0.6 % aerosol
Patanase nasal
-
0.6 % aerosol

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
olopatadine ophthalmic (eye)

OLOPATADINE - OPHTHALMIC SOLUTION

(oh-low-PAT-uh-deen)

COMMON BRAND NAME(S): Pataday, Patanol, Pazeo

USES: This medication is an antihistamine used to treat itching and redness in the eyes due to allergies.This medication is not recommended for the treatment of eye irritation due to wearing contact lenses.

HOW TO USE: If you are using the over-the-counter product to self-treat, read and follow all directions on the product package before using this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, use it as directed.Apply this medication in the affected eye(s) as directed by the product package or by your doctor, usually once or twice a day.To apply eye drops, wash hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.If you are wearing contact lenses, remove them before using eye drops. Wait at least 10 minutes before replacing your contact lenses. 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, gently close your eyes, and place one finger at the corner of your eye (near the nose). Apply gentle pressure for 1 to 2 minutes before opening your eyes. This will prevent the medication from draining out. Try not to blink or rub your eye. If directed to use this medication in both eyes, repeat these steps for your other eye. Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.If your condition lasts or gets worse, or if you think you may have a serious medical problem, get medical help right away.

SIDE EFFECTS: Headache, blurred vision, burning/stinging/redness/dryness of the eye, eyelid swelling, or a feeling as if something is in your eye may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.If your doctor has directed you to use this medication, remember that 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.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, especially of: contact lens use.After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown 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.

OVERDOSE: This medicine may be harmful if swallowed. 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.

NOTES: Keep all regular medical and lab appointments.

MISSED DOSE: If you are using this product on a regular schedule and 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: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. 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 August 2021. Copyright(c) 2021 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.