Dosing & Uses
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
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
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)
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.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%)
Administration
Intranasal Administration
Prime nasal spray before initial use and when not in use for >7 days
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) - | 0.2 % 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 |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 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.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 May 2023. Copyright(c) 2023 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.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
