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 ophthalmiac solution, may be absorbed by soft contact lenses

Instruct patients who wear soft contact lenses and whose eyes are not red, to wait at least 5 minutes after administration before inserting contact lenses

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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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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.