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Product Name
:
PATALERG
Chemical Name
:
Olopatadine HCl
Therapeutic Category
:
Ophthalmic drugs
Pharmacologic Category
:
Histamine H1; Antagonist - Histamine H1; Antagonist, Second Generation - Piperidine Derivative
Pharmaceutical Form
:
Eye Drops
Composition
:
Olopatadine HCl 1.11 mg EQ.V TO Olopatadine 1mg / Olopatadine HCl 2.22 mg EQ.V TO Olopatadine 2mg
Monitoring Parameters
Dosing
 
Dosing: Adult
Allergic conjunctivitis: Ophthalmic:
Olopatadine 1 MG/ML : Instill 1drop into affected eye(s) twice daily (allowing 6-8 hours between doses); results from an environmental study demonstrated that olopatadine was effective when dosed twice daily for up to 6 weeks
Olopatadine 2 MG/ML: Instill 1 drop into affected eye(s) once daily
Dosing: Pediatric
Allergic conjunctivitis: Ophthalmic: Children ≥3 years: Refer to adult dosing.
Use
 
Treatment of the signs and symptoms of allergic conjunctivitis
Adverse Reactions
 
>5%:
Central nervous system: Cold syndrome (up to 10%), headache (up to 7%)
Respiratory: Pharyngitis (up to 10%)
≤5%:
Gastrointestinal: Nausea, taste perversion
Neuromuscular & skeletal: Back pain, weakness
Ocular: Blurred vision, burning, conjunctivitis, dry eyes, eye pain, eyelid edema, foreign body sensation, hyperemia, itching, keratitis, ocular pruritus, stinging
Respiratory: Cough, rhinitis, sinusitis
Miscellaneous: Flu-like syndrome, hypersensitivity, infection
Contraindications
 
Hypersensitivity to olopatadine hydrochloride or any component of the formulation
Warnings / Precautions Drug
 
Other warnings/precautions:
• Contact lens: Not for use to treat contact lens-related irritation. Solution contains benzalkonium chloride; remove lens prior to administration and wait at least 10 minutes before reinserting. Do not use contact lenses if eyes are red.
Interactions
 
There are no known significant interactions.
Pregnancy
 
C
Pregnancy Implications
Teratogenic effects were not observed in animal studies; however, a decrease in fetal weight and a decrease in live births were observed. There are no adequate and well-controlled studies in pregnant women.
Lactation
 
Excretion in breast milk unknown/use caution
Mechanism of Action
 
Selective histamine H1-antagonist; inhibits release of histamine from mast cells. Inhibits histamine induced effects on conjunctival epithelial cells.
Pharmacodynamics / Kinetics
 
Absorption: Low systemic absorption
Protein binding: ~55% (primarily albumin)
Metabolism: Not extensively metabolized
Half-life elimination: ~3 hours
Excretion: Urine (60% to 70%, mostly as unchanged drug); feces (17%)
 
   
 
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