Pataday

Ocular Anti-Allergics, Antihistamines
Topical Nasal Antiallergic Agents

To ensure the correct amount of medication is delivered, the unit must be primed before the initial use. Pointed away from the body, pump the activator 5 times or until a fine mist appears. If the unit has not been used for 7 days, re-prime by pumping twice or until a fine mist appears.
Instruct the patient on the proper use of olopatadine nasal spray. Avoid spraying in the eyes.
After administration, wipe the tip of the spray bottle with a clean tissue. Replace the cap.
Discard after 240 sprays (enough for 30 days at the recommended dosage) have been used even though the bottle is not completely empty. The correct amount of medication cannot be assured after 240 sprays have been used.
To avoid the spread of infection, do not use the sprayer for more than 1 person.

For topical application to the eye only.
Take care to avoid contamination. Wash hands before and after use. Do not touch the tip of the dropper to the eye, fingertips, or other surface. Do not share ophthalmic drops between patients.
Remove contact lenses before instilling drops. Instruct patients to wait at least ten minutes before reinserting contact lenses.
For products supplied in an oval DROP-TAINER dispensers (Pataday and Pazeo):
Remove cap. Hold bottle upside down between thumb and index finger.
Tilt the head back slightly and pull the lower eyelid down with the index finger of the opposite hand to create a pocket between the eye and the lower eyelid.
With the bottle positioned above the eye, gently squeeze the side of the bottle to dispense 1 drop.
Keep head tilted backwards and close eyes for 2 to 3 minutes while gently pressing index finger on the inside corner of the eye.
For products supplied in a round DROP-TAINER dispensers (Patanol):.
Remove cap. Hold bottle upside down between thumb and middle finger.
Tilt the head back slightly and pull the lower eyelid down with the index finger of the opposite hand to create a pocket between the eye and the lower eyelid.
With the bottle positioned above the eye, place the index finger on the bottom of the bottle and push to dispense 1 drop.
Keep head tilted backwards and close eyes for 2 to 3 minutes while gently pressing index finger on the inside corner of the eye.

keratitis / Delayed / 0-5.0
nasal septum perforation / Delayed / Incidence not known

hyperemia / Delayed / 0-5.0
conjunctivitis / Delayed / 0-5.0
blurred vision / Early / 0-5.0
wheezing / Rapid / 3.0-3.0
depression / Delayed / 2.0-2.0

epistaxis / Delayed / 3.2-25.0
dysgeusia / Early / 0-12.8
pharyngitis / Delayed / 10.0-10.0
diarrhea / Early / 0-9.1
headache / Early / 4.4-7.0
asthenia / Delayed / 0-5.0
ocular pruritus / Rapid / 0-5.0
ocular irritation / Rapid / 0-5.0
xerophthalmia / Early / 0-5.0
blepharedema / Early / 0-5.0
foreign body sensation / Rapid / 0-5.0
cough / Delayed / 1.4-5.0
sinusitis / Delayed / 0-5.0
rhinitis / Early / 0-5.0
influenza / Delayed / 0.9-5.0
nausea / Early / 0-5.0
back pain / Delayed / 0-5.0
rhinorrhea / Early / 4.5-4.5
rash / Early / 1.3-1.3
fever / Early / 1.3-1.3
infection / Delayed / 1.2-1.2
fatigue / Early / 0.9-0.9
drowsiness / Early / 0.9-0.9
xerostomia / Early / 0.9-0.9
throat irritation / Early / 0.9-0.9
anosmia / Delayed / Incidence not known

Pataday, Patanase, Patanol

OTC, Rx

Ophthamic and nasal antihistamine (H1-blocker) and mast cell stabilizer
Ophthalmic solution for prevention of ocular pruritus due to allergic conjunctivitis
Nasal spray for seasonal allergic rhinitis

1 drop in the affected eye(s) twice daily at an interval of 6 to 8 hours.[34128]

1 drop in the affected eye(s) twice daily at an interval of 6 to 8 hours.[34128]

1 drop in the affected eye(s) once daily.

1 drop in the affected eye(s) once daily.

2 sprays (665 mcg/spray) in each nostril twice daily.

1 spray (665 mcg/spray) in each nostril twice daily.

1 spray (665 mcg/spray) in each nostril twice daily has been evaluated in 66 children aged 2 to 5 years for safety; however, efficacy has not been established in this population.

No dosage adjustments are needed.

No dosage adjustments are needed.

Ethanol: (Major) Advise patients to avoid alcohol consumption while taking CNS depressants. Alcohol consumption may result in additive CNS depression.

Olopatadine Hydrochloride/Pataday/Patanol Ophthalmic Drops: 0.1%, 0.2%, 0.7%
Olopatadine Hydrochloride/Pataday/Patanol Ophthalmic Sol: 0.1%
Olopatadine Hydrochloride/Patanase Nasal Spray Met: 1actuation, 665mcg

2 drops/day 0.1% ophthalmic solution in each affected eye; 1 drop/day 0.2% or 0.7% ophthalmic solution in each affected eye; 4 nasal sprays/day in each nostril.

2 drops/day 0.1% ophthalmic solution in each affected eye; 1 drop/day 0.2% or 0.7% ophthalmic solution in each affected eye; 4 nasal sprays/day in each nostril.

2 drops/day 0.1% ophthalmic solution each affected eye; 1 drop/day 0.2% or 0.7% ophthalmic solution in each affected eye; 4 nasal sprays/day in each nostril.

12 years: 2 drops/day 0.1% ophthalmic solution each affected eye; 1 drop/day 0.2% or 0.7% ophthalmic solution in each affected eye; 4 nasal sprays/day in each nostril.
6 to 11 years: 2 drops/day 0.1% ophthalmic solution each affected eye; 1 drop/day 0.2% or 0.7% ophthalmic solution in each affected eye; 2 nasal sprays/day in each nostril.
2 to 5 years: 2 drops/day 0.1% ophthalmic solution in each affected eye; 1 drop/day 0.2% or 0.7% ophthalmic solution in each affected eye. Safety and efficacy have not been established for the nasal spray; however, 2 nasal sprays/day in each nostril has been studied.
younger than 2 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Olopatadine exhibits two distinct mechanisms of action. It inhibits histamine release from mast cells and is a relatively selective antagonist of H1-receptors. As a result, olopatadine prevents type 1 immediate hypersensitivity reactions. Topical ocular administration relieves the ocular pruritus associated with allergic conjunctivitis. Intranasal administration relieves symptoms associated with seasonal allergic rhinitis. Olopatadine does not act upon alpha-adrenergic, dopaminergic, type 1 or type 2 muscarinic, or serotonergic receptors.

Olopatadine is administered topically to the eye or intranasally. Olopatadine exhibits moderate protein binding (approximately 55% in human serum) and is mainly bound to serum albumin. Olopatadine is not extensively metabolized. After oral administration, at least 6 minor metabolites are present in human plasma. Excretion is primarily renal with approximately 60—70% of a dose recovered in the urine. Of the recovered drug-related material within the first 24 hours, approximately 86% is unchanged olopatadine. The plasma elimination half-life of olopatadine is 8—12 hours. Olopatadine exhibits linear pharmacokinetics over a large dose range.

Following topical ocular administration, plasma concentrations of olopatadine were in the range of 0.5—1.3 ng/ml within 2 hours of dosing and were undetectable after 2 weeks of dosing in normal volunteers.

Intranasal Route
After twice daily intranasal administration to adults, peak plasma concentrations (Cmax) were reached within 30—60 minutes. The mean steady-state Cmax was 16 +/- 8.99 ng/ml. The average absolute bioavailability of intranasal olopatadine is 57%.

No adequate and well-controlled studies have been conducted to evaluate the use of olopatadine during human pregnancy; however, published data from postmarketing use of antihistamines with similar mechanisms of action to olopatadine have not identified a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. In animal studies, a decrease in the number of live fetuses was observed in rabbits and rats at oral olopatadine doses approximately 88- and 100-times the maximum recommended human dose (MRHD) or 1,460- and 110-times the maximum recommended human daily intranasal dose (MRHDID), respectively. Additionally, maternal and fetal toxicities were observed in rats at drug concentrations 1,080- to 14,400-times the maximum recommended human ophthalmic dose (MRHOD) or 110- to 1,100-times the MRHDID. The use of olopatadine in pregnant women is only justified if the benefits outweigh the possible risks to the fetus.

There are no data on the presence of olopatadine in human milk, the effects on a breastfed infant, or the effects on milk production. Also, it is not known whether intranasal or topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk; however, it is unlikely that nursing infants would be exposed to clinically significant amounts via breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.[34127] [59359]