Document
DailyMed Label: Pataday
Title
DailyMed Label: Pataday
Date
2011
Document type
DailyMed Prescription
Name
Pataday
Generic name
olopatadine hydrochloride
Manufacturer
Physicians Total Care, Inc.
Product information
NDC: 54868-6222
Product information
NDC: 54868-6222
Description
PATADAY™ (olopatadine hydrochloride
ophthalmic solution) 0.2% is a sterile ophthalmic solution containing
olopatadine for topical administration to the eyes.
Olopatadine hydrochloride is a white, crystalline, water-soluble powder with
a molecular weight of 373.88 and a molecular formula of C 21 H 23 NO 3 · HCl.
The chemical structure is presented below:
Chemical Name: 11-[(Z)-3-(Dimethylamino)
propylidene]-6-11-dihydrodibenz[b,e] oxepin-2-acetic acid, hydrochloride
Each mL of PATADAY™ solution contains: Active : 2.22 mg olopatadine hydrochloride equivalent to 2 mg
olopatadine. Inactives: povidone; dibasic sodium
phosphate; sodium chloride; edetate disodium; benzalkonium chloride 0.01% ( preservative ) hydrochloric acid / sodium hydroxide (adjust
pH); and purified water.
It has a pH of approximately 7 and an osmolality of approximately 300
mOsm/kg.
image of chemical structure
Indications
PATADAY™ solution is indicated for the
treatment of ocular itching associated with allergic conjunctivitis.
Dosage
The recommended dose is one drop in each affected eye once a
day.
Contraindications
Hypersensitivity to any components of this product.
Precautions
Information for Patients As with any eye drop, to prevent contaminating the dropper tip
and solution, care should be taken not to touch the eyelids or surrounding areas
with the dropper tip of the bottle. Keep bottle tightly closed when not in use.
Patients should be advised not to wear a contact lens if their eye is red.
PATADAY™ (olopatadine hydrochloride ophthalmic
solution) 0.2% should not be used to treat contact lens related irritation. The
preservative in PATADAY™ solution, benzalkonium
chloride, may be absorbed by soft contact lenses. Patients who wear soft contact
lenses and whose eyes are not red , should be instructed
to wait at least ten minutes after instilling PATADAY™
(olopatadine hydrochloride ophthalmic solution) 0.2% before they insert their
contact lenses.
Carcinogenesis, Mutagenesis, Impairment of
Fertility Olopatadine administered orally was not carcinogenic in mice and
rats in doses up to 500 mg/kg/day and 200 mg/kg/day, respectively. Based on a 40
µL drop size and a 50 kg person, these doses were approximately 150,000 and
50,000 times higher than the maximum recommended ocular human dose (MROHD). No
mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test. Olopatadine administered
to male and female rats at oral doses of approximately 100,000 times MROHD level
resulted in a slight decrease in the fertility index and reduced implantation
rate; no effects on reproductive function were observed at doses of
approximately 15,000 times the MROHD level.
Pregnancy
Teratogenic effects: Pregnancy
Category C
Olopatadine was found not to be teratogenic in rats and rabbits.
However, rats treated at 600 mg/kg/day, or 150,000 times the MROHD and rabbits
treated at 400 mg/kg/day, or approximately 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.
There are, however, no adequate and well-controlled studies in pregnant
women. Because animal studies are not always predictive of human responses, this
drug should be used in pregnant women only if the potential benefit to the
mother justifies the potential risk to the embryo or fetus.
Nursing Mothers Olopatadine has been identified in the milk of nursing rats
following oral administration. It is not known whether topical ocular
administration could result in sufficient systemic absorption to produce
detectable quantities in the human breast milk. Nevertheless, caution should be
exercised when PATADAY™ (olopatadine hydrochloride
ophthalmic solution) 0.2% is administered to a nursing mother.
Pediatric Use Safety and effectiveness in pediatric patients below the age of 3
years have not been established.
Geriatric Use No overall differences in safety and effectiveness have been
observed between elderly and younger patients.
Adverse reactions
Symptoms similar to cold syndrome and pharyngitis were reported
at an incidence of approximately 10%.
How supplied
PATADAY™ (olopatadine hydrochloride
ophthalmic solution) 0.2% is supplied in a white, oval, low density polyethylene
DROP-TAINER® dispenser with a natural low density polyethylene dispensing plug
and a white polypropylene cap. Tamper evidence is provided with a shrink band
around the closure and neck area of the package.
NDC 54868-6222-0 2.5 mL fill in 4 mL oval bottle
Storage Store at 2 o C to 25 o C (36 o F to 77 o F)
U.S. Patents Nos. 4,871,865; 4,923,892; 5,116,863; 5,641,805; 6,995,186
Rx Only
© 2006 Alcon, Inc.
Relabeling of "Additional" barcode label by:
Physicians Total Care, Inc. Tulsa, OK 74146
Clinical pharmacology
Olopatadine is a relatively selective histamine H 1 antagonist and an inhibitor of the release of histamine from
the mast cells. Decreased chemotaxis and inhibition of eosinophil activation has
also been demonstrated. Olopatadine is devoid of effects on alpha-adrenergic,
dopaminergic, and muscarinic type 1 and 2 receptors.
Systemic bioavailability data upon topical ocular administration of PATADAY™ solution are not available. Following topical ocular
administration of olopatadine 0.15% ophthalmic solution in man, olopatadine was
shown to have a low systemic exposure. Two studies in normal volunteers
(totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic
solution once every 12 hours for 2 weeks demonstrated plasma concentrations to
be generally below the quantitation limit of the assay (< 0.5 ng/mL). Samples
in which olopatadine was quantifiable were typically found within 2 hours of
dosing and ranged from 0.5 to 1.3 ng/mL. The elimination half-life in plasma
following oral dosing was 8 to 12 hours, and elimination was predominantly
through renal excretion. Approximately 60 - 70% of the dose was recovered in the
urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were
detected at low concentrations in the urine.
Clinical studies
Results from clinical studies of up to 12 weeks duration
demonstrate that PATADAY™ solution when dosed once a day
is effective in the treatment of ocular itching associated with allergic
conjunctivitis.
Package label
PATADAY™ (olopatadine hydrochloride ophthalmic solution)
0.2%
2.5 mL
image of package label
1 organization
2 products
Product
OlopatadineOrganization
Physicians Total Care, Inc.