OLOPATADINE HYDROCHLORIDE
Generic: OLOPATADINE HYDROCHLORIDE
Basic Information
Manufacturer
Alembic Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
dbcdf10c-5adb-4d48-97ce-f4b82c6bc77d
Indications & Usage
1 INDICATIONSAND USAGE Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Adverse Reactions
6 ADVERSE REACTIONS Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%.
The following adverse experiences have been reported in 5% or less of patients: Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus.
Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion.
Some of these events were similar to the underlying disease being studied.
Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc.
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
The following adverse experiences have been reported in 5% or less of patients: Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus.
Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion.
Some of these events were similar to the underlying disease being studied.
Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc.
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch