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olopatadine hydrochloride
Overview
What is Patanol?
PATANOL® (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H -receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 373.88. The chemical structure is presented below:
Chemical Name:
Each mL of PATANOL contains: 1.11 mg olopatadine hydrochloride equivalent to 1 mg olopatadine.
Preservative:
Inactives:
What does Patanol look like?
What are the available doses of Patanol?
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What should I talk to my health care provider before I take Patanol?
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How should I use Patanol?
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.
What interacts with Patanol?
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What are the warnings of Patanol?
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What are the precautions of Patanol?
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What are the side effects of Patanol?
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What should I look out for while using Patanol?
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of PATANOL.
WARNINGS
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is for topical use only and not for injection or oral use.
What might happen if I take too much Patanol?
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How should I store and handle Patanol?
Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Product: 50090-0593NDC: 50090-0593-0 5 mL in a BOTTLE, PLASTIC Product: 50090-0593NDC: 50090-0593-0 5 mL in a BOTTLE, PLASTIC
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H -antagonist that inhibits the and type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha-adrenergic, dopamine and muscarinic type 1 and 2 receptors. Following topical ocular administration in man, olopatadine was shown to have 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 half-life in plasma was approximately 3 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.
Results from an environmental study demonstrated that PATANOL was effective in the treatment of the signs and symptoms of allergic conjunctivitis when dosed twice daily for up to 6 weeks. Results from conjunctival antigen challenge studies demonstrated that PATANOL, when subjects were challenged with antigen both initially and up to 8 hours after dosing, was significantly more effective than its vehicle in preventing ocular itching associated with allergic conjunctivitis.
Non-Clinical Toxicology
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of PATANOL.WARNINGS
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is for topical use only and not for injection or oral use.
Ranitidine Tablets have been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.
Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.
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. PATANOL® (olopatadine hydrochloride ophthalmic solution) 0.1% should not be used to treat contact lens related irritation. The preservative in PATANOL, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and should be instructed to wait at least ten minutes after instilling PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% before they insert their contact lenses.
Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and taste perversion. Some of these events were similar to the underlying disease being studied.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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