Trade Name: OLOPATADINE HYDROCHLORIDE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Somerset Therapeutics, LLC

Presentation: SOLUTION/ DROPS, HUMAN PRESCRIPTION DRUG

Strength: 1.11 mg/mL

Storage and handling

OLOPATADINE HYDROCHLORIDE Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • Olopatadine hydrochloride ophthalmic solution USP, 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 Olopatadine hydrochloride ophthalmic solution, USP contains:
  • Active:
  • Preservative: n- Inactives:
  • 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 olopatadine hydrochloride ophthalmic solution, 0.1% 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 olopatadine hydrochloride ophthalmic solution, 0.1%, 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.
  • Olopatadine hydrochloride ophthalmic solution USP, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
  • Olopatadine hydrochloride ophthalmic solution, 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution, 0.1%.
  • Olopatadine hydrochloride ophthalmic solution, 0.1% is for topical use only and not for injection or oral use.
  • No data
  • 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.
  • The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.
  • Olopatadine hydrochloride ophthalmic solution USP, 0.1% is supplied as follows: 5 mL in LDPE Bottle.
  • 5 mL: 70069--01
  • Storage: Store at 39u00b0F-77u00b0F (4u00b0C-25u00b0C).
  • Rx Only
  • For Product Inquiry call 1-800-417-9175.
  • Manufactured for:
  • Somerset Therapeutics, LLC
  • Hollywood, FL 33024
  • Customer Care # 1-800-417-9175
  • Made in India
  • Code No.:KR/DRUGS/KTK/28/289/97
  • ST-OLP11/P/02
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  • Revised: November, 2019
  • OLOPATADINE Hydrochloride Ophthalmic Solution USP, 0.1%
  • NDC 70069-007-01
  • 5 mL Sterile
  • Container Label
  • Caton Label

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of OLOPATADINE HYDROCHLORIDE (OLOPATADINE HYDROCHLORIDE) which is also known as OLOPATADINE HYDROCHLORIDE and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 1.11 mg/mL.

OLOPATADINE HYDROCHLORIDE (OLOPATADINE HYDROCHLORIDE) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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