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Olopatadine Hydrochloride (Olopatadine Hydrochloride)

Trade Name : Olopatadine Hydrochloride

Teva Pharmaceuticals USA, Inc.

SOLUTION/ DROPS

Strength 2 mg/mL

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

Delivery Process

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Product information is meant for

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Olopatadine Hydrochloride (Olopatadine Hydrochloride) which is also known as Olopatadine Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 2 mg/mL per ml. Read more

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.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Olopatadine hydrochloride ophthalmic solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
  • Olopatadine hydrochloride ophthalmic solution is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis. ()
  • The recommended dose is one drop in each affected eye once a day.
  • The recommended dose is one drop in each affected eye once a day. ()
  • Ophthalmic solution 0.2%: each mL contains 2.22 mg of olopatadine hydrochloride USP.
  • Ophthalmic solution 0.2%: each mL contains 2.22 mg of olopatadine hydrochloride. ()
  • None.
  • For topical ocular use only. Not for injection or oral use. ()
  • 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:
  • Non-ocular:
  • 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%. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Olopatadine hydrochloride ophthalmic solution USP 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes. Olopatadine hydrochloride, USP is a white or whitish, crystalline, water-soluble powder.
  • The structural formula of olopatadine hydrochloride, USP is:
  • CHNO u2022 HCl M.W. 373.88
  • Chemical Name:
  • Each mL of olopatadine hydrochloride ophthalmic solution USP for topical ocular use only, contains 2.22 mg olopatadine hydrochloride, USP equivalent to 2 mg olopatadine and has the following inactive ingredients: dibasic sodium phosphate anhydrous, edetate disodium, povidone, sodium chloride; benzalkonium chloride 0.01% (preservative); hydrochloric acid/sodium hydroxide (adjust pH); and water for injection.
  • It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg.
  • No data
  • 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 u03bcL 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 bacterial reverse mutation (Ames) test, an mammalian chromosome aberration assay or an 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.
  • Results from clinical studies of up to 12 weeks duration demonstrate that olopatadine hydrochloride ophthalmic solution when dosed once a day is effective in the treatment of ocular itching associated with allergic conjunctivitis.
  • Olopatadine hydrochloride ophthalmic solution USP 0.2% is a clear, colorless to light yellow solution supplied in a white, low density polyethylene (LDPE) bottle with a white dropper tip, and a high density polyethylene cap.
  • 2.5 mL fill in 5 mL bottle (NDC 0093-7684-32)
  • Storage
  • Store at 2u00b0 to 25u00b0C (36u00b0 to 77u00b0F)
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • No data
  • No data

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