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Olopatadine Hydrochloride (Pazeo)

Trade Name : Pazeo

Alcon Laboratories, Inc.

SOLUTION

Strength 7 mg/mL

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

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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 (Pazeo) which is also known as Pazeo and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 7 mg/mL per ml. Read more

Olopatadine Hydrochloride (Pazeo) 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
  • PAZEO is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
  • PAZEO
  • (1)
  • The recommended dosage of PAZEO is to instill one drop in each affected eye once a day.
  • The recommended dose is one drop in each affected eye once a day. u00a0n
  • Ophthalmic solution:u00a0 7.76 mg of olopatadine hydrochloride in one mL solution (0.7%) in a 4 mL bottle.
  • u00a0Ophthalmic solution:u00a0 7.76 mg of olopatadine hydrochloride in one mL of solution (0.7%) in a four mL bottle. n
  • None.
  • None.u00a0 n
  • Contamination of Tip and Solution. u00a0To prevent contaminating the dropper tip and solution, do not touch the eyelids or surrounding areas with the dropper tip of the bottle. n
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. n In a randomized, double-masked, vehicle-controlled trial, patients at risk for developing allergic conjunctivitis received one drop of either PAZEO (N=330) or vehicle (N=169) in both eyes for 6 weeks.u00a0 The mean age of the population was 32 years (range 2 to 74 years).u00a0 Thirty-five percent were male.u00a0 Fifty-three percent had brown iris color and 23% had blue iris color.u00a0 The most commonly reported adverse reactions occurred in 2-5% of patients treated with either PAZEO or vehicle. These events were blurred vision, dry eye, superficial punctate keratitis, dysgeusia and abnormal sensation in eye.
  • The most common adverse reactions (2-5%) were blurred vision, superficial punctate keratitis, dry eye, abnormal sensation in eye, and dysgeusia. n n n
  • No data
  • PAZEO is a sterile ophthalmic solution containing olopatadine, which is a mast cell stabilizer, for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, wateru2011soluble powder with a molecular weight of 373.88 and a molecular formula of CHNOu2022HCl.n The chemical structure is presented below:
  • Chemical Name: 11-[(Z)-3(dimethylamino) propylidene]-6-11dihydrodibenz[b,e] oxepin-2-acetic acid, hydrochloride.u00a0 n Each mL of PAZEO solution contains an active ingredient [7.76 mg of olopatadine hydrochloride (7 mg olopatadine)] and the following inactive ingredients: povidone; hydroxypropyl-gamma-cyclodextrin; polyethylene glycol 400; hypromellose; boric acid; mannitol;u00a0 benzalkonium chloride 0.015% (preservative); hydrochloric acid/sodium hydroxide (to adjust pH); and purified water. n n PAZEO solution has a pH of approximately 7.2 and an osmolality of approximately 300 mOsm/kg.
  • No data
  • 2
  • The efficacy of PAZEO was established in two randomized, double-masked, placebo-controlled, conjunctival allergen challenge (CAC) clinical studies in patients with a history of allergic conjunctivitis (Studies 1 and 2).u00a0 n n In Study 1, patients were randomized to receive one of the following study treatments:u00a0 PAZEO, PATADAY, or vehicle ophthalmic solutions.u00a0 In Study 2, patients were randomized to receive one of the following study treatments:u00a0 PAZEO, PATADAY, PATANOL, or vehicle ophthalmic solutions.u00a0 n Patients were evaluated with an ocular itching severity score ranging from 0 (no itching) to 4 (incapacitating itch) at several time points after CAC administration.u00a0 Table 1 displays the mean ocular itching severity scores after ocular administration of a specific antigen using the CAC model in Studies 1 and 2, respectively.u00a0 A one unit difference compared to vehicle is considered a clinically meaningful change in the ocular itching severity score.u00a0 n n PAZEO demonstrated statistically significantly improved relief of ocular itching compared to vehicle at 30-34 minutes, 16 hours, and 24 hours after study treatment.u00a0u00a0 PAZEO demonstrated statistically significantly improved relief of ocular itching compared to PATADAY at 24 hours after study treatment, but not at 30-34 minutes after study treatment.u00a0
  • *n- Mean score estimates, treatment differences and corresponding 95% confidence intervals (CIs) were based on analysis of repeated measures using a mixed model with itching scores from each eye (left or right) as the dependent variable and fixed effect terms for investigator, treatment, eye-type (left or right), time, and treatment-by-time interaction;n n- The ocular itching score range is 0-4, where 0 is none and 4 is incapacitating itch.
  • PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% is supplied in a white, oval, low density polyethylene DROP-TAINERdispenser 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.u00a0 PAZEO is supplied in a 4 mL bottle that contains 2.5 mL of olopatadine hydrochloride ophthalmic solution [7.76 mg of olopatadine hydrochloride in one mL of solution (0.7%)]. n n NDC 0065-4273-25n n n Store at 2u00b0C to 25u00b0C (36u00b0F to 77u00b0F).u00a0 Keep bottle tightly closed when not in use.
  • U.S. Pat.:n- Array
  • No data

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