My first Lotemax Prescription
"Nothing worthwihile is ever easy " and obtaining Lotemax must be worthwhile based on the effort it took to convince the Opthamologist [3 calls] and 4 trips to the pharmacy [Revco] before the wholesaler finally delivered to their warehouse.
Unfortunately, Yosi my flatbed scanner is down, but transcribed the the full description of Indications & Usage from the B&L insert as follow:
Lotemax is indicated for the treatment of Steroid responsive inflamatory conditions of the palpebral and bulbar conjunctiva, cornea, and exterior segments of the globe, such as allergic conjunctivitis, acne rocea, superficial punctate keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable dimunition in edema and inflmation.
Lotemax is less effective than Prednsione Acetate 1% in two 28 patient controlled clinical studies in acute anterior Uveitis where 72% of patients treated with Lotemax experienced resolution of anterior chamber cells compared to 87% of patients treated with Prednisone acetate 1%.The incidence of patients experiencing clinically significnt increases in IOP was 1% with Lotemax and 6% with Prednisone Acetate 1%.
Lotemax should not be used in patients with who require a more potent cortecosteroid for this inidcation.
End of Indications & Usage section.
Will try to send the information on Contraindications, Clinical Pharmacology, Adverse reactions, Warnings, etc later......or alternately pehaps Pharmos could scan the Lotemax & Alrex label onto the website (presuming no copyright issues are involved).....but didn't see any show stoppers in the other sections of the label.
In retrospect the Uveitis study [an indication not requested by B&L or PARS] seems like a waste of time which delayed the prduct reaching the market.......but did result in a wider indication on the label.......while costing PARS at least 6 months of cash burn and an additional private placement when they could least afford it........but who ever said the bureaucratic FDA could be sensitive to a struggling biotech company.
Look forward to your response and hopefully the return of David Israel Rosen who contributed much to this thread.
Best Regards, and please excuse any typos.
Neil |
