Comment: cost of rhDNase in cystic fibrosis
Published Oct 1, 1995 · C. Marra, B. Carleton, Diana Basmadjian
Annals of Pharmacotherapy
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Abstract
tially was controlledpoorly at a dosage of Synthroid0.075 mg/d, improved temporarily with increasingdosages of Levoxine, but subsequently showeda highTSH concentration at Levoxine 0.2 mg/d.Thereafter, thesamedosage of Synthroid wasadequate for several months, but the patient's needsagainfluctuated between 0.2 and0.175mg/d,finally resulting in alternating dailydosesof 0.2and0.175mg. Finally, with respectto the assayof a singleLevoxine tablet, the author statedthat the tablet's levothyroxine contentwasdetermined to be 74.5% of the label claim, outside the USP requirements of 90-110%. That specification applies onlyto an assayperformed on a mixture of 20 or moretablets. Individual tablets are subject to a USPcontentuniformity requirement of 85-115%,with I of 30 tablets permitted to rangefrom 75% to 125%. In 1993 we alsoreceived I of the secondpatient'stablets forassay,and the resultof our testing (which wasreported to theauthor, although not mentioned in thearticle) was95%of label. During our product'sentirehistory we haveneverhada recall forfailureto meetany USPrequirements within expiration date. We do notbelieve that theseisolated case reports supportlackof therapeutic equivalenceof Levoxine product quality. We regret that theauthordid notdiscusshis speculations withus priorto publication.