Alprazolam labeling

Csernansky JG, Lombrozo L, Gulevich GD, et al. Treatment of negative schizophrenic symptoms with alprazolam a preliminary open-label study. J Clin Psychopharmacol 1984 4 349-352. Douyon R, Angrist B, Peselow E, et al. Neuroleptic augmentation with alprazolam clinical effects and pharmacokinetic correlates. Am J Psychiatry 1989 146 231-234. 

XANAX (Pharmacia Upjohn) (alprazolam) tablets December 2001 labeling... 

Greenblatt DJ, von Moltke LL, Harmatz JS, et al. Alprazolam-ritonavir interaction implications for product labeling. Clin Pharmacol Ther 2000 67 335-341. 

Mania is a special danger in regard to Xanax. Unlike any other benzodiazepine, the FDA-approved label for Xanax, as found in the 2007 Physicians Desk Reference, specifically mentioned the risk of mania. Drug Facts and Comparisons (2007) also made a specific reference to Xanax under Precautions, stating that anger, hostility and episodes of mania and hypomania have been reported with alprazolam (p. 1199). As another... 

In addition to the three more recent withdrawals of Merital, Serzone, and Cylert, I have also reviewed the entire list of serious adverse reactions to psychiatric drugs detected during the postmarketing period in the GAO (1990) study. It seems probable that every one of them was discovered and confirmed through a combination of the SRS, individual case reports, and general clinical experience. As far as I can ascertain, not one of these adverse reactions was primarily, if at all, identified by means of a controlled clinical trial. As a result of postmarket discoveries, alprazolam (Xanax) had rage added to the label as a paradoxical reaction, and amoxapine (Asendin) had NMS added. 

Alprazolam, 269, a popular sedative/hypnotic agent and benzodiazepine receptor agonist, has been labelled " with C in metabolically stable position in reaction of the amidrazone, 7-chloro-5-phenyl-3i/-l,4-benzodiazepine-2-yl hydrazone, 270, with 1-[ CJacetyl chloride followed by pyrolysis of the resulting 1-acetylhydrazone 271. Compound 269 has been obtained in 43--65% yield during 40-55 min at specific activity 0.93-2.18 Ci pmoP and used for metabolism and tissue distribution studies (equation 107). 

Synthesis of 13C- and uC-labelled Alprazolam , Q-chloro-1 -(2-dimethylamino)-ethyl-6-phenyl-4H-S-triazolo [4,3-a] [1,4] benzodiazepine (178) and of its tosylate (178 los OH)... 

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