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This includes study (protocol P/2002/0017: PK and PD of alprazolam relative to meal timing); dissolution profiles from the newly proposed debossed tablet for all strengths; literature-based metabolism and drug-drug interaction to support the labeling language, and PK data to support the proposed once daily or \ - dosage. (b)Are the sponsor proposed dissolution method and specification adequate? (c)How does the sponsor respond to the dissolution specification comments from the agency prior to the (d)Has the sponsor submitted sufficient information to support the level 3 manufacturing site casino phentermine viagra xanax change? Only these new information will be thoroughly reviewed by this reviewer. The event phentermine viagra xanax source of the review will be clearly indicated throughout this review. 4.1.4 Are the to-be-marketed XR formulations identical to the formulations submitted under Formulations are unchanged from those submitted1 . in the original -- hydrocodone substitute 4.2 General Attributes 4.2.1 What are the molecular formula and chemical properties of alprazolam? Alprazolam (8-chloro-l-methyl-6-phenyl-4H-s-triazolo[4,3-a][l,4] benzodiazepine) is a triazolobenzodiazepine related to the benzodiazepine class of drugs. It is distinct from the other drugs in this class because of a triazole ring fused to the diazepine ring of the benzodiazepine ring system.

Alprazolam (molecular formula C17H13CIN4, molecular weight 308.77) occurs as a white to off-white crystalline powder. It is soluble in methanol or ethanol but has no appreciable solubility in water at physiological pH. The octanokbuffer partition ratio for alprazolam is 18, indicating that it is highly lipophilic. Chemical Structure: Cl 4.2.2 What are the pharmacological properties of alprazolam? Pharmacologically, the anxiolytic effect of alprazolam is similar to other CNS agents of the 1,4- benzodiazepine class and they presumably exert their effects by binding at stereo specific receptors at several sites within the central nervous system. However, the antidepressive and antipanic mechanisms are less clear. Alprazolam has a higher binding affinity for the benzodiazepine receptors (K,, affinity constant of alprazolam is 3.4 nM). 4.3 Currently approved formulation and indication 4.3.1.1 Which Xanax formulation and indication are approved? Xanax is currently marketed as immediate release (IR) tablets (0.25, 0.5, 1, and 2mg) for oral use.

Xanax is indicated for (1) the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-IH-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety, and (2) the treatment of panic disorder, with or without agoraphobia.

4.3.1.2What oral dosing regimens of Xanax are recommended for the treatment of panic disorder? The successful treatment of casino phentermine viagra xanax many panic disorder patients has required the use of XANAX at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of XANAX in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received XANAX in dosages of greater than 7 mg/day, including approximately -100 patients who received maximum casino phentermine viagra xanax dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug.

-Thereafter, the dose can be increased at intervals equal to at least 5 times the elimination half-life (about 11 hours in young patients, about 16 hours in elderly patients). Longer titration intervals should probably be used because the maximum therapeutic response may not occur until after the plasma levels achieve steady state.

Dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained. For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated casino phentermine viagra xanax with doses of XANAX greater than 4 mg/day for three months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit.



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