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Paxil-cr indications, dosage, storage, stability - paroxetine ...

Cr dose paxil. histaminergic, and alpha1-adrenergic receptors has been associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs. Because the relative potencies of paroxetine’s major metabolites are at most 1 50 of the parent compound, they are essentially inactive. Pharmacokinetics: Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. The elimination half-life is approximately 15 to 20 hours after a single dose of PAXIL CR. Paroxetine is extensively metabolized and the metabolites are considered to be inactive. Nonlinearity in pharmacokinetics is observed with increasing doses. Paroxetine metabolism is mediated in part by CYP2D6, and the metabolites are primarily excreted in the urine and to some extent in the feces. Pharmacokinetic behavior of paroxetine has not been evaluated in subjects who are deficient in CYP2D6 (poor metabolizers). Absorption and Distribution: Tablets of PAXIL CR contain a d cr dose
 

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Egradable polymeric matrix (GEOMATRIX™) designed to control the dissolution rate of paroxetine over a period of approximately 4 to 5 hours. In addition to controlling the rate of drug release in vivo, an enteric coat delays the start of drug release until tablets of PAXIL CR have left the stomach. Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. In a study in which normal male and female subjects (n = 23) received single oral doses of PAXIL CR at 4 dosage strengths (12.5 mg, 25 mg, 37.5 mg, and 50 mg), paroxetine Cmax and AUC0-inf increased disproportionately with dose (as seen also with immediate-release formulations). Mean Cmax and AUC0-inf values at these doses were 2.0, 5.5, 9.0, and 12.5 ng mL, and 121, 261, 338, and 540 ng& 183; hr. mL, respectively. Tmax was observed typically between 6 and 10 hours post-dose, reflecting a reduction in absorption rate compared with immediate-release formulations. The bioavailability cr dose


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cr dose paxil Nd Distribution: Tablets of PAXIL CR contain a degradable polymeric matrix (GEOMATRIX™) designed to control the dissolution rate of paroxetine over a period of approximately 4 to 5 hours. In addition to controlling the rate of drug release in vivo cr dose paxil, an enteric coat delays the start of drug release until tablets of PAXIL CR have left the stomach. Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. In a study in which normal male and female subjects (n = 23) received single oral doses of PAXIL CR at 4 dosage strengths (12.5 mg cr dose paxil, 25 mg cr dose paxil, 37.5 mg cr dose paxil, and 50 mg) cr dose paxil, paroxetine Cmax and AUC0-inf increased disprop cr dose paxil.

cr dose paxil Ortionately with dose (as seen also with immediate-release formulations). Mean Cmax and AUC0-inf values at these doses were 2.0 cr dose paxil, 5.5 cr dose paxil, 9.0 cr dose paxil, and 12.5 ng mL cr dose paxil, and 121 cr dose paxil, 261 cr dose paxil, 338 cr dose paxil, and 540 ng& 183; hr. mL cr dose paxil, respectively. Tmax was observed typically between 6 and 10 hours post-dose cr dose paxil, reflecting a reduction in absorption rate compared with immediate-release formulations. The bioavailability of 25 mg PAXIL CR is not affected by food. Paroxetine distributes throughout the body cr dose paxil, including the CNS cr dose paxil, with only 1% remaining in the plasma. Approximately 95% and 93% of paroxetine is bound to plasma protein at 100 ng mL and 400 ng mL cr dose paxil, respectively. Under clinical conditions cr dose paxil, paroxetine concentrations would normally be less than 400 ng mL. Paroxetine does not alter the in vitro protein binding of phenytoin or warfarin. Metabolism and Excretion: The mean elimination half-life of paroxetine was 15 to 20 hours throughout a range of single doses of PAXIL CR (12.5 mg cr dose paxil, 25 mg cr dose paxil, 37.5 mg cr dose paxil, and 50 mg). During repeated administration of PAXIL CR (25 mg once daily) cr dose paxil, steady state was reached within 2 weeks (i.e. cr dose paxil, comparable to immediate-release formulations). In a repeat-dose study in which normal male and female subjects (n = 23) received PAXIL CR (25 mg daily) cr dose paxil, mean steady state Cmax cr dose paxil, Cmin cr dose paxil, and AUC0-24 values were 30 ng mL cr dose paxil, 20 ng mL cr dose paxil, and 550 ng& .

cr dose paxil Xetine concentrations would normally be less than 400 ng mL. Paroxetine does not alter the in vitro protein binding of phenytoin or warfarin. Metabolism and Excretion: The mean elimination half-life of paroxetine was 15 to 20 hours throughout a range of single doses of PAXIL CR (12.5 mg cr dose paxil, 25 mg cr dose paxil, 37.5 mg cr dose paxil, and 50 mg). During repeated administration of PAXIL CR (25 mg once daily) cr dose paxil, steady state was reached within 2 weeks (i.e. cr dose paxil, comparable to immediate-release formulations). In a repeat-dose study in which normal male and female subjects (n = 23) received PAXIL CR (25 mg daily) cr dose paxil, mean steady state Cmax cr dose paxil, Cmin cr dose paxil, and AUC0-24 values were 30 ng mL cr dose paxil, 20 ng mL cr dose paxil, and 550 ng& 1.

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