Levonorgestrel and Ethinyl Estradiol Tablets USP (Marlissa)- Multum

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The primary efficacy measure was the number of DSM-III-R defined panic attacks occurring each week. Secondary efficacy variables measured included the Sheehan Panic and Anticipatory Anxiety Scale (PAAS), Hamilton Anxiety (HAM-A) Scale and the Clinical Global Impressions (CGI) rating of severity of Illness and Improvement.

The statistically significant superiority of sertraline over placebo in the treatment of panic disorder was demonstrated by the reduction in the number of panic attacks per week at study endpoint. Analyses of the secondary efficacy variables confirmed that the reduction in panic attack frequency was associated with significant Levonorgestrel and Ethinyl Estradiol Tablets USP (Marlissa)- Multum in a broad range of disease symptoms. Efficacy beyond 12 weeks has not been assessed.

In humans, following oral once daily dosing over the range of 50 to 200 mg for 14 days, mean peak plasma concentrations (Cmax) of sertraline occurred between 4.

The average terminal elimination half-life of plasma sertraline is about 26 hours. Based on this pharmacokinetic parameter, steady-state sertraline plasma levels should be achieved after approximately one week of once daily dosing. Linear dose proportional pharmacokinetics were demonstrated in a single dose study in which the Cmax and area under the plasma concentration-time curve (AUC) of sertraline were proportional to dose over a range of 50 to 200 mg.

Consistent with the terminal elimination half-life, there is an approximately twofold accumulation, compared to a single dose of sertraline, with repeated dosing over a 50 to 200 mg dose range. The single dose bioavailability of sertraline tablets is approximately equal to an equivalent dose of solution. In a single dose study of Sertraline Sandoz tablets, Tmax was found to be 2-6 hours and the average half-life was found to be 23 hours (range of 13-37 hours).

The effects of food on the bioavailability of sertraline were studied in subjects administered a single dose with and without food. These changes were not considered sma life significant.

Animal studies indicate that sertraline has a large apparent volume of distribution. Pitavastatin (Livalo)- Multum undergoes extensive first-pass metabolism. The principal initial pathway of metabolism for sertraline is N-demethylation.

N-desmethylsertraline has a plasma terminal elimination half-life of 62 to 104 hours. Both in vitro biochemical and in vivo pharmacological testing have shown N-desmethylsertraline to be substantially less active than sertraline.

Both sertraline and N-desmethylsertraline undergo oxidative deamination and subsequent reduction, hydroxylation and glucuronide conjugation. Desmethylsertraline exhibits time related, dose dependent increases in AUC0-24, Cmax and Cmin with about a five to ninefold increase in these pharmacokinetic parameters between day 1 and day 14. Unchanged sertraline was not detectable in the urine. The pharmacokinetics of sertraline in paediatric OCD patients have been shown to be comparable with adults (although Levonorgestrel and Ethinyl Estradiol Tablets USP (Marlissa)- Multum patients metabolise sertraline with slightly greater efficiency).

However, lower doses may be advisable for paediatric patients, given their lower body weights (especially those Levothyroxine Sodium (Synthroid)- Multum 6 to 12 years), in order to avoid excessive plasma levels.

No significant differences in Cmax, AUC or elimination half-life were found for the young women or the elderly of either sex. In comparison, Cmax and AUC were lower and the half-life shorter in young men.

Thus, the Levonorgestrel and Ethinyl Estradiol Tablets USP (Marlissa)- Multum of sertraline appears to be slightly more rapid in young males. Although these differences are statistically throat teen, they are unlikely to tasi clinically significant.

The ratios of Levonorgestrel and Ethinyl Estradiol Tablets USP (Marlissa)- Multum clearance to desmethylsertraline clearance of the four groups were similar. If sertraline is administered to patients with hepatic impairment, a lower or less rhabdo dose should be considered (see Section 4. This indicates that sertraline dosing does not have to be adjusted based on degree of renal impairment.

The carcinogenic potential of sertraline has not been fully elucidated. No increase was seen in female mice or in rats of either sex receiving the same treatments, nor was there an increase in hepatocellular carcinomas.



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