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NUVIGIL (ARMODAFINIL) TABLETS: PHARMACOKINETICS FOR SPECIAL POPULATIONS

Data specific to armodafinil in special populations are not available.

Age Effect

A slight decrease (~20%) in the oral clearance (CL/F) of modafinil was observed in a single dose study at 200 mg in 12 subjects with a mean age of 63 years (range 53 - 72 years), but the change was considered not likely to be clinically significant. In a multiple dose study (300 mg/day) in 12 patients with a mean age of 82 years (range 67 - 87 years), the mean levels of modafinil in plasma were approximately two times those historically obtained in matched younger subjects. Due to potential effects from the multiple concomitant medications with which most of the patients were being treated, the apparent difference in modafinil pharmacokinetics may not be attributable solely to the effects of aging. However, the results suggest that the clearance of modafinil may be reduced in the elderly.

Race Effect

The influence of race on the pharmacokinetics of modafinil has not been studied.

Gender Effect

Population pharmacokinetic analysis suggests no gender effect on the pharmacokinetics of armodafinil.

Renal Impairment

In a single dose 200 mg modafinil study, severe chronic renal failure (creatinine clearance <= 20 mL/min) did not significantly influence the pharmacokinetics of modafinil, but exposure to modafinil acid was increased 9-fold.

Hepatic Impairment

The pharmacokinetics and metabolism of modafinil were examined in patients with cirrhosis of the liver (6 men and 3 women). Three patients had stage B or B+ cirrhosis and 6 patients had stage C or C+ cirrhosis (per the Child-Pugh score criteria). Clinically 8 of 9 patients were icteric and all had ascites. In these patients, the oral clearance of modafinil was decreased by about 60% and the steady state concentration was doubled compared to normal patients. The dose of Armodafinil (Nuvigil) should be reduced in patients with severe hepatic impairment.

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