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NUVIGIL (ARMODAFINIL) TABLETS: PHARMACOKINETICS

The active component of Nuvigil is armodafinil, which is the longer-lived enantiomer of modafinil. Nuvigil exhibits linear time-independent kinetics following single and multiple oral dose administration. Increase in systemic exposure is proportional over the dose range of 50 to 400 mg. No time-dependent change in kinetics was observed through 12 weeks of dosing. Apparent steady state for Nuvigil was reached within 7 days of dosing. At steady state, the systemic exposure for Nuvigil (Armodafinil) tablets is 1.8 times the exposure observed after a single dose. The concentration-time profiles of the pure R-enantiomer following administration of 50 mg Nuvigil or 100 mg Provigil (Modafinil) are nearly superimposable.

Absorption

Nuvigil is readily absorbed after oral administration. The absolute oral bioavailability was not determined due to the aqueous insolubility of armodafinil, which precluded intravenous administration. Peak plasma concentrations are attained at approximately 2 hours in the fasted state. Food effect on the overall bioavailability of Armodafinil (Nuvigil) tablets is considered minimal; however, time to reach peak concentration (tmax) may be delayed by approximately 2-4 hours in the fed state. Since the delay in tmax is also associated with elevated plasma levels later in time, food can potentially affect the onset and time course of pharmacologic action for Nuvigil.

Distribution

Nuvigil (Armodafinil) has an apparent volume of distribution of approximately 42 L. Data specific to armodafinil protein binding are not available. However, modafinil is moderately bound to plasma protein (approximately 60%), mainly to albumin. The potential for interactions of Nuvigil with highly protein-bound drugs is considered to be minimal.

Metabolism

In vitro and in vivo data show that armodafinil undergoes hydrolytic deamidation, S-oxidation, and aromatic ring hydroxylation, with subsequent glucuronide conjugation of the hydroxylated products. Amide hydrolysis is the single most prominent metabolic pathway, with sulfone formation by cytochrome P450 (CYP) 3A4/5 being next in importance. The other oxidative products are formed too slowly in vitro to enable identification of the enzyme(s) responsible.

Only two metabolites reach appreciable concentrations in plasma (i.e., R-modafinil acid and modafinil sulfone).

Data specific to Armodafinil (Nuvigil) disposition are not available. However, modafinil is mainly eliminated via metabolism, predominantly in the liver, with less than 10% of the parent compound excreted in the urine. A total of 81% of the administered radioactivity was recovered in 11 days post-dose, predominantly in the urine (80% vs. 1.0% in the feces).

Elimination

After oral administration of Nuvigil, armodafinil exhibits an apparent monoexponential decline from the peak plasma concentration. The apparent terminal t. is approximately 15 hours. The oral clearance of Nuvigil (Armodafinil) tablets is approximately 33 mL/min.

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