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NUVIGIL (ARMODAFINIL) TABLETS: DRUG INTERACTIONS

Potential Interactions with Drugs That Inhibit, Induce, or Are Metabolized by Cytochrome P450 Isoenzymes and Other Hepatic Enzymes

Due to the partial involvement of CYP3A enzymes in the metabolic elimination of armodafinil, coadministration of potent inducers of CYP3A4/5 (e.g., carbamazepine, phenobarbital, rifampin) or inhibitors of CYP3A4/5 (e.g., ketoconazole, erythromycin) could alter the plasma levels of armodafinil.

The Potential of Armodafinil (Nuvigil) tablets to Alter the Metabolism of Other Drugs by Enzyme Induction or Inhibition

Drugs Metabolized by CYP1A2

In vitro data demonstrated that armodafinil shows a weak inductive response for CYP1A2 and possibly CYP3A activities in a concentration related manner and demonstrated that CYP2C19 activity is reversibly inhibited by armodafinil. However, the effect on CYP1A2 activity was not observed clinically in an interaction study performed with caffeine.

Drugs Metabolized by CYP3A4/5 (e.g., cyclosporine, ethinyl estradiol, midazolam and triazolam)

Chronic administration of Nuvigil (Armodafinil) resulted in moderate induction of CYP3A activity. Hence, the effectiveness of drugs that are substrates for CYP3A enzymes (e.g., cyclosporine, ethinyl estradiol, midazolam and triazolam) may be reduced after initiation of concurrent treatment with Nuvigil. A 32% reduction in systemic exposure of oral midazolam was seen upon concomitant administration of armodafinil with midazolam. Dose adjustment may be required. Such effects (reduced concentrations) were also seen upon concomitant administration of modafinil with cyclosporine, ethinyl estradiol, and triazolam.

Drugs Metabolized by CYP2C19 (e.g., omeprazole, diazepam, phenytoin, and propranolol)

Administration of Armodafinil (Nuvigil) resulted in moderate inhibition of CYP2C19 activity. Hence, dosage reduction may be required for some drugs that are substrates for CYP2C19 (e.g., diazepam, phenytoin, and propranolol, omeprazole and clomipramine) when used concurrently with Nuvigil. A 40% increase in exposure was seen upon concomitant administration of armodafinil with omeprazole.

Interactions with CNS Active Drugs

Data specific to armodafinil drug-drug interaction potential with CNS active drugs are not available. However, the following available drug-drug interaction information on modafinil should be applicable to armodafinil.

Concomitant administration of modafinil with methylphenidate, or dextroamphetamine produced no significant alterations on the pharmacokinetic profile of modafinil or either stimulant, even though the absorption of modafinil was delayed for approximately one hour.

Concomitant modafinil or clomipramine did not alter the PK profile of either drug; however, one incident of increased levels of clomipramine and its active metabolite desmethylclomipramine was reported in a patient with narcolepsy during treatment with modafinil.

Data specific to armodafinil or modafinil drug-drug interaction potential with Monoamine Oxidase (MAO) inhibitors are not available. Therefore, caution should be used when concomitantly administering MAO inhibitors and Nuvigil (Armodafinil) tablets.

Interactions with Other Drugs

Data specific to armodafinil drug-drug interaction potential for additional other drugs are not available. However, the following available drug-drug interaction information on modafinil should be applicable to Armodafinil (Nuvigil) tablets.

Warfarin

Concomitant administration of modafinil with warfarin did not produce significant changes in the pharmacokinetic profiles of R- and S-warfarin. However, since only a single dose of warfarin was tested in this study, a pharmacodynamic interaction cannot be ruled out. Therefore, more frequent monitoring of prothrombin times/INR should be considered whenever Nuvigil is coadministered with warfarin.

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