Jun 30 / 2021
Nuvigil specific populations
Clinical studies of Generic Nuvigil.
In some clinical studies a normal and systematic exposure to armodafinil was observed to be higher, approximately 15 % in elderly persons, those who are 65 and older. 12% exposure was noticed in those who were from 18 to 45 years old. As for gender, pharmacokinetic analysis tells that there is not specific reaction of it on armodafinil. The influence of race hasn’t yet been studied.
In Hepatic Impairment the dose must be decreased, especially in those patients who suffer from severe stage of such a diagnosis. As for nursing mothers it is yet not studied whether armodafinil is released into human milk. It is known that many drugs are excreted to human milk, that’s why there should be a caution toward the fact if to prescribe such a woman a Generic Nuvigil or not. It is not yet studied how the medication can influence on children. Its safety and influence has not yet been registered in pediatric patients.
As for geriatric use, it is recommended to give lower doses to elderly people and monitor them during a period of drug taking. It is advised to eliminate the dose because of age in such patients. In Renal Impairment there is no yet concrete information which can state about the dosing safety efficacy in those patients who have severe stage of the disease. Nuvigil is considered to be the pregnancy category C drug.
There are no yet concrete information about the way armodafinil can influence on pregnant women and their fetus. Some studies report about spontaneous abortion and intrauterine growth restriction to the connection of modafinil and armodafinil. There were conducted the studies on some pregnant rats and rabbits who were given modafinil and armodafinil. These animals developed toxicity. That is why it is recommended to use and buy Nuvigil when you are pregnant only when there are more benefits and they outweigh all the disadvantages. When the rats were given armodafinil orally throughout organogenesis there was observed increased incidences of fetal internal and skeletal declinations. The low fetal body weight at its highest dosage was also noticed.
The highest dosage which didn’t bring any effect in rats for embryofetal developmental toxicity was 200 mg per 1 kg per one day and it was closely associated with plasma armodafinil exposure (AUC). It is less than in people, where the highest recommended dose of Nuvigil is 250 mg a day. There is even Pregnancy Registry which was created in order to gather all the women who were taking Nuvigil during the period of pregnancy and receive as much useful information from this as possible.