Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). FDA Safety Alerts for all medications. Available for Android and iOS devices. Narcolepsy Drug Doesn't Raise Odds for Birth Defects: Study Estimates of the background incidence rate for these serious skin reactions in the general population range between 1 to 2 cases per million-person years.There are no factors that are known to predict the risk of occurrence or the severity of rash associated with Modafinil tablets. The highest no-effect dose for embryofetal developmental toxicity in rats (200 mg/kg/day) was associated with a plasma arModafinil AUC less than that in humans at the RHD of Modafinil tablets.Modafinil administered orally to pregnant rabbits throughout organogenesis at doses of up to 100 mg/kg/day had no effect on embryofetal development; however, the doses used were too low to adequately assess the effects of Modafinil on embryofetal development. It is sparingly to slightly soluble in methanol and acetone.Modafinil tablets, USP contain 100 mg or 200 mg of Modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose.The mechanism(s) through which Modafinil promotes wakefulness is unknown.
You may report side effects to FDA at 1-800-FDA-1088.If you take a blood thinner (warfarin, Coumadin, Jantoven), you may need to have more frequent "INR" or prothrombin time tests. Xeloda can have long lasting effects on your body. There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions. Tell your doctor if a pregnancy occurs during treatment.It is not known whether capecitabine passes into breast milk or if it could harm a nursing baby. However, in a subsequent study of up to 480 mg/kg/day of Modafinil, no adverse effects on embryofetal development were observed. Therefore, consideration should be given to the use of lower doses and close monitoring in this population In patients with severe hepatic impairment, the dose of Modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function Modafinil tablets contain Modafinil, a Schedule IV controlled substance.In humans, Modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants. The primary measure of effectiveness was the change from baseline on the ESS at final visit. The trough concentration (CModafinil tablet is readily absorbed after oral administration, with peak plasma concentrations occurring at 2 to 4 hours. Patients should be cautioned about operating an automobile or other hazardous machinery until it is reasonably certain that Modafinil tablets therapy will not adversely affect their ability to engage in such activities.In Modafinil clinical studies, cardiovascular adverse reactions, including chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG occurred in three subjects in association with mitral valve prolapse or left ventricular hypertrophy. The absolute oral bioavailability was not determined due to the aqueous insolubility (<1 mg/mL) of Modafinil, which precluded intravenous administration. If you would like more information, talk with your doctor. Alternative or concomitant methods of contraception are recommended for patients taking steroidal contraceptives (e.g., ethinyl estradiol) when treated concomitantly with Modafinil tablets and for one month after discontinuation of Modafinil tablets treatment.Blood levels of cyclosporine may be reduced when used with Modafinil tablets. Modafinil tablets are not approved for use in pediatric patients for any indication Rare cases of serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide postmarketing experience. Two of the studies were flexible-dose studies (up to 425 mg/day), and the third was a fixed-dose study (340 mg/day for patients <30 kg and 425 mg/day for patients ≥30 kg).

Instead of the initial dose of 800 I felt the need for 2 other doses.

Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.Modafinil, USP is a wakefulness-promoting agent for oral administration. A total of 558 patients were randomized to receive Modafinil tablets 200 or 400 mg/day, or placebo. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Each test session was terminated after 20 minutes if no sleep occurred or 10 minutes after sleep onset. You may need frequent medical tests for a short time after you stop using this medicine.You must remain under the care of a doctor while you are taking Xeloda.Store Xeloda at room temperature away from moisture and heat. We comply with the HONcode standard for trustworthy health information - The child remained stable.

You should not take Xeloda if you are allergic to capecitabine or fluorouracil (Adrucil), or if you have:a metabolic disorder called DPD (dihydropyrimidine dehydrogenase) deficiency.To make sure Xeloda is safe for you, tell your doctor if you have any of these conditions:bleeding or blood clotting disorder such as hemophilia;if you take a blood thinner (warfarin, Coumadin, Jantoven).Use birth control to prevent pregnancy while you are taking Xeloda, whether you are a man or a woman.

Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness).Multi-organ hypersensitivity reactions, including at least one fatality in postmarketing experience, have occurred in close temporal association (median time to detection 13 days: range 4 to 33) to the initiation of Modafinil.Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening.