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The child remained stable. The reporting rate of TEN and SJS associated with Modafinil use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate. Flickr photos, groups, and tags related to the "modafinil" Flickr tag.
In addition, several intentional acute overdoses occurred; the two largest being 4500 mg and 4000 mg taken by two subjects participating in foreign depression studies. The absolute oral bioavailability was not determined due to the aqueous insolubility (<1 mg/mL) of Modafinil, which precluded intravenous administration. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Symptoms most often accompanying Modafinil tablets overdose, alone or in combination with other drugs have included insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, agitation, anxiety, excitation, and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.Cases of accidental ingestion/overdose have been reported in children as young as 11 months of age. No differences were apparent in alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, or total bilirubin.The following adverse reactions have been identified during post approval use of Modafinil tablets.
Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine. This information does not take the place of talking with your doctor about your medical condition or treatment.If you have a severe rash with Modafinil tablets, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.Modafinil tablets are a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:Modafinil tablets will not cure these sleep disorders. However, a retrospective analysis of the use of antihypertensive medication in these studies showed that a greater proportion of patients on Modafinil tablets required new or increased use of antihypertensive medications (2.4%) compared to patients on placebo (0.7%).
Modafinil tablets may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. Your doctor or pharmacist will tell you if it is safe to take Modafinil tablets and other medicines together. 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. Other observed high-dose effects in clinical studies have included anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, sleep disturbances, nausea, diarrhea, and decreased prothrombin time.From postmarketing experience, there have been reports of fatal overdoses involving Modafinil alone or in combination with other drugs.
Therefore, before using this product, tell your doctor or pharmacist of all the products you use. The MSLT, an objective polysomnographic assessment of the patient’s ability to fall asleep in an unstimulating environment, measured latency (in minutes) to sleep onset averaged over 4 test sessions at 2-hour intervals. If you would like more information, talk with your doctor. The adverse reaction profile was similar across these studies.Table 1 presents the adverse reactions that occurred at a rate of 1% or more and were more frequent in Modafinil tablets-treated patients than in placebo-treated patients in the placebo-controlled clinical trials. Increased monitoring of heart rate and blood pressure may be appropriate in patients on Modafinil tablets.
Adverse Reactions in Pooled Placebo-Controlled Trials* in Narcolepsy, OSA, and SWDAdverse Reactions Resulting in Discontinuation of TreatmentEffects of Modafinil Tablets on CYP3A4/5 SubstratesPotential Interactions with Drugs That Inhibit, Induce, or Are Metabolized by Cytochrome P450 Isoenzymes and Other Hepatic EnzymesThe Potential of Modafinil tablets to Alter the Metabolism of Other Drugs by Enzyme Induction or InhibitionTable 2. However, isolated cases have been reported after prolonged treatment (e.g., 3 months).
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