Posted May 18th, 2011 by admin
Modiodal and Modafinil Side Effects
Taken from http://en.wikipedia.org/wiki/Modafinil#Side_effects
In 2007, the FDA ordered Cephalon to modify the Provigil leaflet in bold-face print of several serious and potentially fatal conditions attributed to modafinil use, including TEN, DRESS syndrome, and Stevens-Johnson Syndrome (SJS).
The long term safety and effectiveness of modafinil has not been determined.[72]
Modafinil may have an adverse effect on hormonal contraceptives, lasting for a month after cessation of dosage.[73]
Toxicity
Modafinil toxicity levels vary widely among species. In mice and rats, the median lethal dose (LD50) of modafinil is approximately or slightly greater than 1250 mg/kg. Oral LD50 values reported for rats range from 1000 mg/kg to 3400 mg/kg. Intravenous LD50 for dogs is 300 mg/kg. Clinical trials on humans involving taking up to 1200 mg/day for 7 to 21 days and known incidents of acute one-time overdoses up to 4500 mg did not appear to cause life-threatening effects, although a number of adverse experiences were observed, including excitation or agitation, insomnia, anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, sleep disturbances, nausea, and diarrhea.[74] As of 2004, FDA is not aware of any fatal overdoses involving modafinil alone (as opposed to multiple drugs, including modafinil).[74] Consequently, oral LD50 of modafinil in humans is not known exactly. However, it appears to be higher than oral LD50 of caffeine. Bastuji and Jouvet (1988) describe a suicide attempt using 4500 mg of modafinil; the patient survived with no long-term effects but temporary nervousness, nausea, and insomnia.[75] A similar incident involving a suicide attempt by a 15 year old female using 5000 mg of the drug (102 mg/kg) was observed in 2008 in Israel; the patient experienced severe headache, nausea, abdominal pain, dyskinesia, insomnia, and mild tachycardia, but no cardiovascular distress or abnormalities in liver and kidney function, and recovered in a few days without any apparent long-term effects.[76]
Severe adverse reactions
Modafinil may induce severe dermatologic reactions requiring hospitalization. From the date of initial marketing, December 1998, to January 30, 2007, FDA received six cases of severe cutaneous adverse reactions associated with modafinil, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) involving adult and pediatric patients. The FDA issued a relevant alert. In the same alert, the FDA also noted that angioedema and multi-organ hypersensitivity reactions have also been reported in postmarketing experience
Tags: modafinil, modiodal, side effects
Posted May 18th, 2011 by admin
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Posted May 18th, 2011 by admin
Modiodal Medication Information:
Modiodal is an Analeptic drug, a Central Nervous System (CNS) Stimulant medication. Modiodal increases the release of monoamines, specifically the catecholamines norepinephrine and dopamine, from the synaptic terminals. Modiodal prescription generic name is Modafinil.
Doctors may prescribe Modiodal for the treatment of:
- Schizophrenia
- Shift Work Sleep Disorder
- ADHD
- Excessive Daytime Sleepiness
- Narcolepsy,
- Maintain Alertness,
- Disease-related Fatigue,
- Obstructive Sleep Apnea,
- Parkinson’s Disease and
- Attention-Deficit Hyperactivity Disorder.
Modiodal medicine is available in 200mg Tablets and 100mg Tablets.
PHARMACOKINETICS AND PHARMACODYNAMICS IN HUMAN MODIODAL neurostimulator is a sponsor of the vigil, plus it has a protective effect of cortical neurons from degeneration induced by glutamate.
MODIODAL (modafinil) is not chemically related to the central nervous system stimulants (CNS), such as methylphenidate and amphetamine.
CONTRAINDICATIONS: MODIODAL is contraindicated in patients known to have hypersensitivity to modafinil.
Allergic reactions: Patients should be instructed to notify their physician if they develop a rash, hives, or a related allergic phenomenon.
Pediatric use have not been established safety and efficacy in individuals under 5 years old.
Geriatric Use: There are no established safety and efficacy in people over age 65. Experience in a limited number of patients over 65 years in phase 1 clinical trials, 2 and 3 made in the United States showed a comparable incidence of adverse effects with other age groups.
PRECAUTIONS OR RESTRICTIONS OF USE DURING PREGNANCY OR BREASTFEEDING:
Pregnancy: The FDA classification of the product is in category B. There is a lack of adequate clinical studies in pregnant women. In addition, teratogenic and neonatal combined studies in rats, including behavioral assessments have revealed no evidence of effects on the neonate. There have been no adequate and well controlled studies in pregnant women.
Other prescription names for medications containing Modafinil (Modiodal main ingridient) are: Alertec, Modalert, Provigil, Generic Modalert, Vigicer, Generic Provigil and Modafinil.
Posted May 17th, 2011 by admin
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