MODAFINIL TABLETS USP 200 MG from GenLabs represents a specialized pharmaceutical agent classified as a eugeroic, or wakefulness-promoting medication. It is distinctly different from traditional stimulants like amphetamines. Produced under stringent Good Manufacturing Practice (GMP) standards, this 30-tablet package contains a pure, precisely dosed formulation intended for the management of specific sleep-wake disorders. Each tablet delivers 200 mg of Modafinil, USP grade, ensuring consistent potency, quality, and dissolution as per the United States Pharmacopeia monograph. This product description serves as a detailed, professional resource for understanding this potent medication, which is available by prescription only.
GenLabs Modafinil 200 mg is clinically approved for the treatment of excessive daytime sleepiness (EDS) associated with the following diagnosed medical conditions:
Narcolepsy: A chronic neurological disorder characterized by the brain's inability to regulate sleep-wake cycles normally, leading to overwhelming daytime drowsiness and sudden, uncontrollable sleep attacks.
Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): For patients with diagnosed OSAHS who continue to experience significant EDS despite primary treatment with Continuous Positive Airway Pressure (CPAP) therapy. It is crucial to understand that Modafinil is an adjunctive therapy and does not treat the underlying airway obstruction.
Shift Work Sleep Disorder (SWSD): Specifically indicated to improve wakefulness in individuals with work schedules that overlap the typical sleep period (e.g., night shifts, rotating shifts), leading to insomnia when trying to sleep and excessive sleepiness when needing to be awake and alert.
Modafinil's exact mechanism is complex and not fully understood, but it is known to differ fundamentally from stimulants like amphetamines. Its wakefulness-promoting effects are believed to stem from selective action on key neurotransmitter systems in the brain's hypothalamus and other areas regulating the sleep-wake cycle:
Dopamine Reuptake Inhibition: Modafinil increases extracellular dopamine by binding to the dopamine transporter (DAT), inhibiting dopamine reuptake into neurons. This is considered a primary mechanism for promoting wakefulness and alertness.
Interaction with Orexin/Hypocretin and Histamine Systems: It may also stimulate wakefulness by activating orexin-producing neurons and increasing histamine release in the brain, both critical pathways for maintaining cortical arousal.
Selective Action: Unlike traditional stimulants, Modafinil appears to have a more targeted effect on sleep-regulating centers without causing widespread generalized stimulation of the sympathetic nervous system. This profile often results in a lower incidence of side effects like hypertension, tachycardia, and euphoria.
Dosage: The recommended dose for most indications is 200 mg taken orally once daily. For Shift Work Sleep Disorder, the dose should be taken approximately one hour prior to the start of the work shift.
Administration: Swallow the tablet whole with a full glass of water, with or without food. Taking it in the morning is standard for narcolepsy and OSAHS to avoid interference with nighttime sleep.
Adherence: It is imperative to use this medication exactly as prescribed by your healthcare provider. Do not alter the dose or frequency without medical consultation.
Prescription-Only Medication: MODAFINIL TABLETS USP 200 MG is a prescription drug. A thorough medical evaluation is required to diagnose an appropriate condition and rule out contraindications.
Not for General Fatigue or Recreational Use: This medication is not approved for use by individuals without a diagnosed sleep disorder, to combat general fatigue, or as a "cognitive enhancer" in healthy individuals.
Serious Skin Reactions: Although rare, Modafinil has been associated with serious dermatological reactions, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS). Discontinue use immediately and seek emergency medical attention at the first sign of rash, blistering, peeling skin, mouth sores, or fever.
Psychiatric Effects: Modafinil may induce psychiatric symptoms such as anxiety, agitation, hallucinations, mania, or suicidal ideation, particularly in patients with a pre-existing history of psychosis, mania, or depression. Patients should be monitored for the emergence of these symptoms.
Cardiovascular Considerations: Patients with a history of left ventricular hypertrophy, mitral valve prolapse, or other significant heart conditions should use Modafinil with caution. Blood pressure and heart rate should be monitored regularly during therapy.
Pregnancy and Contraception: Modafinil may reduce the effectiveness of hormonal contraceptives (e.g., birth control pills, patches, implants). Alternative or additional methods of contraception are required during therapy and for one month after discontinuation. Use during pregnancy is not recommended unless clearly necessary.
Dependence Potential: While the potential for abuse and dependence is considered lower than with schedule II stimulants, Modafinil is a Schedule IV controlled substance. A history of substance abuse increases the risk of misuse.
Patients may experience side effects, which are often dose-related. Common side effects include:
Headache
Nausea
Nervousness
Dizziness
Insomnia
Dry mouth
Diarrhea or indigestion
Less common but more serious side effects require immediate medical attention:
Signs of allergic reaction (hives, difficulty breathing, swelling)
Chest pain, irregular heartbeat
Severe skin rash
Depression, anxiety, hallucinations
Signs of infection (fever, chills, sore throat)
Inform your doctor of all medications you are taking. Significant interactions include:
Hormonal Contraceptives: Reduced efficacy, as noted.
Cytochrome P450 Enzymes: Modafinil is both a substrate and an inducer of CYP3A4/5. It may reduce plasma concentrations of drugs metabolized by this enzyme (e.g., some antifungals, antivirals, cyclosporine). Conversely, strong CYP3A4 inducers (e.g., carbamazepine) or inhibitors may affect Modafinil levels.
Warfarin: Closer monitoring of prothrombin time/INR is recommended, as Modafinil may affect its metabolism.
Store GenLabs Modafinil Tablets in their original packaging at a controlled room temperature, between 20°C to 25°C (68°F to 77°F). Protect from light, excess moisture, and heat. Keep out of reach of children and pets. Properly dispose of any expired or unused medication through a drug take-back program.
GenLabs is a pharmaceutical company committed to developing and manufacturing high-quality, bioequivalent medications. The "USP" designation on this product signifies that the Modafinil active ingredient and the finished tablet meet the rigorous public standards for identity, strength, quality, and purity set forth by the United States Pharmacopeia, an independent, scientific nonprofit organization.
MODAFINIL TABLETS USP 200 MG – 30 TABLETS from GenLabs is a potent, targeted pharmacological agent designed for a narrow and specific range of sleep-wake disorders. It offers a distinct mechanism of action to promote wakefulness, often with a more favorable side effect profile than traditional stimulants. However, its use comes with significant responsibilities, including awareness of serious potential risks, strict adherence to prescription guidelines, and ongoing medical supervision.
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