Medication info
Provigil Tablet 200 mg (Modafinil)

Provigil Tablet 200 mg (Modafinil)

Prescription medicationTabletOral
Ingredient · strength
Modafinil›200mg / 1 tablet
Manufacturer / importer
JW Pharmaceutical Corporation
Appearance
White or nearly white oblong tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200200234 · Approved 2002.05.02 · Insurance code 644904330

Summary

Main use
Improvement of excessive sleepiness associated with narcolepsy in adults
Who takes it
Adults
Adult dose
Adults: Take 200mg orally once daily in the morning. (Although 400mg once daily was well tolerated, there is no clear evidence that it is more effective than 200mg.) The dose should be adjusted when this medicine is used concomitantly with CYP3A4 substrate drugs such as triazolam and cyclosporine. Drugs primarily eliminated through CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (or via CYP2C9), and S-mephenytoin, have prolonged elimination when coadministered with this medicine; therefore, reduce their doses and monitor for toxicity. In patients with severe hepatic impairment, reduce the dose to 1/2 of the usual adult dose (100mg/day).

Ingredients

Manufacturer
JW Pharmaceutical Corporation

Efficacy & effects

Improvement of excessive sleepiness associated with narcolepsy in adults

  • Narcolepsy
  • excessive sleepiness
View approved original text

This medication is used to improve excessive sleepiness related to narcolepsy in adults.

How to take

Adult dose

Adults: Take 200mg orally once daily in the morning. (Although 400mg once daily was well tolerated, there is no clear evidence that it is more effective than 200mg.) The dose should be adjusted when this medicine is used concomitantly with CYP3A4 substrate drugs such as triazolam and cyclosporine. Drugs primarily eliminated through CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (or via CYP2C9), and S-mephenytoin, have prolonged elimination when coadministered with this medicine; therefore, reduce their doses and monitor for toxicity. In patients with severe hepatic impairment, reduce the dose to 1/2 of the usual adult dose (100mg/day).

Precautions

This medication is used for patients with severe sleepiness, but in some patients, sleepiness may not return to normal. Therefore, the level of sleepiness should be checked frequently during the use of this medication, and it is advisable to avoid driving or operating dangerous machinery whenever possible. Serious skin rashes may occur while taking this medication, so if a rash develops, it should be stopped immediately and the doctor consulted. It is especially recommended not to use this medication in children under 18 years old. This medication can cause serious allergic reactions, such as angioedema or anaphylaxis, so immediate treatment should be sought if swelling of the face or neck or difficulty breathing occurs. A serious systemic reaction called multi-organ hypersensitivity may rarely occur, so if symptoms such as fever, rash, liver dysfunction, or blood abnormalities occur, the medication should be discontinued. Because psychiatric symptoms may worsen, patients with a history of depression, anxiety, or psychosis should consult a specialist before taking the medication, and it should be stopped immediately if symptoms occur. Patients with cardiovascular disease should have an electrocardiogram before taking the medication, and blood pressure and heart rate should be monitored regularly, discontinuing use if hypertension or arrhythmia worsens. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should develop an appropriate contraceptive plan before taking it. This medication can interact with several drugs, so if other medications are being taken, it should be reported to a doctor or pharmacist. In case of overdose, symptoms such as insomnia, mental confusion, nausea, and heart abnormalities may appear, so immediate medical attention is necessary. Additionally, this medication has potential for dependency or abuse, so it should be taken exactly as prescribed by a doctor, without arbitrarily increasing or decreasing the dose. When storing, keep it out of reach of children, avoid direct sunlight, and store it in a cool, dry place.

Side effects

Headache, nervousness, insomnia, anxiety, depression, abnormal thoughts, mental confusion, dizziness, drowsiness, sensory disturbances, sleep disorders, emotional instability, decreased libido, hostility, depersonalization, personality disorders, abnormal dreams, restlessness, aggression, suicidal thoughts, motor abnormalities, increased muscle tone, excessive movement, amnesia, migraine, tremors, vertigo, CNS excitation, perceptual decline, cooperativeness issues, speech disorders, taste disturbances, hallucinations, mania, psychosis, delusions, abdominal pain, nausea, dry mouth, diarrhea, indigestion, constipation, bloating, reflux, vomiting, speech disorders, glossitis, oral ulcers, tachycardia, palpitations, vasodilation, extra systoles, arrhythmia, bradycardia, hypertension, hypotension, dyspnea, increased cough, asthma, epistaxis, rhinitis, pharyngitis, sinusitis, urinary abnormalities, frequent urination, menstrual disorders, blurred vision, visual disturbances, dry eyes, sweating, rash, acne, itching, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, loss of appetite, hypercholesterolemia, hyperglycemia, diabetes, increased appetite, eosinophilia, leukopenia, mild allergic reactions, angioedema, urticaria, hypersensitivity reactions, back pain, neck pain, myalgia, myasthenia, leg cramps, arthralgia, spasms, weakness, chest pain, peripheral edema, thirst, abnormal liver function tests, abnormal ECG, weight gain, weight loss, flu-like syndrome, chills, neck stiffness, rhinitis, pharyngitis, lung disease, asthma, epistaxis, nausea, diarrhea, indigestion, dry mouth, loss of appetite, constipation, liver dysfunction, bloating, oral ulcers, thirst, nervousness, insomnia, anxiety, dizziness, depression, sensory disturbances, drowsiness, muscle tension, motor abnormalities, excessive movement, restlessness, mental confusion, emotional instability, tremors, vertigo, hypertension, tachycardia, palpitations, vasodilation, eosinophilia, amblyopia, visual disturbances, eye pain, taste disturbances, edema, sweating, herpes simplex, urinary abnormalities, hematuria, pyuria

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is best to store it at room temperature, away from extreme heat or cold.

Appearance and packaging

Appearance

White or nearly white oblong tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.