Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MODAFINIL (UNII: R3UK8X3U3D) (MODAFINIL - UNII:R3UK8X3U3D)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness. Modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions (5.1, 5.2, 5.3)] . Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies of modafinil in pregnant women. Intrauterine growth restriction and spontaneous abortion have been reported in association with mo
Modafinil Tablets USP, 200 mg are white to off-white, capsule-shaped, uncoated tablets, debossed with ‘4’ & ‘2’ separated by score line on one side and ‘J’ on the other side. Bottles of 30 NDC 71205-544-30 Bottles of 60 NDC 71205-544-60 Bottles of 90 NDC 71205-544-90 Store at 20o to 25o C (68o to 77o F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
MODAFINIL- MODAFINIL TABLET Proficient Rx LP ---------- MEDICATION GUIDE Modafinil Tablets, USP CIV (moe daf' i nil) Read this Medication Guide before you start taking modafinil tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. What is the most important information I should know about modafinil tablets? Modafinil tablets may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells. Any of these may need to be treated in a hospital and may be life-threatening. Stop taking modafinil tablets and call your doctor right away or get emergency help if you have any of these symptoms: • skin rash, hives, sores in your mouth, or your skin blisters and peels • swelling of your face, eyes, lips, tongue, or throat • trouble swallowing or breathing • fever, shortness of breath, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine. 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 not approved for use in children for any medical condition. It is not known if modafinil tablets are safe or effective in children under 17 years of age. What are modafinil tablets? 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: • narcolepsy • obstructive sleep apnea (OSA). Modafinil tablets are used to treat excessive sleepiness, but not the obstruction or medical condition that is causing OSA. You should talk with your doctor about treatments for OSA before you start taking modafinil tablets and during treatment with modafinil tablets. Modafinil tablets do not take the place of treatments that your doctor has prescribed for O Belgenin tamamını okuyun
MODAFINIL- MODAFINIL TABLET PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MODAFINIL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MODAFINIL TABLETS. MODAFINIL TABLETS, FOR ORAL USE, CIV INITIAL U.S. APPROVAL: 1998 INDICATIONS AND USAGE Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). (1) Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. DOSAGE AND ADMINISTRATION The recommended dosage of modafinil tablets for each indication is as follows: • • • • DOSAGE FORMS AND STRENGTHS Tablets: 100 mg and 200 mg. (3) CONTRAINDICATIONS Modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil. (4) WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS MOST COMMON ADVERSE REACTIONS (≥5%): HEADACHE, NAUSEA, NERVOUSNESS, RHINITIS, DIARRHEA, BACK PAIN, ANXIETY, INSOMNIA, DIZZINESS, AND DYSPEPSIA. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT RISING HEALTH, LLC AT 1-833-395-6928 OR FDA AT 1-800-FDA- 1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. (8.1) SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE. REVISED: 6/2023 Narcolepsy or OSA: 200 mg once a day in the morning. (2.1) SWD: 200 mg once a day, taken approximately one hour prior to start of the work shift. (2.2) Severe Hepatic Impairment: reduce dose to half the recommended dose. (2.3, 12.3) Geriatric Patients: consider lower dose. (2.4, 12.3) Serious Rash, including Stevens-Johnson syndrome: Discontinue modafinil at the first sign of rash, unless the rash is clearly not drug-related. (5.1) Angioedema and Anaphylaxis Reactions: If suspected, discontinue modafin Belgenin tamamını okuyun