[PDF] ACCUTANE (isotretinoin capsules) - FDA
If pregnancy does occur during treatment of a female patient who is taking Accutane, Accutane must be discontinued immediately and she should be referred to
[PDF] Accutane (isotretinoin) Capsules Label - FDA
20 jui 2002 · I know the risk and severity of fetal injury/birth defects from Accutane • I know how to diagnose and treat the various presentations of acne
[PDF] Medication Guide - FDA
Because Accutane can cause birth defects, Accutane is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program
[PDF] Absorica (isotretinoin) Capsules - FDA
Only FDA- approved isotretinoin products must be distributed, prescribed, dispensed, and used Required components of the iPLEDGE Program are: • Absorica™
[PDF] Label (PDF) - FDA
15 fév 2002 · WARNINGS: Psychiatric Disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide
[PDF] isotretinoin - FDA
30 oct 2001 · I know the risk and severity of fetal injury/birth defects from Accutane will make available urine pregnancy test kits for female Accutane
[PDF] CPY Document - FDA
APPLICATION NUMBER: 18-662 / S-038 Trade Name: Accutane Generic Name : (isotretinoin) Sponsor: Hoffman La Roche Inc Approval Date: May 1, 2000
[PDF] Draft Guidance on Isotretinoin Active Ingredient - FDA
If you want to discuss an alternative approach, contact the Office of Generic Drugs Active Ingredient: Isotretinoin Dosage Form; Route: Capsule; oral
[PDF] Prescriber Contraception Counseling Guide - FDA
The iPLEDGE Program Prescriber Contraception Counseling Guide Helping patients prevent pregnancy Isotretinoin must not be used by female patients who
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