In vitro metabolism studies have demonstrated that several CYP enzymes are involved in the metabolism of isotretinoin to 4-oxo-isotretinoin and tretinoin. This test should ensure the patient is not pregnant when she starts treatment with isotretinoin.Follow-up visits should be arranged at regular intervals, ideally monthly. Allergic cutaneous reactions are reported infrequently. Contraception should be used for at least 1 month prior to starting treatment, throughout treatment and continue for at least 1 month after stopping treatment with isotretinoin, even in patients with amenorrhea. • She has severe acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic anti-bacterials and topical therapy (see section 4.1”Therapeutic indications“). Dry eyes can be helped by the application of a lubricating eye ointment or by the application of tear replacement therapy. Even experimental animals in a poor general state had largely recovered within 1-2 weeks.Like other vitamin A derivatives, isotretinoin has been shown in animal experiments to be teratogenic and embryotoxic.Due to the teratogenic potential of isotretinoin there are therapeutic consequences for the administration to women of a childbearing age (see section 4.3, section 4.4, and section 4.6).Isotretinoin has not been shown to be mutagenic in Karion 83 containing sorbitol, mannitol, hydrogenated hydrolysed starch; Store in the original package and keep blister in the outer carton in order to protect from moisture and light.Duplex (PVC/PVDC)-aluminium blister packs containing 20, 30, 50 or 100 capsulesReturn any unused Roaccutane capsules to the Pharmacist.Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TWTo bookmark a medicine you must sign up and log in.To view the changes to a medicine you must sign up and log in. Because the onset in some patients was sudden, patients should be advised of this potential problem and warned to be cautious when driving or operating machines.Drowsiness, dizziness and visual disturbances have been reported very rarely. When suggestions are available use up and down arrows to review and ENTER to select. The exact mechanism of action of isotretinoin has not yet been elucidated in detail, but it has been established that the improvement observed in the clinical picture of severe acne is associated with suppression of sebaceous gland activity and a histologically demonstrated reduction in the size of the sebaceous glands. It is characterized by severe cyst-like spots as well as more normal acne showing up in places you might not have seen it … Where indicated, follow-up pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.One month after stopping treatment, women should undergo a final pregnancy test.For women of childbearing potential, the prescription duration of Roaccutane should ideally be limited to 30 days in order to support regular follow up, including pregnancy testing and monitoring. Therefore, concomitant treatment with tetracyclines must be avoided (see section 4.3 and section 4.4).Concurrent administration of isotretinoin with topical keratolytic or exfoliative anti-acne agents should be avoided as local irritation may increase (see section 4.4).The foetal malformations associated with exposure to isotretinoin include central nervous system abnormalities (hydrocephalus, cerebellar malformation/abnormalities, microcephaly), facial dysmorphia, cleft palate, external ear abnormalities (absence of external ear, small or absent external auditory canals), eye abnormalities (microphthalmia), cardiovascular abnormalities (conotruncal malformations such as tetralogy of Fallot, transposition of great vessels, septal defects), thymus gland abnormality and parathyroid gland abnormalities. The major metabolite is 4-oxo-isotretinoin with plasma concentrations at steady state, that are 2.5 times higher than those of the parent compound. The dose should then be increased up to 1 mg/kg/day or until the patient is receiving the maximum tolerated dose (see section 4.4).In patients who show severe intolerance to the recommended dose, treatment may be continued at a lower dose with the consequences of a longer therapy duration and a higher risk of relapse. He agreed, so what I did was slowly upping the dose like: 1st week 20mg 3x per week. 20 mg accutane and initial breakout. The duration of treatment will depend on the individual daily dose. Roaccutane is a powerful human teratogen inducing a high frequency of severe and life threatening birth defects.