Roacta Special Precautions

This medication should only be prescribed by prescribers competent in treating severe recalcitrant nodular acne and experienced with the use of systemic retinoid.
May cause depression, psychosis, aggressive or violent behavior, and changes in mood; use with extreme caution in patients with psychiatric disorders. Rarely, suicidal thoughts and actions have been reported during isotretinoin usage. All patients should be observed closely for symptoms of depression or suicidal thoughts. Discontinuation of treatment alone may not be sufficient, further evaluation may be necessary.
Cases of pseudotumor cerebri (benign intracranial hypertension) have been reported; some with concomitant use of tetracycline (avoid using together).
Patients with papilledema, headache, nausea, vomiting, and visual disturbances should be referred to a neurologist and treatment with isotretinoin discontinued.
Hearing impairment, which can continue after therapy is discontinued, may occur.
Clinical hepatitis, elevated liver enzymes, inflammatory bowel disease, skeletal hyperostosis, premature epiphyseal closure, vision impairment, corneal opacities, and decreased night vision have also been reported with the use of isotretinoin.
Use with caution in patients with diabetes mellitus.
Use with caution in patients with a genetic predisposition to bone disorders and with disease states or concomitant medications that can induce bone disorders.
Patients should be instructed not to donate blood during therapy and for 1 month following discontinuation of therapy due to risk of donated blood being given to a pregnant female.
Use in Pregnancy: Do not prescribe isotretinoin for women who are or who are likely to become pregnant while using the drug.
Women of childbearing potential must be capable of complying with effective contraceptive measures and patients must select and commit to two forms of contraception.
Therapy is begun after two negative pregnancy tests; effective contraception must be used for at least 1 month before beginning therapy, during therapy, and for 1 month after discontinuation of therapy.
Prescriptions should be written for no more than a 30-day supply, and pregnancy testing and counseling should be repeated monthly.
Use in Children: Not recommended for children.
Safety and efficacy have not been established in children < 12 years of age.