PATIENTS NOT AT INCREASED RISK FOR HYPONATREMIA: 1 spray ( mcg) in either the left or right nostril approximately 30 minutes before going to bed. THOSE AT INCREASED RISK FOR HYPONATREMIA: 1 spray ( mcg) in either the left or right nostril approximately 30 minutes before going to bed. After at least 7 days of treatment, the dose may be increased to mcg, if needed, provided the serum sodium is within the normal range during treatment with the mcg dose. The mcg dose did not meet all prespecified efficacy endpoints in clinical trials, but may have a lower risk of hyponatremia.
Isotretinoin is contraindicated in pregnancy (FDA pregnancy risk category X). Although not every exposure to isotretinoin has resulted in a birth defect, there is an extremely high risk that birth defects can occur if pregnancy occurs while taking isotretinoin in any amount even for a short period of time. In order to prevent isotretinoin exposure during pregnancy, the iPLEDGE program has been developed. This program requires prescribers, pharmacists and patients to comply with certain conditions prior to prescribing, dispensing or receiving isotretinoin. Isotretinoin therapy should not be initiated in females of childbearing potential, regardless of whether or not they are sexually active, until negative results from two urine or serum pregnancy tests are confirmed and the patient or her guardian completes the consent form. Monthly pregnancy testing during isotretinoin therapy is also required. Women who are, or might become, sexually active with a male partner must also select and use 2 forms of effective contraception simultaneously for at least one month before beginning, during, and for one month following discontinuation of therapy, even when there has been a history of infertility, unless due to hysterectomy. Low-dose progestins may be an inadequate method of contraception during isotretinoin therapy. In addition, females who are using hormonal contraception as a primary form of birth control should not take St. John's Wort, as it may decrease the effectiveness of hormonal contraceptives. They must also sign a Patient Information/Consent form about isotretinoin and birth defects, in addition to the consent form all patients should receive information about other potentially serious risks. If pregnancy does occur during treatment, the prescriber and patient should discuss the desirability of continuing the pregnancy. Prescribers should report all cases of pregnancy to the FDA MedWatch program at 800—FDA—1088 and the iPLEDGE pregnancy registry at 866—495—0654.
Abdominal or stomach pain or burning (continuing); acne; bloody or black, tarry stools; changes in vision; eye pain; filling or rounding out of the face; headache; irregular heartbeat; menstrual problems; muscle cramps or pain; muscle weakness; nausea; pain in arms, back, hips, legs, ribs, or shoulders; pitting, scarring, or depression of skin at place of injection; reddish purple lines on arms, face, groin, legs, or trunk; redness of eyes; sensitivity of eyes to light; stunting of growth (in children); swelling of feet or lower legs; tearing of eyes; thin, shiny skin; trouble in sleeping; unusual bruising; unusual increase in hair growth; unusual tiredness or weakness; vomiting; weight gain (rapid); wounds that will not heal