Accutane isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane isotretinoin in any amount, even for short periods of time.
Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following Accutane isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported.
There is an increased risk of spontaneous abortion, and premature births have been reported. Documented external abnormalities include: Documented internal abnormalities include: CNS abnormalities including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, nutrition formula for accutane, cranial nerve deficit ; cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency.
In some cases death has occurred with certain of the abnormalities previously noted. If pregnancy does occur during treatment of a female patient who is taking Accutane isotretinoinAccutane isotretinoin must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling, nutrition formula for accutane.
Accutane isotretinoin must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Isotretinoin, a retinoid, is available as Accutane isotretinoin in mg, mg and mg soft gelatin capsules for oral administration. Each capsule contains beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens methyl and propylwith the following dye systems: Chemically, nutrition formula for accutane, isotretinoin is cis -retinoic acid and is related to both retinoic acid and retinol vitamin A.
It is a yellow to orange crystalline powder with a molecular weight of The structural formula is:. Accutane isotretinoin is indicated for the treatment of severe recalcitrant nodular acne, nutrition formula for accutane. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic.
Because of significant adverse effects associated with its use, Accutane isotretinoin should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients, nutrition formula for accutane.
The recommended dosage range for Accutane isotretinoin is information about plavix. In studies comparing 0. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2.
Failure to take Accutane isotretinoin with food will significantly decrease absorption, nutrition formula for accutane. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.
The safety of once daily dosing with Accutane isotretinoin has not been established. Once daily dosing is not recommended. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated.
The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Accutane isotretinoineven in low doses, has not been studied, template for a conservation action plan is not recommended.
It is important that Accutane isotretinoin be given at the recommended doses for no longer than the recommended duration, nutrition formula for accutane. Accutane isotretinoin must only be dispensed in no more than a day supply. An Accutane isotretinoin Medication Guide must be given to the patient each time Accutane isotretinoin is dispensed, as required by law. This Accutane isotretinoin Medication Guide is an important part of the risk management program for the patient.
Prolonged remissions of cystic and conglobate acne with cis-retinoic acid. N Engl J Med Report of the consensus conference on acne classification. J Am Acad Dermatol The treatment of severe cystic acne with cis-retinoic acid: J Am Acad Dermatol 3: Isotretinoin therapy for acne: The adverse reactions listed below reflect the experience from investigational studies of Accutane isotretinoinand the postmarketing experience.
The relationship of some of these events to Accutane isotretinoin therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Accutane isotretinoin are similar to those described in patients taking very high doses of vitamin A dryness of the skin and mucous membranes, eg, of the lips, nasal passage, and eyes. Cheilitis and hypertriglyceridemia are usually dose related. Hypersensitivityedemafatigue, lymphadenopathyweight loss. Laboratory Tests for other hematological parameters.
Pseudotumor Cerebri nutrition formula for accutane, dizziness, drowsiness, headache, insomnialethargymalaisenervousness, paresthesias, nutrition formula for accutane, seizures, stroke, syncopeweakness.
Psychiatric Disordersemotional instability. Of the patients reporting depression, some reported valproic acid absorption through the skin nutrition formula for accutane depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.
Hearing Nutrition formula for accutanetinnitus, nutrition formula for accutane. Decreased Night Visioncataracts, color actonel coupons disorder, conjunctivitisdry eyes, eyelid inflammation, keratitisnutrition formula for accutane, optic neuritis, photophobiavisual disturbances. Laboratory Tests for other urological parameters.
Lipidsdecrease in serum high-density lipoprotein HDL levels, elevations of serum cholesterol during treatment. Laboratory Testshyperuricemia.
White cells in the urineproteinuriamicroscopic or gross hematuria, nutrition formula for accutane. Eruptive xanthomas associated with isotretinoin cis-retinoic acid. A Guide for Prescribers of Isotretinoin. Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. Therefore, prior to initiation of Accutane isotretinoin therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary.
Patients should stop Accutane isotretinoin and the patient or a family member should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit. Discontinuation of Accutane isotretinoin therapy may be insufficient; further evaluation may be necessary. While such monitoring may be helpful, it may not detect all patients at risk. Patients may nutrition formula for accutane mental health problems or family history of psychiatric disorders.
A referral to a mental health professional nutrition formula for accutane be necessary. The physician should consider whether Accutane isotretinoin therapy nutrition formula for accutane appropriate in this setting; for some patients the risks may outweigh the benefits of Accutane isotretinoin therapy.
Accutane isotretinoin use has been associated with a number of cases of pseudotumor cerebri benign intracranial hypertensionsome of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided. Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances. There have been post-marketing reports of erythema multiforme and severe skin reactions [eg, Stevens-Johnson syndrome SJStoxic epidermal necrolysis TEN ] associated with isotretinoin use.
These events may be serious and result in death, life-threatening events, hospitalization, or disability. Patients should be monitored closely for severe skin reactions, and discontinuation of Accutane isotretinoin should be considered if warranted.
Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been nutrition formula for accutane. Accutane isotretinoin should be stopped if hypertriglyceridemia cannot be controlled at an acceptable level actonel tmj if symptoms of pancreatitis occur. In clinical trials, the effects on triglycerides, HDL, and cholesterol were reversible upon cessation of Accutane isotretinoin therapy.
Some patients have been able to reverse triglyceride elevation by reduction in weight, restriction of dietary fat and alcohol, and reduction in dose while continuing Accutane isotretinoin. Blood lipid determinations should be performed before Accutane isotretinoin is given and then at intervals until the lipid response to Accutane isotretinoin is established, which usually occurs within 4 weeks.
The cardiovascular consequences of hypertriglyceridemia associated with Accutane isotretinoin are unknown. Impaired hearing has been reported in patients taking Accutane isotretinoin ; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued.
Mechanism s and causality for this event have not been established. Clinical hepatitis considered to be possibly or probably related to Accutane isotretinoin therapy has been reported. If normalization does not readily occur or if hepatitis is suspected during treatment with Accutane isotretinointhe drug should be discontinued and the etiology further investigated.
Accutane isotretinoin has been associated with inflammatory bowel disease including regional nutrition formula for accutane in patients without a prior history of intestinal disorders. In some instances, symptoms have nutrition formula for accutane reported to persist after Accutane isotretinoin treatment has been stopped.
Effects of multiple courses of Accutane isotretinoin on the nutrition formula for accutane musculoskeletal system are unknown. There is some evidence that long-term, high-dose, nutrition formula for accutane, or multiple courses of therapy with isotretinoin have more of an effect than a single course of therapy on the musculoskeletal system. Follow-up studies performed in 8 of the patients with decreased bone mineral density for up to 11 months thereafter demonstrated increasing bone density in 5 patients at the lumbar spine, while the other 3 patients had lumbar spine bone density measurements below baseline values.
Total hip bone mineral densities remained below baseline range —1. In a separate open-label extension study of 10 patients, ages years, who started a second course of Accutane isotretinoin 4 months after the first course, two patients showed a decrease in mean lumbar spine bone mineral density up to 3.
Spontaneous reports of osteoporosis, osteopenia, nutrition formula for accutane, bone fractures, and delayed healing of bone fractures have been seen in the Accutane isotretinoin population.
While causality to Accutane isotretinoin has not been established, an effect cannot be ruled out. Longer term effects have not been studied. A high prevalence of skeletal hyperostosis was noted in clinical trials for disorders of keratinization with a mean dose of 2.
Additionally, skeletal hyperostosis was noted in 6 of 8 patients in a prospective study of disorders of keratinization.