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    (isotretinoin) is a medicine taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. ABSORICA can cause serious side effects, birth defects and mental health problems. Females who are pregnant or who plan to become pregnant must not take ABSORICA. Please see Full Prescribing Information including Boxed Warning and Medication Guide for additional Risk Information. Accutane is derived from Vitamin A, which has been used to fight acne since 1930. Different companies have developed numerous Vitamin-A based acne treatments over the years, including retin-A, isotretinoin and Accutane. Before the release of Accutane, severe acne was primarily treated with oral antibiotics like tetracyclines and erythromycin. While these drugs worked for some patients, they were only effective against one of the bacteria that cause acne, Propionibacterium. Over time, these antibiotics grew less and less effective as the bacteria developed more resistant strains. Another early method of treating acne was to use high doses of fat soluble vitamin A. By using doses as high as 500,000 IU per day, researchers noticed lower rates of sebum, however, dry hair and other significant side effects kept the method from being used in a widespread manner.

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    Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime Day 4: 5 mg PO before breakfast, after lunch, and at bedtime Day 5: 5 mg PO before breakfast and at bedtime Day 6: 5 mg PO before breakfast Immediate-release: ≤10 mg/day PO added to disease-modifying antirheumatic drugs (DMARDs) Delayed-release: 5 mg/day PO initially; maintenance: lowest dosage that maintains clinical response; may be taken at bedtime to decrease morning stiffness with rheumatoid arthritis Take with meal or snack High-dose glucocorticoids may cause insomnia; immediate-release formulation is typically administered in morning to coincide with circadian rhythm Delayed-release formulation takes about 4 hours to release active substances; thus, with this formulation, timing of dose should take into account delayed-release pharmacokinetics and disease or condition being treated (eg, may be taken at bedtime to decrease morning stiffness with rheumatoid arthritis) Allergic: Anaphylaxis, angioedema Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture after recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper- or hypopigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria Endocrine: Abnormal fat deposits, decreased carbohydrate tolerance, development of cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon facies, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in children Fluid and electrolyte disturbances: Fluid retention, potassium loss, hypertension, hypokalemic alkalosis, sodium retention Gastrointestinal: Abdominal distention, elevation of serum liver enzymes levels (usually reversible upon discontinuance), hepatomegaly, hiccups, malaise, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis General: Increased appetite and weight gain Metabolic: Negative nitrogen balance due to protein catabolism Musculoskeletal: Osteonecrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures Neurologic: Arachnoiditis, convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri; 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administer mineralocorticoid concomitantly May cause psychiatric disturbances; monitor for behavioral and mood changes; may exacerbate pre-existing psychiatric conditions Monitor for Kaposi sarcoma Pregnancy category: C (immediate release); D (delayed release) Drug may cause fetal harm and decreased birth weight; maternal corticosteroid use during first trimester increases incidence of cleft lip with or without cleft palate Lactation: Of maternal serum metabolites, 5-25% are found in breast milk; not recommended, or, if benefit outweighs risk, use lowest dose Glucocorticosteroid; elicits mild mineralocorticoid activity and moderate anti-inflammatory effects; controls or prevents inflammation by controlling rate of protein synthesis, suppressing migration of polymorphonuclear leukocytes (PMNs) and fibroblasts, reversing capillary permeability, and stabilizing lysosomes at cellular level; in physiologic doses, corticosteroids are administered to replace deficient endogenous hormones; in larger (pharmacologic) doses, they decrease inflammation The above information is provided for general informational and educational purposes only. 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