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Pharmaceutical Name
Trade (marketing or proprietary) name: Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, Zenatane, Accutane®.
Generic (nonproprietary or active ingredient) name: Isotretinoin
Indication and Usage
Reason the product has been approved for sale on the market.
FDA has approved this prescription medication to treat severe recalcitrant nodular acne.
Manufacturer Insert
Ingredients
Isotretinoin, beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg — iron oxide (red) and titanium dioxide; 20 mg — FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg — FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.
Contraindications
Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.
In addition to the boxed warning for pregnant women (see next section), the manufacturer states the following concerning Allergic Reactions:
Accutane is contraindicated in patients who are hypersensitive to this medication or to any of its components. Accutane should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.
Warnings and Precautions
Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.
Within the insert, the manufacturer has warnings for patients concerning psychiatric disorders, pseudotumor cerebri (benign intracranial hypertension), pancreatitis, lipids, hearing impairment, hepatotoxicity, Inflammatory Bowel Disease, bone mineral density, hyperostosis, premature epiphyseal closure, and vision impairment, including corneal opacities and decreased night vision.
Manufacturer-Listed Adverse Reactions
Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.
Isotretinoin can cause: Allergic reactions including vasculitis, systemic hypersensitivity, edema, fatigue, lymphadenopathy, and weight loss, Palpitation, Tachycardia, Vascular thrombotic disease, Stroke, Hypertriglyceridemia, Alterations in blood sugar levels, Inflammatory bowel disease, Hepatitis, Pancreatitis, Bleeding and inflammation of the gums, Colitis, Esophagitis/esophageal ulceration, Ileitis, Nausea and other nonspecific gastrointestinal symptoms, Anemia, Thrombocytopenia, Neutropenia, Rare reports of agranulocytosis, Skeletal hyperostosis, Calcification of tendons and ligaments, Premature epiphyseal closure, Decreases in bone mineral density, Musculoskeletal symptoms (sometimes severe) including back pain, myalgia, and arthralgia, Transient pain in the chest, Arthritis, Tendonitis, Other types of bone abnormalities, Elevations of CPK/rare reports of rhabdomyolysis, Pseudotumor cerebri, Dizziness, Drowsiness, Headache, Insomnia, Lethargy, Malaise, Nervousness, Paresthesias, Seizures, Syncope, Weakness, Suicidal ideation, Suicide attempts, Suicide, Depression, Psychosis, Aggression, Violent behaviors, Emotional instability, Abnormal menses (period), Voice alteration, Visual disturbances, Bronchospasms (with or without a history of asthma), Respiratory infection, Acne fulminans, Alopecia (which in some cases persists), Bruising, Cheilitis (dry lips), Epistaxis, Eruptive xanthomas, Flushing, Fragility of skin, Hair abnormalities, Hirsutism, Tinnitus, Keratitis, Optic neuritis, Corneal opacities, Hyperpigmentation/hypopigmentation, Enfections (including disseminated herpes simplex), Paronychia, Pruritus, Pyogenic granuloma, Rash (including facial erythema, seborrhea, and eczema), Sunburn susceptibility increased, Sweating, Urticaria, Photoallergic/photosensitizing reactions, Peeling of palms and soles, Vasculitis (including Wegener’s granulomatosis, Abnormal wound healing (delayed healing or exuberant granulation tissue with crusting), Hearing impairment, Decreased night vision which may persist, Cataracts, Color vision disorder, Conjunctivitis, Eyelid inflammation, Thrombocytopenia, White cells in the urine, Proteinuria, Microscopic or gross hematuria, Nail dystrophy, Photophobia, Glomerulonephritis, Nonspecific urogenital findings, Elevation of plasma triglycerides, Decrease in serum high-density lipoprotein (HDL) levels, Elevations of serum cholesterol during treatment Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH, Elevation of fasting blood sugar, elevations of CPK, Hyperuricemia, Dry mouth, nose, skin, and eyes, Decreases in red blood cell parameters, Decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis, Elevated sedimentation rates, and Elevated platelet counts
Specific Populations
Pregnancy
Breastfeeding
It is not known whether this drug is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive Accutane.
Pediatric
The use of Accutane in pediatric patients less than 12 years of age has not been studied. The use of Accutane for the treatment of severe recalcitrant nodular acne in pediatric patients ages 12 to 17 years should be given careful consideration, especially for those patients where a known metabolic or structural bone disease exists.
In studies with Accutane, adverse reactions reported in pediatric patients were similar to those described in adults except for the increased incidence of back pain and arthralgia (both of which were sometimes severe) and myalgia in pediatric patients.
Mechanism of Action
This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.
Isotretinoin is a retinoid, which when administered in pharmacologic dosages of 0.5 to 1.0 mg/kg/day, inhibits sebaceous gland function and keratinization. The exact mechanism of action of isotretinoin is unknown.
Analytical Deep Dive
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