BRAND NAMES
- International: Roaccutane
- Canada: Accutane PI
- Italy: Aisoskin, Isoriac
- Lebanon: Acnogen, Acnotren
- Switzerland: Curakne
- U.S.: Accutane Amnesteem, Claravis
 MECHANISM OF ACTION
Isotretinoin is a vitamin A derivative, belonging to the retinoid class. Isotretinoin is believed to act on the sebaceous glands (sweat producing glands) to reduce sebum excretion. This may indirectly reduce bacterial activity associated with acne and improve the condition.
Treatment of severe forms of acne (nodular and or inflammatory acne) that cannot be cleared up by other acne treatments, including antibiotics
The recommended dosage range is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1.0 mg/kg/day, it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages.
During the first few weeks of treatment, acne may seem to get worse. Redness and itching of the affected skin are common initial effects. These should disappear with time. Most often, the first signs of healing occur after two to three weeks of treatment. It may take one to two months before beneficial effects are seen. Most patients with severe acne notice a marked improvement after one or two courses of treatment.
- Isotretinoin is containdicated in women who are pregnant (Pregnancy Category X (US))
- Isotretinoin is containdicated in women who are breastfeeding
- Isotretinoin is contraindicated in women of childbearing potential unless all the conditions of the pregnancy prevention programme are met. In the US oral Isotretinoin is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE. Oral Isotretinoin must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE.
- Hypersensitivity to Isotretinoin
- Patients with excessively elevated blood lipid values
- Receiving concomitant treatment with tetracyclines
 WARNINGS AND PRECAUTIONS
- Isotretinoin may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.
- Pseudotumor Cerebri: Isotretinoin use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided.
- Pancreatitis: Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been reported. Isotretinoin should be stopped if hypertriglyceridemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur.
- Lipids: Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with Isotretinoin. Marked elevations of serum triglycerides were reported in approximately 25% of patients receiving Isotretinoin in clinical trials. In addition, approximately 15% developed a decrease in high-density lipoproteins and about 7% showed an increase in cholesterol levels. Blood lipid determinations should be performed before Isotretinoin is given and then at intervals until the lipid response to Isotretinoin is established, which usually occurs within 4 weeks. Especially careful consideration must be given to risk/benefit for patients who may be at high risk during Isotretinoin therapy (patients with diabetes, obesity, increased alcohol intake, lipid metabolism disorder or familial history of lipid metabolism disorder). If Isotretinoin therapy is instituted, more frequent checks of serum values for lipids and/or blood sugar are recommended
- Hearing Impairment: Impaired hearing has been reported in patients taking 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. Patients who experience tinnitus or hearing impairment should discontinue Isotretinoin treatment and be referred for specialized care for further evaluation
- Hepatotoxicity: Clinical hepatitis considered to be possibly or probably related to Isotretinoin therapy has been reported. Additionally, mild to moderate elevations of liver enzymes have been observed in approximately 15% of individuals treated during clinical trials, some of which normalized with dosage reduction or continued administration of the drug.
- Inflammatory Bowel Disease: Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Isotretinoin treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Isotretinoin immediately
- Vision Impairment: Visual problems should be carefully monitored.
- Corneal Opacities: Corneal opacities have occurred in patients receiving Isotretinoin for acne and more frequently when higher drug dosages were used in patients with disorders of keratinization.
- Decreased Night Vision: Decreased night vision has been reported during Isotretinoin therapy and in some instances the event has persisted after therapy was discontinued. Because the onset in some patients was sudden, patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night.
- Disorders of the blood: Decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis, elevated sedimentation rates or decrease in platelet count (thrombocytopenia).
- Vitamin A Because of the relationship of Isotretinoin to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.
- Tetracyclines: Concomitant treatment with Isotretinoin and tetracyclines should be avoided because Isotretinoin use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.
- Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations (“minipills” that do not contain an estrogen) may be an inadequate method of contraception during Isotretinoin therapy
- St. John’s Wort: Isotretinoin use is associated with depression in some patients. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John’s Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John's Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John's Wort.
 PREGNANCY AND LACTATION
- Pregnancy Category X (US). 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 Isotretinoin in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. 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.
- Nursing Mothers: It is not known whether this drug is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive Isotretinoin.
 SIDE EFFECTS
Some of the most common side effects are: dryness of the skin, lips, mouth, and lining of the nose. It is recommended to use a skin-moisturizing ointment or cream and a lip balm from the start of treatment.
Other possible side effects that may occur include: facial or body rash, flaking of the skin, itching, peeling of the palms and soles, increased sensitivity to the sun, sunburn, inflammation of the lips, mild nose bleed, bleeding and inflammation of the gums, easily injured skin and increased fatigue. Patients may also experience some redness, dryness, or irritation of the eyes and a decreased tolerance to contact lenses during and after therapy. Dry eyes can be helped by applying a lubricating eye ointment or tear replacement therapy.
In some patients variable amounts of hair loss have occurred. In rare cases, this hair loss persisted after treatment was completed.
 RELATED LINKS
|Oral antibiotics||Clindamycin (Oral route) • Doxycycline • Erythromycin (Oral route) • Josamycin • Lymecycline • Minocycline • Tetracycline|
|Topical antibiotics||Clindamycin (Topical) • Erythromycin (Topical)|
|Topical retinoids||Adapalene • Tazarotene • Tretinoin|
|Oral retinoids||Isotretinoin (Oral)|
|Oral contraceptives||Estradiol valerate/Dienogest • Ethinyl Estradiol/Cyproterone acetate|
|Topical Antibacterial/Keratolytic||Benzoyl peroxide • Hydrogen Peroxide Cream|
|Topical combination products||Clindamycin/Benzoyl peroxide • Adapalene/Benzoyl peroxide • Clindamycin/Tretinoin • Miconazole/Benzoyl peroxide • Erythromycin/Benzoyl peroxide • Erythromycin/Isotretinoin|