about Isotretinoin class, uses, side effects contraindications
Isotretinoin
Short Description
Isotretinoin is a derivative of vitamin A chemically, used in the?treatment of acne?K, it is taken to treat severe cases of pimples or severe acne that does not respond to other treatments.
Category
Chemical class: Retinoid
Therapeutic class: Acne inhibitor
Pregnancy category: X
Indications
To treat severe recalcitrant nodular acne unresponsive to conventional therapy
Adults. Initial: 0.5 mg to 1 mg/kg daily in 2 divided doses, increased as needed up to 2 mg/kg daily given in 2 divided doses. Maximum: 2 mg/kg daily. Course of therapy given for 15 to 20 wk with second course given, as needed, after a period of 2 mo or more off therapy.
Mechanism of Action
Inhibits sebaceous gland function and keratinization, which results in diminished nodular formation associated with recalcitrant nodular acne.
Contraindications
Hypersensitivity to isotretinoin or any of its components, hypersensitivity to parabens, pregnancy
Interactions
corticosteroids (systemic): Possibly increased risk of osteoporosis hormonal contraceptives including microdosed progesterone preparations, medroxyprogesterone injection, levonorgestrel implants: Possibly decreased effectiveness of contraceptive
phenytoin: Possibly increased risk of osteomalacia tetracyclines: Increased risk of benign intracranial hypertension vitamin A supplements: Increased risk of additive toxic effects
Side Efect
CNS: Aggressive or violent behavior, depression, dizziness, drowsiness, emotional instability, fatigue, headache, insomnia, lethargy, malaise, nervousness, paresthesias, pseudotumor cerebri, psychosis, seizures, stroke, suicidal ideation, syncope, weakness
CV: Chest pain, decreased high-density lipoprotein level, edema, elevated creatinine phosphokinase level, hypercholesteremia, hypertriglyceridemia, palpitation, stroke, tachycardia, vascular thrombotic disease, vasculitis
ENDO: Abnormal menses, alterations in blood glucose levels
EENT: Bleeding and inflammation of gums, cataracts, color vision disorder, conjunctivitis, corneal opacities, decreased night vision, dry mouth or nose, dry eyes, epistaxis, eyelid inflammation, hearing impairment, keratitis, optic neuritis, photophobia, tinnitus, visual disturbances, voice alteration
GI: Colitis, hepatitis, ileitis, inflammatory bowel disease, liver enzyme elevation, nausea, pancreatitis
GU: Glomerulonephritis, hematuria, proteinuria, WBCs in urine
HEME: Anemia, agranulocytosis, neutropenia, platelet count elevation, sedimentation rate elevation, thrombocytopenia
MS: Arthralgia, arthritis, back pain (children), bone abnormalities, calcification of tendons and ligaments, premature epiphyseal closure, tendonitis
RESP: Bronchospasms, respiratory infection
SKIN: Alopecia, bruising, disseminated herpes simplex, dry lips or skin, eczema, eruptive xanthomas, facial erythema, flushing, fulminant acne, hair abnormalities, hirsutism, hyperpigmentation, hypopigmentation, increased sunburn susceptibility, infections, nail dystrophy, paronychia, peeling of palms and soles, photoallergic or photosensitizing reactions, pruritus, pyogenic granuloma, rash, seborrhea, skin fragility, sweating, urticaria
Other: Abnormal wound healing, alkaline phosphatase increase, allergic reactions, hyperuricemia, lymphadenopathy, weight loss
Cautions
Ensure that women of childbearing age have had two negative urine or serum pregnancy tests with a sensitivity of at least 50 mIU/ml, joined the Accutane Survey, signed the consent form, and watched the videotape provided by manufacturer prior to beginning isotretinoin therapy. isotretinoin 551 G H I
WARNING Notify prescriber if elevated serum triglyceride levels can’t be controlled or if symptoms of pancreatitis occur (abdominal pain, nausea, vomiting). Drug may need to be discontinued because fatal hemorrhagic pancreatitis has occurred with drug use. Obtain serum lipid level before therapy and periodically thereafter, as ordered, to detect elevated lipid levels that result from isotretinoin therapy. Monitor liver enzyme levels periodically, as ordered, because drug can cause hepatitis. Assess patient frequently for adverse reactions and report to prescriber any that occur; drug may have serious adverse effects that require discontinuation. PATIENT SAFTY
Instruct patient to take isotretinoin with food or milk. Advise women of childbearing age that two forms of contraceptives must be used simultaneously (unless absolute abstinence is the chosen method) 1 month before therapy and for 1 month after therapy has stopped because of potential for fetal harm. Inform women who use oral contraceptives that drug may lessen effectiveness of oral contraceptives. Urge patient to notify prescriber immediately if pregnancy occurs. Stress importance of picking up isotretinoin prescription within 7 days of a pregnancy test or, for male patients or women not of childbearing potential, within 30 days of prescription. Urge patient to report headache, nausea, vomiting and visual disturbances immediately to prescriber because drug will need to be discontinued immediately and patient referred to a neurologist. Caution patient and family that isotretinoin may cause aggressive or violent behavior, depression, psychosis, and suicidal ideation. Instruct patient to notify prescriber immediately if changes in mood occur. Tell patient to report hearing changes or tinnitus, visual difficulties, abdominal pain, rectal bleeding, or severe diarrhea to prescriber because drug may need to be discontinued. Advise patient to avoid hazardous activities until drug’s CNS effects are known. Caution that changes in night vision may occur suddenly. Caution patient not to donate blood during therapy and for 1 month after therapy has stopped because blood might be given to a pregnant woman. Warn patient that transient exacerbation of acne may occur, especially during initial therapy and to notify prescriber if this occurs. Instruct patient to avoid wax epilation and skin resurfacing procedures during therapy and for at least 6 months thereafter because of scarring potential. Caution patient to avoid exposure to direct sunlight or UV light and to wear sunscreen when outdoors. Inform patient that contact lens tolerance may decrease during and after isotretinoin therapy. Alert patient to the potential for mild musculoskeletal Side Efect
, which usually clear rapidly after drug is discontinued. Urge patient to notify prescriber if symptoms become bothersome or serious because drug may need to be discontinued. Advise patient not to take vitamin A supplements while on isotretinoin therapy because of potentially additive toxic effects. Instruct patient to notify all prescribers of isotretinoin use because of the risk of interactions. Inform patient of need for frequent laboratory tests and importance of complying with scheduled appointments.
Trade Name & Company Name
effect of Isotretinoin in Pregnancy, Fetal Health
and Breast feeding
Pregnancy
. Isotretinoin is contraindicated during pregnancy. Only manufacturer-approved physicians may prescribe it. Though many fail to comply patients must be capable of complying with mandatory contraceptive measures. Patients should be cautioned not to self-medicate with St. John?s wort because of a possible interaction with oral contraceptives, increasing the risk of an unplanned pregnancy. It is critical women of childbearing potential select and commit to use 2 forms of effective contraception simultaneously, at least 1 of which must be a primary form, unless absolute abstinence is the chosen method, or the patient has undergone a hysterectomy. In one study, a cohort of 8609 women between 13 and 45 years of age with a first prescription for isotretinoin was identified. Pregnancies, spontaneous and elective abortions, and birth defects were identified using procedure codes and medical diagnoses. Ninety (90) became pregnant for an annual Pregnancy
rate of 32.7/1000 person-years of treatment. Of these, 76 terminated, 3 had a spontaneous abortion, and 2 had trauma during delivery resulting in neonatal death. There were only 9 live births. Among the live births, only one had a congenital anomaly of the face and neck (11%). Adjusting for potential confounders, predictors of becoming pregnant while on isotretinoin were lower socioeconomic level, one or more visits to the doctor or to the emergency department, or one or more hospitalization while on isotretinoin; concomitant isotretinoin and oral contraceptive use had a preventive effect. Fetal Health
There are no adequate reports or well-controlled studies in human fetuses. Isotretinoin and its active metabolites crosses the human (and subhuman primate) placenta, and it is a known human teratogen. Multiple organ systems are affected, including CNS, CV, and endocrine organs. Mental retardation without external malformation has also been reported. Similar malformations occur in rodents. Breastfeeding
There is no published experience in nursing women. It is unknown whether isotretinoin enters human breast milk. Considering its effect on the fetus, Breastfeeding is considered contraindicated.
the follwing drugs will increse Isotretinoin by inhepiting cyp450
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the follwing drugs will decrease Isotretinoin by inhancing cyp450
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trad drugs based on Isotretinoin
| Gen name | Trade name | Catagory name |
| isotretinoin | Absorica | Miscellaneous uncategorized agents |
| isotretinoin | Absorica LD | Miscellaneous uncategorized agents |
| isotretinoin | Accutane | Miscellaneous antineoplastics |
| isotretinoin | Accutane | Miscellaneous uncategorized agents |
| isotretinoin | Amnesteem | Miscellaneous antineoplastics |
| isotretinoin | Amnesteem | Miscellaneous uncategorized agents |
| isotretinoin | Claravis | Miscellaneous antineoplastics |
| isotretinoin | Claravis | Miscellaneous uncategorized agents |
| isotretinoin | Myorisan | Miscellaneous antineoplastics |
| isotretinoin | Myorisan | Miscellaneous uncategorized agents |
| isotretinoin | Sotret | Miscellaneous antineoplastics |
| isotretinoin | Sotret | Miscellaneous uncategorized agents |
| isotretinoin | Zenatane | Miscellaneous uncategorized agents |
| Isotretinoin | ISOTREX Gel 0.05% | |
| Isotretinoin | XERACTAN 10 MG SOFT GELATIN CAPSULE | |
| Isotretinoin | XERACTAN 20 MG SOFT GELATIN CAPSULE | |
other drugs from same cataogory