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Pregnancy Category: X
ClassificationTherapeutic: antiacne agents
Management of severe nodular acne resistant to more conventional therapy, including topical therapy and systemic antibiotics.Not to be used under any circumstances in pregnant patients.
A metabolite of vitamin A (retinol); reduces sebaceous gland size and differentiation.
Diminution and resolution of severe acne. May also prevent abnormal keratinization.
Absorption: Rapidly absorbed following (23–25%) oral administration; absorption ↑ when taken with a high-fat meal.
Distribution: Appears to be widely distributed; crosses the placenta.
Protein Binding: 99.9%.
Metabolism and Excretion: Metabolized by the liver and excreted in the urine and feces.
Half-life: 10–20 hr.
Time/action profile (diminution of acne)
|PO||unknown||up to 8 wk||unknown|
Contraindicated in: Hypersensitivity to retinoids, glycerin, soybean oil, or parabens; Obstetric / Lactation: Pregnancy and lactation;Women of childbearing age who may become or who intend to become pregnant;Patients planning to donate blood.
Use Cautiously in: Pre-existing hypertriglyceridemia;Diabetes mellitus;History of alcohol abuse, psychosis, depression, or suicide attempt;Obese patients;Inflammatory bowel disease. Pediatric: Children <12 yr (safety not established)
Adverse Reactions/Side Effects
Central nervous system
- suicide attempt (life-threatening)
- behavior changes
- pseudotumor cerebri (life-threatening)
- suicidal ideation
Ear, Eye, Nose, Throat
- conjunctivitis (most frequent)
- epistaxis (most frequent)
- blurred vision
- contact lens intolerance
- corneal opacities
- ↓ night vision
- dry eyes
- cheilitis (most frequent)
- dry mouth (most frequent)
- nausea (most frequent)
- vomiting (most frequent)
- abdominal pain
- ↑ appetite
- stevens-johnson syndrome (life-threatening)
- toxic epidermal necrolysis (life-threatening)
- pruritus (most frequent)
- palmar desquamation
- skin infections
- thinning of hair
- anemia (most frequent)
- ↓ high-density lipoprotein cholesterol (most frequent)
- hypercholesterolemia (most frequent)
- hypertriglyceridemia (most frequent)
- arthralgia (most frequent)
- back pain (most frequent)
- muscle/bone pain (↑ in adolescents) (most frequent)
- severe birth defects (life-threatening)
- ↑ thirst
Drug-Drug interactionAdditive toxicity with vitamin A and drugs having anticholinergic properties.↑ risk of pseudotumor cerebri with tetracycline or minocycline.Concurrent use with alcohol ↑ risk of hypertriglyceridemia.Drying effects ↑ by concurrent use of benzoyl peroxide, sulfur, tretinoin, and other topical agents.Excessive ingestion of foods high in vitamin A may result in additive toxicity.
Oral (Adults and Children ≥12 yr) 0.5–1 mg/kg/day (up to 2 mg/kg/day) in 2 divided doses for 15–20 wk. Once discontinued, if relapse occurs, therapy may be reinstituted after an 8-wk rest period
Availability (generic available)
Capsules: 10 mg, 20 mg, 30 mg, 40 mg
- Verify that patient receiving isotretinoin is registered with the iPLEDGE program and is completing all required interactions with their health care provider.
- Assess skin prior to and periodically during therapy. Transient worsening of acne may occur at initiation of therapy. Note number and severity of cysts, degree of skin dryness, erythema, and itching.
- Assess for allergy to parabens; capsules contain parabens as a preservative.
- Monitor patient for behavioral changes throughout therapy. May cause depression, psychosis, and suicide ideation. If behavioral changes occur, they usually resolve with discontinuation of therapy.
- Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome or toxic epidermal necrolysis. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
- Lab Test Considerations: Obtain 2 negative sequential serum or urine pregnancy tests with a sensitivity ≥25 mIU/mL before receiving initial prescription and monthly before each new Rx.
- Monitor liver function (AST, ALT, and LDH) prior to therapy, after 1 mo of therapy, and periodically thereafter. Inform health care professional if these values become ↑; therapy may need to be discontinued.
- Monitor blood lipids (cholesterol, HDL, triglycerides) under fasting conditions prior to beginning therapy, at 1–2 wk intervals until lipid response to isotretinoin is established (usually within 1 mo), and periodically thereafter. Report ↑ cholesterol and triglyceride levels or ↓ HDL.
- Obtain baseline and periodic CBC, urinalysis, and SMA-12. May cause ↑ blood glucose, CPK, platelet counts, and sedimentation rate. May ↓ RBC and WBC parameters. May cause proteinuria, red and white blood cells in urine, and ↑ uric acid.
Potential Nursing DiagnosesRisk for impaired skin integrity (Indications, Side Effects)
Disturbed body image (Indications)
- Do not confuse isotretinoin with tretinoin.
- Isotretinoin is approved for marketing only under the iPLEDGE program, a special restricted distribution program approved by the FDA.
- Only patients who meet all requirements of the iPLEDGE program may receive isotretinoin.
- Isotretinoin may only be prescribed by health care providers registered and activated with the iPLEDGE program.
- Isotretinoin may only be dispensed by pharmacies registered with the iPLEDGE program.
- Oral: Administer with meals. Do not crush or open capsules.
- Explain the iPLEDGE program and its requirements to patient and parent.
- Instruct patient to take isotretinoin as directed. Do not take more than the amount prescribed. Take missed doses as soon as remembered if not almost time for next dose. Do not double doses. Patients must read Medication Guide and sign consent form prior to initiation of therapy.
- Explain to patient that a temporary worsening of acne may occur at beginning of therapy.
- Instruct female patients to use 2 forms of contraception 1 mo before therapy, throughout therapy, and for at least 1 mo after discontinuation of drug. This drug is contraindicated during pregnancy and may cause birth defects. Patient must have 2 negative serum or urine pregnancy tests with a sensitivity ≥25 mIU/mL before receiving initial prescription. First test is obtained by prescriber when decision is made to prescribe isotretinoin. Second pregnancy test should be done during first 5 days of menstrual period immediately preceding beginning of therapy. For patients with amenorrhea, second test should be done 11 days after last act of unprotected sexual intercourse. Each month of therapy patient must have a negative result from a urine or serum pregnancy test. Pregnancy test must be repeated every month prior to female patient receiving prescription. Manufacturer will make available pregnancy test kits to female patients. Patient should discontinue medication and inform health care professional immediately if pregnancy is suspected. Recommended consent form prepared by manufacturer stresses fetal risk. Parents of minors should also read and sign form. Yellow self-adhesive qualification stickers completed by prescriber must accompany prescription.
- Advise patient and family to notify health care professional if rash or thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood occur.
- May cause sudden decrease in night vision. Caution patient to avoid driving at night until response to the medication is known.
- Advise patient to consult with health care professional before using other acne preparations while taking isotretinoin. Soaps, cosmetics, and shaving lotion may also worsen dry skin.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Inform patient that dry skin and chapped lips will occur. Lubricant to lips may help cheilitis.
- Instruct patient that oral rinses, good oral hygiene, and sugarless gum or candy may help minimize dry mouth. Notify health care professional if dry mouth persists for more than 2 wk.
- Discuss possibility of excessively dry eyes with patients who wear contact lenses. Patient should contact health care professional about eye lubricant. Patient may need to switch to glasses during course of therapy and for up to 2 wk following discontinuation.
- Advise patient to avoid alcoholic beverages while taking isotretinoin, as this may further increase triglyceride levels.
- Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions. Health care professional should be consulted about sunscreen, as some sunscreens may worsen acne.
- Instruct patient not to take vitamin A supplements and to avoid excessive ingestion of foods high in vitamin A (liver; fish liver oils; egg yolks; yellow-orange fruits and vegetables; dark green, leafy vegetables; whole milk; vitamin A–fortified skim milk; butter; margarine) while taking isotretinoin; this may result in hypervitaminosis.
- Advise patient not to donate blood while receiving this medication. After discontinuing isotretinoin, wait at least 1 mo before donating blood to prevent the possibility of a pregnant patient receiving the blood.
- Inform diabetic patients that difficulty controlling blood glucose may occur.
- Instruct patient to report burning of eyes, visual changes, rash, abdominal pain, diarrhea, headache, nausea, and vomiting to health care professional.
- Inform patient of need for medical follow-up. Periodic lab tests may be required.
- Decrease in the number and severity of cysts in severe acne. Therapy may take 4–5 mo before full effects are seen. Therapy is discontinued when the number of cysts is reduced by 70% or after 5 mo. Improvement may occur after discontinuation of therapy; therefore, a delay of at least 8 wk is recommended before a second course of therapy is considered.
A trademark for the drug isotretinoin.