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Isotretinoin capsules (Roaccutane): medicine to treat acne - NHS

Two negative pregnancy tests are necessary before the initiation of therapy with isotretinoin. The first pregnancy test occurs up to 30 days before medication initiation. Each subsequent month the patient must have a recorded negative pregnancy test to continue therapy.

After discontinuation of therapy, a final pregnancy test should take place 30 days following therapy completion. Females of child-bearing potential FCBP must be on two effective forms of birth control or complete abstinence while receiving isotretinoin therapy. Secondary forms include male latex condoms, diaphragm, cervical cap, or vaginal sponge, all with the co-use of spermicide.

Natural family planning, birth control pills without estrogen, female condoms, withdrawal, and cervical shield are not acceptable forms of birth control according to the iPLEDGE program. Liver function tests LFTs , fasting lipid profile including triglycerides , blood glucose, creatinine phosphokinase CPK , and complete blood counts CBC with differential should be drawn before initiating therapy with isotretinoin.

Screening for mood alteration, psychosis, aggression, suicidal ideation, skin changes, and visual changes should also occur before starting therapy. Liver function tests LFTs and lipids should require monitoring at a biweekly interval until establishing a response to isotretinoin. There is no commonly used antidote for isotretinoin intoxication. Reports of acute intoxication indicate exacerbations of common, well-known isotretinoin side effects, including cutaneous xerosis and cheilitis.

Isotretinoin may be prescribed by any clinician, including the nurse practitioner. While the drug is effective for the treatment of acne, all prescribers should be familiar with the drug's adverse effect profile- of which one of the most serious is teratogenicity.

Isotretinoin is a pregnancy category X drug and is contraindicated in pregnant women or who may become pregnant. Given the nature of isotretinoin therapy, an interprofessional healthcare team approach is necessary. Pharmacists will play a vital role in working with the patient for iPLEDGE, contacting and keeping in touch with the prescriber, and coordinating with the prescriber's nursing staff to ensure therapy is administered correctly and in the proper situation, particularly in the case of female patients.

Nurses also need to provide counsel, monitor for adverse events, and can collaborate with the pharmacist regarding contraceptive measures for female patients. Both the pharmacists and nurses need an open line to the prescriber so any concerns can be addressed immediately.

This interprofessional team methodology applies to any medication but is especially necessary with isotretinoin to achieve satisfactory and safe therapeutic patient outcomes. This book is distributed under the terms of the Creative Commons Attribution 4. Turn recording back on. Help Accessibility Careers. StatPearls [Internet]. Search term. Isotretinoin Hannah D. Author Information Authors Hannah D. Affiliations 1 Campbell University of Osteopathic Medicine.

Continuing Education Activity Isotretinoin is an oral prescription medication that affects sebaceous glands and is used to treat severe acne. Indications Isotretinoin is an oral prescription medication that affects sebaceous glands and is used to treat severe acne. Non-FDA Approved Indications Isotretinoin has been used for moderate acne, cutaneous T-cell lymphomas, neuroblastoma, and the prevention of squamous cell carcinoma in high-risk patients.

Mechanism of Action Isotretinoin is an orally administered systemic retinoid. Administration Isotretinoin is administered orally in the form of a capsule. At least fifty per cent of patients with acne have a long-lasting response after a single adequate course of isotretinoin. In others, acne may recur a few months to a few years after the medication has been discontinued.

These patients may receive further courses of isotretinoin. Good night vision is important for airline pilots and those flying after dark. Night vision may be affected by isotretinoin. Pilots taking isotretinoin or considering a course of isotretinoin must report to their national aviation authority to discuss how this treatment affects their flying privileges.

Civil aviation licence holders, including Air Traffic Controllers, have an obligation under section 27 C of the Civil Aviation Act to ground self and report to CAA in case of any change in medical condition that may affect flight safety.

CAA considers the use of isotretinoin to be a change in medical condition. Books about skin diseases Books about the skin Dermatology Made Easy book. DermNet does not provide an online consultation service. If you have any concerns with your skin or its treatment, see a dermatologist for advice. Home arrow-right-small-blue Topics A—Z arrow-right-small-blue Isotretinoin info-icon print-icon. Isotretinoin — codes and concepts. Treatment or procedure. Use of isotretinoin in dermatology, Mechanism of action of isotretinoin, Side effects and monitoring of isotretinoin, Isotretinoin fetal syndrome.

Table of contents arrow-right-small. Introduction Uses Contraindications How to use How it works Dosage Course duration Drug interactions General side effects and risks Cutaneous side effects Managing side effects Dose-related side effects Rare side effects Monitoring Contraption considerations for women Isotretinoin and pregnancy Contraption considerations for men Efficacy Recurrent treatment Precautions for pilots.

Some side effects are more serious and need immediate treatment. Have a detailed conversation with a doctor to explore the risks and benefits of taking isotretinoin. A healthcare team can also work with you to manage any side effects.

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What is isotretinoin Accutane? Common side effects of isotretinoin Accutane. Concentrations of isotretinoin in the epidermis are only half of those in serum. Metabolism: After oral administration of isotretinoin, three major metabolites have been identified in plasma: 4-oxo-isotretinoin, tretinoin, all-trans retinoic acid , and 4-oxo-tretinoin. The major metabolite is 4-oxo isotretinoin with plasma concentrations at steady state, that are 2. Other minor metabolites have been detected but are not completely identified, which also includes glucuronide conjugates.

Isotretinoin metabolites have shown biological activity in several in-vitro tests. Thus the observed clinical profile in patients could be the result of the pharmacological activity of isotretinoin and its metabolites. Enterohepatic circulation may play a significant role in the pharmacokinetics of isotretinoin in man.

In-vitro metabolism studies have demonstrated that several CYP enzymes are involved in the metabolism of isotretinoin to 4-oxo-isotretinoin and tretinoin. No single isoform appears to have a predominant role.

CYP 26 is also known to metabolize retinoids. Roaccutane and its metabolites do not significantly affect CYP activity. Elimination: After oral administration of radiolabeled isotretinoin approximately equal fractions of the dose were recovered in urine and feces.

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Isotretinoin - Wikipedia.Isotretinoin | DermNet

Turn recording back on. Medically reviewed by Lindsay Slowiczek, PharmD. Patients should also avoid all skin resurfacing procedures waxing, dermabrasion, laser therapy during treatment and at least six months after treatment to prevent skin irritation and scarring. This article breaks down 5…. Already a member? Plasma concentrations of isotretinoin are about 1. In the rare event that neutropenia or agranulocytosis should occur, isotretinoin should be discontinued.

Isotretinoin is administered orally in the form of a capsule. The drug has low bioavailability and is highly lipophilic. The patient can maximize the oral absorption of isotretinoin by taking the drug with a meal. Isotretinoin should be taken with a full glass of water to avoid esophageal irritation.

Initial dosing of isotretinoin is commonly at 0. Typical therapy requires a to week course of daily isotretinoin administration to achieve complete prolonged remission of the disease. Dry skin xerosis , dry mouth xerostomia , dry nose, and sun sensitivity are also very common adverse effects seen in patients taking isotretinoin. Sun protection and skin moisturizers and barriers are important patient education topics before starting the medication.

Patients should also avoid all skin resurfacing procedures waxing, dermabrasion, laser therapy during treatment and at least six months after treatment to prevent skin irritation and scarring. Hypertriglyceridemia and increased erythrocyte sedimentation rate are also very common side effects of isotretinoin therapy. Frequent laboratory monitoring is indicated during the induction period and throughout treatment with isotretinoin to monitor these common adverse effects.

Itching pruritis , irritation, hair thinning, skin fragility, dry eyes, skin infections, rash, bone or joint pain, muscle aches, and joint pain arthralgias ; back and joint pain is most common in the pediatric population.

Decreased high-density lipoproteins HDLs , increased liver function tests LFTs , increased creatinine phosphokinase CPK , decreased hemoglobin and hematocrit, decreased erythrocyte, and leukocyte counts, and increased platelet counts. In the rare event that neutropenia or agranulocytosis should occur, isotretinoin should be discontinued. There have been controversial associations with isotretinoin in patients who also suffer from inflammatory bowel disease or depression.

However, recent meta-analyses have not shown an association with isotretinoin and these diseases. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported and warrant prompt cessation of isotretinoin if they occur during therapy. There are also reports of acute pancreatitis in patients taking isotretinoin with both normal and elevated serum triglyceride levels.

Therapy should be discontinued if symptoms of pancreatitis occur. Patients taking isotretinoin should avoid blood donation while on isotretinoin and for one month after discontinuing treatment due to the risk of embryo-fetal toxicity. Reports also exist of episodes of depression and psychosis in patients taking isotretinoin.

Pseudotumor cerebri benign intracranial hypertension has been presented in cases of patients taking isotretinoin with concomitant use of tetracyclines. For this reason, tetracyclines should not be administered with isotretinoin. If patients develop signs or symptoms of pseudotumor cerebri, prompt cessation isotretinoin is necessary, and the patient should receive a referral to a neurologist for further evaluation.

Isotretinoin was a pregnancy category X drug under the previous FDA system and is contraindicated in pregnant women or who may become pregnant. There have been severe, documented congenital disabilities when pregnant women have taken isotretinoin. These requirements include negative pregnancy tests and documented abstinence or the use of birth control before and while taking isotretinoin.

Isotretinoin is contraindicated in patients who have hypersensitivity to any of its components, including vitamin A and preservatives within the gel capsule. Two negative pregnancy tests are necessary before the initiation of therapy with isotretinoin. The first pregnancy test occurs up to 30 days before medication initiation.

Each subsequent month the patient must have a recorded negative pregnancy test to continue therapy. After discontinuation of therapy, a final pregnancy test should take place 30 days following therapy completion.

Females of child-bearing potential FCBP must be on two effective forms of birth control or complete abstinence while receiving isotretinoin therapy. When isotretinoin is taken with food, the bioavailability is doubled relative to fasting conditions. The volume of distribution of isotretinoin in man has not been determined since isotretinoin is not available as an intravenous preparation for human use.

Steady-state blood concentrations C min,ss of isotretinoin in patients with severe acne treated with 40 mg b. In humans little information is available on the distribution of isotretinoin into tissue.

Concentrations of isotretinoin in the epidermis are only half of those in serum. Metabolism: After oral administration of isotretinoin, three major metabolites have been identified in plasma: 4-oxo-isotretinoin, tretinoin, all-trans retinoic acid , and 4-oxo-tretinoin.

The major metabolite is 4-oxo isotretinoin with plasma concentrations at steady state, that are 2. Other minor metabolites have been detected but are not completely identified, which also includes glucuronide conjugates. Isotretinoin metabolites have shown biological activity in several in-vitro tests.

Thus the observed clinical profile in patients could be the result of the pharmacological activity of isotretinoin and its metabolites.

Enterohepatic circulation may play a significant role in the pharmacokinetics of isotretinoin in man. In-vitro metabolism studies have demonstrated that several CYP enzymes are involved in the metabolism of isotretinoin to 4-oxo-isotretinoin and tretinoin.

Although isotretinoin is usually very effective for acne, occasionally it responds unexpectedly slowly and incompletely. Poor response is associated with:. At least fifty per cent of patients with acne have a long-lasting response after a single adequate course of isotretinoin. In others, acne may recur a few months to a few years after the medication has been discontinued. These patients may receive further courses of isotretinoin. Good night vision is important for airline pilots and those flying after dark.

Night vision may be affected by isotretinoin. Pilots taking isotretinoin or considering a course of isotretinoin must report to their national aviation authority to discuss how this treatment affects their flying privileges. Civil aviation licence holders, including Air Traffic Controllers, have an obligation under section 27 C of the Civil Aviation Act to ground self and report to CAA in case of any change in medical condition that may affect flight safety.

Isotretinoin — codes and concepts. Treatment or procedure. Use of isotretinoin in dermatology, Mechanism of action of isotretinoin, Side effects and monitoring of isotretinoin, Isotretinoin fetal syndrome. It can also lead to severe birth defects such as:. It can also cause a buildup of fluid and pressure on the brain called hydrocephalus. Babies may be born with an underdeveloped brain and small head, which is called microcephaly. This can lead to intellectual and developmental disabilities.

People should not breastfeed while taking isotretinoin or for at least 8 days after their last dose. It is an FDA-approved restricted distribution program designed to tell people about the risks of birth defects and to prevent pregnancy while taking the drug.

While taking isotretinoin, your red and white blood cell counts may decrease. Symptoms may include feeling faint and having difficulty breathing. Isotretinoin can also build up in your bloodstream. You may develop problems with blood sugar and blood fat levels. Some cases of sexual dysfunction linked to long-term isotretinoin use have been reported, but more detailed studies are needed to better explain these results. Stop taking isotretinoin immediately and talk with a doctor if you experience any of the side effects or symptoms below.

They may potentially lead to longer-term problems, such as organ damage, if not addressed promptly. These symptoms can include:. Some people taking isotretinoin may go through mood changes , such as irritability or sadness. The potential for serious mental health problems, including depression, psychosis, and suicidal thoughts, has been reported with isotretinoin. Warning signs may include:. Some conflicting research exists related to the mental health side effects of taking isotretinoin.

Newer research published in the Journal of the American Academy of Dermatology has not found evidence of an increased risk for depression linked to isotretinoin treatment for acne. A study also suggests the use of isotretinoin in patients with acne was linked with improved depression symptoms.

More research is needed to fully understand the relationship between isotretinoin use and mental health side effects. Most side effects from taking isotretinoin go away within a few days to a few weeks after treatment stops. But side effects may persist longer even after treatment ends. If left untreated, these side effects could result in permanent problems.

In some cases, these may include conditions such as scarring or vision loss. Because of the danger to pregnant people, it is not recommended to donate blood while taking this medication or for a full month after you have stopped taking it. Contact a doctor as soon as possible if your side effects continue for more than a few weeks after you stop taking isotretinoin.

Manufacturer: Roche. Marketer: DKSH. Full Prescribing Info. Pharmacotherapeutic Group: Retinoid for systemic treatment of acne. Pharmacology: Pharmacodynamics: Mechanism of Action: Isotretinoin, the active ingredient of Roaccutane, is a synthetic stereoisomer of all-trans retinoic acid tretinoin. The exact mechanism of action of Roaccutane has not yet been elucidated in detail, but it has been established that the improvement observed in the clinical picture of severe acne is associated with suppression of sebaceous gland activity and a histologically demonstrated reduction in the size of the sebaceous glands.

Furthermore, a dermal antiinflammatory effect of isotretinoin has been established. This is followed by formation of a comedone and, eventually, inflammatory lesions. Roaccutane inhibits proliferation of sebocytes and appears to act in acne by re-setting the orderly program of differentiation. Sebum is a major substrate for the growth of Propionibacterium acnes so that reduced sebum production inhibits bacterial colonisation of the duct.

Pharmacokinetics: Since the kinetics of isotretinoin and its metabolites are linear, its plasma concentrations during therapy can be predicted from single dose data. This property also provides some evidence that the activity of hepatic drug metabolising enzymes is not induced by isotretinoin.

Absorption: The absorption of isotretinoin from the gastro-intestinal tract is variable: the absolute bioavailability of isotretinoin has not been determined, since the compound is not available as an intravenous preparation for human use, but extrapolation from dog studies would suggest a fairly low and variable systemic bioavailability.

Plasma concentrations of isotretinoin are about 1. When isotretinoin is taken with food, the bioavailability is doubled relative to fasting conditions. The volume of distribution of isotretinoin in man has not been determined since isotretinoin is not available as an intravenous preparation for human use. Steady-state blood concentrations C min,ss of isotretinoin in patients with severe acne treated with 40 mg b.

In humans little information is available on the distribution of isotretinoin into tissue. Concentrations of isotretinoin in the epidermis are only half of those in serum.

Metabolism: After oral administration of isotretinoin, three major metabolites have been identified in plasma: 4-oxo-isotretinoin, tretinoin, all-trans retinoic acidand 4-oxo-tretinoin.

Thus the observed clinical profile in patients could be the result of the pharmacological activity of isotretinoin and its metabolites.

No single isoform appears to have a predominant role. CYP 26 is also known to metabolize retinoids. Roaccutane and its metabolites do not significantly affect CYP activity. Elimination: After oral administration of radiolabeled isotretinoin approximately equal fractions of the dose were recovered in urine and feces.

Following oral administration of isotretinoin, the terminal elimination half-life of unchanged drug in patients with acne has a mean value of 19 hours. The terminal elimination half-life of 4-oxo-isotretinoin is longer, with a mean value of 29 hours. Isotretinoin is a physiological retinoid and endogenous retinoid concentrations are reached within approximately two weeks following the end of Roaccutane therapy.

Pharmacokinetics in Special Populations: Since Roaccutane is contraindicated in patients with hepatic impairment, limited information on the kinetics of Roaccutane is available in this patient population.

Toxicology: Nonclinical Safety: Carcinogenicity: Isotretinoin has not been shown to be carcinogenic in in-vitro or in-vivo animal tests.

Genotoxicity: Isotretinoin has not been shown to be mutagenic in in-vitro or in-vivo animal tests. Impairment of Fertility: Isotretinoin, in therapeutic dosages, does not affect the number, motility and morphology of sperm and does not jeopardise the formation and development of the embryo on the part of the men taking isotretinoin. Reproductive Toxicity: Like other vitamin A derivatives, isotretinoin has been shown in animal experiments to be teratogenic and embryotoxic.

Due to the teratogenic potential of isotretinoin there are therapeutic consequences for the administration to women of a child-bearing age see Contraindications, Precautions, and Females and Males of Reproductive Potential under Precautions.

Other: Acute toxicity: The acute oral toxicity of isotretinoin was determined in various animal species. The side effect spectrum of isotretinoin in the rodent thus closely resembles that of vitamin A, but does not include the massive tissue and organ calcifications observed with vitamin A in the rat.

The liver cell changes observed with vitamin A did not occur with isotretinoin. All observed side effects of hypervitaminosis A syndrome were spontaneously reversible after withdrawal of isotretinoin. Even experimental animals in a poor general state had largely recovered within weeks. Exclusive offer for doctors. Continue with Google. Sign Up. Already a member? Sign in.

While the exact mechanism of action is unknown, isotretinoin inhibits sebaceous gland function and keratinization at pharmacologic doses. The. Oral isotretinoin has no direct antimicrobial action, but by dramatically reducing SER and the size of the pilosebaceous duct it alters the microenvironment. NHS medicines information on isotretinoin capsules – what it's used for, side effects, dosage and who can take it. Roaccutane inhibits proliferation of sebocytes and appears to act in acne by re-setting the orderly program of differentiation. Sebum is a major substrate for. Oral(cis retinoic acid) is a retinoid most often used for the treatment of acne vulgaris, particularly severe or recalcitrant disease. Isotretinoin is. Isotretinoin is a pregnancy category X drug and is contraindicated in pregnant women or who may become pregnant. There is no commonly used antidote for isotretinoin intoxication. Note that this may not provide an exact translation in all languages. Liver function tests LFTs and lipids should require monitoring at a biweekly interval until establishing a response to isotretinoin. Reproductive Toxicity: Like other vitamin A derivatives, isotretinoin has been shown in animal experiments to be teratogenic and embryotoxic.

DermNet provides Google Translate, a free machine translation service. Note that this may not provide an exact translation in all languages. Home arrow-right-small-blue Topics A—Z arrow-right-small-blue Isotretinoin. Isotretinoin cis retinoic acid is a vitamin-A derivative retinoid. The liver naturally makes small quantities of isotretinoin from vitamin-A, but the drug we prescribe is made synthetically. Isotretinoin was developed in the s, but only started being used in the mid s.

Isotretinoin is a very effective medication for the treatment of acne. Originally licensed for use in severe disease, it is increasingly prescribed for all grades of acne. Isotretinoin is also useful for other follicular conditions, such as:.

It has also been used as an adjuvant in neuroblastoma. Blood donation by males and females on isotretinoin is not allowed in case the blood is used for a pregnant woman. The range of doses used each day for acne is less than 0. Some patients may only need a small dose once or twice a week. A course of treatment may be completed in a few months or continue for several years. The individual dose prescribed by the dermatologist depends on:.

Isotretinoin is better taken with water or milk after food to help with its absorption. It may be taken on an empty stomach, but absorption may be halved. There is no particular advantage in splitting the dose over the day. A newer formulation isotretinoin-lidose can be taken without food. Most patients should be treated until their skin condition clears and then for a further few months.

However, courses have often been restricted to 16—30 weeks 4—7 months to minimise the risk of teratogenicity risk of congenital abnormalities , and to comply with local regulatory authorities. Isotretinoin may be prescribed for years, usually in low dose or intermittently.

The range and severity of the side effects also depend on personal factors and the disease being treated. Patients with significant liver or kidney disease, high blood fats, diabetes and depression may be advised not to take isotretinoin or to be on a lower dose than usual and to have regular follow-up visits.

Most of the side effects due to isotretinoin are cutaneous or mucocutaneous and relate to the mode of action of the drug. The most common are listed here.

When side effects are troublesome, isotretinoin may need to be withheld or the dose reduced. Cutaneous adverse effects of isotretinoin Acne flare. Pregnancy must be excluded before and during treatment with isotretinoin. In an otherwise healthy individual, blood tests are generally not needed, but monitoring may be a variable prescribing requirement in some countries. Isotretinoin must not be taken in pregnancy because of a very high risk of serious congenital abnormalities in the baby.

Caution needs to be used during breast-feeding as it enters the breast milk and might affect the baby. All females who could biologically have a child should take the following precautions during treatment with isotretinoin and for four weeks after the medication has been discontinued:. A prescription for emergency contraception may be available from a medical practitioner GP or family planning clinic or accredited pharmacy.

If contraception fails, termination of pregnancy an abortion may be advised if pregnancy arises during treatment with isotretinoin or within a month of discontinuing it. Isotretinoin has a very high chance of resulting in a spontaneous miscarriage or a severe birth deformity if a fetus is exposed to it during the first half of pregnancy.

The deformities affect the growth of tissues developing at the time of exposure to the drug:. Isotretinoin has no effect on sperm or male fertility and has not been shown to cause birth defects in children fathered by men taking it.

Books about skin diseases Books about the skin Dermatology Made Easy book. DermNet does not provide an online consultation service. If you have any concerns with your skin or its treatment, see a dermatologist for advice. Home arrow-right-small-blue Topics A—Z arrow-right-small-blue Isotretinoin info-icon print-icon. Isotretinoin — codes and concepts. Treatment or procedure. Use of isotretinoin in dermatology, Mechanism of action of isotretinoin, Side effects and monitoring of isotretinoin, Isotretinoin fetal syndrome.

What is isotretinoin? What is isotretinoin used for? Isotretinoin is also useful for other follicular conditions, such as: Rosacea Seborrhoea Hidradenitis suppurativa Scalp folliculitis. It is also prescribed off-label for many other skin diseases. Examples include: Discoid lupus erythematosus Granuloma annulare Grover disease Sarcoidosis Extensive actinic keratoses Prevention of cutaneous squamous cell carcinoma. Contraindications to isotretinoin Isotretinoin must not be taken in pregnancy, or if there is a significant risk of pregnancy.

New Zealand approved datasheets are the official source of information for these prescription medicines, including approved uses and risk information. Check the individual New Zealand datasheet on the Medsafe website. Does use of isotretinoin rule out a career in flying? Br J Ophthalmol. Sign up to the newsletter. Full name. Email address.

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