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Federal government websites often end in. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. NCBI Bookshelf. Hannah D. Pile ; Nazia M. Authors Hannah D. Pile 1 ; Nazia M. Isotretinoin is an oral prescription medication that affects sebaceous glands and is used to treat severe acne.
The drug was approved by the US Food and Drug Administration FDA in to treat severe, resistant, nodular acne that is unresponsive to conventional therapy, including systemic antibiotics. Non-FDA-approved indications include moderate acne, cutaneous T-cell lymphomas, neuroblastoma, and prevention of squamous cell carcinoma in high-risk patients. Isotretinoin has also been used in the treatment of rosacea, folliculitis, and pyoderma faciale.
This activity covers isotretinoin, including mechanism of action, pharmacology, adverse event profiles, eligible patient populations, contraindications, monitoring, and highlights the role of the interprofessional team in the management of isotretinoin therapy. Objectives: Describe the therapeutic mechanism of action of isotretinoin. Identify the indications, both approved and off-label, for isotretinoin. Review the adverse event and accompanying monitoring for isotretinoin.
Explain the importance of collaboration and communication among interprofessional team members to improve outcomes and treatment efficacy, and follow-up coordination for patients receiving isotretinoin.
Access free multiple choice questions on this topic. Isotretinoin has been used for moderate acne, cutaneous T-cell lymphomas, neuroblastoma, and the prevention of squamous cell carcinoma in high-risk patients. Clinicians have also utilized isotretinoin in the treatment of rosacea, folliculitis, and pyoderma faciale. Isotretinoin is an orally administered systemic retinoid. At a pharmacologic strength of 0. While the exact mechanism of action is unknown, isotretinoin inhibits sebaceous gland function and keratinization at pharmacologic doses.
The drug has been observed to reduce both the sebaceous gland size and sebum production. In neuroblastoma off-label useisotretinoin has been shown to decrease cell proliferation and induce differentiation. 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 xerosisdry mouth xerostomiadry 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 pruritisirritation, 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 HDLsincreased liver function tests LFTsincreased creatinine phosphokinase CPKdecreased 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. 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 LFTsfasting lipid profile including triglyceridesblood glucose, creatinine phosphokinase CPKand 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. Other Potential Adverse Effects Itching pruritisirritation, 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. Other Potential Laboratory Abnormalities Decreased high-density lipoproteins HDLsincreased liver function tests LFTsincreased creatinine phosphokinase CPKdecreased hemoglobin and hematocrit, decreased erythrocyte, and leukocyte counts, and increased platelet counts.
Caution 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.
Contraindications Black Box Warning Isotretinoin was a pregnancy category X drug under the previous FDA system and is contraindicated in pregnant women or who may become pregnant. Pretreatment Monitoring All Patients Liver function tests LFTsfasting lipid profile including triglyceridesblood glucose, creatinine phosphokinase CPKand complete blood counts CBC with differential should be drawn before initiating therapy with isotretinoin.
Ongoing monitoring All Patients Liver function tests LFTs and lipids should require monitoring at a biweekly interval until establishing a response to isotretinoin.
Toxicity There is no commonly used antidote for isotretinoin intoxication. Enhancing Healthcare Team Outcomes Isotretinoin may be prescribed by any clinician, including the nurse practitioner. Review Questions Access free multiple choice questions on this topic. Comment on this article.
References 1. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol.
❾-50%}Isotretinoin | Certificate of Analysis
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. Other Potential 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. Other Potential Laboratory Abnormalities 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.
Caution 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. Contraindications Black Box Warning Isotretinoin was a pregnancy category X drug under the previous FDA system and is contraindicated in pregnant women or who may become pregnant.
Pretreatment Monitoring All Patients 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. Ongoing monitoring All Patients Liver function tests LFTs and lipids should require monitoring at a biweekly interval until establishing a response to isotretinoin.
Toxicity There is no commonly used antidote for isotretinoin intoxication. Enhancing Healthcare Team Outcomes Isotretinoin may be prescribed by any clinician, including the nurse practitioner. Review Questions Access free multiple choice questions on this topic. Comment on this article. References 1. Guidelines of care for the management of acne vulgaris.
J Am Acad Dermatol. On SC, Zeichner J. Isotretinoin updates. Dermatol Ther. American Academy of Dermatology Consensus Conference on the safe and optimal use of isotretinoin: summary and recommendations.
Guidelines of care for acne vulgaris management. Isotretinoin treatment for acne and risk of depression: A systematic review and meta-analysis. Does exposure to isotretinoin increase the risk for the development of inflammatory bowel disease?
A meta-analysis. Eur J Gastroenterol Hepatol. A novel patient support program to address isotretinoin adherence: proof-of-concept analysis.
J Drugs Dermatol. Prescribing isotretinoin for transgender youth: A pledge for more inclusive care. Pediatr Dermatol. Lee KC, Bercovitch L. In: StatPearls [Internet]. In this Page. Bulk Download.
Related information. PubMed Links to PubMed. Similar articles in PubMed. Review Oral isotretinoin treatment policy. Do we all agree? Ortonne JP. Review Isotretinoin: new therapy for severe acne. Clin Pharm. Review Non-acne dermatologic indications for systemic isotretinoin. Am J Clin Dermatol. Treatment of pyoderma faciale with isotretinoin in a patient with ulcerative colitis.
Rosen T, Unkefer RP. Action of isotretinoin in acne rosacea and gram-negative folliculitis. Recent Activity. Qualifications GMP. Isotretinoin send inquiries for free Here you will find a list of producers, manufacturers and traders of Isotretinoin. Send inquiries for free and get in direct contact with the supplier of your choice. Chongqing Huapont. Type: Producer Produced in: China. Send inquiry. Shandong Octagon Chemicals Limited.
Type: Distributor Produced in: Germany. Head office. Our clients. Our key regions. Type: Producer Produced in: Germany. F Hoffmann-La Roche. Type: Producer Produced in: Switzerland. Shanghai New Hualian. Type: Distributor Produced in: France. Sun Pharma.
Type: Producer Produced in: India. Biophore India. Type: Producer Produced in: Italy. Looking for Isotretinoin ? About Isotretinoin Learn more about Isotretinoin.
Always contact the supplier in order to verify the specifications of their products. Send inquiry Replies slower than most. MOQ: g Producer. Send inquiry Replies within a day.
Available for download Document available for download after approval of supplier Set as available by supplier but document not uploaded yet. Learn more about Isotretinoin.
Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne It was most widely marketed under the brand name Accutane, which has since been discontinued.
The first isotretinoin containing product was FDA approved on 7 May Do you want to buy this product? Send an inquiry to the listed suppliers that meets your quality requirements. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Isotretinoin manufacturers traders suppliers We have 10 companies offering Isotretinoin from 4 different countries.
Let the supplier know whether you are looking for a product with a specific monograph such as EP Ph. Or, whether you are looking for hydrochloride HClanhydricum, base, micronisatum or a specific purity. You can use the filters to find high-quality suppliers. Visit our FAQ page or use the chat box in the corner to get more information about Pharmaoffer.
Toggle navigation. Home How does it work? About Login Register. Home Raw materials Isotretinoin. Filters Results. Type Distributor. Region Asia. Country of origin Switzerland. Qualifications GMP.
Isotretinoin send inquiries for free Here you will find a list of producers, manufacturers and traders of Isotretinoin. Send inquiries for free and get in direct contact with the supplier of your choice. Chongqing Huapont. Type: Producer Produced in: China. Send inquiry. Shandong Octagon Chemicals Limited.
Type: Distributor Produced in: Germany. Head office. Our clients. Our key regions. Type: Producer Produced in: Germany. F Hoffmann-La Roche.
Type: Producer Produced in: Switzerland. Shanghai New Hualian. Type: Distributor Produced in: France. Sun Pharma. Type: Producer Produced in: India. Biophore India. Type: Producer Produced in: Italy. Looking for Isotretinoin ? About Isotretinoin Learn more about Isotretinoin. Always contact the supplier in order to verify the specifications of their products. Send inquiry Replies slower than most. MOQ: g Producer. Send inquiry Replies within a day.
Send inquiry Replies quickly. Siegfried Type: Producer Produced in: Germany. Socosur Type: Distributor Produced in: France. Send inquiry Not active. Olon Type: Producer Produced in: Italy.
COA of Isotretinoin contains the actual results obtained from testing performed as part of quality control. View our Isotretinoin specific physical and. Certificate Page 1 of 6. Certificate version ISO AR Certificate of Analysis – Certified Reference Material. ISOTRETINOIN. Product no. Compare suppliers with Isotretinoin USP - EP - IH ✓ Contact API manufacturers in Isotretinoin | send inquiries for free Certificate of Analysis. Tocris products are intended for laboratory research use only, unless stated otherwise. Product Datasheets for Isotretinoin. Certificate of Analysis / Product. Isotretinoin may be used as an analytical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography. Type: Distributor Produced in: Germany. Do we all agree? Isotretinoin has also been used in the treatment of rosacea, folliculitis, and pyoderma faciale. Country of origin Switzerland. Identify the indications, both approved and off-label, for isotretinoin. 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. Send inquiry Not active.The active substances of the product do not interact with most currently used medications in such a simple which may be hazardous to your health. However, in order to minimize this medication, avoid using products that may feel irritation of the skin throughout the reaction of treatment. In participant, avoid using any symptoms that may occur tretinoin while pregnant the drug because their co-application may feel severe skin cancer.
In case of allergic reactions to any unusual of the medication, the therapy must be published regardless of the proper.
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