Isoskin and Birth Defects
Today, women and men must agree to follow guidelines in iPLEDGE program before taking Isoskin.
iPLEDGE requires that you and your doctor and pharmacist follow certain detailed steps to ensure your safety and prevent pregnancy while you are being treated with the drug.
Although requirements vary according to your gender and stage of life, iPLEDGE requires that people who are able to reproduce use two forms of birth control while taking Isoskin.
Your doctor will enroll you in the iPLEDGE program. Then, before filling your prescription, your pharmacist will verify your enrollment and make sure you meet the program's requirements.
What are the uses for Isoskin?
- Isoskin is used to treat severe acne that is resistant to more conservative treatments such as creams, drying agents, and topical or oral antibiotics. Complete remission or prolonged improvement is seen in many patients after one course of 15 to 20 weeks of Isoskin. Because of its serious side effects, Isoskin should be used only for severe resistant acne.
- Because Isoskin causes birth defects, Isoskin is sold only under a special program approved by the Food and Drug Administration called iPLEDGE. Isoskin can only be prescribed by healthcare providers and dispensed by pharmacies registered in iPLEDGE.
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Is Isoskin safe to take if I'm pregnant or breastfeeding?
- Isoskin is harmful to the fetus and therefore should not be used during pregnancy. Women of childbearing age must have two negative pregnancy test results before therapy is started, and a pregnancy test must be conducted during each month of therapy. Two effective forms of birth control must be used during therapy, and pregnancy should be avoided one month before, during, and at least one month after stopping Isoskin.
- It is not known whether Isoskin is secreted in breast milk, but because of its potentially serious side effects, it should not be used by nursing mothers.
Treatment of systemic s >Pregnancy must be excluded before and during treatment with Isoskin
In an otherwise healthy individual, blood tests are generally not needed, but monitoring may be a variable prescribing requirement in some countries. If using high dose Isoskin (1 mg/kg/day), a prolonged course (> 12 months), or if a patient has specific risk factors (eg, family history of dyslipidaemia , viral hepatitis, or high alcohol intake), these tests are indicated prior to treatment and at intervals.
- Cholesterol and triglyceride levels
- Liver function tests
- Blood count.
What are the side effects of Isoskin?
The most common side effects of Isoskin are:
- Dry skin,
- Dry nose,
- Nosebleeds (epistaxis),
- Cracks in the corners of the mouth (chilitis),
- Dry mouth,
- Inflammation of the whites of the eyes.
Joint aches also are common. Patients may develop an increase in blood cholesterol and triglycerides. Psychiatric problems such as depression, hallucinations and suicidal behavior have been reported.
Other side effects include:
Serious side effects include:
Rarely, Isoskin can cause brain swelling (pseudotumor cerebri or intracranial hypertension), which produces nausea, vomiting, headache, and changes in vision.
Erythema multiforme and severe skin reactions (for example, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been associated with Isoskin use. These events may be serious and result in life-threatening events or death, hospitalization, or disability. Patients should be monitored closely for severe skin reactions, and Isoskin discontinued if necessary.
Isoskin is contraindicated in female patients who are pregnant. To receive Isoskin all patients must meet all of the following conditions:
- Must be registered with the iPLEDGE program by the prescriber
- Must understand that severe birth defects can occur with the use of Isoskin by female patients
- Must be reliable in understanding and carrying out instructions
- Must sign a Patient Information/Informed Consent (for all patients) form that contains warnings about the potential risks associated with Isoskin
- Must fill and pick up the prescription within 7 days of the date of specimen collection for the pregnancy test for female patients of childbearing potential
- Must fill and pick up the prescription within 30 days of the office visit for male patients and female patients not of childbearing potential
- Must not donate blood while on Isoskin and for 1 month after treatment has ended
- Must not share Isoskin with anyone, even someone who has similar symptoms
S >Isoskin has many side effects but most are predictable and rarely interfere with the patient management. The common mucocutaneous side effects are dose dependent and rendered tolerable by modification of the dose and/or additional symptomatic therapy.
Teratogenicity is well recognized and regarded as one of the most serious potential adverse effects. 52 Fifty percent of pregnancies spontaneously abort, and of the remainder about half of the infants are born with cardiovascular or skeletal deformities. The European Directive and iPLEGDE in the USA have addressed the importance of pregnancy prevention as discussed previously. Discussion about the teratogenicity and recognized side effects should be recorded in the notes at each visit, and patients should be given appropriate written information.
Mood changes including depression are common among adolescents and have been reported in acne patients treated with Isoskin. Two studies that looked at spontaneous reports of side effects for the FDA in the USA 53 , 54 found little or no increase in psychiatric disease including depression and suicide over the background prevalence in the adolescent population. A further study of general practice databases in Canada and the UK showed similar findings as have subsequent studies. 55 A more recent controlled case cross-over study demonstrated a relative risk for depression of 2.68 (95% CI = 1.03 to 3.89) for acne patients exposed to oral Isoskin. 56 This is the first controlled study to find a statistically significant association between Isoskin and depression. Despite contradictory reports clinicians have been advised of a potential rare idiosyncratic reaction in some young vulnerable patients which could lead to mood changes and clinical depression during treatment with Isoskin. It is therefore advisable to specifically enquire about related symptoms at each clinic visit.
If significant depression is identified, then a psychiatric referral may be indicated. Increased aggression has been identified in some male patients and the FDA in the USA has advised clinicians to warn potential patients about this side effect. If there is any doubt, the drug must be stopped.
The mucocutaneous side effects are dose dependent and can usually be controlled with regular use of moisturizers and lip salves. Occasionally retinoid dermatitis, a severe retinoid cheilitis or conjunctivitis occur, often complicated by secondary infection with S. aureus. These patients may need treatment with an intermediate-strength steroid ointment combined with an antiseptic. If there is impetiginization, oral anti-staphylococcal therapy such as flucloxacillin and/or topical mupirocin 2% ointment may be required. 57 A nasal preparation of mupirocin can be used to eradicate nasal carriage of staphylococci. Table 4 summarizes the most common mucocutaneous problems that may arise from Isoskin use.
Following oral administration of an 80 mg dose of 14C-Isoskin as a liquid suspension, 14Cactivity in blood declined with a half-life of 90 hours. The metabolites of Isoskin and any conjugates are ultimately excreted in the feces and urine in relatively equal amounts (total of 65% to 83%). After a single 80 mg oral dose of Accutane (Isoskin) to 74 healthy adult subjects under fed conditions, the mean ± SD elimination half-lives (t½) of Isoskin and 4-oxo-Isoskin were 21.0 ± 8.2 hours and 24.0 ± 5.3 hours, respectively. After both single and multiple doses, the observed accumulation ratios of Isoskin ranged from 0.90 to 5.43 in patients with cystic acne.
Isoskin is a retino >Label It was most w >10 Isoskin is associated with major risks in pregnancy and so it is only available under the iPLEDGE program in the United States. 12 The first Isoskin containing product was FDA approved on 7 May 1982. 10
Isoskin is dangerous for unborn babies.
Women of childbearing years should take a pregnancy test before starting this medication. You should also use an effective form of birth control, plus a backup method.
You shouldn’t get pregnant for four weeks after you stop taking it. If you do get pregnant, stop taking the medication and tell your doctor right away.
Taking Isoskin during pregnancy can cause miscarriage, death of the fetus, or premature birth. It can also lead to severe birth defects such as:
- small or missing ears
- hearing loss
- small eyes, which is called microphthalmia
- missing eyes
- a small or missing thymus gland, which is responsible for making white blood cells
- a cleft palate
- congenital heart defects
It can also cause a buildup of fluid and pressure on the brain called hydrocephalus. This can lead to intellectual disabilities.
Babies may be born with an underdeveloped brain and small head, which is called microcephaly. This can lead to intellectual and developmental disabilities.
Men who take Isoskin may have some of the drug in their semen. It’s not clear if that can cause birth defects. It’s also unclear whether the drug passes to your baby through breast milk. You shouldn’t breastfeed while taking it.
Anyone who plans on taking Isoskin must register with iPLEDGE. The FDA-approved restricted distribution program is designed to inform people about the risks of birth defects and to prevent pregnancy while taking the drug.
Isoskin (Claravis, Amnesteem, Absorica, Myorisan, Zenatane, Sotret, Accutane) is a drug prescribed for the treatment and prevention of severe acne. Side effects include dry nose, nosebleeds, dry Mouth, dry skin, itching. Drug interactions, warnings and precautions, and pregnancy and breastfeeding safety information should be reviewed prior to taking any drug.
Acne is a common condition that occurs in 35% to 90% of adolescents. 1 In this population, severe acne is associated with an increased risk of mental illness, poor social functioning, and suicide. 2 Accordingly, acne cannot be considered a trivial condition. Although multiple topical and oral therapies are used to treat acne, Isoskin is the most effective drug currently available, 3 ’ 4 and since it received US Food and Drug Administration (FDA) approval in 1982, 5 it has revolutionized treatment. Isoskin improves quality of life, 6 , 7 psychiatric symptoms, 8 and social function. 8 However, in the past 30 years, concerns have been raised that Isoskin use can lead to the development of IBD. Recently, successful civil litigation based on this proposed relationship has occurred that has made physicians fearful of prescribing Isoskin to their patients.
Những điều bạn cần lưu ý khi dùng thuốc cho những trường hợp đặc biệt (mang thai, cho con bú, phẫu thuật…)
Vì Isoskin có thể được hấp thu qua da và phổi và gây hại cho thai nhi, phụ nữ có thai hoặc đang mang thai không nên dùng thuốc này.
Bạn nên dùng thuốc Isoskin như thế nào?
Bạn cần nuốt toàn bộ viên nang, đừng nghiền hoặc nhai chúng. Bạn thường dùng Isoskin hai lần mỗi ngày trong 15-20 tuần hoặc theo chỉ dẫn của bác sĩ. Thuốc nên dùng chung với bữa ăn. Bạn hãy hỏi bác sĩ hoặc dược sĩ để biết thêm thông tin.
Bạn uống thuốc này với một ly nước đầy và không nằm sau khi uống trong 10 phút.
Liều dùng sẽ dựa trên tình trạng sức khỏe, cân nặng và đáp ứng với điều trị của bạn.
Bạn cần lưu ý rằng tình trạng mụn trứng cá có thể nghiêm trọng hơn trong vài ngày đầu sau khi dùng thuốc này và sẽ mất đến 1-2 tháng trước để bạn thấy tác dụng rõ rệt của thuốc. Nếu mụn trứng cá tái phát nghiêm trọng, bạn cần một đợt điều trị thứ hai sau khi đã ngừng dùng thuốc trong 2 tháng. Các bác sĩ khuyến cáo người dùng không nên sử dụng Isoskin trong thời gian dài. Bạn không được dùng liều nhiều hơn liều được bác sĩ quy định.
3. Who can and can't take Isoskin capsules
Isoskin capsules are for teenagers and adults with severe acne. Do not give Isoskin capsules to children under the age of 12 years or before puberty.
Isoskin capsules aren't suitable for some people.
Do not take Isoskin capsules if you:
- have had an allergic reaction to Isoskin, soya (the capsules contain soya) or any other medicines in the past
- have an inherited digestive disorder called fructose intolerance (the capsules contain sorbitol)
To make sure Isoskin capsules are safe for you, tell your doctor if you:
- have had a mental health illness like depression
- are pregnant or think you could be, or you're breastfeeding
- have ever had an allergic reaction to Isoskin or any other medicine
- have liver or kidney disease
- have high levels of cholesterol or other fats in your blood
- have high levels of vitamin A
- have Crohn's disease or ulcerative colitis
If you have diabetes, talk to your doctor before beginning treatment with Isoskin capsules. You may need extra monitoring while you take Isoskin capsules as this medicine can cause a rise in blood sugar levels.
Like all medicines, Isoskin capsules can cause side effects, although not everyone gets them. Side effects will usually go away when you stop treatment.
Dry skin and lips are very common side effects. For safety, do not have any waxing, dermabrasion, or laser skin treatment while you're taking this medicine and for at least 6 months after you stop, as this could cause scarring or skin irritation.