Isocural 20mg/5mg Pierre Fabre is a high-quality generic drug used to treat acne, containing Isotretinoin as an active ingredient. It is manufactured by leading French company, known for high-quality cosmetics and pharmaceutical preparations. It comes in capsules of 5, 10, 20 and 30mg, making easier to choose the right dose.
Isotretinoin is a prescription based drug approved for the treatment of severe acne. It has many other off-label uses too, like the treatment of scars, patchy skin disorders, hyperactivity of sweat glands, wrinkles and stretch marks. It may also be indicated in some forms of cancer.
Isotretinoin must not be taken in pregnancy, and neither should women get pregnant while on therapy with the drug. It is proven to be teratogenic, chances of a child being born with birth defects are very high.
Side effects with Isotretinoin are common though mostly tolerable. Most common side effects are related to drying effect of the molecule on the skin and other secreting glands; hence one may get dry lips, eyes, and nose. The skin may become over sensitive to environment factors .
About Pierre Fabre
Pierre Fabre is a French multinational company, working in more than 130 countries and employing more than 13000 people globally. It claims to be second largest dermo-cosmetics company in the world. The company is involved in producing high-quality products to treat various dermatological conditions .
Pierre Fabre gets more than half of its turnover from dermo-cosmetics range and the rest is from pharmaceuticals and consumer healthcare. In pharmaceuticals apart from dermatology, the company produces drugs for onco-hematology and neuropsychiatry.
The company has strong R&D establishment, having a special focus on developing drugs for psychosis, chronic pain and various other diseases of central nervous system. Other research units of the company are focused on developing monoclonal antibodies and cytotoxic molecules for targeted therapies.
Pierre Fabre produces a wide range of products in consumer healthcare. This segment of products is for day to day health problems, like oral care, sore throat, allergies, nicotine addiction, etc.
Pierre Fabre is also actively developing its range of natural products; it uses more than 70 plant extracts in its products. It uses its expertise of natural extracts in developing and producing products for aromatherapy, skin nutrition, and health food.
Scientific Studies on Isotretinoin
Acne is inflammatory dermatosis and one of the top reasons for people visiting the dermatologist. Timely and adequate therapy is needed to minimize the physical and psychological scars to the patients. Dermatologists have to find the optimal regimen for treatment of acne, by choosing from the available options. Isotretinoin is one of the most effective drugs for the treatment of moderate to severe acne and optimizing the dose for each patient remains a challenge, as dermatologist has to balance between the effectiveness and safety of therapy. Due to common events of side effects isotretinoin is only prescribed when therapy with topical agents and oral therapy with other agents have failed.
In the clinical study done by Ahmad HM, the author compared the safety and efficacy of isotretinoin when taken once a day and twice a day. In his study “Analysis of Clinical Efficacy, Side Effects, and Laboratory Changes Among Patients with Acne Vulgaris Receiving Single Versus Twice-Daily Dose of Oral Isotretinoin” author divided 58 patients into two groups. Group one received isotretinoin once a day while group two was given twice a day. In his study author noticed that there was no difference in clinical efficacy of therapy, but therapy was better tolerated when given twice daily. Therapy did cause the mild rise in ALT, AST, cholesterol, and triglycerides in both groups .
In the study, “Oral Isotretinoin: New Developments Relevant to Clinical Practice. Dermatologic clinics” Tan J et al. concluded that for the treatment of acne isotretinoin is highly effective in efficacy and remission capability. Though lower doses are better in efficacy and tolerance, finding the optimal dose remains a challenge for the prescribers .
No doubt that isotretinoin has revolutionized the way acne vulgaris is treated. But it has also been noted that some patients need more than one course of treatment to achieve long-term remission. In the clinical studies done by Del Rosso JQ “Face to Face with Oral Isotretinoin: A Closer Look at the Spectrum of Therapeutic Outcomes and Why Some Patients Need Repeated Courses” author tried to identify the common reasons for the relapse of therapy in some individuals. For the long-term remission without relapse, patients must be exposed to the cumulative dose of 120 mg to 150mg/kg of isotretinoin. The author noticed and concluded in his studies that many patients fail to achieve this as they take isotretinoin on an empty stomach. Bioavailability of isotretinoin can be greatly increased if taken along with food, hence decreasing the rate of relapse of therapy .
Clinical adverse reactions of isotretinoin ingredient belong to two categories: systemic and mucocutaneous. In the study “Evaluation of Clinical Adverse Effects and Laboratory Alterations in Patients with Acne Vulgaris Treated with Oral Isotretinoin” Brito MD et al. studied the safety profile of isotretinoin in clinical practice. In the study, particular attention was paid to hepatic function and lipid profile of patients apart from commonly expected adverse effects from isotretinoin. In the study, 150 patients aged 15 to 32 were enrolled. In this study, it was noted that inflammation and drying of lips were most common complaints, there weren’t significant changes in ALT, AST, cholesterol and level of triglycerides. The study concluded that isotretinoin is safe and well-tolerated drug .
Description and Mechanism of Action of Isotretinoin
Isotretinoin is very close to vitamin A in its chemical structure. Mechanism of action of isotretinoin has been poorly understood. It is known that there are several mechanisms of action, and most are additive to each other in nature, thus explaining the efficacy of the drug.
Histological studies have established sebo suppression as one of the most important mechanisms of action of isotretinoin, it is also known to suppress the activity of Propionibacterium acnes. Isotretinoin also modulates the inflammatory and immunological responses. It decreases follicular hyperkeratinization.
Isocural Effects for Acne and Scars
Isocural has been approved as a treatment for moderate to severe nodular acne that has failed to respond to other therapeutical measures. Usually, benefits of the product in people suffering from acne are visible after one month of therapy. It clears the skins from scars (suppresses hyper keratinization) and pigmentation patches. Sometimes dermatologists may prescribe the product in low doses as a remedy for wrinkles. Overall therapy with Isocural results in long-term remission of acne, resulting in clear before and after results visible on skin free from scars.
Recommended Doses and Duration of Therapy
Recommended dose for the treatment of acne vulgaris is 0.5 to 1mg/kg/day, and treatment should be continued for at least 4 months, though for most of the patients a longer period of therapy may be required. It has been established that for the long-term remission of disease patient must be exposed to a cumulated dose of 120mg/kg or above. Some trials indicate that if the patient has poor tolerance to the drug than it is better to give the low dose therapy for the longer duration of time.
Side Effects and Warnings
Mucocutaneous and ophthalmological side effects of isotretinoin are common, they are mainly caused due to the drying effect of the drug. Teratogenicity is the biggest issue with isotretinoin, and it is absolutely contraindicated in pregnant women or women who are planning to have a pregnancy. In recent years’ depression related to isotretinoin has also been included in the list of warnings. Musculoskeletal and gastrointestinal side effects are also common. In some people, it may also lead to dyslipidemia or changes in hepatic and pancreatic function .
Retinoids don’t interfere much with other medications. Use of isotretinoin with tetracycline and phenytoin isn’t recommended due to the risk of cranial hypertension. The combination with lithium is to be avoided due to unwanted additive effect, which may worsen depression. The combination with potential hepatotoxic or photosensitizing medicines should also be avoided .
There are no customer reviews available for Isocural. The reason of this lack may be due to the poor online availability of the product or the fact that it is a prescription based product. The lack of online reviews makes decision process for consumers far difficult, as in the online world more than 80% buying decisions are made after reading the reviews of other customers or users of the product.
The absence of customer reviews should not worry consumers regarding this product as a manufacturer of this brand is well known. There are thousands of reviews on the internet about this particular molecule. As one of the customers using Accutane said “This drug is effective at treating acne. No Question. It’s amazing at accomplishing these ends. Period. That being said, Accutane is all about trade-offs. You will have side effects. You well almost certainly have extremely dry/fragile skin, wickedly dry/cracked lips…” This customer review summarizes what can be expected from any brand containing isotretinoin.
Price, Available Forms, and Dosage
Isocural is available in 5, 10, 20 and 30mg capsules. This is a prescription product, and its sale is strictly regulated. Hence in EU member states product can only be shipped after the submission of a copy of prescription by the authorized prescriber. Considering the legal hurdles, it may not be possible to ship to some countries.
Isocural can be shipped to the US, Australia and EU member states after submission of prescription, the cost of the product is 11.20 USD for the 5mg dose (pack of 30 capsules), it should be noted that extra charges for shipment may be applied.
Conclusion and Rating
Beyond doubt, that isotretinoin is the most effective drug for the treatment of moderate to severe acne available in the market today. This fact is well established based on a large number of clinical trials and more than four decades of experience of dermatologists.
From the clinical trials, it could be concluded that product should be taken over an extended period of time, and dosage should be optimized for each individual. For most cases of acne, it should be taken for at least 4 months or more. When it comes to dosing there are two strategies, one is to start with a higher dose and slowly taper down the dose, another being a long term low dose therapy. In the end, for therapy to be efficient and patient to get long-term remission without relapse of acne, it is important that patient is exposed to a cumulative dose of 120mg/kg or above. It has also been established by clinical trials that bioavailability of product is much higher when taken with food. One should avoid taking it on an empty stomach.
When it comes to safety profile, the product is well tolerated by most patients, though some side-effects like drying and cracking of lips, complaints of dry eye are very common. The product has been established as being toxic for growing fetus and hence pregnancy is an absolute contraindication.
At the end taking into consideration the high clinical effectiveness of isotretinoin, and understanding the fact that it helps in most cases where other therapies have failed, it would be wise to give the product 4 points out of 5. The product cannot be given 5 points as safety is a major concern.
Isocural Wiki Facts
- Brand: Isocural
- Active Ingredient: Isotretinoin
- Treatment: Acne
- Manufacturer: Pierre Fabre
- Country of Manufacture: Belgium
- Availability: USA, EU, UK, Belgium ++
- Guidance, Isotretinoin for severe acne: uses and effects. Available from: https://www.gov.uk/government/publications/isotretinoin-for-severe-acne-uses-and-effects/isotretinoin-for-severe-acne-uses-and-effects
- Pierre Fabre. Company information. Available from: http://www.pierre-fabre.com/en
- Ahmad HM. Analysis of clinical efficacy, side effects, and laboratory changes among patients with acne vulgaris receiving single versus twice daily dose of oral isotretinoin. Dermatologic therapy. 2015 May 1;28(3):151-7. Available from: http://onlinelibrary.wiley.com/doi/10.1111/dth.12213/full
- Tan J, Boyal S, Desai K, Knezevic S. Oral Isotretinoin: New Developments Relevant to Clinical Practice. Dermatologic clinics. 2016 Apr 30;34(2):175-84. Available from: https://www.ncbi.nlm.nih.gov/pubmed/27015777
- Del Rosso JQ. Face to face with oral isotretinoin: a closer look at the spectrum of therapeutic outcomes and why some patients need repeated courses. J Clin Aesthet Dermatol. 2012 Nov 1;5(11):17-24. Available from: http://jcadonline.com/face-to-face-with-oral-isotretinoin-a-closer-look-at-the-spectrum-of-therapeutic-outcomes-and-why-some-patients-need-repeated-courses/
- Brito MD, Sant’Anna IP, Galindo JC, Rosendo LH, Santos JB. Evaluation of clinical adverse effects and laboratory alterations in patients with acne vulgaris treated with oral isotretinoin. Anais brasileiros de dermatologia. 2010 Jun;85(3):331-7. Available from: http://www.scielo.br/pdf/abd/v85n3/en_a06v85n3.pdf
- Isotretinoin side effects. Charakida A, Mouser PE, Chu AC. Safety and side effects of the acne drug, oral isotretinoin. Expert opinion on drug safety. 2004 Mar 1;3(2):119-29. Available from: http://www.tandfonline.com/doi/abs/10.1517/147403188.8.131.52
- Isotretinoin drug interactions.Berbis P. [Retinoids: drug interactions (editorial)]. InAnnales de dermatologie et de vénéréologie 1991 Oct 3 (Vol. 118, No. 4, pp. 271-2). Available from: http://www.popline.org/node/317209