Acneral 20/10 mg is an oral treatment for acne which contains Isotretinoin (ISO), an active pharmaceutical ingredient (API) proven effective in treating acne in patients with mild to severe forms of acne . The API contained in Acneral (Isotretinoin) is proven effective, as ISO is the first option and the last line of treatment for acne cases in patients.
The product, Acneral is manufactured by Laboratorio Chile and may be bought in two formulations, the 10 mg and the 20 mg capsules containing the Isotretinoin active ingredient. Currently, the only form of Acneral which can be bought is the capsule form , as there is no other Acneral product manufactured by Laboratorio Chile aside from the oral capsule ISO form. Isotretinoin exists in gel, cream, and soap form too, but the company does not currently offer other ISO product types.
Laboratorio Chile Information
The company, Laboratorio Chile has been in the pharmaceutical manufacturing business for about 120 years, as the company started 1896, and was the first medical laboratory (and the largest, to-date) manufacturing medications in Chile . Being the largest manufacturer of medications in the country, it is said that 1 out of every 4 medications bought in the country is from Laboratorio Chile . It is so because the company is also the largest (in terms of volume) maker of generic medications in Chile.
Medications sold by Laboratorio Chile involve a wide range of products for various medical categories . The company is home to more than 1,800 drugs which is made by the company’s 87 plants and 87,000 employees from all over the world . The company works on a large-scale level and under the accreditation of the WHO for GMP.
Laboratorio Chile is not only a leading company when it comes to the massive production of drugs; it is also an environment-friendly company. It has its own system, the Bioclima, which harnesses the earth’s natural energy in core-temp stabilization in its facilities . Recently, Laboratorio Chile has been made a part of Teva, which is included in the 10 leading pharmaceutical companies in the world .
Studies on Isotretinoin for Acne
According to the study, “A randomized comparative trial of two low-dose oral isotretinoin regimens in moderate to severe acne vulgaris” by Dhaked et.al., oral treatments containing Isotretinoin as an active pharmaceutical ingredient (API) are “highly effective” in treating acne . Even in low doses, or less than 0.5 mg/kg per day, ISO treatments are still effective . The study aimed to compare the effectiveness of the 20 mg daily dose with the 20 mg dose taken alternatively, on moderate to severe acne vulgaris . The results of the study showed that both dosages were effective in treating acne symptoms in patients, though the alternate 20 mg per day was found out to be more efficient in treating the moderate acne type, while the other one, the 20 mg daily dose is better indicated for severe acne .
Although the effectiveness of Isotretinoin for all acne types is implied, other treatments were continuously compared against it to see whether other treatments were also as effective or more effective in treating acne. The study, “Fixed-Dose Combination Gel of Adapalene and Benzoyl Peroxide plus Doxycycline 100 mg versus Oral Isotretinoin for the Treatment of Severe Acne: Efficacy and Cost Analysis” made by Penna et.al. in 2014, tested the effectiveness of a compound gel treatment made of Benzoyl Peroxide, Adapalene, and Doxycycline 100 against the oral ISO treatment . The efficacy of these two treatments was evaluated in the course of the study, and it was determined that both drugs are effective in treating acne in patients. Initial results indicated that the patients showed 72% reduction in acne lesions upon the use of the compound gel treatment, whereas using oral ISO treatment caused 80-90% reduction of the initial lesions. But aside from the effectiveness of the products, a cost-analysis was also done for the two products. It determined, though, that the most cost-effective treatment is the use of the Adapalene gel, which is relatively cheaper when compared with the oral ISO treatment . The authors also concluded that aside from the cost-effectiveness, the gel treatment is also safer to use than the oral formulation of the product .
Albeit Isotretinoin is proven to treat acne, especially the severe ones acne conglobata, and acne nodulocystica, there had been concerns about its adverse effects and its teratogenicity. The study, “Monitoring of isotretinoin therapy by measuring the plasma levels of isotretinoin and 4-oxo-isotretinoin. A useful tool for management of severe acne” conducted by Almond-Roesler et.al. in 1998 examined the mucocutaneous effect of Isotretinoin in patients . The long-term effect of ISO in patients was studied by analyzing the plasma levels of ISO and its 4-oxo-isotretinin, which are correlated to the appearance of adverse effects in patients . Authors concluded that measuring the plasma levels of ISO and its metabolite should be considered to prescribe the most appropriate dose of ISO in patients and avoid systemic and other side effects .
Isotretinoin is known to lessen the inflammation and acne lesions present in the patients by encouraging cell apoptosis, primarily of the sebaceous gland cells, responsible for excessive oil production in patients having severe acne (“Temporal changes in gene expression in the skin of patients treated with isotretinoin provide insight into its mechanism of action” by Nelson et.al.) . Isotretinoin also has a direct effect in lessening the inflammation as manifested by the lessened lesion count in patients. The API also has a direct effect in P.acnes, which is a bacteria mediating the proliferation of acne lesions in patients.
Isotretinoin Effects for Acne and Scars
Since Acneral 20/10 mg contains 20 mg of Isotretinoin which is an effective dose for acne management in patients as determined by research , patients can expect to see the benefits after weeks of Acneral use, or any Isotretinoin-containing product. Patients may expect a significant difference in the before and after effects in terms of lesion counts present also may observe less inflammation and healing on their breakouts. Since Isotretinoin has a direct effect on sebum production, the patients will also observe less oil production and less pore blockage, therefore leading to lesser occurrences of whiteheads, blackheads, and pimples.
Some patients also see improvements on their acne scars due to Isotretinoin’s action in the skin’s collagen fibers. Because of this consequence too, Isotretinoin-containing products are also being used by a number of practitioners for cosmetic purposes, like eliminating wrinkles or stretch marks in their clients. But, since this practice has not yet been approved by the FDA, Isotretinoin continues to be an off-label treatment for these conditions.
Duration of Therapy and Recommended Doses
There are several studies which found the 20 mg per day effective in treating severe acne . The recommended ISO use for acne treatment is the intake of anywhere between 10 mg to 40 mg of Isotretinoin. The doctors are prescribing 0.5 to 2 mg/kg per day , depending on the intensity of the acne condition present. The length of therapy for the treatment is dependent upon the patient’s response to the drug , and usually, the product is prescribed until the acne clears.
Isotretinoin-containing medications like Acneral is recommended to be taken with food, as it is more effectively absorbed when taken with meals . Without food intake, the patients may experience less effectiveness of the drug.
Side effects to Be Aware of and Warnings
Side effects of Isotretinoin had been controversial in the past years, especially regarding its teratogenicity. The drug is highly contraindicated for women who are pregnant or who may get pregnant, as studies link ISO to birth defects, or if not, pre-termination of pregnancies. Common minor side effects if ISO includes scaling or crusting of the skin, general dryness of the mouth/eyes/lips, mild headaches, peeling of the skin, stomach upset, and hair thinning . As for the more common major side effects, patients may experience epistaxis, joint pain, eye inflammation, lip inflammation, and skin infection .
Since the side effects are established for the usage of ISO-containing medication, Acneral users should also be wary of the adverse effects. The minor side effects are nothing to worry about, but if any of the side effects become troublesome and persistent, then patients should immediately seek the advice of their GP.
There are a number of drug interactions detected for Isotretinoin and most of the drug interactions were between ISO and antibiotics. There are about 26 major drug interactions from 235 brand/generic names found for Isotretinoin and some examples of drugs interacting with ISO include Adderall, Ambien, Fish Oil, Ibuprofen, Klonopin, Prozac, Topamax, and several others .
As for Acneral 20/10 mg oral treatment for acne, there were no available reviews for the product. It may be because the product has not been found online, as it may be exclusively sold in Chile. But, since the effectiveness of Isotretinoin is established in acne treatment, it can be said that Acneral may also be effective as an oral treatment for various acne cases, even those which are severe in nature.
Price, Available Forms, and Dosage
Acneral exists in 10 mg and also 20 mg form, and the dose patients should take depend entirely upon the advice of the physician. As for other forms of ISO manufactured by Laboratorio Chile, the company only makes the oral form of ISO. Laboratorio Chile doesn’t have the topical gel or cream form.
As for the product’s availability, Acneral 20/10 mg oral capsules are not available anywhere online. It may be that the product, like mentioned earlier, is exclusively sold in Chile only. Consumers even from the USA, Australia, and Canada may not be able to purchase the product, as there is no online store with Acneral which can ship worldwide. However, there are other oral ISO treatments available which are available internationally.
Conclusion and Rating
Oral ISO formulations are proven effective in the treatment of acne in patients. The effect of Isotretinoin makes it a good choice in acne management, as there is apparent effectiveness noted in its use. The downside of the API, though, is that it has a number of side effects related to its use, and is also teratogenic in nature.
One of the available oral Isotretinoin formulations is Acneral 20/10 mg from Laboratorio Chile. Since it contains ISO in the proven effective doses, it can be said that the product is highly effective too. The product is also manufactured by Chile’s largest and first drug manufacturer, which is compliant with WHO-GMP standards, so there is no actual question about the product quality.
However, there is not much information regarding the product as it is not available online yet. Acneral is not available for international clients, and client/user reviews are also unavailable. Still, I think the product deserves a positive rating—3 stars out of 5 at least since the quality of the product is implied. There may still be restrictions on its international sale, though, which caused its unavailability online and its lack of reviews.
Acneral Wiki Facts
- Brand: Acneral
- Active Ingredient: Isotretinoin
- Treatment: Acne
- Manufacturer: Laboratorio Chile
- Country of Manufacture: Chile
- Availability: Chile +
- Isotretinoin: Treatment for severe acne. Accessible: https://www.aad.org/public/diseases/acne-and-rosacea/isotretinoin-treatment-for-severe-acne
- Md Acneral. Accessible: http://www.doctoralia.cl/medicamento/acneral+md-97558
- Un líder de la industria farmacéutica al servicio de la salud chilena. Accessible: https://www.laboratoriochile.cl/nuestra-empresa/quienes-somos/
- Productos. Accessible: https://www.laboratoriochile.cl/productos/
- Dhaked DR, Meena RS, Maheshwari A, Agarwal US, Purohit S. A randomized comparative trial of two low-dose oral isotretinoin regimens in moderate to severe acne vulgaris. Indian Dermatology Online Journal. 2016 Sep;7(5):378. Accessible: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5038098/
- Penna P, Meckfessel MH, Preston N. Fixed-dose combination gel of adapalene and benzoyl peroxide plus doxycycline 100 mg versus oral isotretinoin for the treatment of severe acne: efficacy and cost analysis. American health & drug benefits. 2014 Jan;7(1):37. Accessible: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4031741/
- Almond-Roesler B, Blume-Peytavi U, Bisson S, Krahn M, Rohloff E, Orfanos CE. Monitoring of isotretinoin therapy by measuring the plasma levels of isotretinoin and 4-oxo-isotretinoin. Dermatology. 1998 Mar 13;196(1):176-81. Accessible: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~yNm8Pa:9:@[email protected]@/cgi-bin/sis/search2/d?./temp/~tvkjPW:[email protected]
- Nelson AM, Zhao W, Gilliland KL, Zaenglein AL, Liu W, Thiboutot DM. Temporal changes in gene expression in the skin of patients treated with isotretinoin provide insight into its mechanism of action. Dermato-endocrinology. 2009 May 1;1(3):177-87. Accessible: http://www.tandfonline.com/doi/abs/10.4161/derm.1.3.8258
- Isotretinoin Dosage. Accessible: https://www.drugs.com/dosage/isotretinoin.html
- Isotretinoin Side Effects. Accessible: https://www.drugs.com/sfx/isotretinoin-side-effects.html
- Accutane (isotretinoin) Drug Interactions. Accessible: https://www.drugs.com/drug-interactions/isotretinoin,accutane.html