Tretizen 10 (Isotretinoin – Accutane)
Substance: Isotretinoin (Accutane)
Package: 10mg (10 capsules)
Isotretinoin (INN) (etymology and pronunciation), also known as 13-cis retinoic acid and first marketed as Accutane by Hoffmann-La Roche, is an oral pharmaceutical drug primarily used to treat severe nodular acne. Rarely, it is also used to prevent certain skin cancers (squamous-cell carcinoma), and in the treatment of other cancers. It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body. Its isomer, tretinoin, is also an acne drug.
Isotretinoin is primarily used as a treatment for severe acne. The most common adverse effects are a transient worsening of acne (lasting 2–3 weeks), dry lips (cheilitis), dry and fragile skin, and an increased susceptibility to sunburn. Uncommon and rare side effects include muscle aches and pains (myalgias), and headaches. Isotretinoin is known to cause birth defects due to in utero exposure because of the molecule’s close resemblance to retinoic acid, a natural vitamin A derivative which controls normal embryonic development.
In the United States a special procedure is required to obtain the pharmaceutical. In most other countries a consent form is required which explains these risks. Women taking isotretinoin must not get pregnant during, and for 1 month after isotretinoin therapy. Sexual abstinence, or effective contraception is mandatory during this period. Barrier methods by themselves (such as condoms) are not considered adequate due to the unacceptable failure rates of approximately 3%. Women who fall pregnant whilst on isotretinoin therapy are generally counselled to have a termination. Isotretinoin has no effect on male reproduction.
In 2009, Roche decided to remove Accutane from the US market after juries had awarded millions of dollars in damages to former Accutane users over inflammatory bowel disease claims. Other common brands are Roaccutane (Hoffman-La Roche, known as Accutane in the United States before July 2009),[D 1] Amnesteem (Mylan),[D 2] Claravis (Teva),[D 3] Absorica (Ranbaxy),[D 4] Isotroin (Cipla), and Epuris (Cipher).
Isotretinoin is used primarily for severe cystic acne and acne that has not responded to other treatments. Acne treatment usually begins with topical retinoids (e.g., tretinoin, adapalene), in combination with topical antibiotics (e.g., clindamycin, erythromycin) or antiseptics (e.g., benzoyl peroxide-containing preparations), followed by oral antibiotics (e.g., doxycycline or minocycline). In women a cyproterone acetate-containing contraceptive pill can be useful if there are no contraindications.
In cases of hormonal acne, such as in women in their 20s and 30s with cyclical acne, often a course of isotretinoin can permanently improve acne obviating the need for lifelong hormonal manipulation.[medical citation needed]
The primary indication for Isotretinoin is the treatment of severe cystic acne vulgaris. Many dermatologists also support its use for treatment of lesser degrees of acne that prove resistant to other treatments, or that produce physical or psychological scarring.
It is also somewhat effective for hidradenitis suppurativa and some cases of severe acne rosacea. It can also be used to help treat harlequin ichthyosis, lamellar ichthyosis and is used in xeroderma pigmentosum cases to relieve keratoses. Isotretinoin has been used to treat the extremely rare condition fibrodysplasia ossificans progressiva. It is also used for treatment of neuroblastoma, a form of nerve cancer.
Isotretinoin therapy has furthermore proven effective against genital warts in experimental use, but is rarely used for this indication as there are more effective treatments. Isotretinoin may represent an efficacious and safe alternative systemic form of therapy for RCA of the cervix. In most countries this therapy is currently unapproved and only used if other therapies failed.
Isotretinoin is a teratogen; there is about a 20%–35% risk for congenital defects in infants exposed to the drug in utero, and about 30%–60% of children exposed to isotretinoin prenatally have been reported to show neurocognitive impairment. Because of this, there are strict controls on prescribing isotretinoin to women who may become pregnant and women who become pregnant while taking isotretinoin are strongly advised to terminate their pregnancies.
In most countries, isotretinoin can only be prescribed by dermatologists or specialist physicians; some countries also allow limited prescription by general practitioners and family doctors. In the United Kingdom and Australia, isotretinoin may be prescribed only by or under the supervision of a consultant dermatologist. Because severe cystic acne has the potential to cause permanent scarring over a short period, restrictions on its more immediate availability have proved contentious. In New Zealand, isotretinoin can be prescribed by any doctor but subsidised only when prescribed by a vocationally-registered general practitioner, dermatologist or nurse practitioner.
In the United States, dispensing of isotretinoin is by an FDA-mandated website called iPLEDGE. iPLEDGE has applied to isotretinoin prescriptions since 1 March 2006. Under it, dermatologists must register their patients on the system before prescribing isotretinoin. Pharmacists must then verify the prescription on the iPLEDGE website before dispensing isotretinoin. The website allows no more than thirty days’ supply of the drug to be prescribed or dispensed; and after issuance, another prescription may not be written for at least 30 days (even in the case of lost prescriptions). Prescriptions expire from iPLEDGE if not picked up from the pharmacy seven days after issuance. Physicians and pharmacists must verify written prescriptions on the system before filling an isotretinoin prescription. Due to the teratogenic effects of isotretinoin, iPLEDGE makes additional requirements of female patients filling prescriptions for the drug: women with child-bearing potential must commit to using two forms of effective contraception simultaneously for the duration of isotretinoin therapy and for a month immediately preceding and a month immediately following therapy. Alerts continue to exist against purchasing isotretinoin online.
Most other national health services emphasise that isotretinoin is a teratogen, but do not impose the same stringent conditions on the dispensing process as the United States does. In Mexico and Brazil the use of the drug is restricted: official identification and a signature must be provided by the patient before an isotretinoin prescription will be filled by a pharmacist.
Clinical guidelines for most countries recommends or mandates that the dispensing physician monitor patients, or provide instructions to the patient’s regular doctor for monitoring. As part of the monitoring, patients’ blood is periodically re-tested throughout treatment for blood lipids, pregnancy, and several other factors. Women, diabetics, and patients with liver problems are particularly at risk and will be monitored especially closely.