Monday, July 26, 2010

Roaccutane- Vitamin A (Isotretinoin) in a Capsule

This product is available for the treatment of severe acne.

However, it must be noted that the product is usually only prescribed by a skin specialist because it has many adverse effects.

It is NOT to be taken by pregnant ladies because it will cause teratogenicity (ie babies born will have physical defects).

Not to be used with Tetracycline antibiotics because it may cause increased in intracranial pressure and may be lead to fatality. 

Other Contraindications & Precautions:
  1. Use effective contraception for one month before, during and at least one month after treatment.
  2. Breast-feeding must stop before treatment can start.
  3. An allergy to Roaccutane, Vitamin A, or other retinoids.
  4. Kidney or liver disease.
  5. Very high levels of fat (triglycerides, cholesterol) in the blood. 
  6. Excessive amount of Vitamin A in your diet (hypervitaminosis A). 

Below is an article from wikipedia (abridged) regarding the above product. Please read 

Clinical use

Except in the most severe cases, isotretinoin is used only after other acne treatments fail to produce results. Treatment of acne usually begins with topical medications (e.g. benzoyl peroxide, adapalene, etc.), followed by oral antibiotics (or a combination) and finally isotretinoin therapy. This is because other treatments, while less effective than isotretinoin, are thought to be associated with fewer adverse effects and lower cost.


Isotretinoin is indicated for 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 effective for hidradenitis suppurativa and some cases of severe acne rosacea.It can also be used to help treat harlequin 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 brain cancer.

Prescribing restrictions

In the United Kingdom, this drug may only be prescribed by, or under the supervision of, a consultant dermatologist. A physician may not prescribe more than a 30-day supply. A new prescription may not be written for at least 30 days. 


The dose of isotretinoin a patient receives is dependent on their weight and the severity of the condition. High dose treatments are administered between 0.5 mg/kg/day to 2 mg/kg/day (usually at 0.5 to 1 mg/kg/day, divided into two doses), for a total treatment of 4–6 months. In some rare cases where the patient's acne is severe or unresponsive the initial course may last up to 9 months. A second course may be used at least 8 weeks following the cessation of the initial course if severe acne recurs. Efficacy appears to be related to the cumulative dose of isotretinoin taken, with a total cumulative dose of 120–150 mg/kg used as a guideline. High dose treatments should only be used as a last resort due to adverse side effects.

Nearly all patients achieve initial clearing of acne during high-dose isotretinoin therapy. Furthermore, about 40% observe complete and long-term remission of the disease following one course of isotretinoin, while another 40% eventually develop less severe recurrent acne, which is treatable with less invasive medications. The remaining 20% relapse significantly enough to warrant an additional course of isotretinoin.

Lower dosage treatments, such as 10–20 mg/day (approximately half the high dosage treatments above), are also highly effective, with greatly diminished side effects.However, such lower dosage courses may be associated with higher relapse rates requiring additional courses of isotretinoin.

Adverse effects 

Increasingly higher dosages will result in higher toxicity, resembling vitamin A toxicity.

Adverse drug reactions associated with isotretinoin therapy include:

    * Common: Extreme severe acne flare, dryness of skin, lips and mucous membranes, infection of the cuticles, cheilitis, itch, rosacea, skin fragility, skin peeling, rash, flushing, nose bleeds, dry eyes, diffuse alopecia areata, eye irritation, conjunctivitis, reduced tolerance to contact lenses, hyperlipidaemia, raised liver enzymes, permanent thin skin, headaches, temporary/permanent hair thinning (this could start or continue after treatment), myalgiaarthralgia, back pain. and/or

    * Infrequent: mild acne flare, raised blood glucose level, decreased libido/erectile dysfunction, increased erythrocyte sedimentation rate, fatigue.

    * Rare: impaired night vision; cataracts; optic neuritis; menstrual disturbances; inflammatory bowel disease; pancreatitis; hepatitis; corneal opacities; papilloedema; idiopathic intracranial hypertension; skeletal hyperostosis; extraosseous calcification; psychosis; depression

There are reports of spontaneous, premature epiphyseal closure in acne patients receiving recommended doses of Accutane. The effect of multiple courses of Accutane on epiphyseal closure is unknown.

The following adverse effects have been reported to persist, even after discontinuing therapy: alopecia (hair loss), arthralgias, decreased night vision, inflammatory bowel disease, degenerative disc disease, keloids, bone disease. High dosages of isotretinoin have been reported to cause rosacea (a disease of severe facial skin redness and irritation).

During of a prospective study in Mexico that evaluated the efficacy and safety of isotretinoin in acne, six male patients reported clinical symptoms of depression along with difficulties in maintaining adequate penile erection, suggesting a potential link between isotretinoin and risk of erectile dysfunction.

Patients receiving isotretinoin therapy are not permitted to donate blood during and for at least one month after discontinuation of isotretinoin therapy due to its teratogenicity.Its most common side effects are mucocutaneous and ocular in nature (ie, cheilitis, ocular sicca, and decreased dark adaptation). It can also cause xerosis. Patients should be made aware of these side effects before taking isotretinoin and also that utilization of moisturizers and eye drops can help to mitigate such side effects. Sometimes, however, the dose of isotretinoin needs to be decreased to reduce the induction of side effects.

Teratogenicity (Birth Defects)

Isotretinoin is a teratogen and is highly likely to cause birth defects if taken during pregnancy. A few of the more common birth defects that this drug can cause are hearing and visual impairment, missing or malformed earlobes, facial dysmorphism, and mental retardation. Isotretinoin is contraindicated in pregnancy.

The manufacturer recommends that pregnancy be excluded in female patients two weeks prior to commencement of isotretinoin, and that they should use two simultaneous forms of effective contraception at least one month prior to commencement, during, and for at least one month following isotretinoin therapy.


Several studies have shown a link between isotretinoin and clinical depression.

Since the 1980s, scientific research has suggested a relationship between isotretinoin administration and the onset of psychological symptoms including depression, suicidal ideation, and psychosis.This finding has prompted members of the scientific community to call for more studies regarding isotretinion's links to depression and suicidal behavior.

Crohn's disease and ulcerative colitis

Several scientific studies have posited that isotretinoin is a possible cause of Crohn's disease and ulcerative colitis in some individuals.


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