Isotretinoin

Isotretinoin Basic Information

 

Product Name: Isotretinoin

Synonyms: Tretinoin Impurity 1

CAS: 4759-48-2

MF: C20H28O2

MW: 300.44

Solubility: Practically insoluble in water, soluble in methylene chloride, slightly soluble in ethanol (96 per cent). It is sensitive to air, heat and light, especially in solution. Carry out all operations as rapidly as possible and avoid exposure to actinic light; use freshly prepared solutions.

Form: Yellow-orange to orange Powder

Isotretinoin is the 9-cis isomer of retinoic acid, a close relative of retinol, or vitamin A. It was originally developed to treat cystic acne, and today this is still its primary use despite several more modern applications of the drug, including a treatment for pancreatic and brain cancers. First shown to be an effective treatment for acne in 1982, its development stemmed from advances in knowledge of the effects of vitamin A to reduce or eliminate sebum production. Since that time, however, several instances of deleterious effects became well known, most notably birth defects arising from the use of isotretinoin.

Isotretinoin is a retinoid derivative with improved bioavailability and percutaneous absorption for acne treatment products. Presently being studied in conjuction with the treatment of photoaged skin.

Isotretinoin is most useful for the treatment of severe recalcitrant nodular acne vulgaris. It may also be helpful in other disorders of keratinization, but it is not useful for psoriasis. High doses of isotretinoin (2mg/kg/day) are effective as cancer chemoprevention agents to reduce the frequency of cutaneous malignancies in patients at increased risk, such as those with xeroderma pigmentosum, an inherited disorder in which DNA repair is deficient, or in immunosuppressed patients.

The mild side effects of isotretinoin can include:

Dry skin

Chapped lips

Dry eyes

Dry nose that may lead to nosebleeds

The more serious side effects of isotretinoin can have long-term or permanent effects. However, apart from increased cholesterol and joint and muscle problems, these side effects are all quite rare.

• Increased cholesterol
• Joint and muscle problems
• Pressure on your brain
• Skin rash
• Organ damage
• Hearing problems
• Vision and eye problems
• Allergic reactions
• Diabetes and other blood sugar problems
• Low red blood cell levels
• Low white blood cell levels
• Mental health issues

Usual Adult Dose for Acne

• Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day
• Maximum dose: Up to 2 mg/kg/day
• Duration of therapy: Up to 20 weeks

Comments:

Patients should take some formulations of this drug with food.

Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food).

Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing.

Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program.

The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended.

12 years or older:

Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day

Maximum dose: 2 mg/kg/day

Duration of therapy: Up to 20 weeks

Patients may discontinue treatment if the total nodule count has reduced by at least 70% before completing the 15 to 20-week treatment.

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