Review Drug.

Isotretinoin

Brand names Isotrex, Roaccutane

Used in the following combined preparations None

General Information
Isotretinoin, a drug that is chemically related to vitamin A, is prescribed for the treatment of severe acne that has failed to respond to other treatments.

The drug acts by reducing production of the skin’s natural oils (sebum) and of the horny protein (keratin) that forms in the outer layers of the skin. This latter effect makes isotretinoin useful for the treatment of some conditions, such as ichthyosis, in which the skin thickens abnormally, causing scaling.

A single course of treatment lasting about 16 weeks often clears the acne completely. During the early weeks of treatment, the skin may be very dry, flaky, and itchy. This usually improves as treatment continues. Serious adverse effects include liver damage, visual impairment, and bowel inflammation.
Information for users

Your drug prescription is tailored for you. Do not alter dosage without checking with your doctor.

How taken

Capsules, gel.

Frequency and timing of doses

1 -2 x daily (take capsules with food).

Adult dosage range

Dosage is determined individually.

Onset of effect

2-4 weeks. Acne may worsen during the first few weeks of treatment in some people.

Duration of action

Effects persist for several weeks after the drug has been stopped. Acne is usually completely cleared.
Diet advice

None.

Storage

Keep in a closed container in a cool, dry place out of the reach of children. Protect from light.

Missed dose

Take as soon as you remember. If your next dose is due within 4 hours, take a single dose now and skip the next.

Stopping the drug

Can be safely stopped as soon as you no longer need it, but best results are achieved when the course of treatment is completed as prescribed.

Exceeding the dose

An occasional unintentional extra dose is unlikely to cause problems. Large overdoses may cause headaches, vomiting, abdominal pain, facial flushing, incoordination, and dizziness. Notify your doctor.

Possible Adverse Effects
Dryness of the nose, mouth, and eyes, inflammation of the lips, and flaking of the skin occur in most people who are treated with isotretinoin. If headache accompanied by symptoms such as nausea and vomiting, abdominal pain with diarrhoea, blood in the faeces, or visual impairment occur, consult your doctor promptly.

Interactions

Tetracycline antibiotics
These may increase the risk of high pressure in the skull, leading to headaches, nausea, and vomiting.

Skin-drying preparations
Medicated cosmetics, soaps, toiletries, and anti-acne preparations increase the likelihood of dryness and irritation of the skin with isotretinoin.

Vitamin A
Supplements of this vitamin increase the risk of adverse effects from isotretinoin.

QUICK REFERENCE

Drug group Drug for acne

Overdose danger rating Medium
Dependence rating Low
Prescription needed Yes
Available as generic No

Special Precautions

Do not donate blood during, or for at least a month after, taking oral isotretinoin. Be sure to tell your doctor if:

You have long-term liver or kidney problems.

You suffer from arthritis. You have diabetes.

You wear contact lenses. You are taking other medications.
Pregnancy

Not prescribed. May cause abnormalities in the developing baby. Effective contraception must be used for at least a month before and during treatment, and for at least a month after stopping.

Breast-feeding

The drug passes into the breast milk and may affect the baby. Discuss with your doctor.

Infants and children

Not prescribed.
Over 60

Not usually prescribed.
Driving and hazardous work

No special problems.
Alcohol

Regular heavy drinking may raise blood fat levels with isotretinoin, thereby increasing the risk of heart and blood vessel disease.

Prolonged Use

Course of treatment rarely exceeds 16 weeks. Prolonged use may cause a rise in fat levels in the blood, thereby increasing the risk of heart and blood vessel disease.

Monitoring

Liver function tests and periodic checks on fat levels in the blood are usually performed.