Isotretinoin

Registered South African indications:

• Acne vulgaris

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding

Cautions

• Renal impairment
• Hepatic impairment
• Contact with mucous membranes and eyes
• Sensitive areas of skin
• Patients with concomitant rosacea or perioral dermatitis
• Previous intolerance to retinoid products
• Eczema
• History of photoallergy
• Exposure to sunlight
• Personal or family history of skin cancer
• Sunburn
• Inflammatory bowel disease
• Hepatobiliary disorders
• Benign intracranial hypertension
• Myalgia and arthralgia
• Rhabdomyolysis
• Calcification of tendons and ligaments
• Dry eyes
• History of Stevens-Johnson syndrom (SJS) and toxic epidermal necrolysis (TEN)
• Psychiatric disorders

Forms avail. in SA and covered in this monograph: gel

Inflammatory and non-inflammatory acne vulgaris - mild to moderate

• Topical (gel): Apply small quantity to affected area, 12-24hrly

May take 6-8 weeks before required therapeutic , is observed

Caution: gel is flammable

Not established for use in children below 12 years

Pregnancy

• Contraindicated
• Topical isotretinoin is contraindicated in pregnancy, or in women planning a pregnancy. If isotretinoin is being used during pregnancy, or if the patient becomes pregnant while taking isotretinoin, treatment should be discontinued
• There are limited data available from the use of topical isotretinoin in pregnant women. However, studies totalling 1535 women exposed to topical tretinoin (an isomer of isotretinoin) in early pregnancy did not provide evidence of an increased risk of congenital abnormalities, including retinoic acid embryopathy or major structural defects
• In the clinical setting, however, the use of topical tretinoin in early pregnancy has been temporally associated with retinoic acid specific embryopathy. There are also a few reports of the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these reports in terms of risk to the foetus is uncertain since no causal association has been established from these cases and these effects have not been reproduced

Breastfeeding

• Contraindicated
• There is insufficient information on the excretion of topically applied isotretinoin in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from isotretinoin therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

• Isotretinoin, in therapeutic dosages, does not affect the number, motility and morphology of sperm and does not jeopardise the formation and development of the embryo on the part of men taking isotretinoin

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Skin and subcutaneous tissue disorders

• Application site erythema
• Skin exfoliation
• Skin pain
• Application site pruritus
• Skin burning sensation
• Application site stinging
• Dry skin
• Skin hyperpigmentation
• Skin hypopigmentation
• Photosensitivity reactions

• Oxidising agents
• Topical acne therapy

None routine

Isotretinoin reduces the production of sebum and shrinks the sebaceous glands. It stabilises keratinisation and prevents comedones from forming. It also reduces inflammation in moderate to severe inflammatory acne. The exact mechanism of action is unknown, however it is known that it alters DNA transcription.

Gel (per 30g) 0.015g

• Isotrex (GSK) originator

Also available in the following form: Capsule.