Clinical Pharmacology Details


Isotretinoin


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Indications & Dose:

Severe recalcitrant cystic acne; keratinization disorders (keratosis follicularis, pityriasis rubra pilaris, lamellar ichthyosis, kexatosis palmaris et plantaris,congenital ichthyosiform erythroderma: rosacea, lichen planus, psoriasis)*; cutaneous T-cell lymphoma (mycosis fungoides) and leukoplakia; prevention of skin cancer, in patients with xeroderma pigmentosum*; prevention of 2nd primary tumors in patients treated for squamous cell carcinoma of the head and neck*


DOSE


Adult


• PO 0.5-2 mg/kg/day divided bid for 15-20 wk or until total cyst count decreases by 70%; a 2nd course may be initiated after >2 mo off therapy if warranted by persistent or recurring severe cystic acne.


Children: Not recommended.

Contraindications:

Pregnancy, hypersensitivity to parabens (preservative in gelatin capsule)

Side Effects:

Cautions:

Precautions:

Diabetes, obesity, family history of hypertriglyceridemia, contact lens use, inflammatory bowel disease

Interaction:

Drugs
Carbamazepine: Decreased concentrations of carbamazepine in one patient

Warnings:

Adverse Effects:

Lactations:

Isotretinoin is a potent human teratogen; excretion into breast milk unknown, but based on the close relationship to vitamin A, the presence of isotretinoin in breast milk should be expected; avoid use in nursing mothers

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Depression, fatigue, headache, pseudotumor cerebri (headache, visual disturbances, papilledema)


CV: Edema, palpitations, tachycardia, transient chest pain, vasculitis


EENT: Cataracts, contact lens intolerance, conjunctivitis, corneal opacities, decreased night vision, dry eyes, dry nose, epistaxis. eyelid inflammation, optic neuritis, photophobia, visual disturbances


GI: Abdominal pain. anorexia, dry mouth gingival bleeding and inflammation, hepatotoxicity, increased liver function tests, inflammatory bowel disease nausea, vomiting weight loss


GU: Abnormal menses, hematuria, proteinuria, pyuria


HEME: Anemia thrombocytopeniac, thrombocytosis


METAB: Glucose intolerance, hypertriglyceridemia


MS: Bone, joint, and muscle pain and stiffness


SKIN: Bruising, cheilitis, drying of mucous membranes, dry skin, erythema nodosum, exaggerated healing response, facial skin desquamation, hyperpigmentation, hypopigmentation, nail brittleness, paronychia, peeling of palms and soles, petechiae, photosensitivity, pruritis, pyogenic granuloma, rash, skin fragility, skin infections, thinning of hair, urticaria

Patient And Carer Advice: