Absorption: Rapidly absorbed following (2325%) oral administration (bioavailability of Absorica LD higher than that of Absorica); absorption ↑ when taken with a high-fat meal.
Distribution: Appears to be widely distributed.
Protein Binding: 99.9%.
Half-Life: 1020 hr.
Contraindicated in:
Use Cautiously in:
CV: edema
Derm: pruritus, palmar desquamation, photosensitivity, skin infections, STEVENS-JOHNSON SYNDROME (SJS), thinning of hair, TOXIC EPIDERMAL NECROLYSIS (TEN)
EENT: conjunctivitis, epistaxis, ↓night vision, blurred vision, contact lens intolerance, corneal opacities, dry eyes
Endo: hyperglycemia
F and E: ↑thirst
GI: cheilitis, dry mouth, nausea, vomiting, abdominal pain, anorexia, hepatitis, pancreatitis
Hemat: anemia
MS: arthralgia, back pain, muscle/bone pain (↑ in adolescents), hyperostosis
Neuro: behavior changes, depression, PSEUDOTUMOR CEREBRI, psychosis, SUICIDAL THOUGHTS/BEHAVIORS
Drug-drug:
Verify that patient receiving isotretinoin is registered with the iPLEDGE REMS and is completing all required interactions with their health care provider.
Lab Test Considerations:
Isotretinoin is approved for marketing only under the iPLEDGE REMS, a special restricted distribution program approved by the FDA.
Only patients who meet all requirements of the iPLEDGE REMS may receive isotretinoin.
Isotretinoin may only be prescribed by health care providers registered and activated with the iPLEDGE REMS
.Isotretinoin may only be dispensed by pharmacies registered with the iPLEDGE REMS.
Explain the iPLEDGE REMS and its requirements to patient and parent.