Roacta

Roacta

isotretinoin

Manufacturer:

MacroPhar

Distributor:

MacroPhar Lab
Concise Prescribing Info
Contents
Isotretinoin
Indications/Uses
Severe recalcitrant nodular acne unresponsive to conventional therapy.
Dosage/Direction for Use
Adult & childn 12-17 yr Severe recalcitrant nodular acne 0.5-1 mg/kg/day in 2 divided doses for 15-20 wk. Max: 2 mg/kg/day. Therapy may be resumed after an interval of ≥2 mth.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to parabens, vit A or other retinoid. Pregnancy.
Special Precautions
Use contraceptive 1 mth prior to & during therapy, & 1 mth after discontinuation of therapy. Prolonged use. Patients w/ psychiatric disorder; depression or suicidal thoughts. DM, hypertriglyceridemia; genetic predisposition to bone disorders & w/ disease states. Concomitant medications that can induce bone disorders. Pseudotumor cerebri (benign intracranial HTN) w/ concomitant use of tetracycline. Discontinue treatment in patients w/ papilledema, headache, nausea, vomiting, visual disturbances. Hearing impairment. Do not donate blood during & after 1 mth of therapy. Lactation. Childn <12 yr.
Adverse Reactions
Chest pain, edema, flushing, palpitation, stroke, syncope, tachycardia, vascular thrombotic disease; aggressive behavior, depression, dizziness, drowsiness, emotional instability, fatigue, headache, insomnia, lethargy, malaise, nervousness, paresthesia, pseudotumor cerebri, psychosis, seizure, stroke, suicidal ideation, attempts & behavior; abnormal wound healing, acne fulminans, alopecia, bruising, cheilitis, dry nose & skin, eczema, eruptive xanthomas, facial erythema, skin fragility, hirsutism, hyper- & hypopigmentation, increased sun-burn susceptibility, nail dystrophy, paronychia, peeling of palms & soles, photoallergic & photosensitizing reactions, pruritus, purpura, rash; increased triglycerides, blood glucose, cholesterol, abnormal menses, decreased HDL, hyperuricemia; bleeding & inflammation of the gums, colitis, esophagitis, esophageal ulceration, inflammatory bowel disease, nausea, nonspecific GI symptoms, pancreatitis, wt loss, xerostomia; nonspecific urogenital findings; anemia, neutropenia, pyogenic granuloma, thrombocytopenia; increased alkaline phosphatase, ALT, AST, γ-glutamyl transpeptidase, lactate dehydrogense, hepatitis; back pain, arthralgia, arthritis, bone abnormalities, decreased bone mineral density, calcification of tendons & ligaments, increased CPK, myalgia, premature epiphyseal closure, skeletal hyperostosis, tendonitis, weakness; cataracts, color vision disorder, conjunctivitis, corneal opacities, dry eyes, eyelid, inflammation, keratitis, decreased night vision, optic neuritis, photophobia, visual disturbances; hearing impairment, tinnitus; glomerulonephritis, hematuria, proteinuria, pyuria, vasculitis; bronchospasm, epistaxis, resp infection, voice alteration, Wegener's granulomatosis; allergic & anaphylactic reactions, disseminated herpes simplex, diaphoresis, infection, lymphadenopathy.
Drug Interactions
Increased toxicity of vit A. Increased toxicity w/ ethyl alcohol, tetracycline derivatives. Decreased effect of estrogens & progestins. May increase triglyceride levels w/ ethanol. Increased bioavailability w/ food or milk. Dong guai, St. John's wort.
ATC Classification
D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.
Presentation/Packing
Form
Roacta cap 10 mg
Packing/Price
3 × 10's
Form
Roacta cap 20 mg
Packing/Price
3 × 10's
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