Roacta

Each capsule contains Isotretinoin 10 mg.

Pharmacology: Pharmacodynamics: Isotretinoin reduces sebaceous gland size and reduces sebum production; regulates cell proliferation and differentiation.
Pharmacokinetics: Distribution: Crosses placenta.
Protein binding: 99% to 100% primary albumin.
Metabolism: Hepatic via CYP2B6, 2C8, 2C9, 2D6, 3A4; forms metabolites; major metabolite: 4-oxo-isotretinoin (active).
Half-life elimination: Terminal: Parent drug: 21 hours; Metabolite: 21-24 hours.
Time to peak, serum: 3-5 hours.
Excretion: Urine and feces (equal amounts).

Treatment of severe recalcitrant nodular acne unresponsive to conventional therapy.

Recommended dose: Children 12 - 17 years and adults: Severe recalcitrant nodular acne: 0.5 - 1 mg/kg/day in 2 divided doses for 15 - 20 weeks or until the total cyst count decreases by 70%, whichever is sooner.
Adults with very severe disease/scarring or primarily involves the trunk may require dosage adjustment up to 2 mg/kg/day. A second course of therapy may be initiated after a period of ≥ 2 months off therapy.
Dosing adjustment in hepatic impairment: Dose reductions empirically are recommended in hepatitis disease.
Mode of Administration: Administer with food.

Overdose and treatment: Overdose has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness and ataxia. All symptoms quickly resolved without apparent residual effects.
An overdose would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, men should use a condom, or avoid reproductive sexual activity with a female patient who is or might become pregnant, for 1 month after the overdose.
Isotretinoin cause serious birth defects at any dosage, so female patients of childbearing potential who present with isotretinoin overdose must be evaluated for pregnancy.
Patients who are pregnant should receive counselling about the risks to the fetus.
Non-pregnant patients must be warned and counseling about contraceptive to avoid pregnancy for at least 1 month after the overdose.
All patients with isotretinoin overdose should not donate blood for at least 1 month.

Hypersensitivity to isotretinoin or any component of the formulation, sensitivity to parabens, vitamin A or other retinoid.
Pregnancy.

1. Depressions, psychosis and suicide attempt may occur.
2. Do not use in patients with liver, kidney disease, hypervitaminosis A or hyperlipidemia.
3. Do not use in patients with hypersensitivity to isotretinoin.
4. This medicine should be used under dermatologist's care.
Use in Pregnancy: Do not use in pregnant women because teratogenic effects have been reported.

This medication should only be prescribed by prescribers competent in treating severe recalcitrant nodular acne and experienced with the use of systemic retinoid.
May cause depression, psychosis, aggressive or violent behavior, and changes in mood; use with extreme caution in patients with psychiatric disorders. Rarely, suicidal thoughts and actions have been reported during isotretinoin usage. All patients should be observed closely for symptoms of depression or suicidal thoughts. Discontinuation of treatment alone may not be sufficient, further evaluation may be necessary.
Cases of pseudotumor cerebri (benign intracranial hypertension) have been reported; some with concomitant use of tetracycline (avoid using together).
Patients with papilledema, headache, nausea, vomiting, and visual disturbances should be referred to a neurologist and treatment with isotretinoin discontinued.
Hearing impairment, which can continue after therapy is discontinued, may occur.
Clinical hepatitis, elevated liver enzymes, inflammatory bowel disease, skeletal hyperostosis, premature epiphyseal closure, vision impairment, corneal opacities, and decreased night vision have also been reported with the use of isotretinoin.
Use with caution in patients with diabetes mellitus.
Use with caution in patients with a genetic predisposition to bone disorders and with disease states or concomitant medications that can induce bone disorders.
Patients should be instructed not to donate blood during therapy and for 1 month following discontinuation of therapy due to risk of donated blood being given to a pregnant female.
Use in Pregnancy: Do not prescribe isotretinoin for women who are or who are likely to become pregnant while using the drug.
Women of childbearing potential must be capable of complying with effective contraceptive measures and patients must select and commit to two forms of contraception.
Therapy is begun after two negative pregnancy tests; effective contraception must be used for at least 1 month before beginning therapy, during therapy, and for 1 month after discontinuation of therapy.
Prescriptions should be written for no more than a 30-day supply, and pregnancy testing and counseling should be repeated monthly.
Use in Children: Not recommended for children.
Safety and efficacy have not been established in children < 12 years of age.

Pregnancy risk factor X: Major fetal abnormalities (both internal and external), spontaneous abortion, premature births and low IQ scores in surviving infants have been reported.
Lactation: Isotretinoin is excreting in breast milk.

Cardiovascular: Chest pain, edema, flushing, palpitation, stroke, syncope, tachycardia, vascular thrombotic disease.
Central nervous system: Aggressive behavior, depression, dizziness, drowsiness, emotional instability, fatigue, headache, insomnia, lethargy, malaise, nervousness, paresthesia, pseudotumor cerebri, psychosis, seizure, stroke, suicidal ideation, suicide attempts, suicide, violent behavior.
Dermatologic: Abnormal wound healing, acne fulminans, alopecia, bruising, cheilitis, dry nose, dry skin, eczema, eruptive xanthomas, facial erythema, fragility of skin, hirsutism, hyperpigmentation, hypopigmentation, increased sun-burn susceptibility, nail dystrophy, paronychia, peeling of palms, peeling of soles, photoallergic reactions, photosensitizing reactions, pruritus, purpura, rash.
Endocrine and metabolic: Triglycerides increased (25%), abnormal menses, blood glucose increased, cholesterol increased, HDL decreased, hyperuricemia.
Gastrointestinal: Bleeding and inflammation of the gums, colitis, esophagitis, esophageal ulceration, inflammatory bowel disease, nausea, nonspecific gastrointestinal symptoms, pancreatitis, weight loss, xerostomia.
Genitourinary: Nonspecific urogenital findings.
Hematologic: Agranulocytosis (rare), anemia, neutropenia, pyogenic granuloma, thrombocytopenia.
Hepatic: Alkaline phosphatase increased, ALT increased, AST increased, GGTP increased, hepatitis, LDH increased.
Neuromuscular and skeletal: Back pain (29% in pediatric patients), arthralgia, arthritis, bone abnormalities, bone mineral density decreased, calcification of tendons and ligaments, CPK increased, myalgia, premature epiphyseal closure, skeletal hyperostosis, tendonitis, weakness.
Ocular: Cataracts, color vision disorder, conjunctivitis, corneal opacities, dry eyes, eyelid inflammation, keratitis, night vision decreased, optic neuritis, photophobia, visual disturbances.
Otic: Hearing impairment, tinnitus.
Renal: Glomerulonephritis, hematuria, proteinuria, pyuria, vasculitis.
Respiratory: Bronchospasms, epistaxis, respiratory infection, voice alteration, Wegener's granulomatosis.
Miscellaneous: Allergic reactions, anaphylactic reactions, disseminated herpes simplex, diaphoresis, infection, lymphadenopathy.

Avoid concomitant use: Tetracycline derivatives, Vitamin A.
Increased effect/Toxicity: Isotretinoin may increase the levels/effects of: Vitamin A.
The levels/effects of isotretinoin may be increased by: Ethyl alcohol, Tetracycline derivatives.
Decreased effect: Isotretinoin may decrease the levels/effects of: Contraceptives (Estrogens), Contraceptives (Progestins).
Ethanol/Nutrition/Herb interactions: Ethanol: Avoid or limit ethanol (may increase triglyceride levels if taken in excess).
Food: Isotretinoin bioavailability increased if taken with food or milk.
Herb/Neutraceuticals: Avoid Dong Quai, St. John's wort (may also cause photosensitization and may decrease the effectiveness of oral contraceptives). Additional vitamin A supplements may lead to vitamin A toxicity (dry skin, irritation, arthralgia, myalgia, abdominal pain, hepatic changes); avoid using it with isotretinoin.

Keep in tight containers. Store below 30°C.

Acne Treatment Preparations

D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.

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