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Roaccutane10 mg
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Medicine overview
Indications of Roaccutane 10 mg
Roaccutane 10 mg should be reserved for patients with severe nodular acne who are unresponsive to conventional therapyincluding systemic antibiotics. In additionRoaccutane 10 mg is indicated only for those female patients who are not pregnantit should not be initiated until at least 8 weeks after completion of the first course
Theropeutic Class
Oral retinoids for Acne
Pharmacology
Roaccutane 10 mg is a synthetic retinoid which reduces sebaceous gland size and inhibits sebum production.
Absorption
It also regulates cell proliferation and differentiation and has dermal anti-inflammatory effect.
Dosage & Administration of Roaccutane 10 mg
Oral- Adult
Dosage:Initially, 0.5 mg/kg daily in single or 2 divided doses, increased to 1 mg/kg daily if necessary
Usual duration of treatment
Dosage:16-24 wk
Notes:May repeat treatment course after at least 8 wk if relapse after first course
Child
Dosage:≥12 yr Same as adult dose
Topical
Dosage:Apply Roaccutane 10 mg 0.05% gel cautiously over the affected area once or twice daily
Notes:Patients should be advised that 6-8 weeks of treatment may be required before a therapeuticeffect is observed. The safety and efficacy of Roaccutane 10 mg have not been established in children since acne vulgaris rarely present in this age group. There are no specific recommendations for use in the elderly. Acne vulgaris does not present in the elderly
| Condition | Dosage | Notes |
|---|---|---|
| Oral- Adult | Initially, 0.5 mg/kg daily in single or 2 divided doses, increased to 1 mg/kg daily if necessary | |
| Usual duration of treatment | 16-24 wk | May repeat treatment course after at least 8 wk if relapse after first course |
| Child | ≥12 yr Same as adult dose | |
| Topical | Apply Roaccutane 10 mg 0.05% gel cautiously over the affected area once or twice daily | Patients should be advised that 6-8 weeks of treatment may be required before a therapeuticeffect is observed. The safety and efficacy of Roaccutane 10 mg have not been established in children since acne vulgaris rarely present in this age group. There are no specific recommendations for use in the elderly. Acne vulgaris does not present in the elderly |
Interaction of Roaccutane 10 mg
Additive adverse effects with vit A or its derivatives. Decreased efficacy of microdosed progesterone (use 2 forms of contraception).Increased risk of local irritation with topical keratolytic or exfoliative anti-acne agents. Oxidising agents (e.g. benzoyl peroxide) may reduce the efficacy of topical Roaccutane 10 mg.
Contraindications
Hypervitaminosis A, hyperlipidaemia. Hepatic impairment. Pregnancy and lactation. Concomitant admin of tetracycylines.
Side Effects of Roaccutane 10 mg
Erythema, skin exfoliation, stinging sensation, pruritus, irritation, tenderness, dry skin, hirsutism, photosensitivity, skin pigmentation, paronychia, nail dystrophy, pyogenic granuloma, increased sweating, corneal opacities, visual disturbances, headache, nausea and vomiting, arthralgia, myalgia, back pain, intracranial HTN, hyperostosis and calcinosis. Elevation of serum triglycerides, LFTs, ESR and blood glucose. Mood changes, psychotic symptoms, depression and suicidal behaviour.
Pregnancy & Lactation
Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Precautions & Warnings
Women of childbearing potential; anorexia nervosa. History of photoallergy, psychiatric disorder (e.g. depression); pre-existing or predisposition to hypertriglyceridaemia (e.g. DM, obesity or increased alcohol intake). Genetic predisposition for age-related osteoporosis, history of childhood osteoporosis, osteomalacia or other bone metabolism disorders. Not intended for the treatment of prepubertal acne. Severe renal impairment.
Storage Conditions
Store between 20-25° C. Protect from light.
Use In Special Populations
Renal Impairment: Oral: Severe: Reduce initial dose (e.g. 10 mg daily), then gradually increase to 1 mg/kg as necessary.Hepatic Impairment: Oral: Contraindicated.
Frequently Asked Questions
What is Roaccutane 10 mg used for?
Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. Because of significant adverse effects associated with its use, Isotretinoin should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic …
What is the dosage of Roaccutane 10 mg?
Oral- Adult: Initially, 0.5 mg/kg daily in single or 2 divided doses, increased to 1 mg/kg daily if necessary. Usual duration of treatment: 16-24 wk. May repeat treatment course after at least 8 wk if relapse after first course. Child: ≥12 yr Same as adult dose. Topical: Apply Isotretinoin 0.05% gel cautiously over the affected area once or twice daily. Patients should be advised that 6-8 weeks of…
What are the side effects of Roaccutane 10 mg?
Erythema, skin exfoliation, stinging sensation, pruritus, irritation, tenderness, dry skin, hirsutism, photosensitivity, skin pigmentation, paronychia, nail dystrophy, pyogenic granuloma, increased sweating, corneal opacities, visual disturbances, headache, nausea and vomiting, arthralgia, myalgia, back pain, intracranial HTN, hyperostosis and calcinosis. Elevation of serum triglycerides, LFTs, ES…
Who should not take Roaccutane 10 mg?
Hypervitaminosis A, hyperlipidaemia. Hepatic impairment. Pregnancy and lactation. Concomitant admin of tetracycylines.
What precautions should be taken with Roaccutane 10 mg?
Women of childbearing potential; anorexia nervosa. History of photoallergy, psychiatric disorder (e.g. depression); pre-existing or predisposition to hypertriglyceridaemia (e.g. DM, obesity or increased alcohol intake). Genetic predisposition for age-related osteoporosis, history of childhood osteoporosis, osteomalacia or other bone metabolism disorders. Not intended for the treatment of prepubert…
Is Roaccutane 10 mg safe during pregnancy and breastfeeding?
Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.