Roaccutane 20 mg (Capsule)
Medicine Details
| Category | Details |
|---|---|
| Generic | Isotretinoin oral |
| Company | Roche bangladesh ltd |
| Also available as |
Title
- Roaccutane Oral Retinoid Capsules
Categories
- Acne Treatment
- Oral Retinoids
- Medication
Description
Roaccutane is indicated in severe forms of acne resistant to standard therapy with systemic antibacterials and topical therapy. It reduces sebum production, prevents blockage of pores, and inhibits the growth of acne causing bacteria. It is available in capsule form and should be taken with food once or twice daily. Isotretinoin, the active ingredient, should only be prescribed by or under the supervision of physicians with expertise in systemic retinoids for the treatment of severe acne. It has various contraindications, precautions, and potential drug interactions, making it unsuitable for pregnant or breastfeeding women, patients with certain health conditions, and those taking specific medications. The therapy includes individual dosage adjustment based on patient response, and the duration of treatment varies. Isotretinoin can induce various adverse effects, and patients need to be closely monitored for proper management. Additionally, specific storage conditions should be adhered to. It belongs to the therapeutic class of oral retinoids for acne treatment.
Indications
- Severe forms of acne
- Nodular acne
- Conglobate acne
- Acne at risk of scarring
Pharmacology
- Reduction of sebum production
- Prevention of pore blockage
- Inhibition of acne causing bacteria growth
- Apoptosis induction in sebocytes
- Reduction of hyperkeratinization
- Alteration of immune mechanisms
Dosage & Administration
- Take with food once or twice daily
- Individual dosage adjustment
- Therapeutic response and adverse effects are dose-related
- Dose ranges from 0.5-1.0 mg/kg per day
- Long-term remission closely related to total dose administered
- Treatment course of 16-24 weeks
- Complete acne clearing with a single treatment course
- Consider lower starting dose in severe renal insufficiency
- Not indicated for prepubertal acne and patients less than 12 years old
- Continued treatment at lower dose for intolerant patients
Interaction
- Additive adverse effects with vitamin A or its derivatives
- Decreased efficacy of microdosed progesterone
- Increased risk of local irritation with topical keratolytic or exfoliative anti-acne agents
- Reduced efficacy with oxidising agents like benzoyl peroxide
Contraindications
- Pregnant or breastfeeding women
- Hypersensitivity to Isotretinoin or excipients
- Hepatic insufficiency
- Excessively elevated blood lipid values
- Hypervitaminosis A
- Concomitant treatment with tetracyclines
Side Effects
- Dose-related
- Reversible with altered dose or discontinuation
- Dryness of skin and mucosae
- Various infection, blood disorders, and immune system disorders
- Metabolism and nutrition disorders
- Psychiatric disorders
- Nervous system disorders
- Eye, ear, and respiratory disorders
- Gastrointestinal disorders
- Hepatobiliary disorders
- Skin and musculo-skeletal disorders
- Renal and urinary disorders
- General disorders and administration site conditions
- Overdose and pharmaceutical precautions
Pregnancy & Lactation
- Pregnancy is absolute contraindication
- Severe risk of severe and serious fetal malformations
- Increased incidence of spontaneous abortion
- Absolute contraindication in nursing mothers
Precautions & Warnings
- Comprehensive contraception information for female patients
- Medically supervised pregnancy tests
- Monthly follow-up visits
- Dispensing restrictions for women of childbearing potential
- Warning for male patients about sharing medication
- Instructions for returning unused capsules and not donating blood
- Mental health monitoring
- Skin and subcutaneous tissues precautions
- Eye disorder precautions
- Musculo-skeletal and connective tissue precautions
- Benign intracranial hypertension, hepatobiliary, and renal insufficiency precautions
- Lipid metabolism, gastrointestinal, and high-risk patient precautions
Therapeutic Class
- Oral retinoids for acne
Storage Conditions
- Keep below 30°C temperature
- Away from light & moisture
- Keep out of the reach of children