Isotretinoin (Accutane) 10 mg, 50 tablets

Substance: Isotretinoin
Form: Oral tablets, film-coated
Common names: Accutane, Roaccutane, 13-cis-Retinoic Acid
Dosage: 10 mg
Packaging: 50 tablets
Purity: >99%

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SKU: ACCUTANE1 Category:

Description

Isotretinoin is a powerful oral retinoid, a derivative of vitamin A, specifically formulated for the treatment of severe, recalcitrant nodular acne that has not responded to standard therapies, including systemic antibiotics. Its development marked a significant advancement in dermatology, offering a solution for patients with debilitating cystic acne.

Mechanism of Action

The substance works through multiple mechanisms to target the fundamental pathophysiological factors of acne vulgaris. It dramatically reduces the size and secretion of sebaceous glands, normalizes the follicular epithelial desquamation process to prevent microcomedone formation, exhibits direct anti-inflammatory properties by inhibiting chemotactic responses, and lowers the population of Cutibacterium acnes on the skin by altering the follicular environment. This multifaceted approach makes it the most effective medication available for severe acne.

Clinical Application and Dosage

The clinical application of Isotretinoin is strictly reserved for the most severe cases due to its potent effects and significant teratogenic potential. It is indicated for patients with severe nodular acne who are unresponsive to conventional treatment.

A critical component of therapy, particularly for female patients, is enrollment in a mandatory risk management program to prevent fetal exposure. The dosage is individualized based on the patient’s body weight and the severity of the condition, typically ranging from 0.5 to 1.0 mg/kg per day, administered in one or two divided doses with a high-fat meal to enhance bioavailability.

Treatment Protocol and Monitoring

A standard course of Isotretinoin therapy typically lasts 15 to 20 weeks, with many patients achieving long-term or permanent remission after a single course. Throughout treatment, patients undergo regular monitoring, which includes baseline and follow-up blood tests to assess liver function and lipid levels, as elevations are a common side effect. Clinical evaluations are also conducted to monitor for other potential adverse effects and to assess therapeutic progress.

Pharmacological Profile

The pharmacological profile of Isotretinoin is characterized by its high bioavailability when taken with fat and its extensive binding to plasma albumin. It is metabolized in the liver via the cytochrome P450 system and has an elimination half-life of approximately 10-20 hours. Its metabolites are excreted in both urine and feces.

Common Side Effects

While highly effective, treatment with Isotretinoin is associated with a well-documented range of potential side effects, which are often dose-dependent. The most common are mucocutaneous and include:

  • Cheilitis: Inflammation and dryness of the lips, experienced by nearly all patients.
  • Xerosis: Generalized dryness of the skin and mucous membranes.
  • Conjunctivitis: Dryness and irritation of the eyes.
  • Epistaxis: Nasal dryness and nosebleeds.
  • Elevated Serum Triglycerides and Cholesterol: A frequent laboratory finding requiring monitoring.
  • Myalgia and Arthralgia: Muscle and joint pain.

More serious, though less common, side effects include idiopathic intracranial hypertension (pseudotumor cerebri), hepatotoxicity, and mood changes or depression. Its absolute contraindication is pregnancy due to its high risk of causing severe life-threatening birth defects.

You can buy Isotretinoin made by Apoxar in bulk in Canada via our website. Navigate to the “Purchase” tab and fill the contact form with details of your wholesale order. Please note: we do not sell single packs or ship directly to consumers, Apoxar is a wholesale fitness medication manufacturer and we work exclusively with our approved distributors.

FAQ

What is the primary mechanism of action of Isotretinoin?

Isotretinoin's primary mechanism involves targeting all four major pathogenic causes of acne: it significantly reduces sebum production, normalizes follicular keratinization, decreases the Cutibacterium acnes population, and exerts anti-inflammatory effects.

For which conditions is Isotretinoin most commonly prescribed?

Isotretinoin is specifically indicated for the treatment of severe, recalcitrant nodular acne that has proven unresponsive to conventional antibiotic and topical therapies.

What is the standard dosage protocol for Isotretinoin treatment?

The dosage of Isotretinoin is individualized, typically starting at 0.5 mg/kg per day and potentially increasing to 1.0 mg/kg per day, administered in divided doses with a high-fat meal for optimal absorption. Treatment duration is usually 15-20 weeks.

Why is rigorous monitoring required during Isotretinoin therapy?

Monitoring is essential to manage potential side effects, particularly elevated liver enzymes and serum lipids (triglycerides and cholesterol). Regular blood tests and clinical evaluations are mandatory throughout the treatment course.

What are the most frequently reported side effects of Isotretinoin?

The most common side effects are mucocutaneous and include severe dryness of the lips (cheilitis), skin (xerosis), eyes, and nasal passages. Muscle aches and elevated blood lipids are also frequently observed.

Why is Isotretinoin absolutely contraindicated during pregnancy?

Isotretinoin is a potent teratogen. Exposure during pregnancy carries an extremely high risk of causing severe, life-threatening congenital malformations in the fetus, including craniofacial, cardiac, and central nervous system defects.

How does Isotretinoin differ from topical retinoids like tretinoin?

While both are retinoids, Isotretinoin is a systemic oral medication that affects the entire body, leading to a profound and often permanent reduction in sebum production. Topical tretinoin works locally on the skin to normalize cell turnover but does not systemically reduce sebaceous gland activity.

Can a patient undergo a second course of Isotretinoin treatment?

Yes, a second course of Isotretinoin may be prescribed if the patient has a relapse of severe acne after an initial successful treatment, provided they still meet the clinical criteria and can be safely monitored.

What is the recommended skincare regimen while taking Isotretinoin?

Patients are advised to use gentle, non-abrasive cleansers and intensive moisturizers to combat skin dryness. It is critical to use a high-SPF, broad-spectrum sunscreen daily due to increased photosensitivity.

How long after completing an Isotretinoin treatment is it safe to conceive?

Due to its elimination profile, it is recommended that females of childbearing potential avoid pregnancy for at least one month after discontinuing Isotretinoin. However, adherence to the specific guidelines of an approved risk management program is mandatory.

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