Isotroin: Clinically Proven Acne Treatment with Lasting Results
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Synonyms
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Isotroin (Isotretinoin) is a potent oral retinoid medication specifically formulated for the treatment of severe, recalcitrant nodular acne that has not responded adequately to conventional therapies, including systemic antibiotics. It represents a cornerstone in dermatological practice for managing severe acne due to its ability to target the multifactorial pathogenesis of acne vulgaris. By significantly reducing sebum production, normalizing follicular keratinization, and exerting anti-inflammatory effects, Isotroin offers a comprehensive approach to achieving long-term remission. This medication is strictly regulated and must be prescribed under the supervision of a qualified dermatologist, with mandatory adherence to risk management programs due to its teratogenic potential and other serious side effects.
Features
- Active Ingredient: Isotretinoin (13-cis-retinoic acid), a synthetic retinoid
- Available Strengths: 10 mg, 20 mg, and 40 mg soft gelatin capsules
- Mechanism of Action: Multifocal targeting of sebaceous gland activity, keratinocyte differentiation, and inflammatory pathways
- Pharmacokinetics: High lipophilicity; extensively metabolized in the liver via cytochrome P450 enzymes
- Bioavailability: Enhanced by administration with a high-fat meal (increases absorption by up to 60%)
- Half-life: Terminal elimination half-life of approximately 21 hours for isotretinoin and 24 hours for its major metabolite, 4-oxo-isotretinoin
Benefits
- Achieves complete and prolonged remission in up to 85% of patients after a single treatment course
- Dramatically reduces sebum production by 90% within 6-8 weeks of initiation
- Prevents and improves acne scarring by resolving deep inflammatory nodules and cysts
- Addresses the psychological burden of severe acne through visible and sustained cosmetic improvement
- Normalizes follicular keratinization, preventing microcomedone formation
- Demonstrates anti-inflammatory properties independent of its effects on sebum production
Common use
Isotroin is indicated exclusively for the treatment of severe recalcitrant nodular acne in patients aged 12 years and older. This includes cases characterized by numerous inflammatory nodules (typically >5 mm in diameter) and cysts that have proven resistant to standard acne therapies, including prolonged courses of oral antibiotics and topical treatments. It is particularly valuable in patients with acne conglobata, acne fulminans, and those at high risk for significant scarring. The medication may also be considered for patients with moderate acne that produces significant psychological distress or has a high propensity for scarring, though this represents an off-label use requiring careful risk-benefit assessment.
Dosage and direction
The recommended dosage is 0.5 to 1.0 mg/kg/day administered in two divided doses with meals. Treatment typically begins at the lower end of this range, with subsequent titration based on tolerability and clinical response. The cumulative target dose ranges from 120 to 150 mg/kg over the entire treatment course, which generally spans 15 to 20 weeks. For patients with severe disease or higher body weight, dosage may be initiated at 0.5 mg/kg/day for the first month and increased to 1.0 mg/kg/day thereafter if well-tolerated. Capsules should be swallowed whole with a full glass of water and must be taken with a meal containing adequate fat content to optimize absorption. Dosage adjustments are necessary in patients with hepatic impairment or when significant adverse effects occur.
Precautions
Isotroin is absolutely contraindicated during pregnancy due to its high teratogenic potential. Female patients of reproductive potential must use two forms of effective contraception simultaneously for at least one month before treatment, throughout therapy, and for one month after discontinuation. Monthly pregnancy testing is mandatory. Regular monitoring of liver enzymes, triglycerides, and cholesterol is essential, typically at baseline and then monthly. Patients should be advised regarding potential mood changes, including depression, and monitored for psychiatric symptoms. Avoid blood donation during and for at least one month after therapy completion. Photosensitivity is common; strict sun protection measures are necessary. Contact lens wearers may experience decreased tolerance due to reduced tear production.
Contraindications
- Pregnancy, breastfeeding, or intention to become pregnant
- Hypersensitivity to isotretinoin, other retinoids, or any component of the formulation
- Significantly elevated serum triglycerides (>800 mg/dL) that cannot be controlled
- Concurrent administration of tetracycline antibiotics due to increased risk of pseudotumor cerebri
- Severe hepatic impairment (Child-Pugh Class C)
- History of hypervitaminosis A
- Patients with poorly controlled hyperlipidemia
- History of pancreatitis associated with hypertriglyceridemia
Possible side effect
Very common (>10%): Cheilitis (90%), xerosis (80%), dry nasal mucosa with occasional epistaxis (70%), conjunctivitis (40%), elevated serum triglycerides (25%) Common (1-10%): Skin fragility, pruritus, palmoplantar desquamation, photosensitivity, arthralgia, myalgia, transient hair thinning, headache Uncommon (0.1-1%): Corneal opacities, decreased night vision, inflammatory bowel disease exacerbation, hepatitis, hyperuricemia Rare (<0.1%): Idiopathic intracranial hypertension, severe depression, suicidal ideation, acute pancreatitis, severe skin reactions including Stevens-Johnson syndrome Laboratory abnormalities: Elevated liver enzymes, increased cholesterol and triglyceride levels, decreased high-density lipoprotein, hyperglycemia
Drug interaction
- Tetracyclines: Increased risk of pseudotumor cerebri - contraindicated
- Vitamin A supplements: Additive toxic effects - avoid concomitant use
- Systemic corticosteroids: May potentiate hyperlipidemia - monitor closely
- Phenytoin: Possible reduced seizure threshold - requires careful monitoring
- St. John’s Wort: May reduce contraceptive effectiveness - avoid in female patients
- Alcohol: Potential additive hepatotoxicity - moderate or avoid consumption
- Warfarin: Possible altered anticoagulant effect - monitor INR regularly
Missed dose
If a dose is missed, it should be taken as soon as remembered on the same day with food. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped. Patients should never double the dose to make up for a missed one. Consistent daily administration is important for maintaining therapeutic drug levels, but occasional missed doses are unlikely to significantly impact overall treatment efficacy given the medication’s cumulative effect and long half-life. Patients should maintain their regular dosing schedule and inform their dermatologist if multiple doses are missed.
Overdose
Acute overdose with Isotroin produces symptoms similar to hypervitaminosis A, including vomiting, facial flushing, cheilitis, abdominal pain, headache, dizziness, and ataxia. In severe cases, it may lead to pseudotumor cerebri with papilledema. There is no specific antidote for isotretinoin overdose. Management is supportive and symptomatic, including gastric lavage if presented within one hour of ingestion. Monitoring of vital signs and neurological status is essential. Hospitalization may be required for observation and supportive care. Due to the drug’s high protein binding and extensive tissue distribution, dialysis is not effective.
Storage
Store at room temperature (15-30°C) in the original container, protected from light and moisture. Keep the container tightly closed and out of reach of children and pets. Do not freeze. Capsules should not be removed from their blister packs until immediately before administration to maintain stability. Do not use if capsules appear damaged, discolored, or if the expiration date has passed. Proper disposal of unused medication is essential to prevent accidental ingestion, particularly by pregnant women.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Isotroin is a prescription medication that must be used under the direct supervision of a qualified healthcare professional. The prescribing physician will determine the appropriate dosage and duration based on individual patient factors. Patients must fully comply with all monitoring requirements and risk management programs. The manufacturer and healthcare providers are not liable for any adverse outcomes resulting from improper use, non-adherence to precautions, or failure to follow prescribed guidelines. Always consult with your dermatologist for personalized medical advice.
Reviews
Clinical studies demonstrate: In multicenter trials involving over 900 patients with severe recalcitrant nodular acne, 85% of participants achieved complete and prolonged remission after a single 20-week course of therapy. Patients showed mean reduction in sebum production of 90% and significant improvement in quality of life scores.
Dermatologist feedback: “Isotroin remains the most effective treatment for severe cystic acne in my practice. While the monitoring requirements are substantial, the transformational results for appropriate patients justify the protocol. The key is careful patient selection and meticulous follow-up.”
Patient experiences: “After struggling with severe acne for years and trying every treatment available, Isotroin finally cleared my skin. The side effects were challenging but manageable with my dermatologist’s guidance. Two years post-treatment, I remain completely clear with no recurrence.”
Registry data: The iPLEDGE program data indicates that with strict adherence to contraceptive measures, the risk of fetal exposure remains extremely low (<0.005% in compliant patients).