Tretiva (Isotretinoin) represents a significant advancement in dermatological treatment, specifically formulated for patients with severe, recalcitrant nodular acne that has proven unresponsive to conventional therapies. As a systemic retinoid, it operates by targeting the fundamental pathological processes of acne, including sebum production, follicular hyperkeratinization, and cutaneous inflammation. This comprehensive guide provides an expert overview of its pharmacological profile, clinical application, and essential safety information to ensure optimal therapeutic outcomes under strict medical supervision.

Features

• Active Pharmaceutical Ingredient: Isotretinoin (10 mg or 20 mg soft gelatin capsules)
• Pharmacological Class: Systemic Retinoid
• Mechanism of Action: Reduces sebaceous gland size and sebum production, normalizes follicular keratinization, and exhibits anti-inflammatory properties
• Administration: Oral
• Standard Treatment Course: Typically 15 to 20 weeks, based on a cumulative dose target

Benefits

• Achieves profound and often long-term remission or significant reduction in severe nodular acne lesions.
• Addresses the root causes of acne pathogenesis rather than merely managing symptoms.
• Can prevent permanent physical scarring and improve skin texture.
• Positively impacts psychosocial well-being by alleviating the emotional distress associated with severe acne.
• Offers a definitive treatment course for many patients, unlike maintenance therapies requiring indefinite use.

Common use

Tretiva is indicated for the treatment of severe recalcitrant nodular acne in patients aged 12 years and older. It is reserved for cases where the acne is characterized by numerous inflammatory, nodular lesions (greater than 5mm in diameter) and has not responded adequately to standard acne treatments, including systemic antibiotics. Its use is strictly contraindicated in milder forms of acne due to its significant side effect profile.

Dosage and direction

Dosage is highly individualized based on patient weight and the severity of the condition, targeting a cumulative dose ranging from 120 to 150 mg/kg per entire course. The daily dose typically ranges from 0.5 to 1.0 mg/kg/day, administered in two divided doses with food to significantly enhance bioavailability. A course of therapy longer than 20 weeks is not recommended. Treatment should not be repeated without a sufficient drug-free interval and a thorough reassessment by the prescribing dermatologist. It is imperative to swallow the capsules whole with a full glass of water; they must not be crushed or chewed.

Precautions

• Pregnancy Prevention Program (PPP): Tretiva is a known potent teratogen and is absolutely contraindicated during pregnancy. Female patients of childbearing potential must use two reliable forms of contraception simultaneously for at least one month before, throughout, and for one month after therapy. Mandatory monthly pregnancy tests are required.
• Psychiatric Effects: Patients should be monitored for symptoms of depression, suicidal ideation, psychosis, and aggressive behavior. Any such symptoms must be reported immediately to the prescriber.
• Hepatotoxicity: Baseline and subsequent periodic liver function tests (LFTs) are required, as elevations in liver enzymes may occur.
• Lipid Monitoring: Significant elevations in serum triglycerides and cholesterol are common. Baseline fasting lipid profiles are mandatory, with follow-up tests until the response to Tretiva is established.
• Ocular Effects: May cause dry eyes, conjunctivitis, and night blindness. Contact lens wearers may experience intolerance. Corneal opacities have been reported.
• Musculoskeletal Effects: May cause musculoskeletal symptoms such as myalgia, arthralgia, and, rarely, premature epiphyseal closure in adolescents.
• Pseudotumor Cerebri: Discontinue use immediately if symptoms such as headache, nausea, vomiting, and visual disturbances occur.

Contraindications

• Pregnancy, breastfeeding, or a positive pregnancy test.
• Hypersensitivity to isotretinoin, other retinoids, or any component of the formulation (including soy, due to the soft gelatin capsule).
• Concomitant use with tetracyclines due to the increased risk of pseudotumor cerebri.
• Severely impaired liver function.
• Hypervitaminosis A.
• Significantly elevated baseline serum triglycerides.

Possible side effect

A wide range of side effects is associated with Tretiva therapy, most of which are dose-related and often manageable. Nearly all patients experience mucocutaneous effects.

• Very Common (>10%): Cheilitis (dry, cracked lips), dry skin, xerosis, dry nose (potentially leading to epistaxis), conjunctivitis, dry eyes, elevated serum triglycerides.
• Common (1-10%): Skin fragility, pruritus, skin infection, nonspecific urogenital findings, arthralgia, myalgia, back pain, headache, photosensitivity.
• Uncommon (0.1-1%): Hair thinning, rash, hyperpigmentation, paronychia, granulomatous lesions, corneal opacities, decreased night vision, hepatitis, inflammatory bowel disease, hyperuricaemia.
• Rare (<0.1%): Idiopathic intracranial hypertension (pseudotumor cerebri), severe skin reactions, seizures, impaired hearing, pancreatitis, aggressive behavior, depression, suicidal ideation.

Drug interaction

• Tetracyclines (e.g., Doxycycline, Minocycline): Contraindicated. Concurrent use significantly increases the risk of pseudotumor cerebri.
• Vitamin A Supplements: Avoid concomitant use due to additive toxic effects (hypervitaminosis A).
• Systemic Corticosteroids: May potentiate the risk of osteoporosis.
• Phenytoin: Isotretinoin may reduce serum levels of phenytoin.
• St. John’s Wort: May reduce the effectiveness of hormonal contraceptives, compromising the PPP.

Missed dose

If a dose is missed, it should be skipped entirely. The patient should not take a double dose to make up for the missed one. They should resume the regular dosing schedule with the next capsule. Consistency is important, but the risk of double dosing outweighs the benefit of catching up on a single missed dose.

Overdose

Symptoms of acute overdose are consistent with hypervitaminosis A. These may include vomiting, facial flushing, cheilitis, abdominal pain, headache, dizziness, and ataxia. The patient must seek immediate medical attention. Treatment is supportive and symptomatic. There is no specific antidote for isotretinoin overdose.

Storage

Store at room temperature (15°-30°C) in a dry place, protected from light and moisture. Keep the bottle tightly closed in its original outer carton. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your dermatologist or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The use of Tretiva must be managed by a qualified physician experienced in the use of systemic retinoids and with strict adherence to all risk management protocols, including the Pregnancy Prevention Program.

Reviews

• Clinical Dermatologist, 15 years experience: “Tretiva remains the most effective drug in our arsenal for severe cystic acne. The transformation in patients who have suffered for years is remarkable. However, its power demands immense respect. Meticulous patient selection, exhaustive education on side effects—especially teratogenicity—and rigorous monitoring are non-negotiable. In the right hands, for the right patient, it is a life-changing therapy.”
• Patient, completed a 20-week course: “After a decade of antibiotics and topical treatments that did nothing for my deep cystic acne, my dermatologist prescribed Tretiva. The side effects were real—incredibly dry lips and skin, some joint aches—but manageable. Six months after finishing my course, my skin is clear for the first time since I was a teenager. The strict rules, especially for women, are challenging but absolutely necessary. It was a tough journey, but worth it.”
• Pharmacist, Hospital Setting: “Dispensing Tretiva comes with a great responsibility. Our role is to be the final checkpoint, ensuring all PPP requirements are documented and that the patient fully understands the administration instructions and potential interactions. It’s a drug that reinforces the critical importance of the entire healthcare team working in concert for patient safety.”