Product Description

Isotretinoin 20 mg Soft Gelatin Capsules IP belong to a class of medications called retinoids (synthetic derivatives of vitamin A), primarily indicated for the treatment of severe recalcitrant nodular (cystic) acne that has not responded to adequate courses of oral antibiotics and topical therapies. Nodular acne involves deep, inflamed, tender lumps (nodules) under the skin due to excessive sebum production, clogged pores, bacterial overgrowth (e.g., Cutibacterium acnes), and inflammation, often leading to scarring if untreated.

Isotretinoin works by targeting multiple acne pathogenesis factors: it dramatically reduces sebaceous gland size and activity (by up to 90%), decreasing sebum (oil) production; normalizes keratinization in hair follicles to prevent clogging; exhibits anti-inflammatory effects; and indirectly reduces bacterial proliferation by creating a less favorable environment. This leads to long-term remission in 80-90% of patients after a single course (typically 4-6 months). The soft gelatin capsule formulation enhances bioavailability when taken with a high-fat meal.

Uses

• Treatment of severe recalcitrant nodular (cystic) acne vulgaris unresponsive to conventional therapies (e.g., antibiotics, topicals)

• Off-label (under specialist care): Certain cases of hidradenitis suppurativa or rosacea (severe subtypes)

How it works

Isotretinoin 20 mg Soft Gelatin Capsules IP contain isotretinoin, a potent retinoid that binds to retinoic acid receptors (RARs) in sebaceous glands and keratinocytes. This induces apoptosis (cell death) in sebaceous cells, reducing gland size and sebum output by 80-90%; promotes normal follicular differentiation to prevent comedone formation; decreases inflammation by modulating cytokines; and reduces the habitat for acne-causing bacteria (Cutibacterium acnes) without direct antibacterial action. Effects peak after 1-2 months, with sustained remission post-treatment due to long-term gland atrophy. Absorption is fat-dependent (take with food for 2x bioavailability), and the soft gelatin shell protects against degradation.

Benefits

• Achieves complete or near-complete clearance of severe nodular acne in most patients after one course, preventing scarring and improving self-esteem/quality of life

• Addresses root causes (sebum overproduction, follicular hyperkeratinization, inflammation) for durable remission (up to 80% long-term success), unlike antibiotics, which only treat symptoms

• Reduces need for ongoing therapies; a single 4-6 month course often suffices, minimizing antibiotic resistance risks

• Improves skin texture and reduces oiliness, with psychological benefits from visible results within weeks

• Soft gelatin formulation ensures better tolerability and absorption compared to tablets

How to use

Take with a meal containing fat (e.g., milk, peanut butter) to enhance absorption; swallow the soft gelatin capsule whole with a glass of water—do not break, crush, chew, or suck on it (to avoid irritation and ensure proper release).

• Dosage is weight-based (0.5-1 mg/kg/day, divided BID), starting low (e.g., 20 mg/day) and increasing as tolerated; follow your doctor's schedule for 4-6 months or until the cumulative dose is reached.

• Use non-comedogenic skincare (moisturizers, lip balm) to manage dryness; apply sunscreen daily (SPF 30+). If a dose is missed, take as soon as remembered unless near the next dose—do not double up.

• Complete the full course even if acne improves; do not stop early without advice to avoid relapse.

Side Effects

• Dryness of skin, lips (cheilitis), eyes (xerophthalmia), nose (epistaxis), or mouth

• Chapped/cracked lips

• Photosensitivity (sunburn risk)

• Mild itching or rash

• Musculoskeletal pain (e.g., backache, arthralgia)

• Nosebleeds or dry nasal passages

• Fatigue or headache

• Elevated lipids (cholesterol/triglycerides) or liver enzymes (reversible)

• Rare but serious: Depression/mood changes/suicidality, severe GI issues (e.g., colitis), vision/hearing changes, hypervitaminosis A symptoms (e.g., hair loss), or teratogenic effects in pregnancy

Safety Advice

• Avoid alcohol while taking Isotretinoin 20 mg Soft Gelatin Capsules IP, as it may exacerbate liver toxicity, hypertriglyceridemia, and pancreatitis risk—regular lipid/liver monitoring is essential.

• Strictly contraindicated in pregnancy (FDA category X; causes craniofacial, cardiac, and CNS birth defects—use two reliable contraceptives starting 1 month before, during, and 1 month after treatment; monthly pregnancy tests required). Not recommended during breastfeeding, as it passes into milk and may harm the infant. If planning pregnancy, wait 1 month post-treatment.

• Caution in patients with liver disease (avoid or monitor closely), hyperlipidemia/diabetes (may worsen), psychiatric history (monitor for depression), or obesity (higher relapse risk). Not for children <12 years without specialist advice.

• Avoid tetracyclines, high-dose vitamin A, or St. John's wort (interactions increase side effects). Do not use waxing/harsh exfoliants (risk of scarring/epidermolysis). Report mood changes, severe headaches, or vision issues immediately. Blood donation is prohibited during and for 1 month after therapy.

• Requires enrollment in a risk management program (e.g., equivalent to iPLEDGE in India) for females of childbearing potential.

Storage Conditions

• Store at temperatures below 25°C (77°F); do not freeze.

FAQs

What is the use of Isotretinoin 20mg Capsule?

Isotretinoin is used to treat a severe form of acne known as nodular acne that cannot be cleared by any other treatments, including antibiotics.

Does Isotretinoin 20mg Capsule cause decreased night vision?

Isotretinoin 20mg tablets may cause decreased night vision temporarily or permanently in some patients. Everyone doesn't need to experience isotretinoin side effects. Avoid driving after taking medication if you are unable to see in the dark, and consult a doctor if you notice any vision changes or have painful or persistent dry eyes.

Does Isotretinoin 20mg Capsule make skin sensitive to sunlight?

Isotretinoin tablets may increase the skin's sensitivity to sunlight. Therefore, avoid or limit exposure to sunlight and sunlamps. You are advised to use sunscreen and wear protective clothing while going out to prevent sunburn.

Is it safe to undergo cosmetic procedures while taking an Isotretinoin 20mg dose?

No, you are not recommended to undergo any cosmetic procedures to smooth your skin, including waxing, laser procedures, or dermabrasion (an exfoliating technique to remove outer layers of skin with a rotating instrument) while taking the pills and for a minimum of 6 months after stopping treatment with Isotretinoin 20mg Capsule, as it may increase the risk of scarring.

Can I take vitamin A supplements with Isotretinoin 20mg Capsule?

You are not recommended to take vitamin A supplements with Isotretinoin 20mg Capsule, as it may cause hypervitaminosis A (excessive levels of vitamin A in the body), leading to an increased risk of adverse effects. However, please consult a doctor before taking other medicines or supplements with Isotretinoin 20mg Capsule.