Product image of Neotigason (Acitretin) supplied by GNH India

Neotigason

Active Ingredient:
Acitretin
Origin:
EU

Neotigason (Acitretin)

Acitretin, the active ingredient in Neotigason, is a retinoid presented as an oral capsule for oral use. It is indicated for the treatment of severe psoriasis and certain disorders of keratinization such as ichthyosis, primarily in adult patients, and is employed when topical therapies are insufficient.

GNH India supplies Neotigason as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product conforms to EU regulatory standards and is distributed under strict quality controls. Manufacturing follows GMP guidelines to ensure batch consistency.

Manufacturer / TM Owner

Teva B.V

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Indications & Clinical Uses

  • Neotigason, a systemic retinoid, is used to manage disorders of keratinocyte proliferation and differentiation.
  • Severe psoriasis: reduces plaque formation and scaling in patients with extensive disease.
  • Ichthyosis: normalizes skin shedding and improves barrier function in inherited keratinization disorders.
  • Palmoplantar keratoderma: decreases hyperkeratosis on palms and soles, improving mobility and comfort.

How It Works

  • Acitretin binds to nuclear retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in keratinocytes, modulating gene transcription that controls cell differentiation and proliferation. This regulation leads to normalization of epidermal growth, reduction of hyperkeratosis, and anti‑inflammatory effects, thereby improving psoriatic plaques and keratinization disorders. Additionally, acitretin down‑regulates inflammatory cytokines such as IL‑6 and TNF‑α, further contributing to clinical improvement.

Side Effects

Acitretin may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Dry skin: excessive epidermal dryness and scaling.
  • Cheilitis: inflammation and cracking of the lips.
  • Elevated triglycerides: increase in serum triglyceride levels.
  • Headache: mild to moderate cephalic discomfort.

Serious or Rare Side Effects

  • Hepatotoxicity: significant elevation of liver enzymes or liver injury.
  • Pseudotumor cerebri: increased intracranial pressure presenting with headache and visual changes.
  • Severe hyperlipidemia: marked rise in cholesterol or triglycerides requiring medical intervention.

Precautions & Warnings

  • Before initiating acitretin therapy, several safety considerations should be observed.
  • Teratogenicity: avoid use in pregnancy and ensure effective contraception for at least 3 years after discontinuation.
  • Liver function: monitor hepatic enzymes regularly due to risk of hepatotoxicity.
  • Lipid profile: assess serum triglycerides and cholesterol before and during treatment.
  • Bone health: use cautiously in patients with pre‑existing skeletal disorders or osteoporosis.
  • Concomitant vitamin A: do not combine with other vitamin A derivatives to prevent additive toxicity.
  • Store below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Acitretin can interact with several medicines, altering efficacy or safety.

Major Interactions (Avoid)

  • Tetracyclines: increased risk of intracranial hypertension.
  • Vitamin A supplements: additive retinoid toxicity.
  • Oral estrogen therapy: may reduce acitretin effectiveness.

Moderate Interactions (Monitor Closely)

  • Statins: potential for exacerbated hyperlipidemia.
  • Systemic corticosteroids: heightened risk of lipid abnormalities.
  • Warfarin: possible alteration of anticoagulant effect.

Frequently Asked Questions

Neotigason contains acitretin, a systemic retinoid prescribed for adults with severe plaque psoriasis and for inherited disorders of keratinization such as ichthyosis. It is also used in certain cases of palmoplantar keratoderma where other therapies have not provided adequate control.

Acitretin binds to nuclear retinoic acid receptors (RAR) and retinoid X receptors (RXR) in skin cells, altering gene expression that regulates keratinocyte growth and differentiation. This leads to reduced epidermal hyperproliferation, normalization of skin shedding, and anti‑inflammatory effects that improve psoriatic lesions and keratinization abnormalities.

The appropriate dose of Neotigason is determined individually by a qualified prescriber based on the severity of the condition, patient weight, and laboratory monitoring. Physicians typically start with a low dose and adjust according to clinical response and safety parameters.

Acitretin is classified as pregnancy category X because it is highly teratogenic. It must not be used during pregnancy, and effective contraception is required for at least three years after the last dose. Use during breastfeeding is also discouraged due to potential risk to the infant.

To order Neotigason, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

Compared with traditional systemic agents such as methotrexate, acitretin offers a non‑immunosuppressive mechanism focused on keratinocyte regulation. Unlike biologics that target specific immune pathways, acitretin is oral, does not require injection, and may be preferred when immunosuppression is contraindicated, though it carries a higher risk of teratogenicity and lipid abnormalities.

Neotigason should be stored below 25 °C in its original packaging, protected from moisture and direct sunlight. Keep the product out of reach of children and avoid exposing it to excessive heat or humidity to maintain its stability and potency.

Neotigason is taken orally as a capsule with a full glass of water, usually with meals to reduce gastrointestinal discomfort. The exact timing and whether it is taken with food should follow the prescribing physician’s instructions.

The most serious risks include teratogenicity (birth defects), severe liver injury, marked hyperlipidemia, and pseudotumor cerebri (increased intracranial pressure). Patients should undergo regular laboratory monitoring and report any new headaches, visual changes, or signs of liver dysfunction promptly.

Neotigason is contraindicated in pregnant women, women planning pregnancy, and individuals who cannot maintain effective contraception for three years after stopping therapy. It should also be avoided in patients with severe hepatic impairment, uncontrolled hyperlipidemia, or pre‑existing bone disorders such as severe osteoporosis.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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