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 a tablet for oral use. It treats severe forms of psoriasis and certain keratinization disorders in adult patients, including severe plaque psoriasis, pustular psoriasis and inherited ichthyosis, providing systemic control when topical therapies are insufficient.

GNH India supplies Neotigason as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, adhering to stringent quality standards and offering reliable global distribution with regulatory‑compliant packaging and traceability.

Manufacturer / TM Owner

Generis Farmacêutica, S.A.

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Indications & Clinical Uses

Neotigason (acetretin) is used in the management of severe keratinization disorders and psoriasis.

  • Severe plaque psoriasis: reduces scaling and erythema by normalizing skin cell turnover.
  • Pustular psoriasis: controls widespread pustular eruptions and accelerates lesion clearance.
  • Ichthyosis: improves skin barrier function and reduces hyperkeratosis in inherited forms.

How It Works

  • Acitretin exerts its therapeutic effect by binding to nuclear retinoic acid receptors (RAR‑α, RAR‑β, and RAR‑γ). This interaction modulates gene transcription involved in epidermal cell differentiation and proliferation, leading to normalization of keratinocyte growth, reduced hyperkeratosis, and anti‑inflammatory effects in the skin. The drug acts directly through receptor engagement without requiring conversion to an active metabolite, sustaining its activity in chronic skin disorders.

Side Effects

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

Common Side Effects

  • Dry skin: increased xerosis and scaling.
  • Cheilitis: inflammation and cracking of the lips.
  • Elevated triglycerides: rise in blood lipid levels.
  • Hair loss: temporary alopecia.
  • Headache: mild to moderate intensity.
  • Nausea: mild gastrointestinal upset.
  • Mucosal dryness: dryness of nasal or oral mucosa.
  • Photosensitivity: increased skin sensitivity to sunlight.

Serious or Rare Side Effects

  • Hepatotoxicity: liver enzyme elevations or liver injury.
  • Pseudotumor cerebri: increased intracranial pressure presenting with headache and visual changes.
  • Severe hyperlipidaemia: marked increase in cholesterol or triglycerides requiring medical intervention.
  • Bone toxicity: premature epiphyseal closure in children (use limited to adults).
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

When prescribing acitretin, several safety considerations should be observed to minimize risk.

  • Pregnancy contraindication: teratogenic; avoid use in women of childbearing potential.
  • Contraception requirement: effective birth control must be used during treatment and for at least 3 years after discontinuation.
  • Liver monitoring: assess hepatic function before initiation and periodically during therapy.
  • Lipid monitoring: check serum triglycerides and cholesterol regularly.
  • Skeletal effects: avoid use in patients with active bone disease or in children due to risk of premature epiphyseal closure.
  • Store at ambient temperature: keep tablets below 25 °C in the original packaging, protected from moisture and light.

Avoid Interactions

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

Major Interactions (Avoid)

  • Tetracyclines: increased risk of intracranial hypertension.
  • Vitamin A supplements: additive teratogenicity and hypervitaminosis A.
  • Systemic corticosteroids: may reduce therapeutic effect and increase liver toxicity.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: reduced effectiveness, requiring additional barrier methods.
  • Lipid‑lowering agents (e.g., fibrates): potential for additive lipid changes.
  • Antifungal azoles (e.g., ketoconazole): may increase acitretin plasma levels.
  • Anticoagulants (e.g., warfarin): possible alteration of INR, requiring monitoring.

Frequently Asked Questions

Neotigason contains acitretin, a systemic retinoid indicated for the treatment of severe plaque psoriasis, pustular psoriasis and inherited forms of ichthyosis. It is prescribed when topical therapies are insufficient to control skin lesions and hyperkeratosis.

Acitretin binds to nuclear retinoic acid receptors (RAR‑α, RAR‑β, RAR‑γ) in skin cells, modulating gene expression that controls epidermal differentiation and proliferation. This normalizes keratinocyte growth, reduces excessive scaling, and exerts anti‑inflammatory effects that improve psoriatic and ichthyotic skin.

The dosage of Neotigason is individualized by the prescribing clinician based on the severity of the condition, patient weight, and laboratory parameters. The prescriber determines the appropriate starting dose and any subsequent adjustments.

Neotigason is classified as pregnancy category X because acitretin is highly teratogenic. It must not be used by pregnant women or women of child‑bearing potential unless reliable contraception is maintained during treatment and for at least three years after stopping. Use during breastfeeding is also contraindicated.

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, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with methotrexate, another systemic option, acitretin offers a non‑immunosuppressive mechanism focused on skin cell differentiation, which can be advantageous for patients with contraindications to immunosuppression. However, acitretin carries a higher risk of teratogenicity and lipid abnormalities, while methotrexate may have more hepatic monitoring requirements.

Neotigason tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister pack to protect them from moisture and light. Keep the medication out of reach of children and do not store in bathrooms or other humid environments.

Neotigason is taken orally as a tablet, usually with a full glass of water. It can be taken with or without food, but consistent administration with respect to meals helps maintain stable absorption. Patients should follow the prescriber’s instructions regarding timing and any dietary considerations.

The most serious risks include teratogenicity (birth defects), severe liver injury (hepatotoxicity), marked hyperlipidaemia, and rare events such as pseudotumor cerebri or severe skin reactions like Stevens‑Johnson syndrome. Prompt medical attention is required if symptoms of these conditions appear.

Neotigason should not be used by pregnant women, women of child‑bearing potential not using effective contraception, children, patients with active liver disease, uncontrolled severe hyperlipidaemia, or those with a history of bone growth disorders. Contraindications also include known hypersensitivity to acitretin or other retinoids.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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