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 tablet for oral use. It is employed in the management of severe psoriasis and other disorders of keratinization, helping to normalize epidermal growth in adult patients.

GNH India supplies Neotigason as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation for importers. Products are shipped in secure packaging to maintain stability during transit.

Manufacturer / TM Owner

Aurovitas Spain,s.A.U.

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Indications & Clinical Uses

Neotigason (acitretin) is indicated for keratinization disorders and related dermatologic conditions.

  • Severe psoriasis: reduces scaling and plaque formation by normalizing keratinocyte differentiation.
  • Congenital ichthyosis: improves skin barrier function and decreases hyperkeratosis.
  • Other disorders of keratinization: helps control abnormal epidermal proliferation in conditions such as palmoplantar keratoderma.

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. By normalizing epidermal growth, it reduces hyperkeratinization and inflammation associated with psoriasis and related disorders. The altered signaling also decreases production of pro‑inflammatory cytokines and normalizes lipid synthesis in the stratum corneum, contributing to clinical improvement.

Side Effects

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

Common Side Effects

  • Dry skin: increased xerosis and scaling.
  • Cheilitis: inflammation and cracking of the lips.
  • Elevated triglycerides: rise in serum lipid levels.
  • Hair loss: temporary alopecia.
  • Headache: mild to moderate intensity.

Serious or Rare Side Effects

  • Hepatotoxicity: signs of liver injury such as jaundice.
  • Severe hyperlipidemia: marked increase in cholesterol or triglycerides.
  • Pseudotumor cerebri: symptoms of increased intracranial pressure.
  • Bone toxicity: premature epiphyseal closure in adolescents.
  • Severe cutaneous reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

Before initiating therapy with Neotigason, several safety considerations should be reviewed.

  • Pregnancy contraindication: drug is classified Category X and must not be used by pregnant women.
  • Contraception requirement: effective contraception is required for women of childbearing potential during treatment and for at least three years after discontinuation.
  • Liver function monitoring: baseline and periodic liver enzyme tests are advised.
  • Lipid profile monitoring: regular assessment of serum cholesterol and triglycerides is recommended.
  • Skeletal monitoring: avoid use in growing children due to risk of premature epiphyseal closure.
  • Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and light.

Avoid Interactions

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

Major Interactions (Avoid)

  • Tetracyclines: increased risk of intracranial hypertension.
  • Vitamin A supplements: additive toxicity leading to hypervitaminosis A.
  • Systemic corticosteroids: may exacerbate lipid abnormalities.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: reduced effectiveness of hormonal contraception.
  • Antifungal azoles (e.g., ketoconazole): may increase acitretin plasma levels.
  • Lipid‑lowering agents (e.g., fibrates): require monitoring of lipid parameters.
  • Warfarin: potential alteration of anticoagulant effect.

Frequently Asked Questions

Neotigason, whose active ingredient is acitretin, is prescribed for severe psoriasis and other keratinization disorders such as congenital ichthyosis and palmoplantar keratoderma. It works by normalizing the growth and differentiation of skin cells, helping to reduce scaling, thickening, and inflammation associated with these conditions.

Acitretin binds to nuclear retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in skin cells, altering gene expression that controls keratinocyte differentiation and proliferation. This modulation reduces excessive skin cell growth, normalizes epidermal turnover, and diminishes inflammatory processes, leading to clinical improvement in psoriasis and related disorders.

The dosage of Neotigason is individualized by the prescribing clinician based on the severity of the disease, patient weight, and response to therapy. Only a qualified healthcare professional can determine the appropriate dose and schedule; patients should follow the prescriber’s instructions and not adjust the dose on their own.

Neotigason is classified as Pregnancy Category X, meaning it is contraindicated in pregnancy because it can cause severe fetal malformations. Women of childbearing potential must use effective contraception during treatment and for at least three years after stopping the drug. Safety during breastfeeding has not been established, so it is generally avoided.

To request Neotigason, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide. After the enquiry, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details and any necessary import documentation.

Neotigason (acitretin) belongs to the retinoid class, whereas many other systemic options are biologics or methotrexate. Retinoids act directly on skin cell differentiation, while biologics target immune pathways. Acitretin is oral and does not require injection, but it carries a higher risk of lipid abnormalities and is contraindicated in pregnancy, unlike some alternatives.

Neotigason tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original packaging to protect from moisture and light, and store them out of reach of children. Do not refrigerate or freeze the tablets, as temperature extremes can affect their stability.

Neotigason is taken orally, usually with a full glass of water. It is often prescribed to be taken with meals to reduce gastrointestinal irritation, but the exact timing and whether it should be taken with food are determined by the prescribing physician. Patients should swallow the tablet whole and not crush or chew it.

The most serious risks include severe liver toxicity, marked hyperlipidemia, and bone toxicity such as premature closure of growth plates in children. Rare but life‑threatening reactions like Stevens‑Johnson syndrome, toxic epidermal necrolysis, and pseudotumor cerebri have also been reported. Patients should be monitored regularly for these adverse events.

Neotigason should not be used by pregnant women, women who may become pregnant, or those who cannot ensure effective contraception for the required period. It is also contraindicated in patients with severe liver disease, uncontrolled hyperlipidemia, or in growing children due to the risk of affecting bone development. A thorough medical evaluation is required before starting therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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