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 indicated for the treatment of severe psoriasis, psoriatic erythroderma, and other keratinization disorders in adult patients who have not responded adequately to topical therapies.

GNH India supplies Neotigason as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, pharmacies, and clinics worldwide with a focus on quality assurance, regulatory compliance and reliable logistics support for global distribution across multiple regions.

Manufacturer / TM Owner

Teva Uk Limited

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Indications & Clinical Uses

  • Neotigason (acitretin) is used in the management of disorders characterized by abnormal keratinocyte proliferation and differentiation.
  • Severe psoriasis: reduces scaling, erythema, and plaque thickness, leading to marked improvement in skin appearance and patient quality of life.
  • Psoriatic erythroderma: helps achieve disease control and diminishes extensive erythema and desquamation across large body surface areas.
  • Other keratinization disorders: normalizes epidermal differentiation and reduces hyperkeratosis, providing clinical benefit in conditions such as pityriasis rubra pilaris.

How It Works

  • Acitretin binds to nuclear retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in keratinocytes, altering gene transcription that regulates cell growth and differentiation. This interaction suppresses excessive epidermal proliferation, promotes normal maturation of skin cells, and reduces inflammatory mediators, thereby improving the pathological features of severe psoriasis and related keratinization disorders.

Side Effects

Adverse reactions may occur with acitretin therapy and are categorized by frequency.

Common Side Effects

  • Dry skin and mucous membranes, including cheilitis.
  • Elevated liver enzymes (transaminases).
  • Hyperlipidemia, particularly increased triglycerides.
  • Hair thinning or loss.
  • Headache or mild dizziness.
  • Gastrointestinal discomfort such as nausea.

Serious or Rare Side Effects

  • Severe hepatotoxicity or liver failure.
  • Acute pancreatitis, especially with marked hypertriglyceridemia.
  • Depression, suicidal ideation, or other psychiatric disturbances.
  • Teratogenic effects leading to severe fetal malformations.
  • Bone toxicity, including premature epiphyseal closure.
  • Severe hypersensitivity reactions such as Stevens‑Johnson syndrome.

Precautions & Warnings

  • Before initiating therapy, clinicians should evaluate several safety parameters.
  • Pregnancy: Contraindicated in pregnancy (Category X) due to high teratogenic risk; effective contraception is required.
  • Women of childbearing potential: Must use reliable contraception for at least 3 years after discontinuation.
  • Liver function: Obtain baseline liver enzymes and monitor periodically during treatment.
  • Lipid profile: Check fasting triglycerides and cholesterol before starting and at regular intervals.
  • Bone health: Assess for skeletal disorders; avoid use in patients with uncontrolled hypercalcemia.
  • Store at ambient temperature: Keep below 25 °C, retain in original packaging, and protect from moisture and direct sunlight.

Avoid Interactions

Acitretin may interact with several medicines, requiring dose adjustments or avoidance.

Major Interactions (Avoid)

  • Tetracyclines: Increased risk of intracranial hypertension.
  • Vitamin A supplements: Additive retinoid toxicity.
  • Methotrexate: Enhanced hepatotoxic potential.

Moderate Interactions (Monitor Closely)

  • Combined oral contraceptives: Reduced contraceptive efficacy.
  • Lipid‑lowering agents (e.g., statins): Potential alteration of lipid levels.
  • Antifungal agents such as ketoconazole: May raise acitretin plasma concentrations.

Frequently Asked Questions

Neotigason, whose active ingredient is acitretin, is prescribed for severe plaque psoriasis, psoriatic erythroderma, and other keratinization disorders such as pityriasis rubra pilaris. It is typically reserved for patients who have not achieved adequate control with topical therapies or phototherapy.

Acitretin binds to nuclear retinoic acid receptors (RARs) and retinoid X receptors (RXRs) within skin cells. This binding modifies gene expression, leading to reduced keratinocyte proliferation, normalization of epidermal differentiation, and decreased inflammatory mediator production, which together improve the clinical signs of psoriasis.

The dose of Neotigason is individualized by the prescribing physician based on disease severity, patient weight, and laboratory parameters. The prescriber determines the appropriate starting dose and any subsequent adjustments, following current clinical guidelines and safety monitoring.

Neotigason is classified as pregnancy category X because it can cause severe fetal malformations. It is contraindicated in pregnancy and should not be used by breastfeeding mothers, as it may be excreted in breast milk and affect the infant.

To request Neotigason, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with 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, acitretin has a different safety profile, lacking immunosuppression but carrying a higher risk of teratogenicity and lipid abnormalities. Biologic agents target specific immune pathways and often provide faster clearance, but they are more costly and require injection, whereas Neotigason is an oral tablet.

Neotigason tablets should be stored at ambient temperature, preferably below 25 °C, in their original blister pack to protect 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, 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 drug levels. Patients should follow the dosing schedule prescribed by their healthcare professional.

The most serious risks include teratogenicity, which can cause severe birth defects; significant liver injury; acute pancreatitis linked to high triglyceride levels; and psychiatric effects such as depression or suicidal thoughts. Prompt reporting of any concerning symptoms to a healthcare provider is essential.

Neotigason should not be used by pregnant women, women who are not using effective contraception, patients with uncontrolled liver disease, severe hyperlipidemia, or known hypersensitivity to acitretin or other retinoids. Caution is also advised in individuals with a history of depression or bone disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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