Product image of Naldix (Naltrexone Hydrochloride) supplied by GNH India

Naldix

Active Ingredient:
Naltrexone Hydrochloride
Origin:
EU

Naldix (Naltrexone Hydrochloride)

Naltrexone Hydrochloride, the active ingredient in Naldix, is an opioid antagonist presented as an oral formulation for oral use. It is indicated for the management of alcohol dependence and opioid dependence in adults. It is formulated for systemic absorption and is marketed under the brand name Naldix in the European Union.

GNH India supplies Naldix as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing, quality assurance and regulatory support for global procurement programmes.

Manufacturer / TM Owner

Poa Pharma Scandinavia Ab

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Indications & Clinical Uses

Naldix (naltrexone hydrochloride) is used in the management of disorders related to opioid and alcohol reward pathways.

  • Alcohol dependence: reduces cravings and supports maintenance of abstinence in individuals with alcohol use disorder.
  • Opioid dependence: blocks μ‑opioid receptors to diminish opioid reward, aiding detoxification and relapse prevention.

How It Works

  • Naltrexone hydrochloride acts as a competitive antagonist at μ‑opioid receptors and also blocks κ and δ receptors. By occupying these sites, it prevents endogenous opioids and exogenous opioid agonists from activating the receptors, thereby reducing the reinforcing effects of alcohol and opioids. The blockade is reversible, allowing normal receptor function to resume after the drug is cleared.

Side Effects

Naldix may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Headache: transient cranial discomfort.
  • Fatigue: general tiredness.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or liver injury.
  • Severe depression or suicidal ideation: mood changes that may lead to self‑harm.
  • Allergic reactions: rash, itching, swelling, or anaphylaxis.

Precautions & Warnings

When prescribing Naldix, clinicians should consider several precautionary measures to minimize risk.

  • Assess liver function: obtain baseline hepatic enzymes before initiating therapy.
  • Monitor mood: watch for signs of depression or suicidal thoughts during treatment.
  • Avoid use in acute opioid intoxication: may precipitate withdrawal syndrome.
  • Use caution in renal impairment: adjust therapy if significant kidney dysfunction is present.
  • Store at ambient temperature: keep tablets in the original container, protect from moisture and light.

Avoid Interactions

Naldix can interact with other medicines; awareness of major and moderate interactions helps ensure safe use.

Major Interactions (Avoid)

  • Opioid agonists (e.g., morphine, heroin): may cause abrupt withdrawal when combined.
  • Opioid analgesics (e.g., oxycodone, hydromorphone): reduce analgesic effect and risk precipitated withdrawal.
  • Alcohol: concurrent use may increase risk of liver toxicity.

Moderate Interactions (Monitor Closely)

  • CYP2C9 inhibitors (e.g., fluconazole): can raise naltrexone plasma levels.
  • CYP3A4 inducers (e.g., rifampin): may lower naltrexone effectiveness.
  • Disulfiram: combined use may enhance hepatotoxic potential.

Frequently Asked Questions

Naldix contains naltrexone hydrochloride and is prescribed for the treatment of alcohol dependence and opioid dependence. In alcohol use disorder it helps reduce cravings and support abstinence, while in opioid dependence it blocks opioid receptors to diminish the rewarding effects of opioids and aid in detoxification.

Naltrexone hydrochloride works by competitively binding to μ‑opioid receptors and also antagonising κ and δ receptors. This blocks both endogenous opioids and exogenous opioid agonists from activating the receptors, thereby lowering the reinforcing and rewarding effects of alcohol and opioid substances.

The exact dose of Naldix is determined by the prescribing clinician based on the individual’s medical condition, response, and tolerance. Typical regimens involve oral administration, but the prescriber sets the strength, frequency and duration of therapy according to current clinical guidelines.

Safety data for naltrexone hydrochloride in pregnancy and lactation are limited. The product is classified as having an unknown pregnancy category, and it should only be used when the potential benefit justifies any potential risk to the fetus or infant. Consultation with a healthcare professional is essential.

To order Naldix, 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 (including any cold‑chain requirements) and the necessary import documentation.

For alcohol dependence, alternatives such as acamprosate act on glutamate pathways, whereas Naldix targets opioid receptors, offering a different mechanism that may be preferred in patients with co‑occurring opioid use. In opioid dependence, methadone and buprenorphine are opioid agonists/partial agonists, while Naldix is a pure antagonist, making it useful for relapse prevention after detoxification.

Naldix tablets should be stored at ambient temperature, below 25 °C, in the original packaging. Protect them from moisture, excessive heat and direct light. Keep the product out of reach of children and do not use after the expiration date.

Naldix is administered orally as a tablet. It can be taken with or without food, but patients should swallow the tablet whole with water and follow the dosing schedule prescribed by their healthcare provider.

The most serious adverse reactions include hepatotoxicity (elevated liver enzymes or liver injury), severe depression or suicidal ideation, and allergic reactions that may progress to anaphylaxis. Patients should report any signs of liver dysfunction, mood changes, or hypersensitivity promptly to their clinician.

Naldix should not be used by individuals currently receiving opioid agonist therapy or who have taken opioids within the past 7–10 days, as it can precipitate acute withdrawal. It is also contraindicated in patients with severe hepatic impairment or known hypersensitivity to naltrexone or any excipients in the formulation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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