Europe — EMA
Naldix (Naltrexone Hydrochloride)
GNH USA supplies Naldix (Naltrexone Hydrochloride), a opioid antagonist for alcohol dependence and opioid dependence. Request a quote for global supply.
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What is 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 USA 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.
What is Naltrexone Hydrochloride used for?
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.
What are the side effects of Naltrexone Hydrochloride?
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.
What precautions apply to Naltrexone Hydrochloride?
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.
What does Naltrexone Hydrochloride interact with?
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
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Product details
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