Product image of Nilfene (Fentanyl Citrate) supplied by GNH India

Nilfene

Active Ingredient:
Fentanyl Citrate
Origin:
EU

Nilfene (Fentanyl Citrate)

Fentanyl citrate, the active ingredient in Nilfene, is an opioid analgesic presented as an intravenous solution for intravenous use. It provides rapid, potent analgesia for severe acute pain, breakthrough cancer pain, and serves as an adjunct to general anesthesia.

GNH India supplies Nilfene as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable logistics for regulated opioid products. Clients benefit from comprehensive regulatory support and timely delivery across global markets.

Manufacturer / TM Owner

Pharmis Biofarmacêutica, Lda.

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Indications & Clinical Uses

  • Nilfene (fentanyl citrate) is used in the management of severe pain conditions where rapid opioid analgesia is required.
  • Severe acute pain: provides rapid, potent analgesia for postoperative, trauma or burn pain.
  • Breakthrough cancer pain: delivers fast relief of episodic pain spikes in patients receiving opioid maintenance therapy.
  • Adjunct to general anesthesia: enhances intra‑operative analgesia and reduces anesthetic requirements during surgical procedures.

How It Works

  • Fentanyl citrate exerts its effect by binding as a high‑affinity agonist to the μ‑opioid receptors located in the central nervous system. Activation of these G‑protein‑coupled receptors inhibits adenylate cyclase activity, reduces calcium influx and increases potassium efflux, leading to decreased neuronal excitability and suppression of pain signal transmission. Its rapid onset is due to high lipid solubility allowing swift crossing of the blood‑brain barrier.

Side Effects

Fentanyl citrate may be associated with a range of adverse reactions, varying from mild to life‑threatening.

Common Side Effects

  • Nausea
  • Vomiting
  • Constipation
  • Dizziness
  • Sedation
  • Respiratory depression (common)

Serious or Rare Side Effects

  • Severe respiratory depression
  • Hypotension
  • Chest wall rigidity
  • Anaphylaxis
  • Adrenal insufficiency
  • Opioid dependence

Precautions & Warnings

  • When using Nilfene, careful clinical assessment and monitoring are essential to minimize risks.
  • Respiratory monitoring: continuously assess breathing rate and oxygen saturation, especially during initiation and dose adjustments.
  • Opioid tolerance assessment: evaluate patient’s prior opioid exposure to determine appropriate starting dose.
  • Elderly patients: use lower initial doses and monitor for heightened sensitivity.
  • Concomitant CNS depressants: avoid or use with caution when combined with benzodiazepines, barbiturates, or alcohol.
  • Hepatic impairment: consider dose reduction and close observation in patients with liver dysfunction.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Fentanyl citrate can interact with other medicines, altering its analgesic effect or increasing the risk of adverse events.

Major Interactions (Avoid)

  • Other opioids: additive respiratory depression and sedation.
  • Benzodiazepines or other CNS depressants: profound sedation and respiratory compromise.
  • Potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): increased fentanyl plasma levels.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): reduced fentanyl efficacy.
  • Alcohol: may increase central nervous system depression.

Frequently Asked Questions

Nilfene contains fentanyl citrate and is indicated for the management of severe acute pain, breakthrough cancer pain, and as an adjunct to general anesthesia. It provides rapid, potent analgesia when administered intravenously in hospital or procedural settings.

Fentanyl citrate is a high‑affinity agonist at the μ‑opioid receptors in the central nervous system. By activating these receptors, it inhibits neuronal firing, reduces transmission of pain signals, and produces sedation, resulting in strong analgesic effects.

The dose of Nilfene is individualized by the prescribing clinician based on the patient’s pain severity, opioid tolerance, age, weight, organ function, and the clinical setting. No fixed dosing regimen is provided in product literature.

Safety data for fentanyl citrate in pregnancy and lactation are limited. Because opioids can cross the placenta and be excreted in breast milk, Nilfene is generally avoided unless the potential benefit justifies the potential risk to the fetus or infant.

Enquiries for Nilfene are submitted via the product page on gnhindia.com, where you specify the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and import documentation.

Fentanyl citrate is considerably more potent than morphine on a milligram‑to‑milligram basis and has a faster onset when given intravenously. It is often chosen for situations requiring rapid, short‑duration analgesia, whereas morphine may be preferred for longer‑acting pain control.

Nilfene should be stored at 2‑8 °C in a refrigerator. Keep the vials in their original packaging, protect from light, and do not freeze or shake the solution. If temperature excursions occur, discard the product according to local regulations.

Nilfene is supplied as an injectable solution for intravenous use. It is administered by a qualified healthcare professional, typically as a bolus or continuous infusion, with dosing adjusted to the patient’s response and clinical condition.

The most serious risks include severe respiratory depression, profound sedation, hypotension, chest wall rigidity, and the potential for anaphylactic reactions. These events require immediate medical intervention and continuous monitoring during and after administration.

Nilfene is contraindicated in patients with known hypersensitivity to fentanyl or other opioids, those with severe respiratory depression, untreated obstructive sleep apnea, or acute head injury. Caution is also advised in patients with significant hepatic impairment or those receiving MAO inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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