Product image of Naloxone Cloridrato Bambini S.A.L.F. (Naloxone Hydrochloride Dihydrate) supplied by GNH India

Naloxone Cloridrato Bambini S.A.L.F.

Active Ingredient:
Naloxone Hydrochloride Dihydrate
Origin:
EU

Naloxone Cloridrato Bambini S.A.L.F. (Naloxone Hydrochloride Dihydrate)

Naloxone Hydrochloride Dihydrate, the active ingredient in Naloxone Cloridrato Bambini S.A.L.F., is an opioid antagonist presented as an injectable solution for intramuscular, intravenous, and subcutaneous use. It rapidly reverses the effects of opioid overdose and opioid‑induced respiratory depression in emergency settings. It is formulated for rapid administration by healthcare professionals in acute care environments.

GNH India supplies Naloxone Cloridrato Bambini S.A.L.F. as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product complies with EU regulatory standards and is packaged in sealed vials.

Manufacturer / TM Owner

S.A.L.F. Spa Laboratorio Farmacologico

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Indications & Clinical Uses

Naloxone, an opioid antagonist, is used to counteract opioid toxicity and associated respiratory depression.

  • Opioid overdose: rapid restoration of normal breathing and consciousness.
  • Opioid‑induced respiratory depression: reversal of depressed ventilation in clinical settings.
  • Opioid toxicity after procedural sedation: immediate antagonism of opioid effects to prevent respiratory compromise.

How It Works

  • Naloxone acts as a competitive antagonist at μ‑opioid receptors, binding with higher affinity than most opioid agonists. By displacing the agonist, it blocks opioid‑mediated activation of G‑protein pathways, rapidly terminating analgesia, euphoria, and respiratory depression. This antagonism restores normal neuronal signaling in the brainstem respiratory centers and reduces opioid‑induced sedation.

Side Effects

Naloxone may be associated with a range of adverse reactions, most of which are transient and related to abrupt opioid withdrawal.

Common Side Effects

  • Nausea: mild to moderate feeling of sickness.
  • Vomiting: occasional emesis after administration.
  • Sweating: increased perspiration.
  • Tremor: involuntary shaking.
  • Anxiety: heightened nervousness.
  • Headache: mild cranial pain.

Serious or Rare Side Effects

  • Cardiac arrhythmia: irregular heart rhythm.
  • Seizure: convulsive episodes.
  • Severe hypertension: sudden high blood pressure.
  • Pulmonary edema: fluid accumulation in lungs.
  • Anaphylaxis: life‑threatening allergic reaction.

Precautions & Warnings

When using naloxone, healthcare providers should observe specific precautions to ensure safety and effectiveness.

  • Patient assessment: confirm opioid overdose before administration.
  • Cardiovascular monitoring: observe heart rate and blood pressure after reversal.
  • Re‑dosing: be prepared to repeat dose if opioid effect persists.
  • Concomitant opioid use: consider that long‑acting opioids may require additional doses.
  • Pregnancy and lactation: use only if benefit outweighs potential risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Naloxone can interact with other substances, influencing its efficacy or safety profile.

Major Interactions (Avoid)

  • High‑dose opioid agonists: may overwhelm naloxone effect, requiring higher or repeated dosing.
  • MAO inhibitors: combined use may increase risk of hypertensive crisis after opioid reversal.
  • Tricyclic antidepressants: may potentiate seizures when opioid withdrawal occurs.

Moderate Interactions (Monitor Closely)

  • Benzodiazepines: concurrent use can mask withdrawal symptoms, requiring careful monitoring.
  • Alcohol: may exacerbate central nervous system depression after naloxone.
  • CNS stimulants: may increase risk of agitation during opioid reversal.

Frequently Asked Questions

Naloxone Cloridrato Bambini is an opioid antagonist indicated for the rapid reversal of opioid overdose and opioid‑induced respiratory depression. It is employed in emergency medical settings to restore normal breathing and consciousness in patients who have received excessive opioid medication.

Naloxone works by competitively binding to μ‑opioid receptors with higher affinity than most opioid agonists. This displaces the opioid molecules, blocking their activity and quickly terminating the pharmacologic effects such as analgesia, sedation, and respiratory depression.

The specific dose of naloxone is determined by the prescribing clinician based on the severity of the opioid exposure, the route of administration, and the patient’s clinical response. Standard emergency protocols may guide initial dosing, but exact amounts are individualized.

Safety data for naloxone in pregnancy and lactation are limited. It should be used only when the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision should be made by a qualified healthcare professional.

To place an order, 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 cold‑chain if needed) and any required import documentation.

The primary alternative to naloxone is naltrexone, another opioid antagonist. Naloxone has a rapid onset and a short duration of action, making it suitable for emergency reversal, whereas naltrexone has a longer half‑life and is used for maintenance therapy in opioid dependence. Their pharmacologic profiles and clinical uses differ accordingly.

Naloxone Cloridrato Bambini should be stored at 2‑8 °C in a refrigerator, protected from light. The vials must not be frozen or shaken. If temporary storage at controlled room temperature is unavoidable, the product should be used within the time frame specified by the manufacturer.

Naloxone is administered by a healthcare professional via intramuscular, intravenous, or subcutaneous injection. The route is chosen based on the clinical situation, with intramuscular injection often used in pre‑hospital settings and intravenous administration preferred in hospital environments for rapid effect.

Serious risks include cardiovascular arrhythmias, severe hypertension, seizures, pulmonary edema, and rare anaphylactic reactions. These events are uncommon but require immediate medical attention if they occur during or after naloxone administration.

Naloxone is contraindicated in individuals with known hypersensitivity to naloxone or any of its excipients. It should also be used with caution in patients with pre‑existing cardiac conditions, uncontrolled hypertension, or a history of severe seizures, and only under professional supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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