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

• Naloxone, an opioid antagonist, is used to counteract the effects of opioid toxicity.
• Opioid overdose: rapidly reverses respiratory depression and loss of consciousness.
• Opioid‑induced sedation: restores alertness and normal breathing.
• Post‑operative opioid toxicity: counteracts excessive respiratory depression after surgery.

• Naloxone acts as a competitive antagonist at the μ‑opioid receptors in the central nervous system. By binding to these receptors without activating them, it displaces opioid agonists such as morphine, heroin or fentanyl, thereby terminating their pharmacologic effects. This rapid receptor blockade restores normal neuronal activity in the brainstem respiratory centers, leading to the reversal of opioid‑induced respiratory depression and sedation.

Naloxone may be associated with a range of adverse reactions, most of which are transient and related to its pharmacologic action.

Common Side Effects

• Nausea or vomiting
• Sweating or flushing
• Headache
• Dizziness or light‑headedness
• Injection‑site pain or erythema

Serious or Rare Side Effects

• Acute opioid withdrawal (agitation, tachycardia, hypertension)
• Cardiac arrhythmias
• Seizures
• Pulmonary edema
• Anaphylaxis or severe allergic reaction
• Severe hypertension or hypotension

• When using naloxone, clinicians should observe several safety precautions to ensure effective reversal while minimizing risks.
• Assess airway and breathing: confirm adequate ventilation before administration.
• Monitor cardiovascular status: watch for hypertension or tachycardia after reversal.
• Observe for acute opioid withdrawal: patients may experience agitation, nausea, or vomiting.
• Avoid use in patients with known hypersensitivity to naloxone or formulation excipients.
• Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Naloxone can interact with other substances that affect the central nervous system or cardiovascular function.

Major Interactions (Avoid)

• Concurrent high‑dose opioid therapy: may precipitate severe withdrawal and cardiovascular instability.
• Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis when combined with naloxone‑reversed opioid effects.

Moderate Interactions (Monitor Closely)

• Benzodiazepines: may mask signs of withdrawal, requiring careful observation.
• Alcohol: additive central nervous system depression may persist after naloxone.
• Tricyclic antidepressants: may increase seizure risk during abrupt opioid reversal.