靶向药盐酸纳洛酮鼻喷剂(naloxone)的中文说明书

Naloxone is a drug approved by the U.S. Food and Drug Administration (FDA) for the rapid reversal of opioid overdose. Naloxone is an opioid antagonist that binds to opioid receptors, thereby reversing and blocking the effects of other opioids.

Naloxone should be administered as soon as possible when signs of a known or suspected opioid overdose emergency occur, such as slowed breathing, severe drowsiness, or the patient's inability to respond (loss of consciousness). Once naloxone is administered, the patient must receive emergency medical care immediately, even if they regain consciousness.

Indications for Naloxone Hydrochloride Nasal Spray

Naloxone Hydrochloride Nasal Spray is used to treat emergencies of known or suspected opioid overdose in children or adults. Signs of an opioid overdose may include:

1. Slowed or no breathing.

2. Extremely narrowed pupils (pinpoint pupils).

3. The heart rate slows down.

4. Extreme drowsiness, especially when the patient cannot be awakened from sleep.

Even if an opioid overdose cannot be confirmed, if the patient is not breathing or unresponsive, emergency medical assistance should be given and sought immediately.

Warning

1. During first aid, you must inform medical staff of your health status and pregnancy/lactation status.

2. Caregivers need to know where the medicine is stored and how to use it.

3. The injection may need to be repeated every 2-3 minutes after administration until emergency services arrive.

4. Alcohol may aggravate side effects. Avoid driving or operating machinery after taking medication.

Precautions before use

‌Contraindications‌

Contraindicated for those who are allergic to naloxone or the inactive ingredients in the preparation.

‌Use with caution‌

1. Patients with heart disease

2. Pregnant or lactating women (may cause fetal withdrawal reaction, but overdose without treatment is more dangerous).

3. The use of opioids during pregnancy may lead to neonatal drug dependence, which requires several weeks of medical intervention.

Dosage method

1. Common doses for adult opioid overdose,

2. Spray 1 spray into one nostril,

3. If the desired effect is not achieved after 2 to 3 minutes, give a second dose into the other nostril; until emergency medical help arrives, additional doses can be given to both nostrils alternately every 2 to 3 minutes.

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Naloxone Nasal Spray Side Effects

Allergic Reactions

If you have signs of an allergic reaction to naloxone, seek emergency medical help immediately. Allergy symptoms include: hives; trouble breathing; swelling of the face, lips, tongue, or throat.

Withdrawal symptoms

Because naloxone reverses the effects of opioids, it may cause sudden withdrawal symptoms after use, such as:

Nausea, vomiting, diarrhea, and stomach pain.

Fever, sweating, body aches, and fatigue.

Trembling or shaking, rapid heartbeat, pounding heartbeat, and elevated blood pressure.

Goosebumps and trembling.

Runny nose and yawning.

Feeling nervous, restless, or irritable.

Infant Withdrawal Symptoms

If an infant under 4 weeks old develops sudden withdrawal symptoms, it may be life-threatening if not handled promptly and properly. Symptoms include crying, stiffness, hyperreflexia and seizures.

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Drug overdose

Seek emergency medical help immediately.

Never leave a patient alone after giving them naloxone. An overdose may affect a person's ability to think or react.

Drug Interactions

Other drugs may interact with naloxone, including prescription drugs, over-the-counter drugs, vitamins, and herbal products.

Tell your doctor about all the medicines you are taking and any medicines you start or stop using.

Main ingredients

Active ingredient: naloxone hydrochloride

Storage method

Storage temperature is below 25°C, short-term exposure to environments up to 40°C is allowed. Do not freeze or expose to temperatures exceeding 40°C. Please store in the original box until use and avoid direct sunlight. Keep this and all medicines out of the reach of children.