靶向药盐酸纳洛酮鼻喷剂(naloxone),Narcan的详细说明书

In 2023, naloxone hydrochloride nasal spray (naloxone) was approved by the US Food and Drug Administration (FDA) and became an over-the-counter (OTC) drug without a prescription. Naloxone Hydrochloride Nasal Spray (naloxone) can be used in adults and children if they have signs of a known or suspected opioid overdose, such as slowed breathing, severe drowsiness, or inability to respond (loss of consciousness).

Indications

Naloxone hydrochloride nasal spray (naloxone) is used to temporarily reverse the effects of opioids. Signs and symptoms of an opioid emergency may include: 1. Unusual drowsiness that cannot be awakened by shouting or rubbing the center of the chest (sternum); 2. Breathing problems, including slow or shallow breathing in a person who is difficult to arouse, or appearing not to be breathing; 3. Extremely narrowed pupils (dark circles in the center of the colored part of the eye) in a person who is difficult to arouse, sometimes called "pinpoint pupils."

Precautions before taking the medication

1. Allergy to ingredients

If you are allergic to naloxone or any ingredients in this nasal spray, you should not use it for treatment.

2. Pregnancy or breastfeeding

Using naloxone hydrochloride nasal spray during pregnancy may also cause opioid withdrawal reactions in the unborn baby. An overdose of opioids can be fatal to both mother and baby. Be sure to let all emergency medical personnel know that you are pregnant.

If you use opioids during pregnancy, your baby may become dependent on the drugs. This can lead to life-threatening withdrawal symptoms after the baby is born. Babies who become dependent on opioids may need weeks of medical treatment.

Usage and Dosage

Precautions before use

1. This medicine must be used strictly in accordance with the prescription of the medical service provider.

2. Each nasal spray device contains only one dose of medicine and cannot be reused.

Usual dosage

Usual dosage for opioid overdose in adults and children:

1. Spray 1 dose into one nostril.

2. If the desired effect is not achieved after 2 to 3 minutes, use a new nasal spray device to administer a second dose intranasally into the other nostril; additional doses may be given in the alternate nostril every 2 to 3 minutes until emergency medical help arrives.

How to use

1. Take out the nasal spray from the packaging box. Open the nasal spray by peeling off the circle-marked pull tab.

2. There is no need to pre-press the naloxone nasal spray (no need to "exhaust").

3. Let the patient lie on his back, support his neck with his hands, tilt his head back, and then use nasal spray.

4. Hold the nasal spray in your hand, place your thumb on the bottom of the red push piston, and place your index and middle fingers on both sides of the nozzle.

5. Gently insert the tip of the nozzle into one nostril until the fingers on both sides of the nozzle touch the bottom of the patient's nostril.

6. Press the red plunger firmly to give a dose of naloxone.

Precautions after administration

1. After administration, remove naloxone from the nostril.

2. Emergency medical assistance must be sought immediately after administration.

3. After administration, you need to stay with the patient and closely observe whether they still have opioid overdose symptoms. Another dose may need to be given every 2 to 3 minutes until emergency medical personnel arrive. If re-dose is required, use a new naloxone nasal spray and administer the dose through the other nostril.

4. While waiting for emergency medical assistance, the patient may need to perform cardiopulmonary resuscitation (CPR).

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Adverse reactions/side effects

The following adverse reactions observed in clinical studies of naloxone hydrochloride nasal spray mainly include increased blood pressure, constipation, toothache, muscle spasm, musculoskeletal pain, headache, dry nose, nasal swelling, nasal congestion, rhinitis, nasal fissure and dry skin.

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Storage method

Store in an environment below 25°C, allowing temperature fluctuations not exceeding 40°C. Do not freeze and store away from light. Keep nasal sprayer in original packaging until ready to use.