Naloxone (nasal)

Naloxone (nasal)

What is Naloxone Nasal?

Naloxone should not be used as a substitute for emergency medical care in the event of an overdose.

Naloxone nasal may also be used for purposes not listed in this medication guide.

Side effects of naloxone in the nose

If necessary, get emergency medical helpSigns of an allergic reaction: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Because naloxone nasal reverses the effects of opioids, this medication may cause sudden withdrawal symptoms such as:

• nausea, vomiting, diarrhea, stomach pain;

• fever, sweating, body aches, weakness;

• shaking or shivering, fast heartbeat, palpitations, increased blood pressure;

• goosebumps, sneezing;

• runny nose, yawning; or

• feeling nervous, restless or irritable.

Sudden withdrawal symptoms in a baby under 4 weeks old can be life-threatening if not treated properly.Symptoms include crying, stiffness, overactive reflexes and seizures. Call your doctor or get emergency medical help if you are not sure how to properly give this medicine to a baby.

Common side effects of naloxone can include:

• stomach pain, constipation;

• increased blood pressure;

• dry skin, toothache, muscle pain;

• weakness, dizziness, headache, lightheadedness; or

• stuffy nose, nasal discomfort and dryness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Warnings

Naloxone nasal is used to reverse the effects of opioid medications and treat opioid overdose.An opioid overdose can be fatal.Symptoms may include severe sleepiness, small pupils, slow breathing, or breathlessness.

A person caring for you may give you naloxone nasally if you stop breathing or don't wake up. Make sure everyone you care for knows where you keep naloxone nasal and how to use it.

Your caregiver still needs emergency medical attention and may need to perform cardiopulmonary resuscitation (CPR) on you while waiting for help to arrive.You may need to give another spray every 2 to 3 minutes until emergency help arrives.

Before you take this medicine

You should not be treated with naloxone nasal if you are allergic to it.

If possible, tell your doctor before using naloxone nasal if:

• You have heart problems.

If you take opioid medications during pregnancy, your baby may be born with life-threatening withdrawal symptoms and may require medical treatment for several weeks.

Using nasal naloxone during pregnancy may also cause opioid withdrawal symptoms in your unborn child.However, an opioid overdose can be fatal for both mother and child.It is much more important to treat an overdose in the mother. After using naloxone nasal, you must seek urgent medical attention.Make sure all emergency medical care providers know you are pregnant and that any treating doctor knows you have received naloxone.

Ask a doctor whether breast-feeding is safe while using this medication.

How should I use naloxone nasal?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

This medicine can be administered by a healthcare provider, an emergency physician, or a family member or caregiver trained in the proper nasal administration of naloxone.

Naloxone nasal should be sprayed into the nose while lying on your back.

Make sure you know how to recognize the signs of an opioid overdose in the person you care for. Symptoms of an overdose may include:

• slowed breathing or no breathing;

• accurately identify students;

• slow heartbeat; or

• extreme sleepiness, especially if you cannot wake the person from sleep.

Even if you are not sure whether you have an opioid overdose,If the person is not breathing or unresponsive, administer nasal naloxone immediatelyand then seek emergency medical attention.

Do not assume that an overdose episode has ended if symptoms improve. After nasal administration of naloxone, you need to get urgent help. You may need to perform cardiopulmonary resuscitation (CPR) on the person while you wait for emergency help to arrive.

Stay with the person and monitor for persistent signs of overdose. You may need to give another dose every 2 to 3 minutes until emergency help arrives. Follow all medication instructions carefully.

Each nasal spray pump is for single use only. Throw away after one use, even if it still contains medicine.

Store at room temperature, protected from moisture, heat and light. Do not freeze. Keep each spray pump in the box until you are ready to administer a dose. Do not use this medicine if the expiration date stated on the label has expired.

What happens if I miss a dose?

Naloxone nasal is used as needed and does not have a daily dose.

What happens if I overdose?

Because naloxone nasal is delivered at the correct dose in a disposable spray pump, overdose is unlikely.

What should I avoid when using naloxone nasal?

Avoid leaving a person alone after administering a dose of naloxone nasally. An opioid overdose can affect a person's thinking or reactions.

What other drugs will affect naloxone nasal?

Other medications can affect naloxone nasal, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.