Kloxxado

Kloxxado (naloxone) nasal spray belongs to a class of medications called opiate antagonists. Naloxone works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood.

Kloxxado nasal spray is a prescription medicine used in adults and children for the treatment of an opioid emergency such as a known opioid overdose or a suspected opioid overdose with signs of breathing problems and severe sleepiness, or not being able to respond.

Kloxxado nasal spray should not be used in place of emergency medical care for an overdose.

Use Kloxxado exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

This medicine may be given by a healthcare provider, emergency medical provider, or a family member or caregiver who is trained to properly give Kloxxado nasal spray.

Kloxxado nasal spray should be sprayed into the nose while the person is lying on his or her back. Support their neck with your hand and allow the head to tilt back before giving the medicine.

Be sure you know how to recognize the signs of an opioid overdose in the person you are caring for. Overdose symptoms may include:

• slowed breathing, or no breathing;
• pinpoint pupils;
• slow heartbeats; or
• extreme drowsiness, especially if you are unable to wake the person from sleep.

Even if you are not sure an opioid overdose has occurred, if the person is not breathing or is unresponsive, give Kloxxado nasal spray right away and then seek emergency medical care.

Do not assume that an overdose episode has ended if symptoms improve. You must get emergency help after giving Kloxxado. Move the person on their side (recovery position) after giving the medicine. You may need to perform CPR (cardiopulmonary resuscitation) on the person while you are waiting for emergency help to arrive.

Stay with the person and watch for continued 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 Kloxxado spray pump contains only one dose and is for one use only. Do not test or prime the nasal spray before use. Throw away after one use.

Store Kloxxado nasal spray at room temperature between 68ºF to 77ºF (20°C to 25°C) away from moisture, heat and light. Do not freeze. Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C). Keep each spray pump in the box until you are ready to give a dose. Do not use this medicine if the expiration date on the label has passed. If the medicine freezes, the device will not spray. Get emergency medical help right away and do not wait for the medicine to thaw. However, the medicine may still be used if it has been thawed after being previously frozen.

Kloxxado is used to reverse the effects of opioid medicine and treat an opioid overdose. An opioid overdose can be fatal. Symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

A person caring for you can give the Kloxxado if you stop breathing or don't wake up. Make sure any person caring for you knows where you keep Kloxxado and how to use it.

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

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

If possible before you use Kloxxado, tell your doctor if:

• you have heart problems.

If you use opioid medicine during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Using Kloxxado while you are pregnant may also cause opioid withdrawal effects in your unborn baby. However, having an opioid overdose can be fatal to both mother and baby. It is much more important to treat an overdose in the mother. You must get emergency medical help after using Kloxxado. Be sure all emergency medical caregivers know that you are pregnant and any follow-up doctor knows you received this medicine.

Ask a doctor if it is safe to breastfeed while using Kloxxado nasal spray. It is not known if naloxone passes into your breast milk.

Get emergency medical help if you have signs of an allergic reaction to Kloxxado: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Because Kloxxado reverses opioid effects, this medicine may cause sudden withdrawal symptoms such as:

• nausea, vomiting, diarrhea, stomach pain;
• fever, sweating, body aches, weakness;
• tremors or shivering, fast heart rate, pounding heartbeats, increased blood pressure;
• goose bumps, sneezing;
• runny nose, yawning; or
• feeling nervous, restless, or irritable.

Sudden withdrawal symptoms in a baby younger than 4 weeks old may be life-threatening if not treated the right way. 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 Kloxxado side effects may include:

• stomach pain, constipation;
• increased blood pressure;
• dry skin, tooth pain, muscle pain;
• weakness, dizziness, headache, feeling light-headed; 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 may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose of Kloxxado nasal spray for Opioid Overdose

Administer 1 spray intranasally into 1 nostril -If desired response is not achieved after 2 or 3 minutes, give a second dose intranasally into alternate nostril; additional doses may be administered every 2 to 3 minutes in alternating nostrils until emergency medical assistance arrives

Usual Adult Dose of Kloxxado nasal spray for Reversal of Opioid Sedation:

-Administer 1 spray intranasally into 1 nostril -If desired response is not achieved after 2 or 3 minutes, give a second dose intranasally into alternate nostril; additional doses may be administered every 2 to 3 minutes in alternating nostrils until emergency medical assistance arrives Comments: -Neonatal opioid withdrawal syndrome may be life-threatening and should be treated according to protocols developed by neonatology experts. - To avoid precipitating opioid withdrawal symptoms, consider use of a naloxone product that can be dosed according to weight and titrated to effect. -The duration of action of some opioids will exceed that of this drug, therefore, repeat doses may be needed; the need for repeat doses will depend on the amount, type, and route of administration of the opioid being antagonized. -Patients should remain under continued surveillance; if a patients responds and relapses back into respiratory depression, additional doses should be given. -Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

Kloxxado is used when needed and does not have a daily dose.

Since Kloxxado is supplied as the correct dose in a single-use spray pump, an overdose is unlikely to occur.

Avoid leaving a person alone after giving a dose of Kloxxado nasal spray. An opioid overdose can impair a person's thinking or reactions.

Other drugs may interact with naloxone nasal, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Active ingredient: naloxone hydrochloride Inactive ingredients: dehydrated alcohol, edetate disodium dihydrate, propylene glycol, sodium hydroxide, hydrochloric acid, purified water.

Distributed by: Hikma Specialty USA Inc. Columbus, OH 4322