Naloxone (injection)

Naloxone (injection)

Uses for Naloxone

This medicine is only available with a doctor's prescription.

Before using naloxone

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Studies conducted to date have not shown any pediatric-specific problems that would limit the benefit of naloxone injection in children.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of naloxone injection in the elderly. However, older patients are at higher risk of age-related kidney, liver, or heart problems, which may require caution and dose adjustment in patients receiving naloxone injection.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Morphium
• Morphinsulfat-Liposom
• Naldemedine
• Naloxegol
• Oxycodon
• Oxymorphon

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but using both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Clonidin
• Yohimbin

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or around the time of eating or consuming certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Herz- oder Blutgefäßerkrankung oder
• Nierenerkrankung bzw
• Lebererkrankung – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

Proper use of naloxone

A home caregiver or family member will give you or your child this medicine. It is given as an injection under the skin or into a muscle.

This medication should be administered immediately if a suspected or known opioid overdose has occurred. This can prevent serious breathing problems and severe sleepiness, which can lead to death.

This medicine includes patient instructions and a training device. Have your home care provider or family member read and follow the instructions carefully. Ask your doctor if you have any questions.

Use:

• Evzio® ist in 2 Dosierungsstärken erhältlich: 0,4 Milligramm (mg)/0,4 Milliliter (ml) Autoinjektor oder 2 mg/0,4 ml Autoinjektor. Zimhi™ ist in einer Fertigspritze mit 5 mg/0,5 ml erhältlich.
• Es enthält gedruckte Anweisungen auf dem Geräteetikett. Evzio® enthält außerdem einen Lautsprecher, der elektronische Anweisungen liefert, die den Benutzer durch jeden Schritt der Injektion führen.
• Injizieren Sie das Arzneimittel bei Bedarf durch die Kleidung in die Außenseite der Oberschenkel. Wenn Sie dieses Arzneimittel einem Kind unter 1 Jahr verabreichen, sollten Sie bei der Verabreichung des Arzneimittels den Oberschenkelmuskel einklemmen.
• Verwenden Sie das Arzneimittel nicht, wenn es trüb oder verfärbt ist oder große Partikel enthält.
• Dieses Arzneimittel kann nur einmal angewendet werden. Entfernen Sie den Sicherheitsschutz erst, wenn Sie ihn verwenden möchten.
• Nachdem Sie dem Patienten die erste Dosis verabreicht haben, holen Sie sofort medizinische Nothilfe ein.
• Beobachten Sie den Patienten genau auf Anzeichen und Symptome eines Opioid-Notfalls, die nach einigen Minuten wieder auftreten können.
• Verabreichen Sie alle 2 bis 3 Minuten eine neue Naloxon-Injektion, wenn die Symptome wieder auftreten, und überwachen Sie den Patienten, bis medizinische Nothilfe verfügbar ist.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Bei Überdosierung mit Opioiden:
  • Für die Injektionsdosisform (Evzio® Autoinjektor):
    • Erwachsene und Kinder – 0,4 oder 2 Milligramm (mg), injiziert unter die Haut oder in einen Muskel.
  • Für die Injektionsdosierungsform (Zimhi™ Fertigspritze):
    • Erwachsene und Kinder – 5 Milligramm (mg), injiziert unter die Haut oder in einen Muskel.

storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Protect from freezing.

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Ask your doctor how to throw away medicines you don't use.

Precautions when using naloxone

The effects of the opioid medicine may last longer than the effects of naloxone. This means that breathing problems and sleepiness may return. Always call emergency services after the first dose of naloxone.

Severe opioid withdrawal symptoms may occur suddenly after taking this medication. These include body aches, fever, sweating, runny nose, sneezing, goosebumps, yawning, weakness, shivering or shaking, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramps, fast heartbeat and increased blood pressure.

For some types of opioid medications (e.g., buprenorphine, pentazocine), higher or repeated doses of naloxone may be required to reverse the opioid effects.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Naloxone side effects

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Consult your doctor immediately if any of the following side effects occur:

Incident not known

• Agitation
• Gliederschmerzen
• Brustschmerzen
• Husten, der manchmal einen rosafarbenen, schaumigen Auswurf erzeugt
• mehr Weinen als üblich (bei Babys)
• Durchfall
• Atembeschwerden oder Schwierigkeiten beim Atmen
• übermäßiges Weinen
• schneller, hämmernder oder unregelmäßiger Herzschlag oder Puls
• Fieber
• Gänsehaut
• vermehrte oder übermäßige unbewusste oder ruckartige Bewegungen
• unregelmäßige, schnelle oder langsame oder flache Atmung
• Reizbarkeit
• Übelkeit oder Erbrechen
• Nervosität
• blasse oder blaue Lippen, Fingernägel oder Haut
• Unruhe
• laufende Nase
• Anfälle
• Zittern
• niesen
• Schwitzen
• Schwellungen in den Beinen und Knöcheln
• Zittern
• Schwäche
• Gähnen

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Evzio
• Narcan
• Zimhi

Available dosage forms:

• Lösung

Therapeutic Class: Antidote

Pharmacological class: Opioid antagonist

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