Kloxxado

Last reviewed on RxList: 5/5/2021
Kloxxado Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Kloxxado?

Kloxxado (naloxone hydrochloride) Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.

What Are Side Effects of Kloxxado?

Side effects of Kloxxado include:

Dosage for Kloxxado

Kloxxado is for intranasal use only. Seek emergency medical care immediately after use. The dose of Kloxxado is a single spray administered to adult or pediatric patients intranasally into one nostril. Administer additional doses of Kloxxado, using a new nasal spray with each dose, if the patient does not respond or responds and then relapses into respiratory depression. Additional doses of Kloxxado may be given every 2 to 3 minutes until emergency medical assistance arrives.

Kloxxado In Children

The safety and effectiveness of Kloxxado has been established in pediatric patients of all ages for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression.

What Drugs, Substances, or Supplements Interact with Kloxxado?

Kloxxado may interact with other medicines.

Tell your doctor all medications and supplements you use.

Kloxxado During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Kloxxado. Naloxone hydrochloride crosses the placenta, and may precipitate withdrawal in the fetus, as well as in the opioid-dependent mother. The fetus should be evaluated for signs of distress after Kloxxado is used. Careful monitoring is needed until the fetus and mother are stabilized. Studies in nursing mothers have shown the drug in Kloxxado does not affect prolactin or oxytocin hormone levels. Kloxxado is minimally orally available and is unlikely to affect the breastfed infant. Consult your doctor before breastfeeding.

Additional Information

Our Kloxxado (naloxone hydrochloride) Nasal Spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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.

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.

SLIDESHOW

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Kloxxado Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Recurrent Respiratory and Central Nervous System Depression [see WARNINGS AND PRECAUTIONS]
  • Precipitation of Severe Opioid Withdrawal [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In two pharmacokinetic studies a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO, one spray in one nostril. The following adverse reactions were reported in two subjects each: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope. On local tissue assessments for nasal irritation, signs of nasal inflammation and nasal congestion were observed.

Postmarketing Experience

The following adverse events have been identified during the post-approval use of naloxone hydrochloride injection in the postoperative setting. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in postoperative patients have resulted in significant reversal of analgesia and have caused agitation.

Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated an acute withdrawal syndrome. Signs and symptoms have included: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, tachycardia. In some patients, there was aggressive behavior upon abrupt reversal of an opioid overdose. In the neonate, opioid withdrawal has included: convulsions, excessive crying, hyperactive reflexes [see WARNINGS AND PRECAUTIONS].

The following most frequently reported events (in decreasing frequency) have been identified primarily during post-approval use of naloxone hydrochloride (all routes of administration): withdrawal syndrome, vomiting, nonresponsiveness to stimuli, drug ineffective, agitation, somnolence, and loss of consciousness.

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Kloxxado (Naloxone Hydrochloride Nasal Spray)

© Kloxxado Patient Information is supplied by Cerner Multum, Inc. and Kloxxado Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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