Naloxone Hcl
Generic Name: naloxone hcl
Brand Names:
Kloxxado
11 DESCRIPTION KLOXXADO (naloxone hydrochloride) nasal spray contains the active moiety naloxone, an opioid antagonist, in the form of hydrochloride salt. The chemical name of Naloxone hydrochloride dihydrate is 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the molecular weight of 399.87 g/mol. Naloxone hydrochloride dihydrate molecular formula is C 19 H 21 NO 4· HCl · 2H 2 O, and it has the following chemical structure, as shown below.
Overview
11 DESCRIPTION KLOXXADO (naloxone hydrochloride) nasal spray contains the active moiety naloxone, an opioid antagonist, in the form of hydrochloride salt. The chemical name of Naloxone hydrochloride dihydrate is 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the molecular weight of 399.87 g/mol. Naloxone hydrochloride dihydrate molecular formula is C 19 H 21 NO 4· HCl · 2H 2 O, and it has the following chemical structure, as shown below.
Uses
1 INDICATIONS AND USAGE KLOXXADO is 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. KLOXXADO is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOXXADO is not a substitute for emergency medical care. KLOXXADO 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. (1) KLOXXADO is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOXXADO is not a substitute for emergency medical care. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • KLOXXADO is for intranasal use only. ( 2.1 ) • Seek emergency medical care immediately after use. ( 2.1 ) • All approved naloxone hydrochloride products achieve plasma concen- trations effective at reversing the effects of opioid overdose. Comparing products on a nominal mg-for-mg basis may be misleading. ( 2.1 ) • Administer a single spray of KLOXXADO to adult or pediatric patients intranasally into one nostril. ( 2.2 ) • 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.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Recurrent Respiratory and Central Nervous System Depression [see Warnings and Precautions ( 5.1 )] • Precipitation of Severe Opioid Withdrawal [see Warnings and Precautions ( 5.3 )] The following adverse reactions were reported with KLOXXADO in two adult subjects each: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Specialty USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
5 WARNINGS AND PRECAUTIONS • Risk of Recurrent Respiratory and CNS Depression : Due to the duration of action of naloxone relative to the opioid, keep patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance. ( 5.1 ) • Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists : Reversal of respiratory depression caused by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be necessary. ( 5.2 ) • Precipitation of Severe Opioid Withdrawal : Use in patients who are opioid dependent may precipitate opioid withdrawal. 4 CONTRAINDICATIONS KLOXXADO is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in KLOXXADO. Hypersensitivity to naloxone hydrochloride or to any of the other ingredients. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from retrospective cohort studies on naloxone use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Naloxone may precipitate opioid withdrawal in the pregnant woman and fetus [see Warnings and Precautions ( 5.3 ) and Clinical Considerations ] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING KLOXXADO (naloxone hydrochloride) nasal spray is a clear, colorless to yellow solution supplied in a single-dose spray device that consists of a stoppered glass vial encased in a container holder fitted with a spray actuator, cannula, and spray pin. It delivers a single dose of 8 mg of naloxone hydrochloride (equivalent to 7.2 mg naloxone) in 0.1 mL.
Frequently Asked Questions
What is Naloxone Hcl used for?▼
1 INDICATIONS AND USAGE KLOXXADO is 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. KLOXXADO is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOXXADO is not a substitute for emergency medical care. KLOXXADO 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. (1) KLOXXADO is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOXXADO is not a substitute for emergency medical care. ( 1 )
What are the side effects of Naloxone Hcl?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Recurrent Respiratory and Central Nervous System Depression [see Warnings and Precautions ( 5.1 )] • Precipitation of Severe Opioid Withdrawal [see Warnings and Precautions ( 5.3 )] The following adverse reactions were reported with KLOXXADO in two adult subjects each: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Specialty USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Naloxone Hcl during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from retrospective cohort studies on naloxone use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Naloxone may precipitate opioid withdrawal in the pregnant woman and fetus [see Warnings and Precautions ( 5.3 ) and Clinical Considerations ] .
What are the important warnings for Naloxone Hcl?▼
5 WARNINGS AND PRECAUTIONS • Risk of Recurrent Respiratory and CNS Depression : Due to the duration of action of naloxone relative to the opioid, keep patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance. ( 5.1 ) • Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists : Reversal of respiratory depression caused by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be necessary. ( 5.2 ) • Precipitation of Severe Opioid Withdrawal : Use in patients who are opioid dependent may precipitate opioid withdrawal. 4 CONTRAINDICATIONS KLOXXADO is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in KLOXXADO. Hypersensitivity to naloxone hydrochloride or to any of the other ingredients. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.