KLOXXADO

In a pharmacokinetic study in up to 72 healthy adult volunteers under fasting conditions, the bioavailability (BA) of a single 4 mg dose (one spray) of KLOXXADO was compared to a single 8 mg nasal dose of KLOXXADO and a single 4 mg nasal dose of a previously approved naloxone nasal spray. Naloxone plasma concentration versus time profiles are shown in Figure 1. The pharmacokinetic parameters of naloxone are summarized in Table 1. Figure 1. Mean ± SD Plasma Concentration Time Profiles of Naloxone...

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 Speci...

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 )

• 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 buprenorphin...