Narcan Naloxone Hci
FDA Drug Information • Also known as: Narcan Naloxone Hci
- Brand Names
- Narcan Naloxone Hci
- Route
- NASAL
- Dosage Form
- SPRAY
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION NARCAN (naloxone hydrochloride) Nasal Spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride with the following structure: C19H21NO4
What Is Narcan Naloxone Hci Used For?
1 INDICATIONS & USAGE NARCAN Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. NARCAN Nasal Spray is not a substitute for emergency medical care. Limitations of Use: Restrict prescription of NARCAN Nasal Spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.
Dosage and Administration
2 DOSAGE & ADMINISTRATION 2.1 Important Administration Instructions NARCAN Nasal Spray is for intranasal use only. No additional device assembly is required. Because treatment of suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of NARCAN Nasal Spray and the Instructions for Use. Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for NARCAN Nasal Spray. Emphasize the following instructions to the patient or caregiver: Administer NARCAN Nasal Spray as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death. Since the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of NARCAN Nasal Spray, as necessary. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of NARCAN Nasal Spray. Additional doses of NARCAN Nasal Spray may be required until emergency medical assistance becomes available. Do not attempt to reuse NARCAN Nasal Spray. Each NARCAN Nasal Spray contains a single dose of naloxone and cannot be reused. Re-administer NARCAN Nasal Spray, using a new nasal spray, every 2 to 3 minutes if the patient does not respond or responds and then relapses into respiratory depression. Administer NARCAN Nasal Spray in alternate nostrils with each dose. Administer NARCAN Nasal Spray according to the printed instructions on the device label and the Instructions for Use. Place the patient in the supine position. Prior to administration, be sure the device nozzle is inserted in either nostril of the patient, and provide support to the back of the neck to allow the head to tilt back. Do not prime or test the device prior to administration. To administer the dose press firmly on the device plunger. Remove the device nozzle from the nostril after use. Turn patient on their side as shown in the InstructionsforUse and call for emergency medical assistance immediately after administration of the first dose of NARCAN Nasal Spray. 2.2 Dosing in Adults and Pediatric Patients Initial Dosing The recommended initial dose of NARCAN Nasal Spray in adults and pediatric patients is one spray delivered by intranasal administration into one nostril. Repeat Dosing Seek emergency medical assistance as soon as possible after administering the first dose of NARCAN Nasal Spray. The requirement for repeat doses of NARCAN Nasal Spray depends upon the amount, type, and route of administration of the opioid being antagonized. Administer NARCAN Nasal Spray in alternate nostrils with each dose. If the...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal [see Warnings and Precautions ( 5- 5.3)] 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. The following adverse reactions were observed in a NARCAN Nasal Spray clinical study. In a pharmacokinetic study of 30 healthy adult volunteers exposed to one spray of NARCAN Nasal Spray in one nostril or two sprays of NARCAN Nasal Spray, one in each nostril, the most common adverse reactions were: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma. The following adverse reactions have been identified primarily during post-approval use of naloxone hydrochloride in the post-operative 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 post-operative 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 may be aggressive behavior upon abrupt reversal of an opioid overdose. In the neonate, opioid withdrawal signs and symptoms also included convulsions, excessive crying, and hyperactive reflexes.
Contraindications
4 CONTRAINDICATIONS NARCAN Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING NARCAN NALOXONE HCI NASAL SPRAY is supplied in the following dosage forms. NDC 51662-1240-1 NARCAN NALOXONE HCI NASAL SPRAY 4mg/.1mL SINGLE UNBOXED NDC 51662-1240-2 NARCAN NALOXONE HCI NASAL SPRAY 4mg/.1mL 2-PACK HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 16.1 How Supplied NARCAN Nasal Spray 2 mg is supplied as a carton containing four (4) blister packages (NDC 69547-212-04) each with a single spray device and as a carton containing twenty-four (24) blister packages (NDC 69547-212-24) each with a single spray device. NARCAN Nasal Spray 4 mg is supplied as carton containing two (2) blister packages (NDC 69547-353-02) each with a single spray device. NARCAN Nasal Spray is not made with natural rubber latex. 16.2 Storage and Handling Store NARCAN Nasal Spray in the blister and cartons provided. Store at room temperature 59°F to 77°F (15°C to 25°C). Excursions permitted up to 104°F (40°C). Do not freeze. Protect from light.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.