DRUGS & SUPPLEMENTS
1 INDICATIONS AND USAGE
Naloxone Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Naloxone Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
Naloxone Nasal Spray is not a substitute for emergency medical care.
Limitations of Use:
Restrict prescription of Naloxone 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.
Naloxone Nasal Sprayis an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. (1)
Naloxone Nasal Sprayis intended for immediate administration as emergency therapy in settings where opioids may be present. (1)
Naloxone Nasal Sprayis not a substitute for emergency medical care. (1)
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Naloxone 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 Naloxone 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 Naloxone Nasal Spray. Emphasize the following instructions to the patient or caregiver:
2.2 Dosing in Adults and Pediatric Patients
The recommended initial dose of Naloxone Nasal Spray in adults and pediatric patients is one spray delivered by intranasal administration into one nostril.
Seek emergency medical assistance as soon as possible after administering the first dose of Naloxone Nasal Spray.
The requirement for repeat doses of Naloxone Nasal Spray depends upon the amount, type, and route of administration of the opioid being antagonized.
Administer Naloxone Nasal Spray in alternate nostrils with each dose.
If the patient responds to Naloxone Nasal Spray and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose of Naloxone Nasal Spray using a new Naloxone Nasal Spray and continue surveillance of the patient.
If the desired response is not obtained after 2 or 3 minutes, administer an additional dose of Naloxone Nasal Spray using a new Naloxone Nasal Spray. If there is still no response and additional doses are available, administer additional doses of Naloxone Nasal Spray every 2 to 3 minutes using a new Naloxone Nasal Spray with each dose until emergency medical assistance arrives.
Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
2.3 Dosing Modifications due to Partial Agonists or Mixed Agonist/Antagonists
Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and require higher doses of Naloxone or repeated administration of Naloxone Nasal Spray using a new nasal spray
3 DOSAGE FORMS AND STRENGTHS
Naloxone Nasal Spray is supplied as a single-dose intranasal spray containing 2 mg or 4 mg of Naloxone in 0.1 mL.
Nasal spray: 2 mg and 4 mg of Naloxone in 0.1 mL. (3)
Naloxone Nasal Spray is contraindicated in patients known to be hypersensitive to Naloxone or to any of the other ingredients.
Hypersensitivity to Naloxone
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Recurrent Respiratory and Central Nervous System Depression
The duration of action of most opioids may exceed that of Naloxone Nasal Spray resulting in a return of respiratory and/or central nervous system depression after an initial improvement in symptoms. Therefore, it is necessary to seek emergency medical assistance immediately after administration of the first dose of Naloxone Nasal Spray and to keep the patient under continued surveillance. Administer additional doses of Naloxone Nasal Spray if the patient is not adequately responding or responds and then relapses back into respiratory depression, as necessary. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
5.2 Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists
Reversal of respiratory depression by partial agonists or mixed agonist/antagonists such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses of Naloxone may be required to antagonize buprenorphine because the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression.
5.3 Precipitation of Severe Opioid Withdrawal
The use of Naloxone Nasal Spray in patients who are opioid-dependent may precipitate opioid withdrawal characterized by the following signs and symptoms: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes. Monitor the patient for the development of the signs and symptoms of opioid withdrawal.
There are limited data to inform if the 2 mg dose of Naloxone Nasal Spray will avoid precipitation of severe opioid withdrawal in the setting of opioid dependence. However, the 2 mg dose may not provide an adequate and timely reversal in persons who may be exposed to an overdose of a potent or very high dose of opioids.
Abrupt postoperative reversal of opioid depression after using Naloxone may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Although a direct cause and effect relationship has not been established, after use of Naloxone, monitor patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects for hypotension, ventricular tachycardia or fibrillation, and pulmonary edema in an appropriate healthcare setting. It has been suggested that the pathogenesis of pulmonary edema associated with the use of Naloxone is similar to neurogenic pulmonary edema, i.e., a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.
There may be clinical settings, particularly the postpartum period in neonates with known or suspected exposure to maternal opioid use, where it is preferable to avoid the abrupt precipitation of opioid withdrawal symptoms. In these settings, consider use of an alternative, naloxone-containing product that can be titrated to effect and, where applicable, dosed according to weight..
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
The following adverse reactions were observed in a Naloxone Nasal Spray clinical study.
In a pharmacokinetic study of 30 healthy adult volunteers exposed to one spray of Naloxone Nasal Spray in one nostril or two sprays of Naloxone 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 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 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.
The following adverse reactions were observed in a Naloxone Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Adapt Pharma, Inc. at 1-844-4NARCAN (1-844-462-7226) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
8 USE IN SPECIFIC POPULATIONS
The limited available data on naloxone use in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations. In animal reproduction studies, no embryotoxic or teratogenic effects were observed in mice and rats treated with Naloxone during the period of organogenesis at doses equivalent to 6-times and 12-times, respectively, a human dose of 8 mg/day based on body surface area comparison.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Fetal/Neonatal adverse reactions
Naloxone 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 Naloxone Nasal Spray is used. Careful monitoring is needed until the fetus and mother are stabilized.
Naloxone was administered during organogenesis to mice and rats at subcutaneous doses up to 10 mg/kg/day (equivalent to 6-times and 12-times, respectively, a human dose of 8 mg (two Naloxone Nasal Sprays)) (based on body surface area comparison). These studies demonstrated no embryotoxic or teratogenic effects due to Naloxone.
Pregnant female rats were administered 2 or 10 mg/kg naloxone subcutaneously from Gestation Day 15 to Postnatal day 21. There were no adverse effects on the offspring (up to 12-times a human dose of 8 mg/day (two Naloxone Nasal Sprays) based on body surface area comparison).
There is no information regarding the presence of naloxone in human milk, or the effects of naloxone on the breastfed infant or on milk production. Studies in nursing mothers have shown that naloxone does not affect prolactin or oxytocin hormone levels. Naloxone is minimally orally bioavailable.
8.4 Pediatric Use
The safety and effectiveness of Naloxone Nasal Spray have been established in pediatric patients of all ages for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. Use of Naloxone in all pediatric patients is supported by adult bioequivalence studies coupled with evidence from the safe and effective use of other Naloxone drug products. No pediatric studies were conducted for Naloxone Nasal Spray.
Absorption of Naloxone following intranasal administration in pediatric patients may be erratic or delayed. Even when the opiate-intoxicated pediatric patient responds appropriately to Naloxone, he/she must be carefully monitored for at least 24 hours, as a relapse may occur as Naloxone is metabolized.
In opioid-dependent pediatric patients,, administration of Naloxone may result in an abrupt and complete reversal of opioid effects, precipitating an acute opioid withdrawal syndrome. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening, if not recognized, and should be treated according to protocols developed by neonatology experts.
In settings such as in neonates with known or suspected exposure to maternal opioid use, where it may be preferable to avoid the abrupt precipitation of opioid withdrawal symptoms, consider use of an alternate naloxone-containing product that can be dosed according to weight and titrated to effect.
Also, in situations where the primary concern is for infants at risk for opioid overdose, consider whether the availability of alternate naloxone-containing products may be better suited than Naloxone Nasal Spray.
8.5 Geriatric Use
Geriatric patients have a greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Therefore, the systemic exposure of Naloxone can be higher in these patients.
Clinical studies of Naloxone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Naloxone (naloxone hydrochloride) Nasal Spray is a pre-filled, single dose intranasal spray. Chemically, Naloxone is the hydrochloride salt of 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride with the following structure:
Naloxone, an opioid antagonist, occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform.
Each Naloxone Nasal Spray contains a 2 mg or 4 mg single dose of Naloxone in a 0.1 mL (100 microliter) aqueous solution.
Inactive ingredients include benzalkonium chloride (preservative), disodium ethylenediaminetetraacetate (stabilizer), sodium chloride, hydrochloric acid to adjust pH, and purified water. The pH range is 3.5 to 5.5.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Naloxone is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Naloxone reverses the effects of opioids, including respiratory depression, sedation, and hypotension. It can also reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.
When Naloxone is administered intravenously, the onset of action is generally apparent within two minutes. The time to onset of action is shorter for intravenous compared to subcutaneous or intramuscular routes of administration. The duration of action is dependent upon the dose and route of administration of Naloxone.
In a pharmacokinetic study in 30 healthy adult subjects, the relative bioavailability (BA) of one nasal spray in one nostril, consisting of a 2 mg total dose (0.1 mL of 20 mg/mL Naloxone solution) and a 4 mg total dose (0.1 mL of 40 mg/mL Naloxone solution), and two nasal sprays administered as one nasal spray in each nostril, consisting of a 4 mg total dose (0.1 mL of 20 mg/mL Naloxone solution in each nostril) and an 8 mg total dose (0.1 mL of 40 mg/mL Naloxone solution in each nostril), were compared to a single dose of 0.4 mg Naloxone intramuscular injection. For intranasal administration, the subjects were instructed not to breathe through the nose during administration of the nasal spray, and remained fully supine for approximately one hour post-dose. For intramuscular administration, naloxone was administered as a single injection in the gluteus maximus muscle. The pharmacokinetic parameters obtained in the study are shown in Table 1.
Table 1 Mean Pharmacokinetic Parameters (CV%) for Naloxone Following Naloxone (Naloxone HCl) Nasal Spray and Intramuscular Injection of Naloxone HCl to Healthy Subjects
†† N=28 for Relative BA.
Figure 1 Mean ± SD Plasma Concentration of Naloxone, (a) 0-6 h and (b) 0-1h Following Intranasal Administration and Intramuscular Injection
The median naloxone tmax after intranasal administration of Naloxone Nasal Spray (one nasal spray in one nostril (2 mg or 4 mg) or two nasal sprays as one spray in each nostril (4 mg or 8 mg) was not significantly different compared to the 0.4 mg dose of Naloxone intramuscular injection (Table 1).
The dose normalized relative bioavailability of one dose (2 mg or 4 mg) or two doses (4 mg or 8 mg) of Naloxone Nasal Spray as compared to the 0.4 mg dose of Naloxone administered by intramuscular injection was 52%, 44%, 54%, and 43%, respectively.
Following parenteral administration, naloxone is distributed in the body and readily crosses the placenta. Plasma protein binding occurs but is relatively weak. Plasma albumin is the major binding constituent, but significant binding of naloxone also occurs to plasma constituents other than albumin. It is not known whether naloxone is excreted into human milk.
Following a single intranasal administration of Naloxone Nasal Spray (2 mg or 4 mg dose of Naloxone), the mean plasma half-life of naloxone in healthy adults was approximately 1.85 (33% CV) hours and 2.08 (30% CV) hours; respectively, which was longer than that observed after administrations of a 0.4 mg Naloxone intramuscular injection, where the half-life was 1.24 hours (26% CV). In a neonatal study of Naloxone injection, the mean (± SD) plasma half-life was observed to be 3.1 (± 0.5) hours.
Naloxone is metabolized in the liver, primarily by glucuronide conjugation, with naloxone-3-glucoronide as the major metabolite.
After an oral or intravenous dose, about 25-40% of naloxone is excreted as metabolites in urine within 6 hours, about 50% in 24 hours, and 60-70% in 72 hours.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies to evaluate the carcinogenic potential of naloxone have not been completed.
Naloxone was weakly positive in the Ames mutagenicity and in the in vitro human lymphocyte chromosome aberration test but was negative in the in vitro Chinese hamster V79 cell HGPRT mutagenicity assay and in the in vivo rat bone marrow chromosome aberration study.
Impairment of Fertility
Male rats were treated with 2 or 10 mg/kg naloxone for 60 days prior to mating. Female rats treated for 14-days prior to mating and throughout gestation with the same doses of naloxone (up to 12-times a human dose of 8 mg/day (two Naloxone Nasal Sprays) based on body surface area comparison). There was no adverse effect on fertility.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Naloxone Nasal Spray 2 mg is supplied as a carton containing four 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.
Naloxone Nasal Spray 4 mg is supplied as carton containing two (2) blister packages (NDC 69547-353-02) each with a single spray device.
Naloxone Nasal Spray is not made with natural rubber latex.
16.2 Storage and Handling
Store Naloxone 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.
17 PATIENT COUNSELING INFORMATION
Advise the patient and family members or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Recognition of Opioid Overdose
Inform patients and their family members or caregivers about how to recognize the signs and symptoms of an opioid overdose such as the following:
Risk of Recurrent Respiratory and Central Nervous System Depression
Instruct patients and their family members or caregivers that, since the duration of action of most opioids may exceed that of Naloxone Nasal Spray, they must seek immediate emergency medical assistance after the first dose of Naloxone Nasal Spray and keep the patient under continued surveillance [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.3 )].
Limited Efficacy for/with Partial Agonists or Mixed Agonist/Antagonists
Instruct patients and their family members or caregivers that the reversal of respiratory depression caused by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and may require higher doses of Naloxone or repeated administration of Naloxone Nasal Spray, using a new nasal spray each time [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.2 )].
Precipitation of Severe Opioid Withdrawal
Instruct patients and their family members or caregivers that the use of Naloxone Nasal Spray in patients who are opioid dependent may precipitate opioid withdrawal [see Warnings and Precautions ( 5.3 ), Adverse Reactions (6)].
Instruct patients and their family members or caregivers to:
Naloxone® is a registered trademark licensed by Adapt Pharma Operations Limited.
Distributed by Adapt Pharma, Inc., Radnor, PA 19087 USA.
Naloxone (nar´ kan)
You and your family members or caregivers should read this Patient Information leaflet before an opioid emergency happens. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about Naloxone Nasal Spray?
Naloxone Nasal Spray is used to temporarily reverse the effects of opioid medicines. The medicine in Naloxone Nasal Spray has no effect in people who are not taking opioid medicines. Always carry Naloxone Nasal Spray with you in case of an opioid emergency.
1. Use Naloxone Nasal Spray right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death. Signs and symptoms of an opioid emergency may include:
- unusual sleepiness and you are not able to awaken the person with a loud voice or by rubbing firmly on the middle of their chest (sternum)
- breathing problems including slow or shallow breathing in someone difficult to awaken or who looks like they are not breathing
- the black circle in the center of the colored part of the eye (pupil) is very small, sometimes called “pinpoint pupils,” in someone difficult to awaken
2. Family members, caregivers, or other people who may have to use Naloxone Nasal Spray in an opioid emergency should know where Naloxone Nasal Spray is stored and how to give Naloxone before an opioid emergency happens.
3. Get emergency medical help right away after giving the first dose of Naloxone Nasal Spray. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
4. The signs and symptoms of an opioid emergency can return after Naloxone Nasal Spray is given. If this happens, give another dose after 2 to 3 minutes using a new Naloxone Nasal Spray and watch the person closely until emergency help is received.
What is Naloxone Nasal Spray?
- Naloxone Nasal Spray is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond.
- Naloxone Nasal Spray is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after giving the first dose of Naloxone Nasal Spray, even if the person wakes up.
- Naloxone Nasal Spray is safe and effective in children for known or suspected opioid overdose.
Who should not use Naloxone Nasal Spray?
Do not use Naloxone Nasal Spray if you are allergic to Naloxone or any of the ingredients in Naloxone Nasal Spray. See the end of this leaflet for a complete list of ingredients in Naloxone Nasal Spray.
What should I tell my healthcare provider before using Naloxone Nasal Spray?
Before using Naloxone Nasal Spray, tell your healthcare provider about all of your medical conditions, including if you:
- have heart problems
- are pregnant or plan to become pregnant. Use of Naloxone Nasal Spray may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use Naloxone Nasal Spray.
- are breastfeeding or plan to breastfeed. It is not known if Naloxone Nasal Spray passes into your breast milk.
Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Naloxone Nasal Spray?
Read the “Instructions for Use” at the end of this Patient Information leaflet for detailed information about the right way to use Naloxone Nasal Spray.
- Use Naloxone Nasal Spray exactly as prescribed by your healthcare provider.
- Each Naloxone Nasal Spray contains only 1 dose of medicine and cannot be reused.
- Naloxone Nasal Spray comes in a 2 mg and 4 mg strength. Your healthcare provider will prescribe the one that is right for you.
- Lay the person on their back. Support their neck with your hand and allow the head to tilt back before giving Naloxone Nasal Spray.
- Naloxone Nasal Spray should be given into one nostril.
- If additional doses are needed, give Naloxone Nasal Spray in the other nostril.
What are the possible side effects of Naloxone Nasal Spray?
Naloxone Nasal Spray may cause serious side effects, including:
- Sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving Naloxone Nasal Spray and may include:
o body aches
o increased heart rate
o runny nose o sneezing
o goose bumps
o nausea or vomiting o nervousness
o restlessness or irritability
o shivering or trembling
o stomach cramping
o increased blood pressure
In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.
These are not all of the possible side effects of Naloxone Nasal Spray. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Naloxone Nasal Spray?
- Store Naloxone Nasal Spray at room temperature between 59°F to 77°F (15°C to 25°C). Excursions permitted up to 104°F (40°C).
- Do not freeze Naloxone Nasal Spray.
- Keep Naloxone Nasal Spray in its box until ready to use. Protect from light.
- Replace Naloxone Nasal Spray before the expiration date on the box.
Keep Naloxone Nasal Spray and all medicines out of the reach of children.
General information about the safe and effective use of Naloxone Nasal Spray.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Naloxone Nasal Spray for a condition for which it was not prescribed. You can ask your pharmacist or healthcare provider for information about Naloxone Nasal Spray that is written for health professionals.
What are the ingredients in Naloxone Nasal Spray?
Active ingredient: Naloxone
Inactive ingredients: benzalkonium chloride (preservative), disodium ethylenediaminetetraacetate (stabilizer), sodium chloride, hydrochloric acid to adjust pH and sterile water
Naloxone Nasal Spray is not made with natural rubber latex.
Distributed by Adapt Pharma, Inc., Radnor, PA 19087 USA.
For more information, go to www.narcannasalspray.com or call 1-844-4NARCAN (1-844-462-7226).
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 02/2017
Instructions for Use
Instructions for Use
Naloxone (nar´ kan)
You and your family members or caregivers should read the Instructions for Use that comes with Naloxone Nasal Spray before using it. Talk to your healthcare provider if you and your family members or caregivers have any questions about the use of Naloxone Nasal Spray.
Use Naloxone Nasal Spray for known or suspected opioid overdose in adults and children.
Important: For use in the nose only.
How to use Naloxone Nasal Spray:
Step 1. Lay the person on their back to receive a dose of Naloxone Nasal Spray.
Step 2. Remove Naloxone Nasal Spray from the box. Peel back the tab with the circle to open the Naloxone Nasal Spray.
Step 3. Hold the Naloxone Nasal Spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.
Step 4. Tilt the person’s head back and provide support under the neck with your hand. Gently insert the tip of the nozzle into one nostril until your fingers on either side of the nozzle are against the bottom of the person’s nose.
Step 5. Press the plunger firmly to give the dose of Naloxone Nasal Spray.
Step 6. Remove the Naloxone Nasal Spray from the nostril after giving the dose.
What to do after Naloxone Nasal Spray has been used:
Step 7. Get emergency medical help right away.
Step 8. Put the used Naloxone Nasal Spray back into its box.
Step 9. Throw away (dispose of) the used Naloxone Nasal Spray in a place that is away from children.
How should I store Naloxone Nasal Spray?
Keep Naloxone Nasal Spray and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA.
For more information, go to www.narcannasalspray.com or call 1-844-4NARCAN (1-844-462-7226).
2-ifu-peel 3-ifu-device 4-ifu-support 5-ifu-plunger 6-ifu-recovery
2 mg - 4 pack
Carton Four Pack
2 mg - 24 pack
Carton 24 Pack
4 mg - 2 pack
Carton Two Pack
blister carton-two-pack blister-2mg carton-four-pack carton-24-pack
Naloxone pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Naloxone available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Naloxone destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Naloxone Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Naloxone pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Naloxone?
Depending on the reaction of the Naloxone after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Naloxone not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Naloxone addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Naloxone, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Naloxone consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
Visitor reported side effectsNo survey data has been collected yet
Visitor reported price estimatesNo survey data has been collected yet
Visitor reported frequency of useNo survey data has been collected yet
Visitor reported dosesNo survey data has been collected yet
One visitor reported time for resultsWhat is the time duration Naloxone drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 1 day to notice the result from using Naloxone drug. The time needed to show improvement in health condition after using the medicine Naloxone need not be same for all the users. It varies based on other factors.
Visitor reported administrationNo survey data has been collected yet
Visitor reported ageNo survey data has been collected yet
The information was verified by Dr. Rachana Salvi, MD Pharmacology