naloxone
Pharmaranks rates Naloxone 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Naloxone (Naloxone Hydrochloride) is an opioid antagonist used to treat Opioid-Related Disorders, Respiration Disorders, Septic Shock.
Naloxone Hydrochloride · by Hikma
Generic of Narcan
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Naloxone Hydrochloride
- Drug class
- Opioid Antagonist
- Form
- Injectable
- Strength
- Naloxone Hydrochloride 0.4MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Hikma
- Half-life
- 30 to 81 minutes (mean 64 ± 12 minutes) (how long it stays in your system)
- What the pharmacy pays
- ~$4.41 per ml — not your price
- FDA application
- ANDA070299
What is Naloxone?
From the FDA label:Naloxone Hydrochloride Injection, USP, an opioid antagonist, is a synthetic congener of oxymorphone. In structure it differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone hydrochloride 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. Naloxone Hydrochloride Injection, USP is available as a sterile solution for intravenous, intramuscular and subcutaneous administration in the concentration 0.4 mg of naloxone hydrochloride per mL. pH 3.0 to 6.5; hydrochloric acid and/or sodium hydroxide used, if needed, for pH adjustment. The 0.4 mg/mL vial contains 8.6 mg/mL of sodium chloride and 2 mg/mL of methylparaben and propylparaben as preservatives in a ratio of 9:1. structure
How to use
Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration, which is recommended in emergency situations. Since the duration of action of some opioids may exceed that of naloxone, the patient should be kept under continued surveillance. Repeated doses of naloxone should be administered, as necessary. Intravenous Infusion Naloxone Hydrochloride Injection, USP may be diluted for intravenous infusion in normal saline or 5% dextrose solutions. The addition of 2 mg of naloxone hydrochloride in 500 mL of either solution provides a concentration of 0.004 mg/mL. Mixtures should be used within 24 hours. After 24 hours, the remaining unused mixture must be discarded. The rate of administration should be titrated in accordance with the patient’s response. Naloxone Hydrochloride Injection, USP should not be mixed with preparations containing bisulfite, metabisulfite, long-chain or high molecular weight anions, or any solution having an alkaline pH. No drug or chemical agent should be added to Naloxone Hydrochloride Injection, USP unless its effect on the chemical and physical stability of the solution has first been established. General Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever…
Side effects
Postoperative The following adverse events have been associated with the use of naloxone hydrochloride injection in postoperative patients: 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 postoperative patients may result in significant reversal of analgesia and may cause agitation (see PRECAUTIONS and DOSAGE AND ADMINISTRATION; Usage in Adults - Postoperative Opioid Depression ). Opioid Depression Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest which may result in death (see PRECAUTIONS ). Opioid Dependence Abrupt reversal of opioid effects in persons who are physically dependent on opioids may precipitate an acute withdrawal syndrome which may include, but is not limited to, the following signs and symptoms: 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 the neonate, opioid withdrawal may also include: convulsions; excessive crying;…
Warnings
Important safety information
Drug Dependence Naloxone hydrochloride injection should be administered cautiously to persons, including newborns of mothers, who are known or suspected to be physically dependent on opioids. In such cases, an abrupt and complete reversal of opioid effects may precipitate an acute withdrawal syndrome. The signs and symptoms of opioid withdrawal in a patient physically dependent on opioids may include, but are not limited to, the following: 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 the neonate, opioid withdrawal may also include: convulsions, excessive crying, and hyperactive reflexes. Repeat Administration The patient who has satisfactorily responded to naloxone should be kept under continued surveillance and repeated doses of naloxone should be administered, as necessary, since the duration of action of some opioids may exceed that of naloxone. Respiratory Depression Due to Other Drugs Naloxone is not effective against respiratory depression due to non-opioid drugs and in the management of acute toxicity caused by levopropoxyphene. Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete or require higher doses of naloxone. If an incomplete response occurs, respirations should be mechanically assisted as clinically indicated.
Who should not take Naloxone
Naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in naloxone hydrochloride injection.
Overdose — what happens if you take too much
There is limited clinical experience with naloxone hydrochloride injection overdosage in humans. Adult Patients In one small study, volunteers who received 24 mg/70 kg did not demonstrate toxicity. In another study, 36 patients with acute stroke received a loading dose of 4 mg/kg (10 mg/m 2 /min) of naloxone hydrochloride injection followed immediately by 2 mg/kg/hr for 24 hours. Twenty-three patients experienced adverse events associated with naloxone use, and naloxone was discontinued in seven patients because of adverse effects. The most serious adverse events were: seizures (2 patients), severe hypertension (1), and hypotension and/or bradycardia (3). At doses of 2 mg/kg in normal subjects, cognitive impairment and behavioral symptoms, including irritability, anxiety, tension, suspiciousness, sadness, difficulty concentrating, and lack of appetite have been reported. In addition, somatic symptoms, including dizziness, heaviness, sweating, nausea, and stomachaches were also reported. Although complete information is not available, behavioral symptoms were reported to often persist for 2 to 3 days. Pediatric Patients Up to 11 doses of 0.2 mg of naloxone (2.2 mg) have been administered to children following overdose of diphenoxylate hydrochloride with atropine sulfate. Pediatric reports include a 2-1/2 year-old child who inadvertently received a dose of 20 mg of naloxone for…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Large doses of naloxone are required to antagonize buprenorphine since 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. The barbiturate methohexital appears to block the acute onset of withdrawal symptoms induced by naloxone in opiate addicts.
How long does Naloxone Hydrochloride stay in your body?
The elimination half-life of naloxone hydrochloride is 30 to 81 minutes (mean 64 ± 12 minutes) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the serum elimination half-life in adults with normal organ function; naloxone is metabolized in the liver by glucuronide conjugation (major metabolite naloxone-3-glucuronide, which is inactive) and excreted in urine. The half-life is much longer in neonates (mean 3.1 ± 0.5 hours). Because naloxone's half-life is short — often shorter than that of the opioids it reverses — its effects can wear off before the opioid does, so repeat dosing may be needed. Half-life is a pharmacokinetic elimination measure, not a drug-test detection window.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: NALOXONE HYDROCHLORIDE injection — DailyMed FDA label.
Drug class
How this class works, per Opioid Antagonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Naloxone ranks — best-rated opioid antagonist for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Naloxone treat?
- Naloxone (Naloxone Hydrochloride) may be used to treat opioid-related disorders, respiration disorders, septic shock, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Naloxone work?
- Naloxone is a opioid antagonist. Opioid antagonists attach to the same brain and body receptors that opioids use, but without switching them on. By occupying those receptors, they block opioids from binding and can rapidly reverse an overdose or curb opioid cravings.
- How is Naloxone rated?
- pharmaranks gives Naloxone a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Naloxone cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $4.41 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Naloxone?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Naloxone. To pay less, Naloxone is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Naloxone?
- Naloxone is marketed by Hikma. You can see Hikma's full profile, rating, and other products on pharmaranks.
- Is Naloxone a brand-name or generic drug?
- Naloxone is a generic medication; its active ingredient is Naloxone Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Naloxone available over the counter?
- No. Naloxone is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Naloxone come in?
- Naloxone is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Naloxone?
- Naloxone is classified as opioid antagonist, per the FDA's Established Pharmacologic Class.
- Is Naloxone FDA-registered?
- Naloxone is on record with the U.S. FDA under application number ANDA070299. You can verify this on its official FDA label.
- Has Naloxone been recalled by the FDA?
- Naloxone has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Naloxone safe?
- There's no single safe-or-not verdict. pharmaranks gives Naloxone a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Naloxone?
- Naloxone's side effects are taken directly from its FDA label. From the label: Postoperative The following adverse events have been associated with the use of naloxone hydrochloride injection in postoperative patients: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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naloxone
72/100