Naloxone Hydrochloride .4 mg/mL
Naloxone Hydrochloride · INJECTION, SOLUTION · Henry Schein, Inc.
Naloxone hydrochloride is a medication given by injection into the muscle that rapidly reverses the effects of opioid overdose by blocking opioids in the body. It is used as an emergency treatment to restore normal breathing in people who have overdosed on opioid drugs.
Key Facts
- Brand Name
- Naloxone Hydrochloride
- Generic Name
- Naloxone Hydrochloride
- NDC Code (Product)
0404-9920- Manufacturer
- Henry Schein, Inc.
- Strength
- .4 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA070172
- Marketing Start
- 01/13/2022
Recall History
HOSPIRA INC, LAKE FOREST
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Pentazocine and Naloxone Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including Pentazocine and Naloxone Tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Dosage & Administration
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Pentazocine and Naloxone Tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions ] . Reserve titration to higher doses of Pentazocine and Naloxone Tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain…
Warnings
WARNINGS Addiction, Abuse, and Misuse Pentazocine and Naloxone Tablets contain pentazocine, a Schedule IV controlled substance. As an opioid, Pentazocine and Naloxone Tablets expose users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Pentazocine and Naloxone Tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see ADVERSE REACTIONS; Postmarketing Experience ]. Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing Pentazocine and Naloxone Tablets, and reassess all patients receiving Pentazocine and Naloxone Tablets for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol ab…
Contraindications
CONTRAINDICATIONS Pentazocine and Naloxone Tablets are contraindicated in patients with: Significant respiratory depression [see WARNINGS ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ]. Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] Patients with hypersensitivity to either pentazocine, naloxone, or any of the formulation excipients (e.g., anaphylaxis) [see WARNINGS ].
Drug Interactions
DRUG INTERACTIONS Benzodiazepines and Other Central Nervous System (CNS) Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, benzodiazepines and other sedative hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction, educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider prescribing an opioid overdose reversal agent [see WARNINGS, DOSAGE AND ADMINISTRATION]. Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 rec…
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions associated with the use of Pentazocine and Naloxone were identified in clinical studies or postmarketing reports. Because some of these reactions were 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. Cardiovascular - Hypertension, hypotension, circulatory depression, tachycardia, syncope. Respiratory - Rarely, respiratory depression. Acute CNS Manifestations - Hallucinations (usually visual), disorientation, and confusion. Other CNS Effects - Grand mal convulsions, increase in intracranial pressure, dizziness, lightheadedness, hallucinations, sedation, euphoria, headache, confusion, disorientation; infrequently weakness, disturbed dreams, insomnia, syncope, and depression; and rarely tremor, irritability, excitement, tinnitus. Autonomic - Sweating; infrequently flushing; and rarely chills. Gastrointestinal - Nausea, vomiting, constipation, diarrhea, anorexia, dry mouth, biliary tract spasm, and rarely abdominal distress. Allergic - Edema of the face; anaphylactic shock; dermatitis, including pruritus; flushed …
Frequently Asked Questions
What is Naloxone Hydrochloride used for?
Naloxone hydrochloride is a medication given by injection into the muscle that rapidly reverses the effects of opioid overdose by blocking opioids in the body. It is used as an emergency treatment to restore normal breathing in people who have overdosed on opioid drugs.
Is Naloxone Hydrochloride a controlled substance?
Naloxone Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Naloxone Hydrochloride?
The generic name for Naloxone Hydrochloride is Naloxone Hydrochloride. There are 7 other brand versions of Naloxone Hydrochloride.
What is the NDC code for Naloxone Hydrochloride .4 mg/mL?
The NDC (National Drug Code) for Naloxone Hydrochloride .4 mg/mL is 0404-9920, listed by Henry Schein, Inc..