Methadone Hydrochloride 200 mg/20mL
Methadone Hydrochloride · INJECTION · Long Grove Pharmaceuticals, LLC
Methadone Hydrochloride is a injection containing methadone hydrochloride at 200 mg/20mL, taken intravenous. Manufactured by Long Grove Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Methadone Hydrochloride
- Generic Name
- Methadone Hydrochloride
- NDC Code (Product)
81298-7500- Manufacturer
- Long Grove Pharmaceuticals, LLC
- Strength
- 200 mg/20mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA208306
- Marketing Start
- 06/28/2025
Recall History
VistaPharm, Inc.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
West-Ward Columbus Inc
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
VistaPharm, Inc.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
VistaPharm, Inc.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 1. Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration (see WARNINGS ), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. • Methadone Hydrochloride Injection is not indicated as an as-needed (prn) analgesic. 2. For use in temporary treatment of opioid dependence in patients unable to take oral medication. Limitations of Use • Injectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients. Conditions for Distribution and Use of Methadone Products for the T…
Dosage & Administration
DOSAGE AND ADMINISTRATION Important General Information Consider the following important factors that differentiate methadone from other opioids: • The peak respiratory depressant effect of methadone occurs later and persists longer than its peak pharmacologic effect. • A high degree of opioid tolerance does not eliminate the possibility of methadone overdose, iatrogenic or otherwise. Deaths have been reported during conversion to methadone from chronic, high-dose treatment with other opioid agonists and during initiation of methadone treatment of addiction in subjects previously abusing high doses of other opioid agonists. • There is high interpatient variability in absorption, metabolism, and relative analgesic potency. Population-based conversion ratios between methadone and other opioids are not accurate when applied to individuals. • With repeated dosing, methadone is retained in the liver and then slowly released, prolonging the duration of potential toxicity. • Steady-state plasma concentrations are not attained until 3 to 5 days after initiation of dosing . • Methadone has a narrow therapeutic index, especially when combined with other drugs. It is safer to underestimate a …
Warnings
WARNINGS Addiction, Abuse and Misuse Methadone Hydrochloride Injection contains methadone, a Schedule II controlled substance. As an opioid, Methadone Hydrochloride Injection exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Methadone Hydrochloride Injection. Addiction can occur at recommended doses 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 Methadone Hydrochloride Injection, and reassess all patients receiving Methadone Hydrochloride Injection 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 addiction or abuse) or mental ill…
Contraindications
CONTRAINDICATIONS Methadone Hydrochloride Injection is contraindicated in patients with: • Significant respiratory depression • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment • Known or suspected gastrointestinal obstruction, including paralytic ileus • Hypersensitivity to methadone hydrochloride (e.g. anaphylaxis) or any other ingredient in Methadone Hydrochloride Injection.
Drug Interactions
Drug Interactions Table 1: Clinically Significant Drug Interactions with Methadone Hydrochloride Injection Inhibitors of CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 Clinical Impact: Methadone undergoes hepatic N-demethylation by several cytochrome P450 (CYP) isoforms, including CYP3A4, CYP2B6, CYP2C19, CYP2C9, and CYP2D6. The concomitant use of Methadone Hydrochloride Injection and CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 inhibitors can increase the plasma concentration of methadone, resulting in increased or prolonged opioid effects, and may result in a fatal overdose, particularly when an inhibitor is added after a stable dose of Methadone Hydrochloride Injection is achieved. These effects may be more pronounced with concomitant use of drugs that inhibit more than one of the CYP enzymes listed above. After stopping a CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 inhibitor, as the effects of the inhibitor decline, the methadone plasma concentration can decrease (see CLINICAL PHARMACOLOGY ), resulting in decreased opioid efficacy or withdrawal symptoms in patients physically dependent on methadone. Intervention: If concomitant use is necessary, consider dosage reduction of Methadone …
Adverse Reactions
ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse (see WARNINGS ) • Life Threatening Respiratory Depression (see WARNINGS ) • QT Prolongation (see WARNINGS ) • Neonatal Opioid Withdrawal Syndrome (see WARNINGS ) • Interactions with CNS Depressants (see WARNINGS ) • Serotonin Syndrome (see WARNINGS ) • Adrenal Insufficiency (see WARNINGS ) • Severe Hypotension (see WARNINGS ) • Gastrointestinal Adverse Reactions (see WARNINGS ) • Seizures (see WARNINGS ) • Withdrawal (see WARNINGS ) • Hypoglycemia (see WARNINGS ) The following adverse reactions associated with the use of methadone were identified in clinical studies or post-marketing 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. The major hazards of methadone are respiratory depression and, to a lesser degree, systemic hypotension. Respiratory arrest, shock, cardiac arrest, and death have occurred. The most frequently observed adverse reactions include lighth…
Frequently Asked Questions
What is Methadone Hydrochloride used for?
Methadone Hydrochloride contains Methadone Hydrochloride. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Methadone Hydrochloride a controlled substance?
Yes, Methadone Hydrochloride is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Methadone Hydrochloride?
The generic name for Methadone Hydrochloride is Methadone Hydrochloride. There are 4 other brand versions of Methadone Hydrochloride.
What is the NDC code for Methadone Hydrochloride 200 mg/20mL?
The NDC (National Drug Code) for Methadone Hydrochloride 200 mg/20mL is 81298-7500, listed by Long Grove Pharmaceuticals, LLC.
Other Methadone Hydrochloride Dosages
- Methadone Hydrochloride10 mg/mL0054-0391
- Methadone Hydrochloride10 mg/113107-089
- Methadone Hydrochloride5 mg/131722-946
- Methadone Hydrochloride10 mg/142806-318
- Methadone Hydrochloride40 mg/166689-898
- Methadone Hydrochloride5 mg/113107-088
- Methadone Hydrochloride10 mg/166689-820
- Methadone Hydrochloride5 mg/5mL68094-031
Other Methadone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)