Drugplain

Methadone Hydrocloride dye-free, sugar-free, unflavored 10 mg/mL

methadone hydrochloride · CONCENTRATE · Bryant Ranch Prepack

No Recall History
Plain English

Methadone Hydrocloride dye-free, sugar-free, unflavored is a concentrate containing methadone hydrochloride at 10 mg/mL, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Methadone Hydrocloride dye-free, sugar-free, unflavored
Generic Name
methadone hydrochloride
NDC Code (Product)
63629-2098
Manufacturer
Bryant Ranch Prepack
Strength
10 mg/mL
Dosage Form
CONCENTRATE
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
ANDA212093
Marketing Start
11/02/2020

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Methadone Hydrochloride contains methadone, an opioid agonist indicated for the: detoxification treatment of opioid addiction (heroin or other morphine-like drugs). maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8 [see Dosage and Administration ( 2.1 )] . Methadone Hydrochloride is an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). ( 1 ) Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. ( 1 ) Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec. 8. ( 1 , 2.1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Strongly consider recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) at the time Methadone Hydrochloride is initiated or renewed because patients being treated with methadone may be at risk for opioid overdose during initiation or titration, or in the case of relapse to illicit use. ( 2.3 ) Initiation of Detoxification and Maintenance Treatment : A single dose of 20 to 30 mg may be sufficient to suppress withdrawal syndrome. ( 2.4 ) Maintenance Treatment : Clinical stability is most commonly achieved at doses between 80 to 120 mg/day. ( 2.5 ) Do not rapidly reduce or abruptly discontinue Methadone Hydrochloride in a physically-dependent patient. ( 2.6 , 5.15 ) 2.1 Conditions for Distribution and Use of Methadone Products for the Treatment of Opioid Addiction Code of Federal Regulations, Title 42, Sec 8 : Methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Adm…

Contraindications

4 CONTRAINDICATIONS Methadone Hydrochloride is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions ( 5.1 )] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.8 )] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.13 )] Hypersensitivity (e.g., anaphylaxis) to methadone or any other ingredient in Methadone Hydrochloride [see Adverse Reactions ( 6 )] Significant respiratory depression ( 4 ) Acute or severe bronchial asthma ( 4 ) Known or suspected paralytic ileus ( 4 ) Known hypersensitivity to methadone ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Intervention: Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate. Before co-prescribing benzodiazepines for anxiety or insomnia, ensure that patients are appropriately diagnosed and consider alternative medications and non-pharmacologic treatments [see Warnings and Precautions ( 5.2 )] . If concomitant use is warranted, strongly consider recommending or prescribing an opioid overdose reversal agent, as is recommended for all patients in treatment for opioid use disorder [see Warnings and Precautions ( 5.1 )] . Examples: Alcohol, benzodiazepines, and other sedatives/hypnotics, anxiolytics, tra…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions and/or conditions are described, or described in greater detail, in other sections: Respiratory Depression [see Warnings and Precautions ( 5.1 )] Interactions with Benzodiazepines and other CNS Depressants [see Warnings and Precautions ( 5.2 )] QT Prolongation [see Warnings and Precautions ( 5.3 )] Serotonin Syndrome [see Warnings and Precautions ( 5.9 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.10 )] Severe Hypotension [see Warnings and Precautions ( 5.11 )] Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.13 )] Seizures [see Warnings and Precautions ( 5.14 )] Withdrawal [see Warnings and Precautions ( 5.15 )] Hypoglycemia [see Warnings and Precautions ( 5.17 ) ] The following adverse reactions have been identified during post-approval use of methadone. 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 . The major hazards of methadone are respiratory depression and, to a lesser degree, systemic hypotension. Respiratory arrest, shock, cardi…

Frequently Asked Questions

What is Methadone Hydrocloride dye-free, sugar-free, unflavored used for?

Methadone Hydrocloride dye-free, sugar-free, unflavored contains methadone hydrochloride. It is a concentrate taken oral. Consult your doctor for specific uses.

Is Methadone Hydrocloride dye-free, sugar-free, unflavored a controlled substance?

Yes, Methadone Hydrocloride dye-free, sugar-free, unflavored is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Methadone Hydrocloride dye-free, sugar-free, unflavored?

The generic name for Methadone Hydrocloride dye-free, sugar-free, unflavored is methadone hydrochloride. There are 10 other brand versions of methadone hydrochloride.

What is the NDC code for Methadone Hydrocloride dye-free, sugar-free, unflavored 10 mg/mL?

The NDC (National Drug Code) for Methadone Hydrocloride dye-free, sugar-free, unflavored 10 mg/mL is 63629-2098, listed by Bryant Ranch Prepack.

Product NDC

63629-2098

Package NDC

63629-2098-1

Other Methadone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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