METHADOSE DISPERSIBLE 40 mg/1

Methadone Hydrochloride · TABLET · SpecGx LLC

No Recall History

Plain English

METHADOSE DISPERSIBLE is a tablet containing methadone hydrochloride at 40 mg/1, taken oral. Manufactured by SpecGx LLC.

Key Facts

Brand Name: METHADOSE DISPERSIBLE
Generic Name: Methadone Hydrochloride
NDC Code (Product): 0406-0540
Manufacturer: SpecGx LLC
Strength: 40 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: ANDA074184
Marketing Start: 04/29/1993

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

toxicity to various agents1,004 reports

overdose702 reports

drug abuse612 reports

dependence527 reports

drug dependence523 reports

death414 reports

foetal exposure during pregnancy413 reports

exposure during pregnancy356 reports

pain341 reports

drug withdrawal syndrome neonatal337 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Methadone hydrochloride tablets for oral suspension contain 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 42 CFR 8.12 [see Dosage and Administration ( 2.1 )] . Methadone hydrochloride tablets for oral suspension are 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 prescribing naloxone at the time methadone hydrochloride tablets for oral suspension are initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. ( 2.3 ) Initiation of Detoxification and Maintenance Treatment : A single dose of 20 to 30 mg may be sufficient to suppress withdrawal syndrome. ( 2.5 ) Maintenance Treatment : Clinical stability is most commonly achieved at doses between 80 to 120 mg/day. ( 2.6 ) Do not abruptly discontinue methadone hydrochloride tablets for oral suspension in a physically dependent patient. ( 2.7 , 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 Administration and approved by the designated state authori…

Contraindications

4 CONTRAINDICATIONS Methadone hydrochloride tablets for oral suspension are 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 tablets for oral suspension [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 prescribing naloxone for the emergency treatment of opioid overdose, 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,…

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, cardiac…

Frequently Asked Questions

What is METHADOSE DISPERSIBLE used for?

METHADOSE DISPERSIBLE contains Methadone Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is METHADOSE DISPERSIBLE a controlled substance?

Yes, METHADOSE DISPERSIBLE is classified as CII under the DEA Controlled Substances Act.

What is the generic name for METHADOSE DISPERSIBLE?

The generic name for METHADOSE DISPERSIBLE is Methadone Hydrochloride. There are 12 other brand versions of Methadone Hydrochloride.

What is the NDC code for METHADOSE DISPERSIBLE 40 mg/1?

The NDC (National Drug Code) for METHADOSE DISPERSIBLE 40 mg/1 is 0406-0540, listed by SpecGx LLC.

Product NDC

0406-0540

Package NDC

0406-0540-34

Other Methadone Brands

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

Data from openFDA · Public domain (CC0 1.0)