DISKETS 40 mg/1

Methadone Hydrochloride · TABLET · Hikma Pharmaceuticals USA Inc.

No Recall History

Plain English

DISKETS is a tablet containing methadone hydrochloride at 40 mg/1, taken oral. Manufactured by Hikma Pharmaceuticals USA Inc..

Key Facts

Brand Name: DISKETS
Generic Name: Methadone Hydrochloride
NDC Code (Product): 0054-4538
Manufacturer: Hikma Pharmaceuticals USA Inc.
Strength: 40 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: NDA017058
Marketing Start: 03/14/1973

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 abuse611 reports

dependence527 reports

drug dependence521 reports

foetal exposure during pregnancy413 reports

death411 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 DISKETS Dispersible Tablets 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 )] . DISKETS Dispersible Tablets 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 recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) at the time DISKETS Dispersible Tablets 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. ( 2.5 ) • Maintenance Treatment: Clinical stability is most commonly achieved at doses between 80 to 120 mg/day. ( 2.6 ) • Do not rapidly reduce or abruptly discontinue DISKETS Dispersible Tablets 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…

Contraindications

4 CONTRAINDICATIONS DISKETS Dispersible Tablets 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 DISKETS Dispersible Tablets [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 Table 1: Clinically Significant Drug Interactions with DISKETS Dispersible Tablets 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 )]. Ex…

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 a…

Frequently Asked Questions

What is DISKETS used for?

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

Is DISKETS a controlled substance?

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

What is the generic name for DISKETS?

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

What is the NDC code for DISKETS 40 mg/1?

The NDC (National Drug Code) for DISKETS 40 mg/1 is 0054-4538, listed by Hikma Pharmaceuticals USA Inc..

Product NDC

0054-4538

Package NDC

0054-4538-25

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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