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Methadone Hydrochloride
Overview
What is DISKETS?
DISKETS Dispersible Tablets (Methadone Hydrochloride Tablets for Oral Suspension USP), contain methadone, an opioid agonist, available as 40 mg dispersible tablets for oral administration. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride USP is a fine white powder. It is very soluble in water, soluble in isopropanol and in chloroform, and practically insoluble in ether and in glycerine. It is present in DISKETS Dispersible Tablets as the racemic mixture. Methadone hydrochloride has a melting point of 235°C, a pKa of 8.25 in water at 20°C, a solution (1 part per 100) pH between 4.5 and 6.5, a partition coefficient of 117 at pH 7.4 in octanol/water and a molecular weight of 345.91. Its molecular formula is CHNO•HCl and its structural formula is:
Each DISKETS Dispersible Tablet contains 40 mg of methadone hydrochloride USP and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, orange lake blend, orange/pineapple flavor, potassium phosphate monobasic, pregelatinized starch and stearic acid.
DISKETS Dispersible Tablets are cross-scored, allowing for flexible dosage adjustment. Each tablet may be broken or cut in half to yield two 20 mg doses, or in quarters to yield four 10 mg doses.
DISKETS Dispersible Tablets (Methadone Hydrochloride Tablets for Oral Suspension USP), are for oral administration following dispersion in a liquid.
DISKETS Dispersible Tablets contain insoluble excipients and must not be injected.
What does DISKETS look like?
What are the available doses of DISKETS?
Tablets Intended for Dispersion in a Liquid Immediately Prior to Oral Administration: 40 mg. ()
What should I talk to my health care provider before I take DISKETS?
How should I use DISKETS?
DISKETS Dispersible Tablets contain methadone, an opioid agonist indicated for the:
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 .
Code of Federal Regulations, Title 42, Sec 8:
Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program.
Regulatory Exceptions to the General Requirement for Certification to Provide Opioid Agonist Treatment:
What interacts with DISKETS?
Sorry No Records found
What are the warnings of DISKETS?
Sorry No Records found
What are the precautions of DISKETS?
Sorry No Records found
What are the side effects of DISKETS?
Sorry No records found
What should I look out for while using DISKETS?
DISKETS Dispersible Tablets are contraindicated in patients with:
What might happen if I take too much DISKETS?
Clinical Symptoms
Acute overdosage with methadone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal-muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations . In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur.
Treatment of Overdose
In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
The opioid antagonists, such as naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to methadone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to methadone overdose.
Because the duration of reversal would be expected to be less than the duration of action of methadone, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to opioid antagonists is suboptimal or not sustained, administer additional antagonist as directed in the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
How should I store and handle DISKETS?
Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP] for up to 1 hour if necessary. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze. Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP] for up to 1 hour if necessary. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze. DISKETS Dispersible Tablets (Methadone Hydrochloride Tablets for Oral Suspension USP) 40 mg supplied as light pinkish orange, pillow shaped, compressed dispersible tablet with product identification “54 883” debossed on one side and cross scored on the other side.NDC 0054-4538-25: Bottle of 100 Dispersible TabletsDISKETS Dispersible Tablets, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].DISKETS Dispersible Tablets (Methadone Hydrochloride Tablets for Oral Suspension USP) 40 mg supplied as light pinkish orange, pillow shaped, compressed dispersible tablet with product identification “54 883” debossed on one side and cross scored on the other side.NDC 0054-4538-25: Bottle of 100 Dispersible TabletsDISKETS Dispersible Tablets, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].DISKETS Dispersible Tablets (Methadone Hydrochloride Tablets for Oral Suspension USP) 40 mg supplied as light pinkish orange, pillow shaped, compressed dispersible tablet with product identification “54 883” debossed on one side and cross scored on the other side.NDC 0054-4538-25: Bottle of 100 Dispersible TabletsDISKETS Dispersible Tablets, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].DISKETS Dispersible Tablets (Methadone Hydrochloride Tablets for Oral Suspension USP) 40 mg supplied as light pinkish orange, pillow shaped, compressed dispersible tablet with product identification “54 883” debossed on one side and cross scored on the other side.NDC 0054-4538-25: Bottle of 100 Dispersible TabletsDISKETS Dispersible Tablets, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].DISKETS Dispersible Tablets (Methadone Hydrochloride Tablets for Oral Suspension USP) 40 mg supplied as light pinkish orange, pillow shaped, compressed dispersible tablet with product identification “54 883” debossed on one side and cross scored on the other side.NDC 0054-4538-25: Bottle of 100 Dispersible TabletsDISKETS Dispersible Tablets, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Methadone hydrochloride is a mu-agonist; a synthetic opioid with multiple actions qualitatively similar to those of morphine, the most prominent of which involves the central nervous system and organs composed of smooth muscle. The methadone withdrawal syndrome, although qualitatively similar to that of morphine, differs in that the onset is slower, the course is more prolonged, and the symptoms are less severe.
Some data also indicate that methadone acts as an antagonist at the N-methyl-D-aspartate (NMDA) receptor. The contribution of NMDA receptor antagonism to methadone’s efficacy is unknown.
Non-Clinical Toxicology
DISKETS Dispersible Tablets are contraindicated in patients with:Serious, life-threatening, or fatal respiratory depression has been reported with the use of methadone, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with a “sighing” pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide (CO) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status
While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of DISKETS, the risk is greatest during the initiation of therapy or following a dose increase. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak pharmacologic effect, especially during the initial dosing period. Monitor patients closely for respiratory depression, when initiating therapy with DISKETS and following dose increases.
Instruct patients against use by individuals other than the patient for whom methadone was prescribed and to keep methadone out of the reach of children, as such inappropriate use may result in fatal respiratory depression.
To reduce the risk of respiratory depression, proper dosing and titration of methadone are essential Overestimating the methadone dosage when initiating treatment can result in fatal overdose with the first dose.
To further reduce the risk of respiratory depression, consider the following:
The following serious adverse reactions and/or conditions are described, or described in greater detail, in other sections:
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 arrest, and death have occurred.
The most frequently observed adverse reactions included lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seemed to be more prominent in ambulatory patients and in those who are not suffering severe pain.
Other adverse reactions include the following:
Body as a Whole
Cardiovascular
torsade de pointes
Central Nervous System:
Endocrine:
Gastrointestinal:
Hematologic:
Metabolic:
Musculoskeletal:
Renal:
Reproductive:
Respiratory:
Skin and Subcutaneous Tissue:
Hypersensitivity:
Serotonin Syndrome:
Adrenal Insufficiency:
Anaphylaxis
Androgen Deficiency:
[see Clinical Pharmacology ()]
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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