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Methadone Hydrochloride (Methadone Hydrochloride)

Trade Name : Methadone Hydrochloride

VistaPharm, Inc.

TABLET

Strength 10 mg/1

METHADONE HYDROCHLORIDE Full Opioid Agonists [MoA],Opioid Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Methadone Hydrochloride (Methadone Hydrochloride) which is also known as Methadone Hydrochloride and Manufactured by VistaPharm, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Methadone Hydrochloride (Methadone Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Dosage and Administration ()u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 10/2019
  • Warnings and Precautions (, )u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 10/2019
  • Arrayn- Array
  • Methadone hydrochloride tablets exposeu00a0n- pn- an- tin- ents and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing methadone hydrochloride tablets, and monitor all patients regularly for the development of these behaviors and conditions .
  • Arrayn- Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
  • Arrayn- To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Foodu00a0n- and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautionsu00a0n- ()]. Under the requirements of the REMS, drug companies with approved opioid analgesic products mustu00a0n- make REMS-compliant education programs available to healthcare providers. Healthcare providers areu00a0n- strongly encouraged to
  • Arrayn- Arrayn- Arrayn- Arrayn- Array
  • Serious, life-threatening, or fatal respiratory depression may occur with use of methadone hydrochloride tablets. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak analgesic effect, especially during the initial dosing period.u00a0 Monitor for respiratory depression, especially during initiation of methadone hydrochloride tablets or following a dose increase .
  • Arrayn- Array
  • An- ccidental ingestion of even one dose of methadone hydrochloride tablets, especially by children, can result in a fatal overdose of methadone .
  • Arrayn- Arrayn- Arrayn- Arrayn- Arrayn- Array
  • Qn- T interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone,n- although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients with risk factors for development of prolonged QT interval, a historyn- of cardiac conduction abnormalities, and those taking medications affecting cardiac conduction for changes in cardiac rhythm during initiation and titration of methadone hydrochloride tablets .
  • Arrayn- Array
  • Nn- eonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of methadone hydrochloride tablets during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. Theu00a0n- balance between the risks of NOWS and the benefits of maternal methadone hydrochloride tablets use may differ based on theu00a0n- risks associated with the motheru2019s underlying condition, pain, or addiction. Advise the patient of the risk of NOWS so that appropriate planning for management of the neonate can occur n .
  • Arrayn- Array
  • Tn- he concomitant use of methadone hydrochloride tablets with all cytochrome P450 3A4, 2B6, 2C19, 2C9 or 2D6 inhibitors may result in an increase in methadone plasma concentrations, which could cause potentially fatal respiratory depression. In addition, discontinuation of concomitantly used cytochrome P450 3A4, 2B6, 2C19, or 2C9 inducers may also result in an increase in methadone plasma concentration. Follow patients closely for respiratory depression and sedation, and consider dosage reduction with any changes of concomitant medications that can result in an increase in methadone levels [n
  • Arrayn- Arrayn- Array
  • Cn- oncomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death see n n- Array
  • Arrayn- Array
  • WARNING: ADDICTION, ABUSE, AND MISUSE; RISKu00a0EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and TREATMENT FOR OPIOID ADDICTION
  • See full prescribing information for complete boxed warning.
  • Methadone hydrochloride n- tn- an- bln- en- tn- s expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk before prescribing, and monitor regularly for development of these behaviors and conditions. ()
  • Arrayn- Array
  • Sn- ern- in- on- un- s, life-threatening, or fatal respiratory depression may occur. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak analgesic effect. Monitor closely, especially upon initiation or following a dose increase. ()
  • An- ccin- dn- en- nn- tn- an- l ingestion of methadone hydrochloride tablets, especially by children, can result in fatal overdose of methadone. ()
  • QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone. Closely monitor patients with risk factors for development of prolonged QT interval, a history of cardiac conduction abnormalities, and those taking medications affecting cardiac conduction ()
  • Nn- eon- nn- an- tn- an- l opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of methadone hydrochloride tablets during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. The balance between the risks of NOWS and the benefits of maternal methadone hydrochloride tablets use may differ based on the risks associated with the motheru2019s underlying condition, pain, or addiction. Advise the patient of the risk of NOWS so that appropriate planning for management of the neonate can occur. ()
  • Cn- on- ncomitant use with CYP3A4, 2B6, 2C19, 2C9 or 2D6 inhibitors or discontinuation of concomitantly used CYP3A4, 2B6, 2C19, or 2C9 inducers can result in a fatal overdose of methadone (, )
  • Cn- on- nn- cn- on- mn- in- tn- an- nn- t use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (, )
  • u00a0n- Methadone products, when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by certified opioid treatment programs as stipulated in 42 CFR 8.12. (, )
  • Methadone hydrochloride tablets are indicated for the:
  • 1. Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
  • Limitations of Use
  • 2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
  • 3. Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate .
  • 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 n .
  • Methadone hydrochloride tablets are an opioid agonist indicated for the:
  • 1. Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
  • 2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
  • 3. 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 ().
  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, reserve methadone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic.
  • No data
  • 10 mg, white, round, biconvex, tablet, debossed u201cu201d over u201c131u201d on one side and bisected on the other side.
  • Tablets: 10 mg. ()
  • Methadone hydrochloride tablets are 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 ()
  • No data
  • Rin- sn- k of Life-Threatening Respiratory Depression in Patients with Chronicu00a0n- Pn- un- ln- monary Disease or in Elderly, Cachectic, or Debilitated Patients
  • Sn- en- ron- tn- on- nin- n Syndrome
  • An- dn- rn- en- nan- l Insufficiency
  • Sn- en- vn- en- rn- e Hypotension
  • Rin- sn- kn- s of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
  • The following serious adverse reactions are described, or described in greater detail, in other sections:
  • The following adverse reactions associated with the use of methadone were identified in clinical studies or postmarketing reports.u00a0 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 lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not suffering severe pain. In such individuals, lower doses are advisable.
  • Other adverse reactions include the following:
  • Body as a Whole:
  • Cardiovascular: n- torsades de pointes
  • Central Nervous System:
  • Endocrine:
  • Gastrointestinal:
  • Hematologic:
  • Metabolic:
  • Renal:
  • Reproductive:
  • Respiratory:
  • Skin and Subcutaneous Tissue:
  • Hypersensitivity:
  • Serotonin Syndrome
  • Adrenal Insufficiency
  • Androgen Deficiencyn- [see Clinicalu00a0n- Pharmacology ()]
  • Most common adverse reactions are: lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc. at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Paradoxical Effects of Antiretroviral Agents on Methadone Hydrochloride Tablets
  • Concurrent use of certain antiretroviral agents with CYP3A4 inhibitory activity, alone and in combination, such as abacavir, amprenavir, darunavir+ritonavir, efavirenz, nelfinavir, nevirapine, ritonavir, telaprevir, lopinavir+ritonavir, saquinavir+ritonavir, and tipranvir+ritonavir, has resulted in increased clearance or decreased plasma levels of methadone. This may result in reduced efficacy of methadone hydrochloride tablets and could precipitate a withdrawal syndrome. Monitor methadone-maintained patients receiving any of these anti-retroviral therapies closely for evidence of withdrawal effects and adjust the methadone dose accordingly.
  • Effects of
  • Methadone Hydrochloride
  • Tablets on Antiretroviral Agents
  • Didanosine and Stavudine
  • Zidovudine
  • Effects of Methadone Hydrochloride Tablets on Antidepressants
  • Desipramine:
  • An- ntin- -n- Rn- en- tn- rovn- in- rn- an- l Agents
  • Pon- tn- en- ntian- lln- y Arrhythmogenic Agents
  • Min- xn- en- d Agonist/Antagonist and Partial Agonist Opioid Analgesics
  • 5.15n- 7
  • Mn- on- nn- on- an- mn- inn- e Oxidase Inhibitors (MAOIs)
  • No data
  • 8.2
  • No data
  • Clinical Presentation
  • Acute overdose 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, naloxone and 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.u00a0 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 in methadone hydrochloride tablets, 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 productu2019s 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 begun with care and by titration with smaller than usual doses of the antagonist.
  • Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder. Its molecular formula is CHNOu00b7HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235u00b0C, and a pKa of 8.25 in water at 20u00b0C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula:u00a0
  • Each methadone hydrochloride tablet, USP contains 10 mg methadone hydrochloride USP and the following inactive ingredients: anhydrous lactose, compressible sugar, corn starch, magnesium stearate, microcrystalline cellulose, and talc.
  • No data
  • Carcinogenesis
  • u00a0
  • Mutagenesis
  • u00a0
  • in vivo
  • in vivo
  • E. coli
  • Neurospora crassa
  • Drosophila
  • Impairment of Fertility
  • u00a0
  • Methadone Hydrochloride Tablets, USP
  • 10 mgwhite, round, biconvex, tablet, de-bossed u00a0u201cEu201d over u201c131u201d on one side and bisected on the other side and available as:
  • NDC 66689-820-10: Bottles of 100
  • DEA order form required.
  • Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP/NF.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F), with excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). [See USP Controlled Room Temperature.]
  • Store methadone hydrochloride tablets securely and dispose of properly [].n
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide)
  • Storage and Disposal
  • u00a0n- see Warnings and Precautions (, ), Drug Abuse and Dependence ()
  • Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused methadone hydrochloride tablets should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
  • Addiction, Abuse, and Misuse
  • u00a0n- [see Warnings and Precautions ()]
  • Life-Threatening Respiratory Depression
  • u00a0n- [see Warnings and Precautions ()]
  • Accidental Ingestion
  • u00a0n- [see Warnings and Precautions ()]
  • Symptoms of Arrhythmia
  • u00a0n- [see Warnings and Precautions (n- Array
  • Interactions with Benzodiazepines and Other CNS Depressants
  • u00a0n- [see Warnings and Precautions (), Drug Interactions ()].
  • u00a0n- Serotonin Syndrome
  • u00a0n- [see Warnings and Precautions (), Drug Interactions ()]
  • Mn- AOI Interaction
  • u00a0n- [see Warnings and Precautions (), Drug Interactions ()]
  • Adrenal Insufficiency
  • u00a0n- [see Warnings and Precautions ()]
  • Important Administration Instructions
  • u00a0
  • Important Discontinuation Instructions
  • In order to avoid developing withdrawal symptoms, instruct patients not to discontinue methadone hydrochloride tablets without first discussing a tapering plan with the prescriber [].
  • u00a0n- Hypotension
  • u00a0n- see Warnings and Precautions ()
  • Anaphylaxis
  • u00a0n- see Contraindications (), Adverse Reactions ()
  • Pregnancy
  • u00a0n- Nn- eonatal Opioid Withdrawal Syndrome:n- [see Warnings and Precautions (), Specific Populations ()]
  • Embryo-Fetal Toxicity:n- [see Use in Specific Populations ()].
  • u00a0n- Lactation
  • u00a0n- [see Use in Specific Populations ()]
  • In- nfertility
  • u00a0n- [see Use in Specific Populations ()].
  • u00a0n- Dn- riving or Operating Heavy Machinery
  • u00a0n- [see Warnings and Precautions ()]
  • Cn- onstipation
  • u00a0n- [see Adverse Reactions (), Clinical Pharmacology (n n )
  • Distributed by:
  • VistaPharm, Inc.
  • Largo, FL 33771 USA
  • Manufactured by:
  • Epic Pharma, LLC
  • Laurelton, NY 11413
  • Distributed by:
  • VistaPharm, Inc.
  • Largo, FL 33771 USA
  • OS7953
  • Rev.October 2019
  • MF0131REV10/19
  • NDC 66689--10
  • METHADONE HYDROCHLORIDE TABLETS, USP CII
  • 10 mg
  • PHARMACIST: Please dispense the accompanying Medication Guide to each patient.
  • 100 Tablets
  • Rx only
  • VistaPharm
  • L7888
  • Rev. 01-2019-01
  • Arrayn- Array

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