Methadone Hydrochloride (Methadone Hydrochloride)

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Trade Name: Methadone Hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: VistaPharm, Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 40 mg/1

Storage and handling

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

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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Boxed Warningu00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 02/2018
Warnings and Precautions (, ) 02/2018

Arrayn- Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients to methadone, and even when the drug has been used as recommended and not misused or abused [. Proper dosing and titration are essential and methadone hydrochloride tablets for oral suspension should only be prescribed by healthcare professionals who are knowledgeable in the use of methadone for detoxification and maintenance treatment of opioid addiction. Monitor for respiratory depression, especially during initiation of methadone hydrochloride tablets for oral suspension 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.
Arrayn- Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants
Concomitant use with benzodiazepines or other central nervous system (CNS) depressants,u00a0n- including alcohol, is a risk factor for respiratory depression and death n n- Array
Arrayn- Life-Threatening QT Prolongation
QT interval prolongation and serious arrhythmia () have occurred during treatment with methadone . Most cases involve patients being treated for pain with large, multiple daily doses of methadone, 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 history of cardiac conduction abnormalities, and those taking medications affecting cardiac conduction for changes in cardiac rhythm during initiation and titration of methadone hydrochloride tablets for oral suspension.
Arrayn- Accidental Ingestion
Accidental ingestion of methadone hydrochloride tablets for oral suspension, especially by children, can result in fatal overdose of methadone n
Arrayn- Misuse, Abuse, and Diversion of Opioids
Methadone hydrochloride tablets for oral suspension contain methadone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit .
Arrayn- Interactions With Drugs Affecting Cytochrome P450 Isoenzymes
The concomitant use of methadone hydrochloride tablets for oral suspension 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- Conditions for Distribution and use of Methadone Products for the Treatment of Opioid Addiction
For detoxification and maintenance of opioid dependence, methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8, including limitations on unsupervised administrationu00a0n- Array
WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL INGESTION, ABUSE POTENTIAL, INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES, AND TREATMENT FOR OPIOID ADDICTION
See full prescribing information for complete boxed warning.

Fatal respiratory depression may occur, with highest risk at initiation and with dose increases. Instruct patients on proper administration of methadone hydrochloride tablets for oral suspension to reduce the risk. ()
Concomitant use with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, and death. (, )
QT Interval prolongation and serious arrhythmia () have occurred with treatment with methadone. ()
Accidental ingestion of methadone hydrochloride tablets for oral suspension can result in fatal overdose of methadone, especially in children. ()
Methadone hydrochloride tablets for oral suspension contain methadone, a Schedule II controlled substance and can be abused and criminally diverted. ()
Concomitant 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 (, )
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 for oral suspension, USP 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 n .
Methadone hydrochloride tablets for oral suspension, USP are an opioid agonist indicated for the:
Limitations of Use

No data

Initiation of Detoxification and Maintenance Treatment:
Do not abruptly discontinue methadone hydrochloride tablets for oral suspension in a physically dependent patient (, )
Maintenance Treatment:

40 mg are white, round, biconvex, dispersible tablets, imprinted u201cE 132u201d on one side and quadrisected on both sides.
Tablets intended for dispersion in a liquid immediately prior to oral administration: 40 mg. ()

Methadone hydrochloride tablets for oral suspension are contraindicated in patients with:

Significant respiratory depression ()
Acute or severe bronchial asthma ()
Known or suspected paralytic ileus ()
Known hypersensitivity to methadone ()

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Nn- en- on- nataln- Opn- in- on- in- d Withdrawal Syndrome:
Ln- in- fn- en- -n- Tn- hn- rn- en- atn- en- ninn- g Respiratory Depression in Patients with Chronic Pulmonary 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 Head Injury and Increased Intracranial Pressure:

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: n- torsades 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:n- [see Clinical Pharmacology ()].
Most common adverse reactions are
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
Concurrent use of certain protease inhibitors with CYP3A4 inhibitory activity, alone and in combination, such as abacavir, amprenavir, darunavir+ritonavir, efavirenz, nelfinavir, nevirapine, ritonavir, telaprevir, lopinavir+ritonavir, saquinavir+ritonavir, and tipranavir+ritonavir, has resulted in or decreased plasma levels of methadone. This may result in reduced efficacy of methadone hydrochloride tablets for oral suspension and could precipitate a withdrawal syndrome. Monitor patients receiving methadone hydrochloride tablets for oral suspension any of these anti-retroviral therapies closely for evidence of withdrawal effects and adjust the methadone hydrochloride tablets for oral suspension dose accordingly.n
Effects of Methadone on Antiretroviral Agents
Dn- in- danosine and Stavudine
Zn- in- dovudine:
Effects of Methadone on Antidepressants
Desipraminen n- u00a0

Pon- tn- en- ntian- lln- y Arrhythmogenic Agents:
In- ntn- en- rn- actin- on- nn- s with CNS depressants:
Min- xn- en- d Agonist/Antagonist and Partial Agonist Opioids:
5.15n- 7

L
actati
o
n
:
8.2

No data

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 re-established. 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. 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.

Methadone hydrochloride tablets for oral suspension, USP contain methadone, an opioid agonist, available as 40 mg dispersible tablets for oral administration. Methadone hydrochloride, USP is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride, USP is a white, essentially odorless, bitter-tasting crystalline powder. It is very soluble in water, soluble in isopropranol and in chloroform, and practically insoluble in ether and in glycerine. It is present in methadone hydrochloride tablets for oral suspension as the racemic mixture. Methadone hydrochloride, USP has a melting point of 235u00b0C, a pKa of 8.25 in water at 20u00b0C, 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 CHNOu2022HCl and its structural formula is:
Each methadone hydrochloride tablets for oral suspension, USP contain 40 mg of methadone hydrochloride, USP and the following inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, and microcrystalline cellulose.
Methadone hydrochloride tablets for oral suspension, USP 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.
Methadone hydrochloride tablets for oral suspension, USP are for oral administration following dispersion in a liquid.
Methadone hydrochloride tablets for oral suspension, USP contain insoluble excipients and must not be injected.

No data

Carcinogenesis
The results of carcinogenicity assessment in B6C2F1 mice and Fischer 344 rats following dietary administration of two doses of methadone hydrochloride have been published. Mice consumed 15 mg/kg/day or 60 mg/kg/day methadone for two years. These doses were approximately 0.6 and 2.5 times a human daily oral dose of 120 mg/day on a body surface area basis (HDD). There was a significant increase in pituitary adenomas in female mice treated with 15 mg/kg/day but not with 60 mg/kg/day. Under the conditions of the assay, there was no clear evidence for a treatment-related increase in the incidence of neoplasms in male rats. Due to decreased food consumption in males at the high dose, male rats consumed 16 mg/kg/day and 28 mg/kg/day of methadone for two years. These doses were approximately 1.3 and 2.3 times the HDD. In contrast, female rats consumed 46 mg/kg/day or 88 mg/kg/day for two years. These doses were approximately 3.7 and 7.1 times the HDD. Under the conditions of the assay, there was no clear evidence for a treatment-related increase in the incidence of neoplasms in either male or female rats.
Mutagenesis
There are several published reports on the potential genetic toxicity of methadone. Methadone tested positive in the mouse dominant lethal assay and the mammalian spermatogonial chromosome aberration test. Additionally, methadone tested positive in the DNA repair system and and mouse lymphoma forward mutation assays. In contrast, methadone tested negative in tests for chromosome breakage and disjunction and sex-linked recessive lethal gene mutations in germ cells of using feeding and injection procedures.
Fertility
Published animal studies show that methadone treatment of males can alter reproductive function. Methadone produces decreased sexual activity (mating) of male rats at 10 mg/kg/day (corresponding to 0.3 times the human daily oral dose of 120 mg/day based on body surface area). Methadone also produces a significant regression of sex accessory organs and testes of male mice and rats at 0.2 and 0.8 times the HDD, respectively.u00a0 Methadone treatment of pregnant rats from Gestation Day 14 to 19 reduced fetal blood testosterone and androstenedione in males.u00a0 Decreased serum levels of testosterone were observed in male rats that were treated with methadone (1.3 to 3.3 mg/kg/day for 14 days, corresponding to 0.1 to 0.3 times the HDD) or 10 to 15 mg/kg/day for 10 days (0.8 to 1.2 times the HDD).

Methadone hydrochloride tablets for oral suspension, USP 40 mg tablets are white, round, biconvex, dispersible tablets, imprinted u201cE 132u201d on one side and quadrisected on both sides.
NDC 66689-898-40 Bottles of 100 dispersible tablets.
Methadone hydrochloride tablets for oral suspension, USP if dispensed, must be packaged in child-resistant containers.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from moisture.
DEA order form required.

Provide the following information to patients receiving methadone hydrochloride tablets for oral suspension or to their caregivers:
Life-Threatening Respiratory Depression
Discuss the risk of respiratory depression with patients, explaining that the risk is greatest when starting methadone hydrochloride tablets for oral suspension or when the dose is increased n . Advise patients how to recognize respiratory depression and to seek medical attention if they are experiencing breathing difficulties.
Interactions with Benzodiazepines and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if methadone hydrochloride tablets for oral suspension are used with benzodiazepines or other CNS depressants, including alcohol. Counsel patients that such medications should not be used concomitantly unless supervised by a healthcare provider n .
Symptoms of Arrhythmia
Instruct patients to seek medical attention immediately if they experience symptoms suggestive of an arrhythmia (such as palpitations, near syncope, or syncope) when taking methadone hydrochloride tablets for oral suspension n .
Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death n .u00a0 Instruct patients to take steps to store methadone hydrochloride tablets for oral suspension securely. Advise patients to dispose of unused methadone hydrochloride tablets for oral suspension by flushing the tablets down the toilet.
Abuse Potential
Inform patients that methadone hydrochloride tablets for oral suspension contain methadone, a Schedule II controlled substance that is subject to abuse n . Instruct patients not to share methadone hydrochloride tablets for oral suspension with others and to take steps to protect methadone hydrochloride tablets for oral suspension from theft or misuse.
Important Administration Instructionsn- [n- sn- ee Dosage and Administration (n- Array
Instruct patients how to properly take methadone hydrochloride tablets for oral suspension, including the following:
Serotonin Syndrome
Inform patients that methadone hydrochloride tablets for oral suspension could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications n .
Mn- AOI Interaction
Inform patients to avoid taking methadone hydrochloride tablets for oral suspension while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking methadone hydrochloride tablets for oral suspension n n
Adrenal Insufficiency:
Inform patients that methadone hydrochloride tablets for oral suspension could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms n .
Hypotension
Inform patients that methadone hydrochloride tablets for oral suspension may cause orthostatic hypotension and syncope. Instruct patients on how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) n .
Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in methadone hydrochloride tablets for oral suspension. Advise patients how to recognize such a reaction and when to seek medical attention n .
Neonatal Opioid Withdrawal
Advise women that if they are pregnant while being treated with methadone hydrochloride tablets for oral suspension, the baby may have signs of withdrawal at birth and that withdrawal is treatable .
Lactation
Instruct nursing mothers using methadone hydrochloride tablets for oral suspension to watch for signs of methadone toxicity in their infants, which include increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to their babyu2019s healthcare provider immediately if they notice these signs. If they cannot reach the healthcare provider right away, instruct them to take the baby to the emergency room or call 911 (or local emergency services) n
Driving or Operating Heavy Machinery
Inform patients that methadone hydrochloride tablets for oral suspension may impair the ability to perform potentially hazardous activities such as driving or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication n
Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention n .
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.
The brands listed are the registered trademarks of their respective owners and are not trademarks of VistaPharm, Inc.
Manufactured by:
Epic Pharma, LLC
Laurelton, NY 11413
Distributed by:
VistaPharm, Inc.
Largo, FLu00a0 33771
Rev. December 2018
MF 0132
OS7946

NDC 66689-898-40
Methadone Hydrochloride Tablets for Oral Suspension, USP CII
40 mg
DISPERSIBLE TABLETS FOR METHADONE TREATMENT PROGRAMS
100 TABLETS
Rx Only

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters 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 40 mg/1.

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.