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: SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 5 mg/5mL

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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Arrayn- Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering Methadone Hydrochloride Oral Solution. Dosing errors due to confusion between mg and mL, and other methadone hydrochloride oral solutions of different concentrations can result in accidental overdose and death [n ].
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Methadone n- Hydrochloriden- Oral Solution exposes patients 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 Oral Solution, and monitor all patients regularly for the development of these behaviors or conditions [].
Arrayn- Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products []. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
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Serious,n- life-threatening, or fatal respiratory depression may occur with use of Methadone Hydrochloride Oral Solution. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak analgesic effect, especially during the initial dosing period. Monitor for respiratory depression, especially during initiation of Methadone Hydrochloride Oral Solution or following a dose increase [].
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Accidental n- ingestion n- of n- even onen- dose of Methadone Hydrochloride Oral Solution, especially by children, can result in a fatal overdose of methadone [n ].
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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 Oral Solution [n ].
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Neonatal n- opioid n- withdrawal n- syndromen- (NOWS) is an expected and treatable outcome of use of Methadone Hydrochloride Oral Solution 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 Oral Solution 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 [].
Arrayn- Cytochrome P450 Interaction
The concomitant use of Methadone Hydrochloride Oral Solution 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 [].
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Concomitant n- usen- of n- opioids n- with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [].
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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 administration [].
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUG 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

Ensure accuracy when prescribing, dispensing, and administering Methadone Hydrochloride Oral Solution. Dosing errors due to confusion between mg and mL, and other methadone hydrochloride oral solutions of different concentrations can result in accidental overdose and death. (, )
Methadone n- Hydrochloride n- Oral n- Solution n- exposes n- users n- to n- risksn- 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. ()
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. ()
Serious, life-threatening, or fatal respiratory n- depressionn- may occur. The peak respiratory depression effect of methadone occurs later, and persists longer than the peak analgesic effect. Monitor closely, especially upon initiation or following a dose increase. ()
Accidental ingestion n- of n- Methadone Hydrochloride Oral n- Solution, especially n- in children, can result in fatal overdose of methadone. ()
QT n- intervaln- prolongation n- 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. ()
Neonatal opioid n- withdrawal n- syndrome n- (NOWS)n- is an expected and treatable outcome of use of Methadone Hydrochloride Oral Solution 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 Oral Solution 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. ()
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. (, )
Concomitantn- use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. (, )
Methadone n- products, n- 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. (, )

Boxed Warningu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 06/2018
Warnings and Precautions u00a0u00a0u00a0u00a0u00a0u00a0 06/2018

Methadone Hydrochloride Oral Solution is indicated for the:
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject tou00a0the conditions for distribution and use required under 42 CFR 8.12 [].
Methadone Hydrochloride Oral Solution is 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 ().

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.u00a0n n
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. n

Management of Pain:
Initiation of Detoxification and Maintenance Treatment

Each 5 mL of orangeu00a0Methadone Hydrochloride Oral Solutionu00a0contains methadone hydrochloride 5 mg or 10 mg. The concentration of the 5 mg per 5 mL solution is 1 mg/mL and the concentration of the 10 mg per 5 mL solution is 2 mg/mL.
Oral Solution: each 5 mL contains 5 mg or 10 mg of Methadone Hydrochloride Oral Solution. ()

Methadone Hydrochloride Oral Solution is contraindicated in patients with:

Significant respiratory depression ()
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipmentu00a0()
Known or suspected gastrointestinal obstruction, including paralytic ileus ()
Hypersensitivity to methadone ()

No data

Risk of Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, Debilitated Patients: Monitor closely, particularly during initiation and titration ().
Serotonin Syndrome:
Adrenal Insufficiency:
Severe Hypotension:
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness:

The following serious adverse reactions are described, or describedu00a0in greater detail, in other sections:
The following adverse reactions associated with the use of methadone were identified in clinical studies or postmarketing reports. 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 Deficiency:n- see Clinical Pharmacology ()
Most common adverse reactions are: lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. ()n n n

Paradoxical Effects of Antiretroviral Agents on Methadone Hydrochloride Oral Solution
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 tipranavir+ritonavir, has resulted in increased clearance or decreased plasma levels of methadone. This may result in reduced efficacy of Methadone Hydrochloride Oral Solution 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 Oral Solution on Antiretroviral Agents
Didanosine and Stavudine
Zidovudine
Effects of Methadone Hydrochloride Oral Solution on Antidepressants:
Desipramine:

Anti-retroviral Agents:
Potentially Arrhythmogenic Agents:
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics:
Monoamine Oxidase Inhibitors (MAOIs):

No data

Lactation:
8.2

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Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Its molecular formula is CHNOu2219HCl 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:
Each 5 mL of oral solution contains 5 or 10 mg of Methadone Hydrochloride USP and the following inactive ingredients: alcohol (9.8% v/v), artificial wild cherry flavor, benzoic acid, citric acid, D&C Red #33, FD&C Red #40, glycerin, sorbitol, and water.

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Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Manufactured and Distributed by
VistaPharm, Inc.Largo, FL 33771,USA
VP1095R808/19

METHADONE HYDROCHLORIDE (methu2019 a done hyeu201d droe kloru2019 ide) Oral Solution, CII
Methadonen- Hydrochloriden- Oral Solution USP is:
Importantn- information about n- Methadonen- Hydrochloride Oral Solution:
Don- not take Methadone Hydrochloride Oral Solution if you have:
Before taking Methadone Hydrochloride Oral Solution, tell your healthcare provider if you have a history of:
Tell your healthcare provider if you are:
When taking n- Methadone Hydrochloride Oral Solution:
Whilen- taking Methadone Hydrochloride Oral Solution DO NOT:
The possible side effects of Methadone Hydrochloride Oral Solution are:
Get emergency medical help if you have:
These are not all the possible side effects of Methadone Hydrochloride Oral Solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. n
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This Medication Guide has been approved by the U.S. Food and Drug Administration.
VP2069R9
05/19

NDC 66689-711-16
METHADONE HYDROCHLORIDE
ORAL SOLUTION, USP CII
5 mg per 5 mL
(1 mg per mL)
PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATIONu00a0GUIDE TO EACH PATIENT.
Each 5 mL Contains:
u00a0Methadone Hydrochloride, USP________ 5 mg
Alcohol ______________________9.8% v/v
USUAL DOSAGE:
STORAGE:
FOR ORAL USE ONLY - NOT TO BE INJECTED
500 mLu00a0
Keep in secure area and protect from diversion.
u00a0Manufactured by:
Rxu00a0only
VP1096R3
08/18
VistaPharmu00ae

NDC 66689-711-16
METHADONE HYDROCHLORIDE
ORAL SOLUTION, USP CII
5 mg per 5 mL
(1 mg per mL)
Contains: Alcohol 9.8% v/v
PHARMACIST: DISPENSE THE ENCLOSED MEDICATIONu00a0GUIDE TO EACH PATIENT.
FOR ORAL USE ONLY - NOT TO BE INJECTED
500 mL
Rx Only
VP2265
08/18
VistaPharmu00ae

NDC 66689-712-16
METHADONE HYDROCHLORIDE
ORAL SOLUTION, USP CII
10 mg per 5 mL
(2 mg per mL)
PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATIONu00a0GUIDE TO EACH PATIENT.
Each 5 mL Contains:
Methadone Hydrochloride, USP________ 10 mg
Alcohol ______________________9.8% v/v
USUAL DOSAGE:u00a0
STORAGE:
FOR ORAL USE ONLY - NOT TO BE INJECTED
500 mL
Keep in secure area and protect from diversion.
u00a0Manufactured by:
Rxu00a0only
VP1097R3
08/18
VistaPharmu00ae

NDC 66689-712-16
METHADONE HYDROCHLORIDE
ORAL SOLUTION, USP CII
10 mg per 5 mL
(2 mg per mL)
Contains: Alcohol 9.8% v/v
PHARMACIST: DISPENSE THE ENCLOSED MEDICATIONu00a0GUIDE TO EACH PATIENT.
FOR ORAL USE ONLY - NOT TO BE INJECTED
500 mL
Rx Only
VP2266
08/18
VistaPharmu00ae

Select Strength and Packaging*

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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 5 mg/5mL.

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.