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Methadone Hydrochloride (Methadone Hydrochloride)

Trade Name : Methadone Hydrochloride

West-Ward Pharmaceuticals Corp.

CONCENTRATE

Strength 10 mg/mL

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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 West-Ward Pharmaceuticals Corp.. It is available in strength of 10 mg/mL 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.

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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
  • Arrayn- Addiction, Abuse, and Misuse
  • Methadone 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, and monitor all patients regularly for the development of these behaviors or conditions .
  • Arrayn- Life-threatening Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur with use of methadone. Monitor for respiratory depression, especially during initiation of methadone or following a dose increase .
  • Arrayn- Accidental Ingestion
  • Accidental ingestion of even one dose of methadone, especially by children, can result in a fatal overdose of methadone .
  • Arrayn- Life-threatening QT Prolongation
  • QT 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, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients for changes in cardiac rhythm during initiation and titration of methadone .
  • Arrayn- Neonatal Opioid Withdrawal Syndrome
  • Prolonged use of methadone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .
  • 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 administration .
  • WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and TREATMENT FOR OPIOID ADDICTION
  • See full prescribing information for complete boxed warning
  • Methadone exposes 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 or conditions. (, )
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. ()
  • Accidental ingestion of methadone, especially in children, can result in fatal overdose of methadone. ()
  • QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone. ()
  • Prolonged use of methadone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available ().
  • 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 INTENSOL (oral concentrate)
  • 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 Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8.12). See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment.
  • 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
  • During an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility (pursuant to 21CFR 1306.07(b)).
  • Methadone hydrochloride n (oral concentrate) is an opioid agonist indicated for the:
  • Limitations of Use
  • No data
  • 2.4n- 5.12
  • Each mL of clear, colorless Methadone Hydrochloride n (oral concentrate USP) contains 10 mg methadone hydrochloride USP. The concentration of Methadone Hydrochloride n (oral concentrate USP) is 10 mg/mL.
  • Oral Concentrate: each mL contains 10 mg of methadone hydrochloride USP. ()
  • Methadone hydrochloride n (oral concentrate USP) is contraindicated in patients with:
  • No data
  • 5.5n- 7.1
  • 5.6n- 5.7
  • The following serious adverse reactions are discussed elsewhere in the labeling:
  • 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:
  • Central Nervous System:
  • Endocrine:
  • Gastrointestinal:
  • Hematologic:
  • Metabolic:
  • Renal:
  • Reproductive:
  • Respiratory:
  • Skin and Subcutaneous Tissue:
  • Hypersensitivity: n- Intensol
  • Maintenance on a Stabilized Dose:
  • Methadone for the Detoxification and Maintenance Treatment of Opioid Dependence:
  • Most common adverse reactions are: lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or n
  • No data
  • 5.12n- 7.4
  • No data
  • No data
  • Clinical Presentation
  • Acute overdosage of methadone is manifested by respiratory depression, somnolence progressing to stupor or coma, maximally constricted pupils, skeletal-muscle flaccidity, cold and clammy skin, and sometimes, bradycardia and hypotension. 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, are specific antidotes to respiratory depression resulting from opioid overdose. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to methadone overdose. Such agents should be administered cautiously to patients who are known, or suspected to be, physically dependent on methadone. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome.
  • 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, additional antagonist should be given as directed in the productu2019s prescribing information.
  • In an individual physically dependent on opioids, administration of an opioid receptor antagonist may precipitate an acute withdrawal. The severity of the withdrawal produced 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, crystalline material that is water-soluble. Its molecular formula is CHNOu2022 HCl 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 mL of Methadone Hydrochloride n (oral concentrate USP) contains 10 mg of methadone hydrochloride USP and the following inactive ingredients: citric acid, sodium benzoate and water.
  • No data
  • Carcinogenesis:
  • Mutagenesis:
  • in vivo
  • in vivo
  • E. coli
  • Neurospora crassa
  • Drosophila
  • Fertility:
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide)
  • Addiction, Abuse, and Misusen- [see ]
  • Life-threatening Respiratory Depressionn- [see ]
  • Accidental Ingestionn- [see ]
  • Symptoms of Arrhythmia
  • Neonatal Opioid Withdrawal Syndromen- [see ]
  • Interactions with Alcohol and other CNS Depressantsn- Array
  • Important Administration Instructions
  • Hypotension
  • Driving or Operating Heavy Machinery
  • Constipation
  • Anaphylaxisn- Intensol
  • Breastfeeding
  • Disposal of Unused Methadone
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 4056351//11
  • Revised June 2016
  • No data
  • Methadone Hydrochloride u2122
  • NDC 0054-3553-44
  • Rx only

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