Methadone Hydrochloride (Dolophine)

Trade Name : DOLOPHINE

West-Ward Pharmaceuticals Corp.

TABLET

Strength 5 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 (Dolophine) which is also known as DOLOPHINE and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 5 mg/1 per ml. Read more

Methadone Hydrochloride (Dolophine) 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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5.3n- 5.15

Arrayn- Addiction, Abuse, and Misuse
DOLOPHINE Tablets expose 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 DOLOPHINE Tablets, and monitor all patients regularly for the development of these behaviors and 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 [see Warnings and Precautions ()]. 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
Arrayn- Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of DOLOPHINE Tablets. 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 DOLOPHINE Tablets or following a dose increase .
Arrayn- Accidental Ingestion
Accidental ingestion of even one dose of DOLOPHINE Tablets, 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 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 DOLOPHINE Tablets .
Arrayn- Neonatal Opioid Withdrawal Syndrome
Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of DOLOPHINE 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 DOLOPHINE 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 DOLOPHINE 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 .
Arrayn- Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death .
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; RISK EVALUATION 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.

DOLOPHINE Tablets 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. ()
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 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. ()
Accidental ingestion of DOLOPHINE, 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 ()
Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of DOLOPHINE 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 DOLOPHINE 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 (, )
Concomitant 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 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. (, )

DOLOPHINE Tablets are indicated for the:
Limitations of Use
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 [].
DOLOPHINE is an opioid agonist indicated for the:
Limitations of Use
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
Initiation of Detoxification and Maintenance Treatment

5 mg Tablets: round and white, debossed with tablet identifier u201c54 162u201d on one side and scored on the other side.
10 mg Tablets: round and white, debossed with tablet identifier u201c54 549u201d on one side and scored on the other side.
Tablets: 5 mg and 10 mg. ()

DOLOPHINE Tablets are contraindicated in patients with:

No data

Risk of Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients:
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 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. 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:u00a0
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 Clinical Pharmacology ()]
Most common adverse reactions are: lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. ()

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

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

No data

u2022
Lactation
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. 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 DOLOPHINE 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 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:
DOLOPHINE Tablets are available for oral administration containing either 5 mg or 10 mg of methadone hydrochloride USP. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose and pregelatinized starch.

No data

Carcinogenesis:
The results of carcinogenicity assessment in B6C2F1 mice and Fischer 344 rats following dietary administration of two doses of methadone HCl 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.
Impairment of 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. Methadone treatment of pregnant rats from Gestation Day 14 to 19 reduced fetal blood testosterone and androstenedione in males. 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).

DOLOPHINE (methadone hydrochloride USP) Tablets
5 mg tablets are round, white biconvex tablets debossed with tablet identifier 54 162 on one side and scored on the other side.
NDC 0054-4218-25: Bottle of 100 Tablets
The 10 mg tablets are round, white biconvex tablets debossed with tablet identifier 54 549 on one side and scored on the other side.
NDC 0054-4219-25: Bottle of 100 Tablets
Store at 20u00ba to 25u00baC (68u00ba to 77u00baF), with excursions permitted between 15u00ba to 30u00baC (59u00ba to 86u00baF). [See USP Controlled Room Temperature.]
Store DOLOPHINE securely and dispose of properly .

Advise the patient to read the FDA-approved patient labeling (Medication Guide)
Storage and Disposal:
Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store DOLOPHINE securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home n . Inform patients that leaving DOLOPHINE unsecured can pose a deadly risk to others in the home.
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused DOLOPHINE 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 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:
Inform patients that the use of DOLOPHINE Tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose or death . Instruct patients not to share DOLOPHINE Tablets with others and to take steps to protect DOLOPHINE Tablets from theft or misuse.
Life-Threatening Respiratory Depression:
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting DOLOPHINE Tablets or when the dosage is increased, and that it can occur even at recommended dosages n n . Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Accidental Ingestion:
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death .
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 .
Interactions with Benzodiazepines and Other CNS Depressants:
Inform patients and caregivers that potentially fatal additive effects may occur if DOLOPHINE Tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care providern
Serotonin Syndrome:
Inform patients that opioids 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 .
MAOI Interaction:
Inform patients to avoid taking DOLOPHINE while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking DOLOPHINE .
Adrenal Insufficiency:
Inform patients that opioids 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 n n .
Important Administration Instructions:
Instruct patients how to properly take DOLOPHINE Tablets, including the following:
Anaphylaxis:
Inform patients that anaphylaxis has been reported with ingredients contained in DOLOPHINE Tablets. Advise patients how to recognize such a reaction and when to seek medical attention .
Pregnancy:
Neonatal Opioid Withdrawal Syndrome:n- [see Warnings and Precautions (), Specific Populations ()]
Embryo-Fetal Toxicity:n- [see Use in Specific Populations ()].
Lactation:
Instruct nursing mothers using DOLOPHINE Tablets 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 the 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) .
Infertility:
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible n
Driving or Operating Heavy Machinery:
Inform patients that DOLOPHINE Tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication .
Constipation:
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention .
Distr. by:n
Pharmaceuticals Corp.
Eatontown, NJ 07724
4077444//12
Revised October 2019

4077444//12Revised October 2019

No data

No data

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Methadone Hydrochloride (Dolophine)

Trade Name : DOLOPHINE

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

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Methadone Hydrochloride (Dolophine)

Trade Name : DOLOPHINE

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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