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: CONCENTRATE, HUMAN PRESCRIPTION DRUG

Strength: 10 mg/mL

Storage and handling

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

Disclaimer:
  1. 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.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
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  • Methadone Hydrochloride Oral Concentrate, USP
  • Arrayn- and
  • Methadone Hydrochloride Oral Concentrate, USP
  • (dye-free, sugar-free, unflavored)
  • 10 mg/mL
  • CII
  • Rx only
  • u00a0
  • FOR ORAL USE ONLY
  • 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
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  • 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 (n ). Proper dosing and titration are essential and methadone hydrochloride oral concentrate 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 oral concentrate 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 (n ).
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  • Concomitant use with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, is a risk factor for respiratory depression and death (n n- Arrayn- Arrayn- Arrayn- ).
  • Arrayn- Life-Threatening QT Prolongation
  • QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone (see ). 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 concentrate (n ).
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  • Accidental ingestion of methadone hydrochloride oral concentrate, especially by children, can result in fatal overdose of methadone (n ).
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  • Methadone hydrochloride oral concentrate contains methadone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit (n ).
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  • The concomitant use of methadone hydrochloride oral concentrate 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 u00a0n ).
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  • Methadone hydrochloride oral concentrate, USP, contains methadone, an opiate agonist, and is available as a cherry flavored liquid concentrate for oral administration. Methadone hydrochloride oral concentrate, USP sugar-free is a dye-free, sugar-free, unflavored liquid concentrateu00a0of methadone hydrochloride for oral administration. Each liquid concentrate contains 10 mg of methadone hydrochloride per mL.
  • Methadone hydrochloride is chemically described as 3-heptanone, 6-(dimethylamino)-4,4-diphenyl-, hydrochloride. Methadone hydrochloride is a white, essentially odorless, bitter-tasting crystalline powder. It is very soluble in water, soluble in isopropanol and in chloroform, and practically insoluble in ether and in glycerine. It is present in methadone hydrochloride oral concentrate as the racemic mixture. Methadone hydrochloride 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. Its structural formula is:
  • CHNOu2022HClu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0MW = 345.91
  • Other ingredients of methadone hydrochloride oral concentrate, USP: artificial cherry flavor, sorbic acid, potassium sorbate, FD&C red no. 40, D&C red no. 33, poloxamer 188, propylene glycol, glycerin, sucrose, and purified water.
  • Other ingredients of methadone hydrochloride oral concentrate, USP (Dye-Free, Sugar-Free, Unflavored): citric acid anhydrous, purified water, and sodium benzoate.
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  • 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 21 CFR, Title 42, Sec 8 (n ).
  • Methadone hydrochlorideu00a0oral concentrate is contraindicated in patients with:
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  • 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. In such individuals, lower doses are advisable.
  • Other adverse reactions include the following: (listed alphabetically under each subsection)
  • Body as a Whole
  • Cardiovascular n- see n- Array
  • Digestive
  • Hematologic and Lymphatic
  • Metabolic and Nutritional
  • Nervous
  • Respiratory n- see n- Array
  • Skin and Appendages
  • Special Senses
  • Urogenital
  • The following adverse reactions have been identified during post-approval use of methadone hydrochloride oral concentrate.
  • Serotonin syndrome
  • see
  • and
  • Adrenal insufficiency
  • see
  • Anaphylaxis
  • see
  • Androgen deficiency
  • see
  • Methadone hydrochloride oral concentrate contains methadone, a Schedule II opioid agonist. Schedule II opioid substances, which also include hydromorphone, morphine, oxycodone, and oxymorphone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Methadone, like morphine and other opioids used for analgesia, has the potential for being abused and is subject to criminal diversion.
  • Abuse of methadone hydrochloride oral concentrate poses a risk of overdose and death. This risk is increased with concurrent abuse of methadone hydrochloride oral concentrate with alcohol and other substances. In addition, parenteral drug abuse is commonly associated with transmission of infectious disease such as hepatitis and HIV.
  • Because methadone hydrochloride oral concentrate may be diverted for non-medical use, careful record keeping of ordering and dispensing information, including quantity and frequency is strongly advised.
  • Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
  • Methadone hydrochloride oral concentrate, when used for the treatment of opioid addiction in detoxification or maintenance programs, may be dispensed only by opioid treatment programs certified by the Substance Abuse and Mental Health Services Administration (and agencies, practitioners or institutions by formal agreement with the program sponsor).
  • Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy (n n n ).
  • Physical dependence can develop during chronic opioid therapy.
  • Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or significant dose reduction of a drug. Withdrawal is also precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene) or mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Physical dependence is expected during opioid agonist therapy of opioid addiction.
  • Methadone hydrochloride oral concentrate should not be abruptly discontinued (n ). If methadone hydrochloride oral concentrate is abruptly discontinued in a physically dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate (n ).u00a0
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  • Methadone hydrochloride oral concentrate, USP 10 mg/mL is supplied as a red, cherry flavored liquid concentrate, as follows:
  • 1 fl. oz. Bottle (30 mL) u2026u2026u2026u2026u2026u2026NDC 66689-694-30 (Supplied with calibrated dropper);
  • 1 Liter Bottle (1000 mL) u2026u2026u2026u2026u2026..NDC 66689-694-79
  • Methadone hydrochloride oral concentrate, USP 10 mg/mL, is supplied as a dye-free, sugar-free, unflavored liquid concentrate, as follows:
  • 1 fl. oz. Bottle (30 mL) u2026u2026u2026u2026u2026u2026NDC 66689-695-30u00a0 (Supplied with calibrated dropper);
  • 1 Liter Bottle (1000 mL) u2026u2026u2026u2026u2026..NDC 66689-695-79
  • Dispense in tight containers, protected from light. Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].u00a0
  • Manufactured by:
  • Arrayn- Array
  • Largo, FL 33771, USA
  • VP798R10
  • 10/19u00a0 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
  • NDC 66689-695-30
  • METHADONE HYDROCHLORIDE ORAL CONCENTRATE, USP CII
  • 10 mg/mL Dye-Free, Sugar-Free, Unflavored
  • Each 1 mL Contains:
  • Methadone Hydrochloride, USP.............10 mg
  • 1 fl. oz.
  • (30 mL)
  • Rx Only
  • Arrayn- VistaPharm
  • VP2066R1
  • 10/18
  • NDC 66689-695-30
  • METHADONE HYDROCHLORIDEu00a0u00a0
  • ORAL CONCENTRATE, USP CII
  • 10 mg/mL
  • Dye-Free, Sugar-Free, Unflavored
  • STORAGE:
  • Dispense in a tight container protected from light.
  • At the time of dispensing, replace cap with safety cap dropper.
  • Rx Only
  • VistaPharmu00ae
  • VP2067R1
  • 10/18
  • NDC 66689-694-30
  • METHADONE HYDROCHLORIDEu00a0u00a0
  • u00a0n- ORAL CONCENTRATE, USP CII
  • 10 mg/mL
  • (Cherry Flavored)
  • Each 1 mL Contains:
  • Methadone Hydrochloride, USP .......10 mg
  • 1 fl. oz.
  • (30 mL)
  • u00a0n- Rx Onlyu00a0
  • Arrayn- VistaPharm
  • VP2026R1
  • 10/18
  • NDC 66689-694-30
  • METHADONE HYDROCHLORIDEu00a0u00a0
  • ORAL CONCENTRATE, USP CII
  • 10 mg/mL
  • (Cherry Flavored)
  • STORAGE: Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight container protected from light.
  • At the time of dispensing, replace cap with safety cap dropper.
  • Rx Only
  • Arrayn- Arrayn- u00ae
  • VP2025R2
  • 10/18

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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 10 mg/mL.

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.

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