Methadone Liquid Bottle
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See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment. Chemically, Methadone Hydrochloride is 3-Heptanone, 6- dimethylamino -4,4-diphenyl- hydrochloride, methadone liquid bottle water can be represented by the following structural formula:. Methadone hydrochloride is a white, essentially ordorless, bitter-tasting crystalline powder.
It is very soluble in water, methadone liquid bottle water in isopropranolol and in chloroform, and practically insoluble in ether and in glycerine. It is present in Methadone Hydrochloride Oral Concentrate as the racemic mixture. Each mL of the unflavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride.
Each mL of the cherry-flavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride. The principal actions of therapeutic value are analgesia and sedation and detoxification or maintenance in opioid addiction. The methadone abstinence syndrome, although qualitatively similar to that of morphine, differs in that the onset is slower, the course is more prolonged, and the symptoms are less severe.
Other NMDA receptor antagonists have been shown to produce neurotoxic effects in animals. Dose proportionality of methadone pharmacokinetics is not known. Effect of food on the bioavailability of methadone has not been evaluated. Methadone methadone liquid bottle water a lipophilic drug and the steady state volume of distribution ranges between 1. Methadone is secreted in saliva, breast milk, amniotic fluid and umbilical cord plasma.
Methadone is primarily metabolized by N-demethylation to an inactive metabolite, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene EDDP. The elimination of methadone is mediated by extensive biotransformation, followed by renal and fecal excretion. After multiple dose administration the apparent plasma clearance of methadone ranged between 1. Since methadone is lipophilic, it methadone liquid bottle water been known to persist in the liver and other tissues. The slow release from the liver and other tissues may prolong the duration of methadone action despite low plasma concentrations.
There are no pharmacokinetic studies of parenteral methadone in pregnancy. The disposition of oral methadone has been studied in approximately 30 pregnant patients in 2nd and 3rd trimesters. Elimination of methadone was significantly changed in pregnancy. Total body clearance of methadone was increased in pregnant patients compared to the same patients postpartum or to non-pregnant opioid-dependent methadone liquid bottle water. The terminal half-life of methadone is decreased during second and third trimesters.
The decrease in plasma half-life and increased clearance of methadone resulting in lower methadone trough levels during pregnancy can lead to withdrawal symptoms in some pregnant patients.
The dosage may need to be increased or the dosing interval decreased in pregnant patients receiving methadone. Methadone pharmacokinetics have not been extensively evaluated in patients with renal insufficiency. Unmetabolized methadone and its metabolites are methadone liquid bottle water in urine to a variable degree. Urine acidification has been shown to increase renal elimination of methadone. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for increasing methadone or metabolite elimination.
Methadone has not been extensively evaluated in patients with hepatic insufficiency. Methadone is metabolized by hepatic pathways, therefore patients with liver impairment may be at risk of accumulating methadone after multiple dosing. Methadone liquid bottle water pharmacokinetics of methadone have not been evaluated in the geriatric population. The pharmacokinetics of methadone have not been evaluated in the pediatric population. Coadministration of methadone with inducers of these enzymes may result in more rapid methadone metabolism, and potentially, decreased effects of methadone.
Therefore, drugs administered concomitantly with methadone should be evaluated for interaction potential. Clinicians are advised to evaluate individual response to drug therapy. Methadone Hydrochloride Oral Concentrate is contraindicated in patients with a known hypersensitivity to methadone hydrochloride or any other ingredient methadone liquid bottle water Methadone Hydrochloride Oral Concentrate. Methadone Hydrochloride Oral Concentrate is contraindicated in any situation methadone liquid bottle water opioids are contraindicated such as: Methadone Hydrochloride Oral Concentrate is for oral administration only.
The preparation must not be injected. Methadone Hydrochloride Oral Concentrate, if dispensed, should be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion.
This information is provided to alert the prescribing physician, and is not intended to deter the appropriate use of methadone in patients with a history of cardiac disease. Laboratory studies, both in vivo and in vitrohave demonstrated that methadone inhibits cardiac potassium channels and prolongs the QT interval. Cases of QT interval prolongation and serious arrhythmia torsades de pointes have been observed during treatment with methadone.
Although most cases involve patients being treated for pain with large, multiple daily doses of methadone, cases have been reported in patients receiving doses commonly used in maintenance treatment of opioid addiction. However, the evidence strongly suggests that methadone possesses the potential for adverse cardiac conduction effects in some patients. Methadone should be administered with particular caution to patients already at risk for development of prolonged QT interval e.
Careful monitoring is recommended when using methadone in patients with a history of cardiac conduction disease, those taking medications affecting cardiac conduction, and methadone liquid bottle water other cases where history or physical exam suggest an increased risk of dysrhythmia.
Patients developing QT prolongation while on methadone treatment should be evaluated for the presence of modifiable risk factors, such as concomitant medications with cardiac effects, drugs which might cause electrolyte abnormalities, and drugs which might act as inhibitors of methadone metabolism.
The potential risks of methadone, including the risk of life-threatening arrhythmias, should be weighed against the risks of discontinuing methadone treatment. In the patient being treated for opiate dependence methadone liquid bottle water methadone maintenance therapy, these risks include a very high likelihood of relapse to illicit drug use following methadone discontinuation.
The use of methadone in patients already known to have a prolonged QT interval methadone liquid bottle water not been systematically studied. The potential risks of methadone should be weighed against the substantial morbidity and mortality associated with untreated opioid addiction. Respiratory depression is the chief hazard associated with methadone hydrochloride administration. Respiratory depression is of particular concern in elderly or debilitated patients as well as methadone liquid bottle water those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation.
Methadone Hydrochloride Oral Concentrate should be administered with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as: In these patients, even usual therapeutic doses of methadone may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Alternative, non-opioid analgesics should be considered, and methadone should be employed only under careful medical supervision at the lowest effective dose.
Methadone's peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects, in the short-term use setting. These characteristics can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration.
Patients tolerant to other opioids may be incompletely tolerant to methadone. Deaths have been reported during conversion from chronic, high-dose treatment with other opioid agonists.
Methadone is a mu-agonist opioid with an abuse liability similar to morphine and is a Schedule II controlled substance. Methadone, like morphine and other opioids used for analgesia, has the potential for being abused and is subject to criminal diversion. Methadone can be abused in a manner similar to other opioid agonists, legal or illicit.
This should be considered when dispensing Methadone Hydrochloride Oral Concentrate in situations where the clinician is concerned about an increased risk of misuse, abuse, or diversion. Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product. Methadone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.
Deaths associated with illicit methadone liquid bottle water of methadone frequently have involved concomitant benzodiazepine abuse. The respiratory depressant effects of opioids and their capacity to elevate cerebrospinal-fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase methadone liquid bottle water intracranial pressure.
Furthermore, opioids produce effects which may obscure the clinical course of patients with head injuries. In such patients, methadone must be used with caution, and only if it is deemed essential. The administration of opioids may obscure the diagnosis or clinical course of patients methadone liquid bottle water acute abdominal conditions. The administration of methadone may result in severe hypotension in patients whose ability to maintain normal blood pressure is compromised e.
Methadone Hydrochloride Oral Concentrate should be used with caution in elderly and debilitated patients; patients who are known to be sensitive to central nervous system depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease; and in patients with comorbid conditions or concomitant medications which may predispose to dysrhythmia or reduced ventilatory drive.
Therefore, drugs administered concomitantly with methadone should be evaluated for interaction potential; clinicians are advised to evaluate individual response to drug therapy. Examples of such agents are naloxone, naltrexone, pentazocine, nalbuphine, butorphanol, and buprenorphine. Coadministration of these anti-retroviral agents resulted in increased clearance or decrease plasma levels of methadone. Methadone-maintained patients beginning treatment with above antiretroviral drugs should be monitored for evidence of withdrawal effects and methadone dose should be adjusted accordingly.
Experimental evidence methadone liquid bottle water that methadone decreased the AUC and peak levels for didanosine and stavudine, with a more significant decrease for didanosine. Methadone disposition was not substantially altered. Experimental evidence demonstrated that methadone increased the area under the concentration-time curve AUC of zidovudine which could result in methadone liquid bottle water effects.
Methadone-maintained patients beginning treatment with CYP3A4 inducers should be monitored for evidence of withdrawal effects and methadone dose should be adjusted accordingly. The following drug interactions were reported following coadministration of methadone with inducers of cytochrome P enzymes:. In patients well-stabilized on methadone, concomitant administration of rifampin resulted in methadone liquid bottle water marked reduction in serum methadone levels and a concurrent appearance of withdrawal symptoms.
In a pharmacokinetic study with patients on methadone maintenance therapy, phenytoin administration mg b. Upon discontinuation of phenytoin, the incidence of withdrawal symptoms decreased and methadone exposure increased to a level comparable to that prior to phenytoin administration.
Administration of methadone along with other CYP3A4 inducers may result in withdrawal symptoms. Since the metabolism of methadone is mediated primarily by CYP3A4 isozyme, coadministration of drugs that inhibit CYP3A4 activity may cause decreased clearance of methadone.
The expected clinical results would be increased or prolonged opioid effects. Thus, methadone-treated patients coadministered strong inhibitors methadone liquid bottle water CYP3A4 such as azole antifungal agents e.
Some selective serotonin reuptake inhibitors SSRIs e. Increased plasma concentrations of methadone have been associated with toxicity including QT prolongation. Frequent monitoring for adverse events and toxicity related to methadone is recommended during coadministration. Dose reduction of methadone may be needed. Therapeutic methadone liquid bottle water of meperidine have precipitated severe reactions in patients concurrently receiving monoamine oxidase inhibitors or those who have received such agents within 14 days.
Similar reactions thus far have not been reported with methadone. However, if the use of methadone is necessary in such patients, a sensitivity test should be performed in which repeated small, incremental doses of methadone are administered over the course of several hours while the patient's condition and vital signs are under careful observation.
