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Methadone Powder

Proper dosing and titration are essential and Methadone Hydrochloride should only be prescribed by healthcare professionals who are knowledgeable in the use of methadone for detoxification and maintenance prostate volume normal ml of opioid addiction. Monitor for respiratory depression, especially during initiation of Methadone Hydrochloride 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 see WARNINGS.

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 see WARNINGS.

Interactions with Drugs Affecting Cytochrome P Isoenzymes The concomitant use of Methadone Hydrochloride with all cytochrome P 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 P 3A4 2B6, 2C19, or 2C9 inducers may also result in an increase in methadone plasma concentration.

Methadone Powder Description Methadone Hydrochloride Powder, an opioid agonist, is for oral administration only and is used in the preparation of a liquid by dissolving the powder in an appropriate vehicle. This product is for prescription drug compounding only. 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.

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Methadone hydrochloride has a melting point of °C, a pKa of 8. Its structural formula is: Methadone Powder - Clinical Pharmacology Mechanism of Action Methadone hydrochloride is a mu-agonist; a synthetic opioid analgesic with multiple actions quantitatively similar to those of morphine, the most prominent of which involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value are analgesia 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. When administered orally, methadone is approximately one-half as potent as when given parenterally.

Oral administration results in a delay of the onset, a lowering of the peak, and an increase in the duration of analgesic effect. Pharmacodynamics Effects on the Central Nervous System Methadone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.

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Methadone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic e. Marked mydriasis rather than miosis may prostate volume normal ml seen due to hypoxia in overdose situations. Some NMDA receptor antagonists have been shown to produce neurotoxic effects in animals. Effects on the Gastrointestinal Tract and Other Smooth Muscle Methadone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.

Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Effects on the Cardiovascular System Methadone produces peripheral vasodilation, which may result in orthostatic hypotension or syncope.

They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon.

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Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date.

Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive. Concentration—Adverse Reaction Relationships There is a relationship between increasing [drug substance] plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.

In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions. Dose proportionality of methadone pharmacokinetics is prostate volume normal ml known.

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Effect of food on the bioavailability of methadone has not been bugyi a prosztatitis csalásból. Distribution Methadone is 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.

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Metabolism Methadone is primarily metabolized by N-demethylation to an inactive metabolite, 2-ethylidene-1, 5-dimethyl-3,3-diphenylpyrrolidene EDDP. Excretion The elimination of methadone is mediated by extensive biotransformation, followed by renal and fecal excretion. Published reports indicate that after multiple dose administration the apparent plasma clearance of methadone ranged between 1. Since methadone is lipophilic, it has 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. Specific Populations Use During Pregnancy The disposition of oral methadone has been studied in approximately 30 pregnant patients in the second and third 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 women. 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. Hepatic Impairment 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. Renal Impairment Methadone pharmacokinetics have not been extensively evaluated in patients with renal insufficiency.

Unmetabolized methadone and its metabolites are excreted in urine to a variable degree. Urine acidification has been shown to increase renal elimination of methadone. Forced prostate volume normal ml, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for increasing the elimination of methadone or its metabolites.

Sex The pharmacokinetics of methadone have not been evaluated for sex specificity.

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Race The pharmacokinetics of methadone have not been evaluated for race specificity. Age The pharmacokinetics of methadone have not been evaluated in the geriatric population. Pediatric 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. Pharmacokinetics of methadone may be unpredictable when coadministered with drugs that are known to both induce and inhibit CYP enzymes.

Methadone Powder - Clinical Pharmacology

Cytochrome P Inducers The following drug interactions were reported following coadministration of methadone with inducers of cytochrome P enzymes: Rifampin: In patients well-stabilized on methadone, concomitant administration of rifampin resulted in a marked reduction in serum methadone levels and a concurrent appearance of withdrawal symptoms. Phenytoin: 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. 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.

Methadone Powder - FDA prescribing information, side effects and uses

Didanosine and Stavudine: Experimental evidence demonstrated that methadone decreased the area under the concentration-time curve AUC and peak levels for didanosine and stavudine, with a more significant decrease for didanosine. Methadone disposition was not substantially altered.

Zidovudine: Experimental evidence demonstrated prostate volume normal ml methadone increased the AUC of zidovudine which could result in toxic effects. Indications and Usage for Methadone Powder 1.

For detoxification treatment of opioid addiction heroin or other morphine-like drugs. For maintenance treatment of opioid addiction heroin or other morphine-like drugsin conjunction with appropriate social and medical services. 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.

See below for important regulatory exceptions to the general requirement for certification prostate volume normal ml 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.

During an emergency period of no longer than 3 prostate volume normal ml while definitive care for the addiction is being sought in an appropriately licensed facility pursuant to 21 CFR Contraindications Methadone Hydrochloride Powder is contraindicated in patients with: Significant respiratory depression Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment Known or suspected gastrointestinal obstruction, including paralytic ileus Hypersensitivity e.

This preparation must not be injected. It is recommended that the methadone hydrochloride liquid preparation, A prosztata hiperplázia rák vagy sem dispensed, be packaged in child-resistant containers and kept out of the reach of children to prevent accidental ingestion.

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of methadone, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to prostate volume normal ml arrest and death.

Carbon dioxide CO2 retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Methadone Hydrochloride, the risk is greatest during the initiation of therapy 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.

Monitor patients closely for respiratory depression, when initiating therapy with Methadone Hydrochloride and gyakori késztetés a wc használatára dose increases.

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Instruct patients against use by individuals other than the patient for whom methadone was prescribed and to keep methadone out of the reach of children, as such inappropriate use may result in fatal respiratory depression. Overestimating the methadone dosage when initiating treatment can result in fatal overdose with the first dose. To further reduce the risk of respiratory depression, consider the following: Patients tolerant to other opioids may be incompletely tolerant to methadone.

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Incomplete cross-tolerance is of particular concern for patients tolerant to other mu-opioid agonists. Deaths have been reported during conversion from chronic, high-dose treatment with other opioid agonists. Proper dosing and titration are essential and methadone should be overseen only by healthcare professionals who are knowledgeable in the pharmacokinetics and pharmacodynamics of methadone.

Life-Threatening QT Prolongation Cases of QT interval prolongation and serious arrhythmia torsades de pointes have been observed during treatment with methadone. However, the evidence strongly suggests that methadone possesses the potential for adverse cardiac prostate volume normal ml effects in some patients.

The effects of methadone on the QT interval have been confirmed in in vivo laboratory studies, and methadone has been shown to inhibit cardiac potassium channels in in vitro studies.

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