Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, e.g., naloxone, mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine).
Furthermore, decreased pup viability and pup body weight gain at 2.5 mg/kg or greater (0.2 times the HDD) were noted during the preweaning period.Additional animal data demonstrates evidence for neurochemical changes in the brains of offspring from methadone-treated pregnant rats, including changes to the cholinergic, dopaminergic, noradrenergic and serotonergic systems at doses below the HDD. Do not abruptly discontinue methadone.For detoxification and maintenance of opioid dependence methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8.12, including limitations on unsupervised administration.Administer the initial methadone dose under supervision, when there are no signs of sedation or intoxication, and the patient shows symptoms of withdrawal. Several studies have suggested that infants born to narcotic-addicted women treated with methadone during all or part of pregnancy have been found to have decreased fetal growth with reduced birth weight, length, and/or head circumference compared to controls.
Untreated opioid addiction in pregnancy is associated with adverse obstetrical outcomes and risk of continued or relapsing illicit opioid use. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined.
Avoid the use of mixed agonist/antagonist and partial agonist analgesics in patients receiving methadone.Anticholinergics or other drugs with anticholinergic activity when used concurrently with opioids may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Information from this source is evidence-based and objective, and without commercial influence. Discontinue methadone hydrochloride tablets if serotonin syndrome is suspected.Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Exploring the reciprocal relationship between cognitive function and edentulism among middle-aged and older adults in China
In such individuals, lower doses are advisable.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 growth deficit does not appear to persist into later childhood.
Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to methadone overdose.
(See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.Methadone hydrochloride tablets, USP are indicated for the:Consider the following important factors that differentiate methadone from other opioid analgesics:Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse The potency of methadone relative to other opioid analgesics is nonlinear and increases with increasing dose. Respiratory arrest, shock, cardiac arrest, and death have occurred.The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating.
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