Treatment intervals were gradually lengthened from every 6 hours to every 24 hours when methadone was discontinued. Outcomes of these patients were compared with recent control patients who had also been treated with enteral methadone but not under a standard protocol.
Among the protocol patients, there were no treatment failures. Weaning was accomplished in a median of 9 days range, 5—10 days , which was significantly less than the median of 20 days range, 9—31 days observed in the nonprotocol children. Concurrent use of benzodiazepines occurred in 6 of the protocol children, compared with 3 of the nonprotocol group, so that the decreased taper time on protocol was unlikely to have been confounded by other drug therapy.
Weaning and discontinuation from benzodiazepines were successful during the methadone taper in all protocol patients. Meyer et al described a protocol for rescue therapy in 29 patients 1 day to 20 years of age on admission who developed withdrawal during the course of nonstandardized tapers of prolonged continuous fentanyl infusion.
The daily fentanyl dose for the period 24 to 48 hours before withdrawal symptoms was used to calculate an equipotent dose of morphine sulfate. An equipotent amount of methadone was then determined by using the effective morphine dose. Three loading doses of methadone at hour intervals were administered. Ten patients were receiving concomitant treatment with a benzodiazepine or chloral hydrate, but these medications were not weaned during the methadone taper. Twenty-five of 29 patients successfully completed this taper over 10 days.
Three patients required 21 days, and 1 patient died of sepsis. Sixteen of the patients were discharged from the hospital and completed methadone tapers on an outpatient basis. Nine of the patients had been started on clonidine during the phase of nonstandardized opioid weaning in unsuccessful attempts to prevent withdrawal. A subsequent randomized double-blind follow-up study by the same group of investigators found that in a group of 37 fentanyl-treated patients, a 5-day methadone taper was as successful as the longer day course 13 of 16 vs 17 of 21 [not significant] in discontinuing opioid infusions without causing withdrawal.
In contrast to their previous study, a standardized taper of lorazepam was allowed in 17 of the 37 patients while on the methadone protocol. Only 1 of these 17 patients who underwent dual tapers required rescue treatment with an increased dose of opioids. Several factors potentially complicate the adoption of the protocols reported by Robertson, Meyer, and Berens see Table 4 into routine neonatal clinical practices. Most obvious is that these studies were conducted in a PICU setting; few neonates were included, and their outcomes were not separately analyzed.
Other investigators have emphasized that the Finnegan instrument common to all 3 studies has been validated only in term infants undergoing withdrawal secondary to in utero opioid exposure. A third concern is that opioids and benzodiazepines are often used concurrently in the same patient, yet symptoms of opioid and benzodiazepine withdrawal overlap to a great extent.
Hence, current instruments will not reliably differentiate whether withdrawal symptoms stem from relative opioid or benzodiazepine abstinence. Nonetheless, because many critically ill infants and children do receive treatment with prolonged courses of opioids and benzodiazepines, the following practices are reasonable based on the available evidence: Each clinical unit can establish a threshold level of cumulative exposure to opioids and benzodiazepines above which drug dependency can be expected to occur with a likelihood that justifies anticipatory initiation of a weaning protocol.
Many such children will not subsequently exhibit drug dependency. Signs and symptoms of withdrawal will develop within 24 hours of discontinuation or during the course of a rapid taper of an opioid. If this occurs, 1 of the rescue approaches in Table 4 can be chosen as a guide to facilitate conversion to enteral methadone management and to initiate a weaning strategy, with 2 caveats.
Infants on very high daily doses of continuous intravenous opioid may require less than the calculated methadone equivalent to achieve a successful conversion. Also, the rate of weaning should be adjusted on the basis of careful continuing clinical assessment. Eighty percent of children can be successfully weaned from methadone completely within 5 to 10 days. Signs and symptoms of withdrawal from benzodiazepine therapy can be delayed.
Intravenous benzodiazepines can be converted to oral lorazepam Table 4. The required time for weaning can be expected to be proportional to the duration of intravenous benzodiazepine treatment.
Infants and children at risk for withdrawal are prudently observed in the hospital for signs and symptoms. Each clinical unit can choose 1 assessment tool and train staff to minimize individual variability in scoring. These effects appear to increase with the duration of treatment. The clinical significance of these findings is not known. Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies in pregnant women.
Hydrocodone Bitartrate and Acetaminophen Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity, abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight.
The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate.
Hydrocodone Bitartrate and Acetaminophen Tablets are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions.
However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Nursing Mothers Hydrocodone is present in human milk.
Infants exposed to Hydrocodone Bitartrate and Acetaminophen Tablets through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Pediatric Use Safety and effectiveness of Hydrocodone Bitartrate and Acetaminophen Tablets in pediatric patients have not been established. Geriatric Use Elderly patients aged 65 years or older may have increased sensitivity to Hydrocodone Bitartrate and Acetaminophen Tablets.
In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.
Hydrocodone and acetaminophen are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Hepatic Impairment Patients with hepatic impairment may have higher plasma hydrocodone concentrations than those with normal function.
Use a low initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets in patients with hepatic impairment and follow closely for adverse events such as respiratory depression and sedation. Renal Impairment Patients with renal impairment may have higher plasma hydrocodone concentrations than those with normal function. Use a low initial dose Hydrocodone Bitartrate and Acetaminophen Tablets in patients with renal impairment and follow closely for adverse events such as respiratory depression and sedation.
Because these reactions are 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 most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. Other adverse reactions include: Central Nervous System- Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes.
Genitourinary System- Ureteral spasm, spasm of vesical sphincters, and urinary retention. Special Senses- Cases of Hearing impairment, or permanent loss have been reported predominantly in patients with chronic overdose. Dermatological- Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions Hematological- Thrombocytopenia, agranulocytosis.
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Acetaminophen Tablets. It can be more harmful to the baby if you are in pain all the time than if you take manageable dosages and take it only as needed.
I hope this helps. Bren32 I too take Vicodin ES for my scoliosis. I am 34 weeks pregnant and tend to worry that it will affect my baby. My main concern is that she will be born addicted to codeine.
I cut back to taking my vicodin about times a week. If it were up to my pain, I would take it more often but I take it only when I can't bear the lower back pain. Do not just stop using your opiates. Stopping them cold turkey can cause severe problems for you and your baby.
Getting help to quit opiates is your safest and best option. Treatment can help you quit using opiates and is safer than receiving no treatment at all. Fortunately, medication-assisted treatment is safe for you and your baby, and NAS in babies whose mothers obtain medication-assisted treatment during pregnancy is easier to treat.
The medicines used in medication-assisted treatment for pregnant women are methadone and buprenorphine.
Even though Methadone is still relatively safe for the fetus, it is still associated with NAS. Buprenorphine, on the other hand, has shown a lower severity of NAS symptoms, meaning less hospitalization and less medication is needed for babies after they are born.
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