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VICODIN, VICODIN ES, VICODIN HP (HYDROCODONE/ACETAMINOPHEN) TABLETS: USE IN SPECIAL POPULATIONS
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Vicodin (Hydrocodone Bitartrate and Acetaminophen) tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Fetal / Neonatal Adverse Reactions
Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. 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. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly.
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. Vicodin, Vicodin ES, Vicodin HP are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Vicodin (Hydrocodone Bitartrate and Acetaminophen), 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.
Hydrocodone is present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hydrocodone bitartrate and acetaminophen tablets and any potential adverse effects on the breastfed infant from Vicodin, Vicodin ES, Vicodin HP or from the underlying maternal condition.
Infants exposed to Vicodin (Hydrocodone Bitartrate and Paracetamol) 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.
Safety and effectiveness of this medication in pediatric patients have not been established.
Elderly patients (aged 65 years or older) may have increased sensitivity to Vicodin, Vicodin ES, Vicodin HP. 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. Titrate the dosage of Vicodin (Hydrocodone Bitartrate with Acetaminophen) tablets slowly in geriatric patients and follow closely for signs of central nervous
system and respiratory depression.
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.
Patients with hepatic impairment may have higher plasma hydrocodone concentrations than those with normal function. Use a low initial dose of Vicodin, Vicodin ES, Vicodin HP in patients with hepatic impairment and follow closely for adverse events such as respiratory depression and sedation.
Patients with renal impairment may have higher plasma hydrocodone concentrations than those with normal function. Use a low initial dose Vicodin (Hydrocodone Bitartrate with Paracetamol) in patients with renal impairment and follow closely for adverse events such as respiratory depression and sedation.
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