Nucynta Er (tapentadol HCl)

Dosage of tapentadol hydrochloride is expressed in terms of tapentadol.

Opioid analgesics should be given at the lowest effective dosage and for the shortest duration of therapy consistent with the treatment goals of the patient. The dosage regimen should be individualized according to severity of pain, response, prior analgesic use, and risk factors for addiction, abuse, and misuse. If concomitant therapy with other CNS depressants is required, the lowest effective dosage and shortest possible duration of concomitant therapy should be used.

For acute pain not related to trauma or surgery, the prescribed quantity should be limited to the amount needed for the expected duration of pain severe enough to require opioid analgesia (generally 3 days or less and rarely more than 7 days).

Appropriate dosage selection and titration are essential to reduce the risk of respiratory depression. Tapentadol should be prescribed only by clinicians who are knowledgeable in the use of potent opioids and how to mitigate the associated risks.

Patients receiving opioid analgesia should be reevaluated continually for adequacy of pain control and for adverse effects, as well for the development of addiction, abuse, or misuse. During long-term therapy, the continued need for opioid analgesics should be periodically reevaluated. Frequent communication among the prescriber, other members of the healthcare team, the patient, and the patient's caregiver or family is important during periods of changing analgesic requirements, including the initial dosage titration period. If the level of pain increases after dosage stabilization, an attempt should be made to identify the source of increased pain before increasing the tapentadol dosage.

Tapentadol hydrochloride immediate- and extended-release tablets are administered orally without regard to food.

Tapentadol immediate-release tablets are administered every 4-6 hours as needed for pain. On the first day of therapy, the second dose of tapentadol may be administered as soon as 1 hour after the first dose if adequate analgesia is not attained.

Tapentadol extended-release tablets are administered twice daily (approximately every 12 hours). The extended-release tablets should be swallowed whole, one at a time, with enough water to ensure that each tablet is completely swallowed immediately after it is placed in the mouth; crushing, chewing, or dissolving the tablets will result in uncontrolled delivery of tapentadol and can result in overdosage and death. Patients receiving tapentadol extended-release tablets should not consume alcoholic beverages or use prescription or nonprescription preparations containing alcohol; intake of alcohol with the extended-release tablets may result in increased peak plasma concentrations of tapentadol and ingestion of a potentially toxic dose of the drug.

Store tapentadol immediate- and extended-release tablets protected from moisture at 20-25degreesC; excursions are permitted to 15-30degreesC. Tapentadol should be stored in a secure location out of the reach of children.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Substantial respiratory depression.

*Acute or severe bronchial asthma or hypercarbia in unmonitored settings or in the absence of resuscitative equipment.

*Known or suspected GI obstruction, including paralytic ileus.

*Hypersensitivity (e.g., anaphylaxis, angioedema) to the drug or any ingredient in the formulation.

*Concurrent or recent (i.e., within 2 weeks) therapy with a monoamine oxidase (MAO) inhibitor.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse effects of tapentadol immediate-release tablets (>=10%) in adult patients are nausea, dizziness, vomiting, and somnolence. The most common adverse effects of tapentadol immediate-release tablets (>=5%) in pediatric patients are vomiting, constipation, nausea, pruritus, and pyrexia.

The most common adverse effects of tapentadol extended-release tablets (>=10%) are nausea, constipation, dizziness, headache, and somnolence.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of tapentadol immediate-release tablets have been established in pediatric patients >=6 years of age weighing >=40 kg. Safety and efficacy were established based on the results of one randomized, double-blind, placebo-controlled, multiple-dose trial and three open-label, single-dose trials of tapentadol oral solution. Safety and efficacy of tapentadol immediate-release tablets have not been established in pediatric patients <6 years of age or <40 kg. Tapentadol immediate-release tablets have not been evaluated in pediatric patients with hepatic or renal impairment; use in these populations is not recommended.

Safety and efficacy of tapentadol extended-release tablets in pediatric patients <18 years of age have not been established.

The manufacturer states that available data regarding use of tapentadol in pregnant women are not sufficient to establish the risk of major birth defects, spontaneous abortion, or adverse maternal outcomes with the drug. In animal studies, embryofetal mortality and structural malformations were observed in rabbits and delays in skeletal maturation and increased pup mortality were observed in rats at exposure levels equivalent to or less than those associated with the maximum recommended human dosage. Based on animal data, patients should be apprised of potential risks to the fetus if tapentadol is used during pregnancy.

Use of opioids in pregnant women during labor can result in respiratory depression and psychophysiological effects in neonates. Opioids can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions; this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Tapentadol is not recommended for use during or immediately prior to labor and delivery. Neonates exposed to opioids during labor should be monitored for respiratory depression and withdrawal symptoms; an opioid antagonist (e.g., naloxone) should be available to reverse opioid-induced respiratory depression in the neonate.

Prolonged maternal use of opioids, including tapentadol, during pregnancy can result in neonatal opioid withdrawal syndrome with manifestations of irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. In contrast to adults, the withdrawal syndrome in neonates may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Women who require prolonged opioid agonist therapy during pregnancy should be advised of the risk of neonatal opioid withdrawal syndrome, and availability of appropriate treatment should be ensured. The onset, duration, and severity of the syndrome vary depending on the specific opioid agonist used, duration of use, timing and amount of last maternal use, and rate of drug elimination by the neonate.

There are no data on the presence of tapentadol in human milk, the effects on the breast-fed infant, or the effect on milk production. Tapentadol is distributed into animal milk. The benefits of breast-feeding and the importance of tapentadol therapy to the woman should be considered along with the potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. Because of the potential for serious adverse effects (e.g., sedation, respiratory depression) in nursing infants, breast-feeding is not recommended during therapy with tapentadol extended-release tablets.

Infants exposed to tapentadol through breast milk should be monitored for excessive sedation and respiratory depression. Symptoms of withdrawal can occur in opioid-dependent infants when maternal administration of opioids is discontinued or breast-feeding is stopped.

Geriatric patients may exhibit increased sensitivity to tapentadol. Because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in geriatric patients, dosage selection of tapentadol in such patients should be cautious, usually initiating therapy with dosages in the lower end of the usual range. Dosage of tapentadol should be titrated slowly with close monitoring for CNS and respiratory depression.

In clinical studies of tapentadol administered as immediate- or extended-release tablets, 19 or 28%, respectively, of patients were >=65 years of age and 5 or 7%, respectively, were >=75 years of age. No overall differences in efficacy were observed between geriatric patients and younger adults; however, in patients receiving tapentadol immediate-release tablets, the incidence of constipation was higher in geriatric patients >=65 years of age compared with those younger than 65 years of age (12 versus 7%). Systemic exposure to tapentadol, as measured by AUC, was similar in geriatric patients and young adults; the mean peak plasma tapentadol concentration was 16% lower in geriatric patients compared with young adults.

Geriatric patients may have increased sensitivity to tapentadol. Tapentadol is known to be substantially excreted by the kidney, and the risk of adverse effects may be greater in patients with impaired renal function. Because geriatric patients are more likely to have decreased renal function, consideration should be given to dosage selection and monitoring of renal function. In general, the initial dosage of tapentadol should be 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. Dosage titration should occur slowly, with frequent evaluations for signs of CNS and respiratory depression.