Discontinue all other tapentadol and tramadol products when beginning and while taking NUCYNTA ER [see Warnings and Precautions (5.6)]. Although the maximum approved total daily dose of NUCYNTA immediate-release formulation is 600 mg per day.
If you are a consumer or patient please visit this version.
Assess each patient’s risk prior to prescribing NUCYNTA ER, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )]. Life-threatening Respiratory Depression. NUCYNTA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
Overestimating the NUCYNTA ER dosage when converting patients from another opioid product can result in fatal overdose with the first dose.
CONVERSION FROM NUCYNTA TO NUCYNTA ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII2. Patients can be converted from NUCYNTA to NUCYNTA ER using the equivalent total daily dose of NUCYNTA and dividing it into 2 equal doses, separated by ~12-hour intervals*; Although the maximum.
As an opioid, NUCYNTA tablets exposes users to the risks of addiction, abuse, and misuse. Addiction, Abuse, and Misuse: NUCYNTA tablets contains tapentadol, a Schedule II controlled substance.
Patients with Chronic Pulmonary Disease: NUCYNTA tablets-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of NUCYNTA tablets.
Serotonergic Drugs: Please see Warnings and Precautions for more information.
Please see Warnings and Precautions above for information on Abuse and Dependence and the full Prescribing Information for more information on abuse and Dependence with NUCYNTA tablets.
The starting dose of Nucynta ER is 50 mg orally twice daily (approximay every 12 hours). Nucynta ER tablets must be taken whole. Crushing, chewing, or dissolving Nucynta ER tablets will result in uncontrolled delivery of tapentadol and can lead to overdose or death. Nucynta ER may interact with cold or allergy.
RxList does not provide medical advice, diagnosis or treatment. See additional information. 2017 by RxList Inc.
The mean age was 57 years old; 63% were female and 37% were male; 83% were White, 10% were Black, and 5% were Hispanic. The safety data described in Table 1 below are based on three pooled, randomized, double-blind, placebo-controlled, parallel group, 15-week studies of NUCYNTA ER (dosed 100 to 250 mg BID after a 50 mg BID starting dose) in patients with chronic pain due to low back pain (LBP) and osteoarthritis (OA).
Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended. NUCYNTA tablets may be.
Initiating Treatment with NUCYNTA Tablets.
If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the NUCYNTA tablets dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Initiate treatment with NUCYNTA tablets in a dosing range of 50 mg to 100 mg every 4 to 6 hours as needed for pain.
Pregnancy Category Risk cannot be ruled out.
The safety and efficacy of NUCYNTA tablets has not been studied in patients with severe hepatic impairment (Child-Pugh Score 10-15) and use in this population is not recommended [see Warnings and Precautions ( 5.15 )]
Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
Use lowest effective dose for shortest duration. ≥18yrs: initially 50–100mg every 4–6 hrs as needed. First day of dosing: may give second dose one hour after first dose if pain relief is inadequate; subsequent doses should be given every 4–6 hrs. Max 700mg/day on the first day, 600mg/day on subsequent days. Moderate.
Use only if alternative treatment options (eg, non-opioid analgesics, opioid combination products) are ineffective, not tolerated, or otherwise inadequate to provide sufficient analgesia.
Tapentadol 50mg, 75mg, 100mg tabs. Depomed, Inc.
≥18yrs: initially 50–100mg every 4–6 hrs as needed. First day of dosing: may give second dose one hour after first dose if pain relief is inadequate; subsequent doses should be given every 4–6 hrs. Max 700mg/day on the first day, 600mg/day on subsequent days. Use lowest effective dose for shortest duration. Withdraw gradually by 25–50% every 2–4 days. Moderate hepatic impairment: initially 50mg every 8 hours; max 3 doses/24 hours.
Acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.