Product: Nucynta

Company: PriCara

Pharmacologic class:

Active ingredient:
Tapentadol 50 mg, 75 mg, 100 mg tabs.

Indication: Moderate-to-severe acute pain in patients >18 years of age.

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Pharmacology: Tapentadol is a centrally-acting synthetic analgesic. Although its mechanism of action is unknown, analgesic efficacy is thought to be due to mu-opioid agonist activity and the inhibition of norepinephrine reuptake.

Clinical trials: Two randomized, double-blind, placebo- and active- controlled studies were conducted to evaluate the efficacy and safety of tapentadol in the treatment of moderate-to-severe acute pain from first metatarsal bunionectomy and end-stage degenerative joint disease.

In the bunionectomy study, patients 18-80 years of age with moderate-to-severe pain following unilateral, first metatarsal bunionectomy surgery were given tapentadol 50 mg, 75 mg, 100 mg, or placebo every four to six hours for 72 hours. The proportion of patients who showed reduction in pain intensity at 48 hours of >30% or >50% were significantly higher in patients treated with tapentadol at each dose vs. placebo.

In the end-stage degenerative joint disease study, patients age 18-80 years with moderate-to-severe pain from end-stage degenerative joint disease of the hip or knee were given tapentadol 50 mg, 75 mg, or placebo every four to six hours for 10 days. The proportion of patients who showed reductions in pain at five days of >30%, or >50% were significantly higher in patients treated with tapentadol at each dose vs. placebo.

Adults: >18 years: 50-100 mg every four to six hours depending on pain intensity. First day of dosing: may give second dose one hour after first dose if adequate pain relief not attained with first dose; subsequent doses should be given every four to six hours. Maximum 700 mg/day on the first day, 600 mg/day on subsequent days. Moderate hepatic impairment: initially 50 mg every eight hours; maximum three doses/24 hours.

Children: <18 years: not recommended.

Contraindications: Significant respiratory depression, acute or severe asthma or hypercapnia (in unmonitored settings or in the absence of resuscitative equipment). Paralytic ileus. During or within 14 days of monoamine oxidase inhibitors (MAOIs).

Precautions: Severe renal or hepatic impairment: not recommended. Asthma. Chronic pulmonary obstructive disease. Cor pulmonale. Severe obesity. Sleep apnea syndrome. Myxedema. Kyphoscoliosis. Central nervous system (CNS) depression. Coma. Head injury. Increased intracranial pressure. Seizure disorders. Biliary tract disease. Acute pancreatitis. Drug abusers. Avoid abrupt cessation. Elderly. Debilitated. Pregnancy (Cat. C). Labor and delivery, nursing mothers: not recommended.

Interactions: See Contraindications. Additive CNS depression with other CNS depressants (e.g., general anesthetics, phenothiazines, sedatives, hypnotics, alcohol); consider reducing dose. Serotonin syndrome possible with concomitant selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclics, MAOIs, triptans, other drugs that impair metabolism of serotonin.

Adverse reactions: GI upset, dizziness, somnolence; respiratory, CNS depression.

How supplied: Tabs—100

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