ConZip® CIV (tramadol hydrochloride) Extended-Release Capsules


CONTRAINDICATIONS

  • Patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. (4)
  • Patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment. (4)
  • Patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. (4)
  • All other opioid contraindications, including intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. (4)

WARNINGS AND PRECAUTIONS

  • Seizures: Can occur within the recommended dose range. Concomitant use with certain other drugs may increase the seizure risk. Risk of convulsions may increase in patients with epilepsy, history of seizures, and with a recognized risk for seizure. (5.1, 5.9)
  • Suicide: Do not prescribe for suicidal or addiction-prone patients. (5.2)
  • Serotonin Syndrome: May be life-threatening. Can occur with tramadol alone or with concomitant use of other serotonergic drugs or those that inhibit metabolism of tramadol. (5.3. 5.9)
  • Anaphylactoid Reactions: Serious and rarely fatal anaphylactoid reactions have occurred. Increased risk in patients with history of anaphylactoid reactions to other opioids. (5.4)
  • Hypersensitivity reactions: Serious and rarely fatal anaphylactoid reactions have occurred, often after the first dose. Other reactions include pruritus, hives, bronchospasm, angioedema, TEN, SJS. (5.4)
  • Respiratory Depression: Administer cautiously in patients at risk for respiratory depression. (5.5)
  • CNS Depression: Use with caution and in reduced dosages in patients taking CNS depressants and in patients at risk for CNS depression. Patients should not consume alcohol-containing beverages while using ConZip®. (5.6, 5.12)
  • Increased Intracranial Pressure or Head Trauma: Use with caution in patients with increased intracranial pressure or head injury. (5.7)
  • Ambulatory Patients: Tramadol may impair mental and/or physical abilities required for potentially hazardous tasks. (5.8)
  • Tapering may reduce withdrawal symptoms. (5.10)
  • Misuse, Abuse, and Diversion: Tramadol can be abused in a manner similar to other opioid agonists, legal or illicit. (5.11)
  • Overdosage can cause CNS and respiratory depression and death. (5.13)
  • ConZip® may complicate clinical assessment of acute abdominal conditions. (5.14)

ADVERSE REACTIONS

  • Most common adverse reactions (incidence ≥ 10% and twice placebo) are nausea, constipation, dry mouth, somnolence, dizziness, and vomiting. (6)
  • ConZip® is classified as a schedule IV controlled substance by federal regulation.

To report SUSPECTED ADVERSE REACTIONS, contact Vertical at (877) 958-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.