Once a day, all day

ConZip® CIV (tramadol hydrochloride) Extended Release Capsules

ConZip®—Biphasic formulation provides around-the-clock pain relief

INDICATION

ConZip® is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve ConZip® for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ConZip® is not indicated as an as-needed (prn) analgesic.ConZipPainVisuals4

ConZip® is specifically designed to treat persistent painConZipAllDayGraphic-1

Offered in multiple strengths for dosing flexibility1

Capsule Strength Immediate-Release Tramadol Extended-Release Tramadol
ConZip® 100 mg 25 mg 75 mg
ConZip® 200 mg 50 mg 150 mg
ConZip® 300 mg 50 mg 250 mg

ConZip® offers equivalent plasma concentrations under fasting and fed conditions.2

Continuous delivery may help maintain consistent blood Tramadol levelsConZipChecklistGraphic3 (1)

 

ConZip® is classified as a schedule IV controlled substance by federal regulation.

ISI

ConZip® is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; hypersensitivity to tramadol, codeine, and other opioids; or with concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days.

A potentially life-threatening serotonin syndrome could result from concomitant serotonergic drug administration. Discontinue ConZip® if serotonin syndrome is suspected.

Seizure may present within recommended dose range. Seizure risk is increased with higher than recommended doses and concomitant use of SSRIs, SNRIs, anorectics, tricyclic antidepressants and other tricyclic compounds, other opioids, MAOIs, neuroleptics, other drugs that reduce seizure threshold, in patients with epilepsy or at risk for seizures.

If diagnosed with adrenal insufficiency, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Do not use ConZip® in suicidal or addiction-prone patients. Use with caution in those taking tranquilizers, antidepressants or abuse alcohol.

Life-threatening respiratory depression may occur in patients with Chronic Pulmonary Disease or in elderly, cachectic, or debilitated patients: monitor patient closely, particularly during initiation and titration.

There is  a risk of sedation and respiratory depression in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness.  Monitor patient closely, particularly during initiation and titration.  Avoid the use of ConZip® in patients with impaired consciousness or coma.

Severe hypotension may occur in patients with circulatory shock.  Monitor patient closely, particularly during initiation and titration.

Most common adverse reactions (incidence > 10% and twice placebo) are nausea, constipation, dry mouth, somnolence, dizziness, and vomiting.

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

References: 1. ConZip® [package insert]. Bridgewater, NJ: Vertical Pharmaceuticals, LLC; 2016. 2. Data on file, Vertical Pharmaceuticals, LLC.

ConZip® Full Prescribing Information

Medication Guide