"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
Inform patients that:
- ConZip™ is for oral use only and should be swallowed whole. The capsule should not be chewed, dissolved, crushed or split.
- ConZip™ may cause seizures and/or serotonin syndrome with concomitant use of serotonergic agents (including SRIs, NRIs, and triptans) or drugs that significantly reduce the metabolic clearance of tramadol.
- Not to change the prescribed single-dose or 24-hour dosing regimen of ConZip™, and that exceeding the prescribed dose can result in respiratory depression, seizures or death.
- ConZip™ may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
- ConZip™ should not be taken with alcohol containing beverages.
- ConZip™ should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
- Instruct female patients to inform the prescriber if they are pregnant, think they might become pregnant, or are trying to become pregnant.
- ConZip™ is to be taken once-a-day and at approximately the same time every day. Also, exceeding these recommendations and the maximum recommended daily dose can result in respiratory depression, seizures or death.
- Elderly patients, especially those over 75 years of age, and other patients who have renal or hepatic impairments may need to be cautioned about reduced dosages.
- Not to abruptly withdraw or discontinue tramadol therapy, as clinical experience with tramadol suggests the possible onset of signs and symptoms of withdrawal. These affects may be reduced by tapering tramadol therapy.
- ConZip™ must be kept out of reach of children.
Last reviewed on RxList: 4/25/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional ConZip Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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