Generic name: TRAMADOL HYDROCHLORIDE 100mg
Dosage form: capsule, extended release
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Important Dosage and Administration Instructions
CONZIP should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
- Do not use CONZIP concomitantly with other tramadol products [see Warnings and Precautions (5.5), (5.13)].
- Do not administer CONZIP at a dose exceeding 300 mg per day.
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Dosage and Administration (2.3)].
- Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
- Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with CONZIP and adjust the dosage accordingly [see Warnings and Precautions (5.2)].
- Instruct patients to swallow CONZIP capsules whole [see Patient Counseling Information (17)], and to take it with liquid. Breaking, chewing, splitting, or dissolving CONZIP capsules will result in uncontrolled delivery of tramadol and can lead to overdose or death [see Warnings and Precautions (5.1)].
- CONZIP may be taken without regard to food. It is recommended that CONZIP be taken in a consistent manner [see Clinical Pharmacology (12.3)].
Patients Currently on Tramadol Immediate-Release (IR) Products
Calculate the 24-hour tramadol IR dose and initiate a total daily dose of CONZIP rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need.
Due to limitations in flexibility of dose selection with CONZIP, some patients maintained on tramadol IR products may not be able to convert to CONZIP.
Titration and Maintenance Therapy
Individually titrate CONZIP by 100 mg every five days to a dose that to a dose that provides adequate analgesia and minimizes adverse reactions. The maximum daily dose of CONZIP is 300 mg per day.
Continually reevaluate patients receiving CONZIP to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)]. 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. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.
Patients who experience breakthrough pain may require a dosage adjustment of CONZIP, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the CONZIP dosage.
If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation of CONZIP
When a patient no longer requires therapy with CONZIP, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between doses, decreasing the amount of change in dose, or both. Do not abruptly discontinue CONZIP [see Warnings and Precautions (5.16), Drug Abuse and Dependence (9.3)].
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- Drug class: narcotic analgesics