Patient Therapy Controller (PTC
®
) Guide, For use with Prometra
®
Programmable Infusion Systems
6
Patient Therapy Controller
Software Revision: 2.01.1
PTC® Description
The Patient Therapy Controller is an accessory to the Prometra
®
Programmable Infusion System that allows you to periodically deliver additional
doses of Infumorph® (a drug bolus) as prescribed by your doctor. When you activate the delivery of a drug bolus with the Patient Therapy
Controller, it communicates with the implanted Programmable Pump and tells it to deliver the drug bolus. The PTC can only be used to deliver
patient controlled boluses of Infumorph®. The PTC CANNOT be used to administer patient controlled boluses of intrathecal baclofen.
Purpose of the PTC®
(FDA approved indications)
The Patient Therapy Controller is indicated for use with the Prometra® Programmable Infusion Systems. It enables the patient to activate delivery
of supplemental doses of Infumorph® (preservative-free morphine sulfate sterile solution) from the Programmable Pump as prescribed by a
physician. The Patient Therapy Controller is not indicated for delivery of supplemental doses with intrathecal Baclofen.
Potential Benefits
Your doctor may have prescribed the use of the Patient Therapy Controller if you need additional doses of Infumorph® to treat your symptom
variations, intolerable side effects or your current treatment regimen is not decreasing your symptoms. The use of the Patient Therapy Controller
may help you better manage your drug delivery therapy from your Programmable Pump.
Potential Risks
The possible risks of using the Patient Therapy Controller include the potential side effects from receiving additional doses of Infumorph
®
.
The potential side effects of Infumorph
®
are as follows:
•
If nausea occurs, consult your doctor or pharmacist for ways to decrease it (such as taking antihistamines, lying down for 1 to 2 hours with as
little head movement as possible).
•
This medication may cause dependence, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal
reactions (such as restlessness, watery eyes, widened pupils, sweating, and runny nose) may occur if you suddenly stop this drug. To prevent
withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any
withdrawal reactions immediately.
•
When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication.
Talk with your doctor if this medication stops working well.
•
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have
abused alcohol or drugs in the past. Use this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.
