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Patient Information Sheet
Ziconotide (marketed as Prialt)
PDF Print Version
This is a summary of the most important information
about Prialt. For details, talk to your health care professional.
What is the most important information I should know
about Prialt?
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Prialt may cause serious mental symptoms and
neurological problems.
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Do not receive Prialt if you have or had a mental
condition called psychosis.
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You or a caregiver should call your doctor right
away if you:
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If you have mental symptoms or neurological
problems, Prialt treatment can be interrupted or stopped suddenly
without experiencing withdrawal effects.
What is Prialt?
Prialt is a prescription medicine that a doctor injects into your
spinal fluid through a special device. It is used to treat severe
chronic pain in adults who cannot take other treatments or when
other treatments have not worked. Other treatments include systemic
pain medicines, treatments used in combination with pain medicines,
or morphine injected into the spinal fluid.
The safety and effectiveness of Prialt in pediatric patients has not
been established.
Who Should Not Receive Prialt?
You should not be given Prialt if you:
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are allergic to Prialt or any ingredient in it.
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have a condition or are receiving a treatment that would cause an
injection in your spinal fluid to be unsafe.
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have or had a mental illness called psychosis.
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have an infection at the device injection site, uncontrolled
bleeding problems, or a blockage in your spinal cord area.
What are The Risks?
Prialt can cause serious problems that you should tell your doctor
or health care professional about immediately such as:
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Severe Psychiatric Symptoms or Neurological Impairment including
changes in mood or perception (hallucinations, including unusual
sensations in the mouth and throat), changes and slowing in
thinking, depression or suicidal thoughts, confusion, memory
impairment, speech disorder, or inability to eat.
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Unconsciousness or Reduced Mental Alertness indicated by changes
in mental status (tiredness, confusion, disorientation, or decreased
alertness). Some people have lost consciousness while being treated
with Prialt. It may not be safe for you to engage in hazardous
activity requiring complete mental alertness or motor coordination
such as operating machinery or driving a motor vehicle during
treatment.
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Meningitis or Other Infections indicated by signs and symptoms
that include but are not limited to fever, headache, stiff neck,
altered mental status (tiredness, confusion, disorientation or
decreased alertness), nausea or vomiting, and sometimes seizures.
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Serious muscle damage. Your doctor should regularly monitor you
for muscle damage by doing a blood test to check foran increase in
Serum Creatine Kinase (CK). Increased CK levels in the blood may
mean there is damage to your muscles. High levels of CK in the blood
can damage your kidneys. Call your doctor right away if you have new
muscle pain, soreness, weakness, or your urine is dark in color.
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The most common side effects with Prialt are dizziness, nausea,
confusion, headache, sleepiness, problems with vision, weakness, and
pain.
What Should I Tell My Health Care Professional?
Before you receive Prialt, tell your health care professional if
you:
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have or had a mental illness called psychosis.
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are taking narcotic pain medicines called opiates. Prialt is not
an opiate medicine and cannot replace your opiate pain medicines.
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are taking other medicines that can affect your nervous system
such as antidepressant medicines, anti-anxiety medicines, seizure
medicines, antipsychotic medicines, or sleeping pills.
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are pregnant, trying to become pregnant, or are breast-feeding.
Are There Any Interactions With Medicines or Foods?
Prialt and certain other medicines can interact and cause serious
side effects. Tell your doctor or healthcare professional about all
the medicines you take, including prescription and non-prescription
medicines, vitamins, and herbal supplements. Your doctor may have to
adjust your dose of Prialt or watch you more closely if you take
other medicines that affect your nervous system.
How Am I Given Prialt?
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Prialt is administered by your doctor by injection into your
spinal fluid (intrathecally). It should not be given into the vein.
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Prialt is intended for injection into the spinal fluid using a
programmable implanted device or external device and catheter.
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Prialt should only be used in the Medtronic SynchroMed EL, SynchroMed II Infusion System and Simms Deltec Cadd Micro External Microinfusion Device and Catheter.
Prialt FDA Approved 2004
Patient Information Sheet Revised 06/2004
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Date created: June 22, 2005 |
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