What is ziconotide?
Ziconotide is a non-narcotic pain reliever that works by blocking pain signals from the nerves to
the brain.
Ziconotide is used to treat severe chronic pain in people who cannot use or do not respond to
standard pain-relieving medications.
Ziconotide may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking ziconotide?
Severe psychiatric symptoms and neurological impairment may occur during treatment with
ziconotide. You should not receive ziconotide if you have a history of psychiatric illness or psychotic
event.
You should not use this medication if you are allergic to ziconotide, or if you have an
uncontrolled bleeding or blood clotting disorder.
FDA pregnancy category C. It is not known whether ziconotide is harmful to an unborn
baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant
during treatment.
It is not known whether ziconotide passes into breast milk or if it could harm a nursing
baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take ziconotide?
Ziconotide is given as an injection into the space around your spinal cord (intrathecal injection)
using a computerized, portable infusion pump to control the rate of medication you receive. You may
need to use this medication for a period of many years.
Ziconotide must be given only as an intrathecal injection through an infusion pump and
should not be injected directly into a vein or other part of the body. Your doctor, nurse, or other
healthcare provider will give you this injection.
Your doctor may occasionally change your dose or infusion pump flow rate to make sure you
get the best results from this medication.
Tell your doctor if the medicine seems to stop working as well in relieving your pain.
To be sure ziconotide is helping your condition and not causing harmful effects, your doctor will
need to check your progress on a regular basis. Do not miss any scheduled appointments.
If you also use a narcotic pain medication, do not stop using it suddenly or you may have
unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the narcotic
medication before stopping completely.
What happens if I miss a dose of ziconotide?
Since ziconotide dosing and infusion pump programming is administered by a healthcare
professional, you are not likely to miss a dose.
Where can I get more information about ziconotide?
Your pharmacist has information about ziconotide written for health professionals that you may read.
What are the possible side effects of ziconotide?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
-
problems with memory, speech, walking, or thinking;
-
feeling like you might pass out;
-
double vision or other vision problems;
-
new or worsening muscle pain, cramps, soreness, or
weakness, and/or dark urine;
-
unusual bleeding or signs of infection around the
microinfusion entry or catheter exit sites;
-
fever, headache, neck stiffness, chills, increased sensitivity
to light, purple spots on the skin, nausea, vomiting, and/or seizure (convulsions);
-
extreme drowsiness or tired feeling, depressed mood;
-
feeling paranoid, hostile, disoriented, or confused;
-
strange sensations in your mouth;
-
hallucinations, unusual thoughts or behavior, thoughts of
hurting yourself; or
-
feeling less alert, decreased consciousness (stupor or lack of
response).
Less serious side effects may include:
-
headache, joint pain;
-
mild drowsiness or weakness;
-
dizziness, spinning sensation;
-
sleep problems, unusual dreams;
-
stomach pain, diarrhea, constipation, loss of appetite;
-
urinating less than usual; or
-
loss of balance or coordination.
This is not a complete list of side effects and others may occur. Tell your
doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about ziconotide?
Severe psychiatric symptoms and neurological impairment may occur during treatment with
ziconotide. You should not receive ziconotide if you have a history of psychiatric illness or psychotic
event.
You should not use this medication if you are allergic to ziconotide, or if you have an
uncontrolled bleeding or blood clotting disorder.
Ziconotide must be given only as an intrathecal injection through an infusion pump and
should not be injected directly into a vein or other part of the body. Your doctor, nurse, or other
healthcare provider will give you this injection.
Your doctor may occasionally change your dose or infusion pump flow rate to make sure you
get the best results from this medication.
Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Tell your doctor if you regularly use other medicines that make you sleepy. Ziconotide can
add to sleepiness caused by these other medications.
Call your doctor at once if you have a serious side effect, especially fever, neck stiffness, seizure
(convulsions), extreme drowsiness or tired feeling, confusion, disorientation, hallucinations, thoughts of
hurting yourself, or decreased consciousness.
What should I avoid while taking ziconotide?
Avoid drinking alcohol while you are using ziconotide.
Ziconotide can cause side effects that may impair your thinking or reactions. Avoid driving
or doing anything that requires you to be awake and alert.
What other drugs will affect ziconotide?
Before receiving ziconotide, tell your doctor if you regularly use other medicines that make
you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle
relaxers, and medicine for seizures, depression, or anxiety). Ziconotide can add to sleepiness caused by
these other medications.
Also tell your doctor if you are taking a diuretic (water pill).
This list is not complete and there may be other drugs that can interact with ziconotide. Tell
your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal
products, and drugs prescribed by other doctors. Do not start a new medication without telling your
doctor.
What happens if I have an overdose of ziconotide?
