What is the most important information I should know about ziconotide?
Some people using ziconotide have had new or worsening mental problems. Tell your doctor right away if you have any unusual changes in mood or behavior.
You should not receive ziconotide if you have an uncontrolled bleeding disorder, a problem affecting your spine, or a history of psychosis.
What is ziconotide?
Ziconotide is a non-narcotic pain medicine that is used for around-the-clock treatment of severe chronic pain that cannot be treated with other pain medications.
Ziconotide may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving ziconotide?
You should not be treated with ziconotide if you are allergic to it, or if you have:
- an uncontrolled or untreated bleeding disorder; or
- a problem affecting your spine (such as arthritis, bone disorder, or narrowing of the spinal canal).
Some people using ziconotide have had new or worsening mental problems. You should not be treated with ziconotide if you have a history of psychosis (delusions or loss of contact with reality).
Tell your doctor if you have recently used opioid medicine.
Tell your doctor if you are pregnant or plan to become pregnant.
You should not breastfeed while using ziconotide.
How is ziconotide given?
Ziconotide is given around the clock using an infusion pump attached to a catheter placed into the space around your spinal cord (intrathecal injection). The infusion pump may be surgically implanted into your body or worn on the outside of your body. The pump controls how quickly the medicine is injected into your body.
Ziconotide may affect your thoughts, memory, speech, or daily activities. This effect may come on gradually after you've used this medicine for several weeks. Your doctor may occasionally change your dose or infusion pump flow rate.
Ziconotide doses are based on weight. Your dose needs may change if you gain or lose weight.
Tell your doctor if the medicine seems to stop relieving your pain, or if your infusion pump is not working properly.
If your catheter becomes contaminated, you may develop an infection. Call your doctor right away if you have symptoms such as fever, headache, confusion, neck stiffness, nausea, or vomiting.
If you also use opioid pain medicine, do not stop using it suddenly or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using opioid medicine.
You may need to use ziconotide for a period of many years.
Your doctor will need to check your progress on a regular basis.
What happens if I miss a dose?
Since your infusion pump programming control your dosing, you are not likely to miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include severe dizziness or drowsiness, vision problems, speech problems, stiffness in your neck or back, nausea and vomiting, or loss of consciousness.
What should I avoid while receiving ziconotide?
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Avoid drinking alcohol.
What are the possible side effects of ziconotide?
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Ziconotide can affect your central nervous system and you may feel less alert. A person caring for you should seek emergency medical attention if you are hard to wake up.
Call your doctor at once if you have:
- new or worsening muscle pain, soreness, or weakness, and/or dark urine;
- a light-headed feeling (like you might pass out);
- strange sensations in your mouth;
- skin sores, itching, blisters, breakdown of the outer layer of skin;
- confusion (especially in older adults);
- problems with memory or thought;
- unusual changes in mood or behavior --anger, aggression, paranoia, hallucinations, racing thoughts, risk-taking behavior;
- symptoms of depression --feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself; or
- symptoms of meningitis --fever, headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, or drowsiness.
Common side effects may include:
- nausea; or
- unusual or involuntary eye movements.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect ziconotide?
Using ziconotide with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Tell your doctor about all your other medicines, especially:
- a diuretic or "water pill";
- seizure medicine; or
- medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia.
This list is not complete. Other drugs may affect ziconotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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