"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
Prialt Patient Information Including Side Effects
Brand Names: Prialt
Generic Name: ziconotide (Pronunciation: zye KON oh tide)
- What is ziconotide (Prialt)?
- What are the possible side effects of ziconotide (Prialt)?
- What is the most important information I should know about ziconotide (Prialt)?
- What should I discuss with my healthcare provider before using ziconotide (Prialt)?
- How should I use ziconotide (Prialt)?
- What happens if I miss a dose (Prialt)?
- What happens if I overdose (Prialt)?
- What should I avoid while using ziconotide (Prialt)?
- What other drugs will affect ziconotide (Prialt)?
- Where can I get more information?
What is ziconotide (Prialt)?
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 are the possible side effects of ziconotide (Prialt)?
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.
Read the Prialt (ziconotide) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about ziconotide (Prialt)?
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.
Additional Prialt Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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