"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 Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: decreased alertness (unresponsiveness), confusion, memory problems, mental/mood changes (e.g., anxiety, depression, hallucinations, thoughts of suicide), new or worsening muscle pain/soreness, numbness/tingling, trouble speaking/swallowing, difficult/unsteady walking, trouble urinating, dark urine, vision changes.
A very serious infection (meningitis) may occur if the site of your infusion or the solution going into your spinal cord becomes contaminated. Symptoms of meningitis include mental changes (e.g., extreme drowsiness, confusion), high fever, seizures, severe headache, stiff neck, nausea, and vomiting. Seek immediate medical attention if any of these unlikely but very serious side effects occur.
A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Prialt (ziconotide) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using ziconotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled bleeding, any infection near the injection site, mental/mood disorders (e.g., depression, psychosis, thoughts of suicide), spinal canal blockage.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: regular/long-term use of narcotic medication.
This medication is not a narcotic (morphine-like drug). If you have been using a narcotic (e.g., codeine, hydrocodone, morphine) regularly for more than a few weeks, or if it has been used in high doses, you may be dependent on it. In such cases, if you suddenly stop the narcotic, withdrawal reactions may occur. This medication will not prevent withdrawal reactions from narcotics. When stopping extended, regular treatment with narcotics, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially confusion.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk, and it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
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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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