Severe mental/mood changes (e.g., confusion, depression, hallucinations, decreased alertness) may occur in some patients. This medication should not be used if you have a history of certain mental disorders (e.g., psychosis) because it increases the risk of those side effects. (See also Side Effects, Precautions sections.)Who should not take ziconotide intrathecal?
This medication is a non-narcotic pain reliever that is used to treat ongoing pain when other treatments or medications cannot control your pain. Ziconotide works by blocking the nerves in the spinal cord that send pain signals. It decreases ongoing pain caused by cancer, AIDS, failed back surgery, multiple sclerosis, neuropathy, and other causes.
Read the instruction manual and directions that come with your infusion pump. If you have any questions regarding the information, consult your doctor or pharmacist.
This medication is injected, usually continuously, into the spinal fluid (intrathecal) using a small pump or as directed by your doctor. To decrease the risk of side effects, treatment is usually started slowly and then gradually increased to the best dose for you. Your dose is based on your condition and response to therapy.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.
To prevent infection, learn how to handle the infusion pump, and learn proper care of the injection site. Call your doctor immediately if there is any sign of infection around the injection site (e.g., swelling, redness, tenderness). See also Side Effects section.
Contact your doctor or pharmacist to set up a schedule for refilling your pump.
Inform your doctor if your pain persists or worsens.
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.
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.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: "water pills" (e.g., furosemide, thiazide diuretics).
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Laboratory and/or medical tests (e.g., CK levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Do not share this medication with others.
Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light and moisture at all times, including during transport. After being mixed with saline, it may be refrigerated for up to 24 hours. Do not freeze. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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