Ziconotide

Warning

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.)

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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: mental/mood disorders (such as depression, psychosis, thoughts of suicide), regular/long-term use of opioid medication.

This medication is not an opioid (morphine-like drug). If you have been using an opioid (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 opioid, withdrawal reactions may occur. This medication will not prevent withdrawal reactions from opioids. When stopping extended, regular treatment with opioids, 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. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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.

Side Effects

Dizziness, drowsiness, nausea, headache, and weakness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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Information expires December 2020.