Ziconotide

Warning

Severe mental/mood changes (such as 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 (such as psychosis) because it increases the risk of those side effects.

Precautions

See also Warning section.

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).

This medication is not an opioid (morphine-like drug). If you have been using an opioid (such as 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).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially confusion.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Side Effects

See also How to Use section.

Dizziness, drowsiness, nausea, headache, and weakness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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), memory problems, mental/mood changes (such as agitation, 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. Get medical help right away if you have any symptoms of meningitis, including confusion, high fever, seizures, severe headache, stiff/painful neck, vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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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