ziconotide 25 mcg/mL intrathecal solution

Generic name:
Ziconotide - injection

Pronunciation
(zye-KON-oh-tide)

Brand name(s)
Prialt

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.

This medication is a non-opioid 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, ask your doctor or pharmacist.

This medication is given by injection as directed by your doctor, usually continuously into area around the spinal cord (intrathecal) using a small pump. To decrease the risk of side effects, treatment is usually started slowly and then gradually increased to the best dose for you. The dosage is based on your medical condition and response to treatment.

This medication should not be given into a vein or under the skin. It can cause fainting due to a dangerous drop in blood pressure if it is accidentally given into a vein.

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 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 right away if there is any sign of infection around the injection site (such as swelling, redness, tenderness).

Contact your doctor or pharmacist to set up a schedule for refilling your pump.

Tell your doctor if your pain lasts or gets worse.

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.

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 breastfeeding.

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.

Tell your doctor or pharmacist if you are using other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as CK levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If your dose is interrupted or stopped, contact your doctor right away to establish a new dosing schedule.

Store in the refrigerator away from light. Do not freeze. After being mixed with saline, it may be refrigerated for up to 24 hours. 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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.