Prialt

DRUG DESCRIPTION

PRIALT contains ziconotide, a synthetic equivalent of a naturally occurring
conopeptide found in the piscivorous marine snail, Conus magus. Ziconotide
is a 25 amino acid, polybasic peptide containing three disulfide bridges with
a molecular weight of 2639 daltons and a molecular formula of C₁₀₂H₁₇₂N₃₆O₃₂S₇.
The amino acid sequence and disulfide bridging pattern are given below:

Ziconotide is a hydrophilic molecule that is freely soluble in water and is
practically insoluble in methyl t-butyl ether.

PRIALT is formulated as a sterile, preservative-free, isotonic solution for
intrathecal administration using an appropriate microinfusion device [see DOSAGE
AND ADMINISTRATION]. Each 1 or 5 mL vial of PRIALT (100 mcg/mL) respectively
contains 100 or 500 mcg of ziconotide acetate, and the 20 mL vial of PRIALT
(25 mcg/mL) contains 500 mcg of ziconotide acetate, with L-methionine and sodium
chloride as excipients at pH 4.0–5.0. Each vial is intended for single use only,
either undiluted or after dilution to the appropriate concentration with 0.9%
Sodium Chloride Injection, USP (preservative free).

What are the possible side effects of ziconotide (Prialt)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• problems with memory, speech, walking, or thinking;


• feeling like you might pass out;


• double vision or other vision problems;


• new or worsening muscle pain, cramps, soreness, or weakness, and/or dark urine;


• unusual bleeding or signs of infection around the...

Read All Potential Side Effects and See Pictures of Prialt »

What are the precautions when taking ziconotide (Prialt)?

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...

Read All Potential Precautions of Prialt »

Prialt Consumer (continued)

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.

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

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.

Prialt Patient Information Including Side Effects

Brand Names: Prialt

Generic Name: ziconotide (Pronunciation: zye KON oh tide)

• What is ziconotide (Prialt)?


• What are the possible side effects of ziconotide (Prialt)?


• What is the most important information I should know about ziconotide (Prialt)?


• What should I discuss with my healthcare provider before using ziconotide (Prialt)?


• How should I use ziconotide (Prialt)?


• What happens if I miss a dose (Prialt)?


• What happens if I overdose (Prialt)?


• What should I avoid while using ziconotide (Prialt)?


• What other drugs will affect ziconotide (Prialt)?


• Where can I get more information?

What is ziconotide (Prialt)?

Ziconotide is a non-narcotic pain reliever that works by blocking pain signals from the nerves to the brain.

Ziconotide is used to treat severe chronic pain in people who cannot use or do not respond to standard pain-relieving medications.

Ziconotide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ziconotide (Prialt)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• problems with memory, speech, walking, or thinking;


• feeling like you might pass out;


• double vision or other vision problems;


• new or worsening muscle pain, cramps, soreness, or weakness, and/or dark urine;


• unusual bleeding or signs of infection around the microinfusion entry or catheter exit sites;


• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, nausea, vomiting, and/or seizure (convulsions);


• extreme drowsiness or tired feeling, depressed mood;


• feeling paranoid, hostile, disoriented, or confused;


• strange sensations in your mouth;


• hallucinations, unusual thoughts or behavior, thoughts of hurting yourself; or


• feeling less alert, decreased consciousness (stupor or lack of response).

Less serious side effects may include:

• headache, joint pain;


• mild drowsiness or weakness;


• dizziness, spinning sensation;


• sleep problems, unusual dreams;


• stomach pain, diarrhea, constipation, loss of appetite;


• urinating less than usual; or


• loss of balance or coordination.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ziconotide (Prialt)?

Severe psychiatric symptoms and neurological impairment may occur during treatment with ziconotide. You should not receive ziconotide if you have a history of psychiatric illness or psychotic event.

You should not use this medication if you are allergic to ziconotide, or if you have an uncontrolled bleeding or blood clotting disorder.

Ziconotide must be given only as an intrathecal injection through an infusion pump and should not be injected directly into a vein or other part of the body. Your doctor, nurse, or other healthcare provider will give you this injection.

Your doctor may occasionally change your dose or infusion pump flow rate to make sure you get the best results from this medication.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Tell your doctor if you regularly use other medicines that make you sleepy. Ziconotide can add to sleepiness caused by these other medications.

Call your doctor at once if you have a serious side effect, especially fever, neck stiffness, seizure (convulsions), extreme drowsiness or tired feeling, confusion, disorientation, hallucinations, thoughts of hurting yourself, or decreased consciousness.

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