Prialt 500mcg/5ml Inj, 5ml

Ziconotide is a synthetic peptide that is a selective blocker of N-type voltage-sensitive calcium channels (VSCCs). These channels are predominantly located on the afferent nociceptive neurons in the superficial laminae of the spinal cord. By blocking these channels, ziconotide inhibits the release of pronociceptive neurotransmitters (e.g., substance P, calcitonin gene-related peptide, glutamate) from the primary afferent nerve terminals, thereby interrupting pain signal transmission.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of meningitis, including:
+ Headache with fever
+ Stiff neck
+ Upset stomach
+ Confusion
+ Sensitivity to light
Seizures
Changes in balance
Feeling sluggish
Anxiety
Muscle pain or weakness
Dark urine
Difficulty passing urine
Muscle cramps
Muscle spasms
Inability to control eye movements
Changes in eyesight
Trouble walking
Shakiness
Skin ulcers
Severe skin irritation
Pain in arms or legs
Pneumonia symptoms, such as:
+ Fever
+ Chest pain
+ Cough
+ Shortness of breath
+ Wheezing (note: pneumonia has been reported in some cases, and in rare instances, it has been fatal)

Other Possible Side Effects

As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Feeling dizzy, sleepy, tired, or weak
Diarrhea
Upset stomach
Vomiting
Sinus pain
Decreased appetite
Headache

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bleeding problems
+ Infections at the injection site
+ Spinal problems

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. While using this drug, avoid operating a vehicle or engaging in any activities that require alertness, as it may impair your ability to do so.

Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.

Before consuming alcohol, using marijuana or other cannabis products, or taking any prescription or over-the-counter medications that may cause drowsiness, consult with your doctor to ensure safe use.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to experiencing side effects.

If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of using this medication to make an informed decision about its use.

• CNS depressants (e.g., opioids, benzodiazepines, sedatives, alcohol): May potentiate CNS adverse effects such as somnolence, dizziness, and confusion. Monitor closely.
• Drugs that can cause bradycardia (e.g., beta-blockers, calcium channel blockers): Ziconotide can cause bradycardia; concurrent use may increase risk.

• Severe psychiatric symptoms (e.g., hallucinations, delusions, psychosis, suicidal ideation, severe depression)
• Severe neurological symptoms (e.g., severe cognitive impairment, confusion, memory loss, speech difficulties, gait disturbance, muscle weakness, ataxia, tremor, nystagmus)
• Signs of meningitis (e.g., fever, headache, stiff neck, altered mental status)
• Signs of overdose (e.g., severe somnolence, stupor, coma, respiratory depression, severe hypotension, bradycardia, seizures)

Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

It is not known whether ziconotide is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established. Use is not recommended.

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, elderly patients may be more sensitive to the adverse effects of ziconotide, particularly cognitive and psychiatric effects. Initiate therapy at the lower end of the dosing range and titrate slowly, monitoring closely for adverse reactions.

• Prialt is a highly potent analgesic reserved for severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are refractory to other treatments, such as systemic analgesics, adjunctive therapies, and intrathecal morphine.
• Strict adherence to the titration schedule is crucial to minimize adverse events. Do not increase the dose more frequently than every 2-3 days.
• Patients must be carefully monitored for severe psychiatric and neurological adverse events, especially during titration. These can include hallucinations, psychosis, severe depression, suicidal ideation, cognitive impairment, and gait disturbances.
• Accidental intravenous administration is extremely dangerous and can lead to severe hypotension, bradycardia, and respiratory depression. Ensure proper intrathecal administration technique.
• Aseptic technique is paramount during pump refills and any manipulation of the intrathecal system to prevent meningitis.
• Patients should be educated on the potential side effects and instructed to report any concerning symptoms immediately.
• Consider a trial of intrathecal morphine before ziconotide if appropriate, as morphine has a more established safety profile for intrathecal use.

• Intrathecal morphine
• Other intrathecal analgesics (e.g., bupivacaine, clonidine, hydromorphone - often used in combination)
• Systemic opioids (e.g., morphine, oxycodone, hydromorphone)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
• Neuropathic pain medications (e.g., gabapentin, pregabalin, tricyclic antidepressants, SNRIs)
• Interventional pain procedures (e.g., nerve blocks, radiofrequency ablation, spinal cord stimulation, dorsal root ganglion stimulation)
• Physical therapy, occupational therapy, psychological therapies (e.g., CBT)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.