ZICONOTIDE

ZICONOTIDE
(zi-con'o-tide)
Prialt
Classifications: nonnarcotic analgesic; n-type calcium channel blocker;
Therapeutic: nonnarcotic analgesic

Pregnancy Category: C

Availability

25 mcg/mL, 100 mcg/mL injection

Action

Ziconotide binds to N-type calcium channels located on the afferent nerves in the dorsal horn in the spinal cord. It is thought that these binding blocks of N-type calcium channels lead to a blockade of excitatory neurotransmitter release in the afferent nerve endings.

Therapeutic Effect

Ziconotide is effective in controlling severe chronic pain that is intractable to other analgesics.

Uses

Management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted.

Unlabeled Uses

Spasticity associated with spinal cord trauma.

Contraindications

Hypersensitivity to ziconotide; epidural or intravenous administration; preexisting history of psychosis; sepsis; depression with suicidal ideation; cognitive impairment; bipolar disorder; schizophrenia; dementia; presence of infection at the injection site, uncontrolled bleeding, or spinal canal obstruction that impairs circulation of CSF; coagulopathy; seizures; pregnancy (category C); lactation. Safety and efficacy in children or infants are not established.

Cautious Use

Elderly; renal, hepatic, and cardiac impairment; concurrent use of CNS depressant(s); older adults.

Route & Dosage

Severe Chronic Pain
Adult: Intrathecal Initial 0.1 mcg/h; may titrate up 0.1 mcg/h q2–3d to 0.8 mcg/h (19.2 mcg/d)

Administration

Intrathecal
  • May be administered undiluted (25 mcg/mL in 20 mL vial) or diluted using the 100 mcg/mL vials. Diluted ziconotide is prepared with NS without preservatives.
  • Administer using an implanted variable-rate microinfusion device or an external microinfusion device and catheter.
  • Note: Due to serious adverse events, 19.2 mcg/d (0.8 mcg/h) is the maximum recommended dose.
  • Doses should normally be titrated upward by no more than 2.4 mcg/d (0.1 mcg/h) at intervals of 2–3 times/wk.
  • Refrigerate all ziconotide solutions after preparation and begin infusion within 24 h. Discard any unused portion left in a vial.

Adverse Effects (≥1%)

Body as a Whole: Accidental injury, back pain, catheter complication, catheter-site pain, cellulitis, chest pain, chills, fever, flu syndrome, infection, malaise, neck pain, neck rigidity, pain, pump-site complication, pump-site mass, pump-site pain, viral infection. CNS: Abnormal dreams, abnormal gait, agitation, anxiety, aphasia, asthenia, ataxia, CSF abnormal, confusion, depression, difficulty concentrating, dizziness, dry mouth, dysesthesia, emotional lability, headache, hostility, hyperesthesia, hypertonia, incoordination, insomnia, memory impairment, mental slowing, meningitis, nervousness, neuralgia, paranoid reaction, paresthesia, reflexes decreased, somnolence, speech disorder, stupor, abnormal thinking, tremor, twitching, vertigo. CV: Hypertension, hypotension, postural hypotension, syncope, tachycardia, vasodilation. GI: Abdominal pain, anorexia, constipation, diarrhea, dyspepsia, gastrointestinal disorder, nausea, vomiting. GU: Dysuria, urinary incontinence, urinary retention, urinary tract infection, impaired urination. Hematologic: Anemia, ecchymosis. Metabolic/Nutritional: Creatinine phosphokinase increased, dehydration, edema, hypokalemia, peripheral edema, weight loss. Musculoskeletal: Arthralgia, arthritis, leg cramps, myalgia, myasthenia. Respiratory: Bronchitis, cough increased, dyspnea, lung disorder, pharyngitis, pneumonia, rhinitis, sinusitis. Skin: Cutaneous surgical complication, dry skin, pruritus, rash, skin disorder, sweating. Special Senses: Abnormal vision, diplopia, nystagmus, photophobia, taste perversion, tinnitus.

Interactions

Drug: Ethanol and other cns depressants may increase drowsiness, dizziness, and confusion.

Pharmacokinetics

Distribution: 50% protein bound. Metabolism: Hydrolyzed by peptidases. Half-Life: 4.6 h.

Nursing Implications

Assessment & Drug Effects

  • Monitor for and report S&S of meningitis, cognitive impairment, hallucinations, changes in mood or consciousness, or other psychiatric symptoms.
  • Lab tests: Serum creatine kinase every other week for first month and monthly thereafter.

Patient & Family Education

  • Report any of the following to physician: muscle pain, soreness, or weakness, confusion, unusual behavior, symptoms of depression or suicidal thoughts, fever, headache, stiff neck, nausea or vomiting, seizures.
  • Note: Taking this drug with other depressants (e.g., alcohol, sedatives, tranquilizers) will increase the risk of side effects.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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