CNS depressants-
use of CNS depressants activities may be associated  with an increase
incidence of CNS adverse reactions such as dizziness, and confusion

Analgesia

Adverse reactions-

CNS -   81%       dizziness 45%    somnolence 20%      confusion 16%       abnormal gait  14% 
                            ataxia 15%        headache 14%          hypertonia 10%     memory impairment 10%    
                            speech disorder 8%      anxiety 8%         dysesthesia  6%       hallucinations 6%     
                            nervousness 6%     nyastagmus  6%       vertigo 6%

GI  - 60%             Nausea  41%  Diarrhea  18%  Vomiting 14%    Anorexia 10%

GU  22%            urinary retention  8%

Special senses 20%  -   abnormal vision  9%

Miscellaneous  56%     Asthenia  20%   pain 10%  fever  6%

Hypersensitivity to the drug or any of itsformulation components

Special precautions-
Psychotic symptoms- serious psychiatric symptoms and neurological  impairmentmay occur
during treatment .with zincontide.
Do not treat patients with a pre-existing history of psychosis with zinconatide.
Monitor all patients frequuently for evidence of cognitive impairment.

Meningitis and other infections- menigitis can occur because of inadvertent contamination of
microinfusion devise. Patients and cargivers must be particularly vigilant for signs and
symptoms of menigitis.

Reduced level of consciousness - patients have become unresponsive while receiving
ziconitide. Patients taking other concomittant antiepileptics, neuroleptics sedatives or diuretics
may be at higher risks of depressed levels of consciousness. 
If altered consciousness occurs, discontinue other  CNS depressants as appropriate.

Hazardous tasks- caution patients against engaging in hazardous tasks requiring complete
alterness or motor coordination such as driving or operating machinery. Also caution patients
about possible combined effects with CNS depressant drugs. Dosage adjustments may be
necessary when such agents are administrered .

Pregnancy- use zinconotide during pregnancy only if the potential benefits justifies
the potential risk to the fetus.

Lactation- decide whether to discontinue nursing or the drug depending on the importance
to the mother

Children- safety and efficacy in children have not been establshed

Elderly- in general the dose selection for an elderly patient should be cautious, usually
starting with low end of the dosing range, reflecting the greater frequency of decreased
fequency of hepatic, renal, or cardiac function and of concomittant disease or or other drug therapy

Indication-
Analgesia - for management of severe pain

Dosage-

Intrathecal-
Maximum dose 19.2mcg/day ( 0.8mcg/hr)
Initial dosage- initiate zinconotide intrathecal at no more than 2.4mcg/day ( 0.1mch/hr )
and titrate to patient response

Dosage titration- dose may be titrated upward by upto 2.4mcg/day ( 0.2mch/hr ) at intervals
of no more than 2 to 3 times per week up to a recommended mximum of 19.2mcg/day
( 0.8mcg/hr ) by day 21

Dose increase in increments of less than 2.4mcg/day ( 0.1mcg/hr ) and increases in dose
less frequently than 2 to 3 times per week may be used

1.Caution patients against engaging in hazardous tasks requiring complete
   alterness or motor coordination such as driving or operating machinery.

2. Caution patients about the combined effects of other CNS depressant drugs.
    Dosage adjustmnts may be necesary when zinconotide is administered with
    such agents.

3. Advice patients to contact their doctor if they experience new or worsening of
   muscle pain, soreness, or weakness with or without darkened urine.

4. Advice patients if they experience ,-
    - a change in mental status,eg.  lethargy, confusion, disoreintation , decreased alterness
    - a change in mood or perception eg halucination,  including tactile sensation in the
     oral cavity
    - symptoms of depression or suicidal ideation
    - nausea, vomiting. seizures, fever, heaache, and or stiff neck, as these are symptoms
     of developing menigitis

Pregnancy-
Use zinconotide during pregnancy only if the potential benefits justifies
the potential risk to the fetus.

Lactation-
Decide whetherto discontinue nursing or the drug depending on the importance
to the mother

Children-
Safety and efficacy in children have not been establshed

Elderly-
In general the dose selection for an elderly patient should be cautious, usually
starting with low end of the dosing range, reflecting the greater frequency of decreased
fequency of hepatic, renal, or cardiac function and of concomittant disease or other drug therapy