Alcohol - combined use of alcohol with sodium oxybate may result in potentiation of
CNS depressant effects. Wrn patients stronly against the use alholic beverages in conjunction
with sodium oxybate.

Do not use sodium oxybate in combination with sedative hypnotics or other CNS depressants

Excessive daytime sleepiness
Cataplexy

Adverse reactions-

Cardiovascular -  hypertension 1%   heart rate increased , hypotension, syncope,
                                tachcardia 0.1 to 1%

CNS-            abnormal dreams, balance disorder, confusional state, fatigue, headache,
                     mood altered, panic disoder, rstlessness, sedation, sinus headache, sleep attacks,
                     strees symptoms, sudden onset of sleep, tension hedache ( 0.1% to 1% )

Dermatologic-   pruritus 1%    acne, cold sweat, contact dermatitis, night sweats, skin irritation ,
                         urticaria ( 0.1% to 1% )

  GI -             anorexia, constipation, dyspepsia, tothache, viral gastroenteritis,( 1% )
                     abdominal distention, dysphagia, eructation, fecal incontinence,
                     salivary hypersecretion , stomach discomfort, ( 0.1% to 1% )

GU-             urinary tract infection, 1%, bladder infection, hematuria, incontinence, micturation,
                     urgency, nocturia, ovarian cyst, urinary incontinence   ( 0.1% to 1%) 

Hematologic /lymphatic - leukopenia, lymphanopathy ( 0.1 to 1% )

Hypersensitivity - multiple allergies ( 0.1% to 1% )

Metabolic/nutrional - weight decreased, 1% decreased appetite, edema, hypernatremia,
                                    hypocalcemia, increased appetite ( 0.1% to 1% )

Musculoskeletal - arthalgia, back pain, myalgia, neck pain, 1%  arthiritis, chest pain,
                               joint stiffness, joint swelling, muscular weakness, sensation of heaviness
                               tendonitis ( 0.1% to 1% )

Respiratory - bronchitis cough, nasal congestion, sinus congestion, 1%  allergic rhinitis,
                       allergic sinusitis, bronchial infection, dry throat, hiccups, pneumonia,
                      respiratory disorder, sinus disorder, upper respiratory tract congestion
                      ( 0.1% to 1% )

Special senses-   ear pain 1%    ear discomfort , ear infection, otitis extrena ( 0.1% to 1% )

Hypersensitivity to drug or its components

Special precautions-
Respiratory effects- observe caution if sodium oxybate is precscribed to patients compromised
respiratary function.

CNS effects- emergence of thought disorders and or behaviour abnormalities when patients
aretreated with sodium oxybate requires careful evalution

Depression- monitor patients with a history of depressive illness and or suicide attempt especially
for emergence of depressive symptoms while taking sodium oxybate

Sleep walking- confused behaviour occuring at night associated with wandering has been
reported. Fully evaluate episodes of sleep walking and consider appropriate interventions

Renal function impairment- consider the sodium load associated with administration of
sodium  oxybate in patients with renal function impairment

Hepatic function impairment- patientsith compromised liver function will have an increased
elimination of elimination half-life  sodium oxybate.Decrease the starting dose by half in
such patients and closely monitor response to dose increments

Abuse, dependence, and tolerance- Ilicit use and abuse have reported.
Sodium oxybate is pschoactive drug that produces a widev range of pharmacological effects.
 The onset  of effect is rapid enhancing the desirability as a drug of abuse or misuse. 

Carefully evaluate patients fot a history of drug abuse and follow such patients closely,
observing them for signs of misuse or abuse of sodium oxybate eg increase in size or
freqency of dosing, drug seeking behaviour )

Hazardous tasks- Patients must not engage in hazardous occupations or activites requiring
complete alertness or motor coordination. eg operating machinery or driving motor vehicle
or  flying airplane.

Pregnancy- use this drug during pregnancy  only if needed

Lactation- excercise caution when sodium oxybate is administered in breast feeding woman.

Children- safety and efficacy inpatients younger than 18 years have not been evaluated

Elderly- closely monitor elderly patients taking sodium oxybate for  impared motor and/or
cognitive function.

Indication-

Excessive daytime sleepiness
Cataplexy

Dosage-
Sodium oxybate is required to be taken at bedtime while in bed and again 2.5 to 4 hours later

The recommended starting dose- 4.5mg/night  divided into 2 equal doses of 2.25mg 
The starting dose can be increased to a maximum of 9mg/night in increases of 1.5mg/night
( 0.75mg/dose )

1. Patients must read and understand instructions on use or abuse of sodium oxybate before
    starting therapy

2. Food significantly decreases the bioavailability of sodium oxybate . Patients should be
   made aware of this and try and take the first dose several hours after a meal 

3. Instruct patients to lie down and sleep after each dose of sodium oxybate and not take
   sodium oxybate any time other than at night, immediately before bed time and 2.5 to 4 hours
   later.

4. Instruct patients that they  should not take alcohol or other sedative hynotics with sodium
   oxybate

Pharmacology-
The precise mechanism by which sodium oxybate produces the effect on cataplexy is
unknown

Administration of sodium oxybate immediately after a highly fat meal resulted in delayed
absorption and reduction in Cmax  AUC.
Patients should be made of this and should take the first dose several hours after a meal.

Pregnancy-
Use this drug during pregnancy  only if needed

Lactation-
Excercise caution when sodium oxybate is administered in breast feeding woman.

Children-
Safety and efficacy inpatients younger than 18 years have not been evaluated