Adverse Reaction:
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% )
Contra-Indications:
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.
Manufacturer Details