Risperidone GPO Oral Solution

Risperidone GPO Oral Solution

risperidone

Manufacturer:

GPO

Distributor:

GPO
Concise Prescribing Info
Contents
Risperidone
Indications/Uses
Schizophrenia in adults & adolescents 13-17 yr. Acute manic or mixed episodes associated w/ Bipolar I disorder in adult (as adjunctive therapy w/ lithium or valproate), & childn & adolescents 10-17 yr. Irritability associated w/ autistic disorder in childn & adolescents 5-17 yr. Short-term treatment (up to 6 wk) of persistent aggression in patients w/ moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches & when there is a risk of harm to self or others. Short-term symptomatic treatment (up to 6 wk) of persistent aggression in conduct disorder in childn from 5 yr & adolescents w/ subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom severity of aggressive or other disruptive behaviors require pharmacologic treatment.
Dosage/Direction for Use
Schizophrenia Adult Initially 2 mg/day. May increase dose at intervals of ≥24 hr in increments of 1-2 mg/day as tolerated, to a recommended dose of 4-8 mg/day. Maintenance therapy: 2-8 mg/day. Adolescents 13-17 yr Initially 0.5 mg once daily as a single daily dose in the morning or evening. May be adjusted at intervals of ≥24 hr in increments of 0.5 mg or 1 mg/day as tolerated to a recommended dose of 3 mg/day. Bipolar disorder Adult Initially 2-3 mg/day. Dose may be adjusted at intervals of ≥24 hr in increments of 1 mg/day. Childn & adolescent 10-17 yr Initially 0.5 mg once daily as single-daily dose in the morning or evening. Dose may be adjusted at intervals of ≥24 hr in increments of 0.5 or 1 mg/day, as tolerated to a recommended target dose of 1-2.5 mg/day. Irritability associated w/ autistic disorder Childn & adolescent 5-17 yr Total daily dose can be administered once daily, or ½ the total daily dose can be administered bid. Patients weighing ≥20 kg Initially 0.5 mg daily. After a min of 4 days, dose may be increased to 1 mg/day. If clinical response is insufficient, dose may be increased at intervals of ≥14 days, in increments of 0.5 mg/day. Patients weighing <20 kg Initially dose at 0.25 mg daily. After a min of 4 days, dose may be increased to recommended dose of 0.5 mg/day. Maintain this dose for a min of 14 days. If clinical response is insufficient, dose may be increased at intervals of ≥14 days, in increments of 0.25 mg/day. Persistent aggression in patients w/ moderate to severe Alzheimer's dementia Initially 0.25 mg bid. Dose may be individually adjusted by increments of 0.25 mg bid, not more frequently than every other day, if needed. Optimum dose: 0.5 mg bid. May increase up to 1 mg bid. Conduct disorder Childn & adolescent 5-18 yr weighing ≥50 kg Initially 0.5 mg once daily. Dose may be adjusted by increments 0.5 mg once daily not more frequently than every other day. Optimum dose: 1 mg once daily, <50 kg Initially 0.25 mg once daily. Dose may be adjusted by increments of 0.25 mg once daily not more frequently than every other day, if needed. Optimum dose: 0.5 mg once daily. Elderly Initially 0.5 mg bid followed by careful titration. Max dose: 3 mg daily. Renal & hepatic impairment Initiate at a reduced dose of 0.5 mg bid in adults & increased as necessary & tolerated at increments of 0.5 mg bid. Increases >1.5 mg bid should be made at intervals of at least 7 days.
Administration
May be taken with or without food: Administer directly from the syringe or mix w/ a beverage (eg, water, coffee, orange juice, low-fat milk) prior to administration.
Contraindications
Hypersensitivity.
Special Precautions
Not for dementia-related psychosis. Risk of neuroleptic malignant syndrome may increase in patients w/ Parkinson's disease or Lewy body dementia. Patients w/ history of seizures; at risk for aspiration pneumonia (eg, Alzheimer's disease); who will be exposed to extreme temp; preexisting hyperprolactinemia & those w/ possible prolactin-dependent tumors; known CV disease (eg, history of MI, ischemic heart disease, heart failure, conduction abnormalities); cerebrovascular disease, conditions that would predispose to hypotension (eg, dehydration, hypovolemia & treatment w/ antihypertensives) or mitral insufficiency; family history of QT prolongation, bradycardia or electrolyte disturbances (hypokalemia, hypomagnesaemia). May mask manifestation of overdosage or cause of vomiting in various disorders eg, brain tumor, intestinal obstruction, Reye's syndrome. Regularly monitor patients w/ DM, & wt. Consider discontinuation if signs & symptoms of tardive dyskenia occurs. Priapism & venous thromboembolism may occur. Intraoperative floppy iris syndrome during cataract surgery in patients receiving drugs w/ α-1 adrenergic antagonist effect. Concomitant use w/ drugs known to prolong QT interval; alcohol. Orthostatic hypotension. Disorders where CNS depression is a feature. Renal & hepatic impairment. Caution in operating hazardous machinery including driving automobiles. Pregnancy & lactation. Childn w/ schizophrenia or acute mania associated w/ bipolar 1 disorders; w/ acute illnesses (eg, chickenpox, CNS infections, measles, gastroenteritis) or dehydration. Elderly patients w/ dementia-related psychosis.
Adverse Reactions
Extrapyramidal reactions, insomnia, agitation, anxiety & headache; orthostatic hypotension associated w/ dizziness, tachycardia, syncope. Somnolence, dizziness, aggressive reaction, increased sleep duration or dream activity, diminished sexual desire, fatigue & nervousness; palpitation, HTN, hypotension, AV block & MI; rash, dry skin, seborrhea & increased pigmentation; constipation, nausea, dyspepsia, vomiting, abdominal pain, increased/decreased salivation, toothache & anorexia; polyuria, polydipsia, menorrhagia, orgasmic dysfunction & vag dryness; back or chest pain & arthralgia; rhinitis, cough, sinusitis, pharyngitis, upper resp infection & dyspnea; abnormal vision.
Drug Interactions
Drugs known to prolong the QT interval eg, antiarrhythmics (eg, quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), TCAs (ie, amitriptyline), tetracyclic antidepressants (ie, maprotiline), some antihistamines, other antipsychotics, some antimalarials (ie, quinine & mefloquine) & drugs causing electrolyte imbalance, bradycardia or those inhibiting the hepatic metabolism of risperidone. Increased risk of sedation w/ centrally acting drugs & alcohol, opiates, antihistamines & benzodiazepines. Increase Cmax of valproate. May antagonize the effects of levodopa & dopamine agonists. Increased plasma & conc levels w/ fluoxetine, paroxetine. Increased plasma conc w/ strong CYP2D6 inhibitors, CYP3A4 &/or P-gp inhibitors (eg, itraconazole, ketoconazole, verapamil, ritonavir). Decreased clearance w/ clozapine. May enhance effects of antihypertensive agents. Decreased absorption w/ charcoal. Decreased plasma conc w/ strong CYP3A4 &/or P-gp inducers eg, rifampicin, carbamazepine, phenytoin, phenobarb. Beverages containing tannin or pectinate (cola or tea).
MIMS Class
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Risperidone GPO Oral Solution oral soln 1 mg/mL
Packing/Price
30 mL x 1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in