Resdone Tablet
Risperidone
2 mg
Intas Pharmaceuticals Ltd.
Pack size | |
---|---|
Dispensing mode | |
Source | |
Agent | |
Retail Price | 59.14 NPR |
Available as:
Indications
Resdone Tablet is used for:
Acute and chronic psychoses, Mania, Schizophrenia, Bipolar disorder.
Adult Dose
Oral
Schizophrenia
2 mg/day initially; may be increased in increments of 1-2 mg/day at intervals >24 hours
Recommended target dosage: 2-8 mg/day once daily or divided q12hr (efficacy follows bell-shaped curve; 4-8 mg/day more effective than 12-16 mg/day)
Bipolar Mania
2-3 mg/day initially; may be increased if necessary in increments of 1 mg/day at intervals of 24 hours to 6 mg/day; dosage recommendations not available for treatment duration >3 weeks
Tourette Syndrome
0.5-1 mg/day PO; may be increased or decreased in increments of 0.5 mg q12hr at intervals >3 days; not to exceed 6 mg/day
Posttraumatic Stress Disorder
0.5-8 mg/day PO
Elderly: Initially, 0.5 mg bid gradually increased in increments of 0.5 mg bid. Maintenance: 1-2 mg bid.
Hepatic impairment: Initially, 0.5 mg bid, may increase in steps of 0.5 mg bid, up to 1-2 mg bid.
Dose increments above 1.5 mg bid should be made at intervals of at least 1 wk.
Child Dose
Oral
Schizophrenia
<13 years: Safety and efficacy not established
>13 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of 0.5-1 mg/day at intervals >24 hr to recommended dosage of 3 mg/day; dosage range: 1-6 mg/day (dosages >3 mg/day have not been proved more effective and are associated with increased incidence of adverse effects)
If persistent somnolence occurs, daily dose may be divided q12hr
Bipolar Mania
<10 years: Safety and efficacy not established
>10 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of 0.5-1 mg/day at intervals >24 hr to recommended dosage of 2.5 mg/day; dosage range: 0.5-6 mg/day (dosages >2.5 mg/day have not been proved more effective and are associated with increased incidence of adverse effects)
If persistent somnolence occurs, daily dose may be divided q12hr
Autism
Irritability associated with autistic disorder in children aged 5-16 years
<5 years: Safety and efficacy not established
5-16 years (<20 kg): 0.25 mg/day PO initially; may be increased after >4 days to recommended dosage of 0.5 mg/day
5-16 years (>20 kg): 0.5 mg/day PO initially; may be increased after >4 days to recommended dosage of 1 mg/day
Renal Dose
Renal impairment: Initially, 0.5 mg bid, may increase in steps of 0.5 mg bid, up to 1-2 mg bid.
Dose increments above 1.5 mg bid should be made at intervals of at least 1 wk.
Administration
May be taken with or without food.
Contra Indications
Risperidone is contraindicated in patients with a known hypersensitivity to the product.
Precautions
Preexisting CV diseases; discontinue use if signs and symptoms of tardive dyskinesia occur; renal and hepatic impairment, elderly, epilepsy; parkinsonism; pregnancy. May cause drowsiness and orthostatic hypotension. Gradual withdrawal is recommended. Monitor blood glucose in diabetics and patients at risk of developing diabetes.
Lactation: Drug distributed in breast milk; do not nurse
Pregnancy-Lactation
Interactions
May antagonise the effects of levodopa and dopamine agonists. May increase serum levels of clozapine when used together. Increased serum levels of carbamazepine when used concurrently. Carbamazepine may also decrease the serum levels of risperidone. Increased risk of neuroleptic malignant syndrome when used with indinavir and ritonavir.
Potentially Fatal: Risperidone may enhance the hypotensive effect of certain antihypertensives.
Adverse Effects
Side effects of Risperidone :
>10%
Somnolence (40-45%),Insomnia (26-30%),Agitation (20-25%),Anxiety (10-15%),Headache (10-15%),Rhinitis (10-15%),Fatigue (18-31%),Parkinsonism (28-62%),Akathisia (5-11%),Increased appetite (4-44%),Vomiting (10-20%),Drooling (<12%),Urinary incontinence (5-22%),Tremor (11-24%),Nasopharyngitis (4-19%),Rhinorrhea (4-12%),Enuresis (1-16%)
1-10%
Constipation (5-10%),Dyspepsia (5-10%),Nausea (5-10%),Abdominal pain (1-5%),Aggressive reaction (1-5%),Facial edema (<4%),QT prolongation (<4%),Dizziness (1-5%),Extrapyramidal symptoms (EPS; 1-5%),Gynecomastia in children (1-5%),Rash (1-5%),Tachycardia (1-5%),Syncope (1-2%),Bradycardia (<4%),Palpitation (<4%),Chest pain (<4%),Agitation (<4%),Postural dizziness (<4%),Pruritus (<4%),Acne (1-2%),Hyperprolactinemia (<4%),Sexual dysfunction (<4%),Xerostomia (7-10%)
<1%
Agranulocytosis,Cholesterol increased,Delirium,Ketoacidosis,Orthostatic hypotension,Seizures
Frequency Not Defined
Diabetes mellitus,Hyperthermia,Hypoglycemia,Hypothermia,Myelosuppression,Neuroleptic malignant syndrome (NMS),Priapism,Prolonged QT interval,Tardive dyskinesia,Thrombotic thrombocytopenic purpura (TTP),Sleep apnea syndrome,Urinary retention
Potentially Fatal: Neuroleptic malignant syndrome may occur rarely; seizures. May cause increased mortality in elderly with dementia-related psychosis.
Mechanism of Action
Risperidone is an atypical antipsychotic. Its activity is mediated through a combination of dopamine (D2) and serotonin (5-HT2) receptor antagonism. It also exhibits affinity to adrenergic (alpha1 and alpha2) and histamine (H1) receptors. It is less likely to cause extrapyramidal effects than conventional antipsychotics.
Note
Resdone 2 mg Tablet manufactured by Intas Pharmaceuticals Ltd.. Its generic name is Risperidone. Resdone is availble in Nepal.
Farmaco Nepal drug index information on Resdone Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.