Buy Risperdal Online

Risperidone (risperidone)

BOXED WARNING

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Not approved for the treatment of patients with dementia-related psychosis.

OTHER BRAND NAMES

Risperdal, Risperdal M-Tab

THERAPEUTIC CLASS

Atypical antipsychotic

DEA CLASS

RX

INDICATIONS

Treatment of schizophrenia in adults and adolescents (13-17 yrs of age). Treatment of acute manic or mixed episodes associated with bipolar I disorder as monotherapy in adults and pediatrics (10-17 yrs of age) or as adjunctive therapy with lithium or valproate in adults. Treatment of irritability associated with autistic disorder, (eg, symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) in children and adolescents (5-17 yrs of age).

ADULT DOSAGE

Schizophrenia

May be administered qd or bid
Initial: 2mg/day
Titrate: May increase at intervals of ≥24 hrs, by 1-2mg/day
Target: 4-8mg/day; efficacy demonstrated in a range of 4-16mg/day
Maint: 2-8mg/day
Max: 16mg/day

If experiencing persistent somnolence, may administer 1/2 daily dose bid

Bipolar Mania

Acute Manic or Mixed Episodes Associated w/ Bipolar I Disorder:
Monotherapy:
Initial:
2-3mg/day
Titrate: May increase at intervals of ≥24 hrs, by 1mg/day
Target: 1-6mg/day
Max: 6mg/day

If experiencing persistent somnolence, may administer 1/2 daily dose bid

Also indicated as adjunctive therapy w/ lithium or valproate for the treatment of acute manic or mixed episodes associated w/ bipolar I disorder

PEDIATRIC DOSAGE

Schizophrenia

13-17 Years:
Initial: 0.5mg qd in am or pm
Titrate: May increase at intervals of ≥24 hrs, by 0.5-1mg/day
Target: 3mg/day; efficacy demonstrated in a range of 1-6mg/day
Max: 6mg/day

If experiencing persistent somnolence, may administer 1/2 daily dose bid

Bipolar Mania

Acute Manic or Mixed Episodes Associated w/ Bipolar I Disorder:
Monotherapy:
10-17 Years:

Initial: 0.5mg qd in am or pm
Titrate: May increase at intervals of ≥24 hrs, by 0.5-1mg/day
Target: 1-2.5mg/day; efficacy demonstrated in range of 0.5-6mg
Max: 6mg/day

If experiencing persistent somnolence, may administer 1/2 daily dose bid

Autistic Disorder

Irritability Associated w/ Autistic Disorder (eg, Symptoms of Aggression Towards Others, Deliberate Self-Injuriousness, Temper Tantrums, Quickly Changing Moods):
5-17 Years:
Total daily dose may be administered qd or divided bid
Initial:
<20kg: 0.25mg/day
≥20kg: 0.5mg/day
Titrate: May increase after a minimum of 4 days
Target:
<20kg: 0.5mg/day
≥20kg: 1mg/day
Maintain target dose for a minimum of 14 days. If not achieving sufficient response, may increase at intervals of ≥2 weeks, by 0.25mg/day (<20kg) or 0.5mg/day (≥20kg)
Range: 0.5-3mg/day

Once sufficient response is achieved and maintained, consider gradually lowering the dose
If experiencing persistent somnolence, may give qd dose hs, divide daily dose bid, or reduce dose

DOSING CONSIDERATIONS

Concomitant Medications
Enzyme Inducers (eg, Carbamazepine, Phenytoin, Rifampin): Increase risperidone dose up to double usual dose when coadministered; may need to decrease dose when enzyme inducers are discontinued

Enzyme Inhibitors (eg, Fluoxetine, Paroxetine): Reduce risperidone dose during coadministration; may need to increase dose when enzyme inhibitors are discontinued
Max: 8mg/day of risperidone in adults during coadministration


Renal Impairment
Adults:
Severe (CrCl <30mL/min):

Initial: 0.5mg bid
Titrate: May increase by ≤0.5mg, administered bid. For doses >1.5mg bid, increase in intervals of ≥1 week

Hepatic Impairment
Adults:
10-15 Points on Child-Pugh System:

Initial: 0.5mg bid
Titrate: May increase by ≤0.5mg, administered bid. For doses >1.5mg bid, increase in intervals of ≥1 week

Elderly
Start at lower end of dosing range

Other Important Considerations
Reinitiation of Treatment in Patients Previously Discontinued:
After an interval off risperidone, follow initial titration schedule

ADMINISTRATION

Oral route

May be given w/ or w/o meals

Sol
May be administered directly from calibrated pipette, or may be mixed w/ a beverage prior to administration (not compatible w/ cola or tea)

Tab, Disintegrating
Immediately place the entire tab on the tongue after removing from blister
Swallow w/ or w/o liquid
Do not split or chew

HOW SUPPLIED

Tab, Disintegrating: 0.25mg, (Risperdal M-Tab) 0.5mg, 1mg, 2mg, 3mg, 4mg; (Risperdal) Sol: 1mg/mL [30mL]; Tab: 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg

WARNINGS/PRECAUTIONS

May cause neuroleptic malignant syndrome (NMS); d/c and treat immediately if this occurs. Tardive dyskinesia (TD) may develop; consider discontinuation if signs/symptoms appear. Associated with metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain) that may increase cardiovascular (CV)/cerebrovascular risk. Hyperglycemia and diabetes mellitus (DM), in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, reported; monitor for worsening of glucose control in patients with DM, and perform FPG testing in patients at risk for DM. Somnolence, seizures, and elevation of prolactin levels reported. May induce orthostatic hypotension; consider dose reduction if hypotension occurs. Caution with known CV disease (CVD), cerebrovascular disease, and conditions that predispose to hypotension. Leukopenia, neutropenia, and agranulocytosis reported; monitor CBC in patients with history of clinically significant low WBC counts or drug-induced leukopenia/neutropenia, and consider discontinuation at 1st sign of clinically significant decline in WBC counts without other causative factors. D/C and follow WBC counts until recovery in patients with severe neutropenia (absolute neutrophil count <1000/mm3). May impair mental/physical abilities. Esophageal dysmotility and aspiration reported; caution in patients at risk for aspiration pneumonia. Priapism reported. May disrupt body temperature regulation; caution when prescribing for patients who will be exposed to temperature extremes. Patients with Parkinson's disease or dementia with Lewy bodies may experience increased sensitivity. Caution in elderly. (Tab, Disintegrating) Contains phenylalanine.

ADVERSE REACTIONS

Parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, N/V, upper abdominal pain, stomach discomfort, salivary hypersecretion, increased appetite, fatigue, constipation.

DRUG INTERACTIONS

Adjust dose when used with CYP2D6 inhibitors (eg, fluoxetine, paroxetine) and enzyme inducers (eg, carbamazepine). May increase valproate peak plasma concentrations. Caution with other centrally-acting drugs and alcohol. May enhance hypotensive effects of other therapeutic agents with this potential. May antagonize effects of levodopa and dopamine agonists. Chronic administration of clozapine may decrease clearance.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

Benzisoxazole derivative; not established. In schizophrenia, proposed to be mediated through a combination of dopamine type 2 and serotonin type 2 receptor antagonism.

PHARMACOKINETICS

Absorption: Well-absorbed. Absolute bioavailability (70%); Tmax=1 hr, 3 hrs (9-hydroxyrisperidone, extensive metabolizers), 17 hrs (9-hydroxyrisperidone, poor metabolizers). Distribution: Vd=1-2L/kg; plasma protein binding (90% [risperidone]), (77% [9-hydroxyrisperidone]); found in breast milk. Metabolism: Liver (extensive) via CYP2D6; hydroxylation (major pathway), N-dealkylation (minor pathway); 9-hydroxyrisperidone (major active metabolite). Elimination: Urine (70%), feces (14%); T1/2=3 hrs (extensive metabolizers), 20 hrs (poor metabolizers), 21 hrs (9-hydroxyrisperidone, extensive metabolizers), 30 hrs (9-hydroxyrisperidone, poor metabolizers).

ASSESSMENT

Assess for dementia-related psychosis, DM, risk for hypotension, history of seizures, drug hypersensitivity or any other conditions where treatment is cautioned, hepatic/renal function, pregnancy/nursing status, and possible drug interactions. Obtain FPG in patients at risk for DM.

MONITORING

Monitor for NMS, TD, hyperglycemia, hyperprolactinemia, orthostatic hypotension, leukopenia, neutropenia, agranulocytosis, cognitive/motor impairment, seizures, esophageal dysmotility, aspiration, priapism, disruption of body temperature, metabolic changes, and other adverse reactions. Monitor for worsening of glucose control in patients with DM and FPG in patients at risk for DM. Monitor CBC frequently during the 1st few months of therapy in patients with history of clinically significant low WBC count or drug-induced leukopenia/neutropenia. In patients with clinically significant neutropenia, monitor for fever or other symptoms or signs of infection. Periodically reevaluate long-term risks and benefits of the drug.

PATIENT COUNSELING

Advise about the risk of orthostatic hypotension, especially during the period of initial dose titration. Inform that therapy has the potential to impair judgment, thinking, or motor skills; advise to use caution when operating hazardous machinery. Instruct to notify physician if pregnant/planning to become pregnant, nursing, and if taking/planning to take any prescription or OTC drugs. Advise to avoid alcohol during treatment. Inform that orally disintegrating tab contains phenylalanine. Inform that treatment can be associated with hyperglycemia and DM, dyslipidemia, and weight gain. Inform about risk of TD.

STORAGE

20-25°C (68-77°F). (Risperdal/Risperdal M-Tab) 15-25°C (59-77°F). Sol: Protect from light and freezing. Tab: Protect from light and moisture.

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