ris·per·i·done (r -spâr  -d n )n. A dopamine and serotonin antagonist used to treat the hallucinations, delusions, and thought disturbances of schizophrenia and other psychoses. |
risperidone (risper´
dōn),drug class: antipsychotic;
action: may be related to antagonism for dopamine and serotonin receptors; also has affinity for alpha receptors and histamine (H1) receptors;
use: psychotic disorders.
risperidone
Risperdal, Risperdal Consta, Risperdal M-Tab
Pharmacologic class: Benzisoxazole derivative
Therapeutic class: Antipsychotic
Pregnancy risk category C
FDA Boxed Warning
• Elderly patients with dementia-related psychosis are at increased risk for death. Over course of 10-week controlled trial, death rate in drug-treated patients was about 4.5%, compared to about 2.6% in placebo group. Although causes of death varied, most appeared to be cardiovascular or infectious. Don't give drug to patients with dementia-related psychosis.
Action
Antagonizes serotonin2 and dopamine2 receptors in CNS. Also binds to alpha1- and alpha2-adrenergic receptors and histamine H1 receptors.
Availability
Oral solution: 1 mg/ml in 30-ml bottles
Powder for injection (extended release): 25-mg, 37.5-mg, 50-mg vials in dose pack with diluent in prefilled syringes
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg
Tablets (orally disintegrating): 0.5 mg, 1 mg, 2 mg
⊘Indications and dosages
➣ Schizophrenia
Adults: 1 mg P.O. b.i.d., increased by 1 mg b.i.d. as tolerated on days 2 and 3, up to a target dosage of 3 mg b.i.d. by day 3. May adjust in increments or decrements of 1 mg b.i.d. at weekly intervals; usual dosage range is 4 to 8 mg/day. Alternatively, may give as a single daily dose after initial titration. Or 25 mg deep I.M. q 2 weeks. Maximum dosage is 50 mg q 2 weeks.
Adolescents ages 13 to17: 0.5 mg P.O. as single daily dose in morning or evening. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours, in increments of 0.5 or 1 mg/day, as tolerated, to recommended dosage of 3 mg/day.
➣ Bipolar mania
Adults: Initially, 2 to 3 mg/day P.O. May adjust in increments or decrements of 1 mg/day at 24-hour intervals. Range is 1 to 6 mg/day.
Children: 0.5 mg P.O. as single daily dose in morning or evening. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours, in increments of 0.5 or 1 mg/day, as tolerated, to recommended dosage of 2.5 mg/day.
➣ Irritability symptoms of aggression toward others, deliberate self-injury, and temper tantrums associated with autistic disorder
Adolescents and children: Initially, 0.25 mg P.O. (Risperdal) daily for patients weighing less than 20 kg (44 lb) and 0.5 mg/day for patients weighing 20 kg or more. After minimum of 4 days, increase as needed to recommended dosage of 0.5 mg/day for patients weighing less than 20 kg and 1 mg/day for patients weighing 20 kg or more. Maintain this dosage for minimum of 14 days. If sufficient clinical response not achieved, consider dosage increases at 2-week or more intervals in increments of 0.25 mg/day for patients weighing less than 20 kg or 0.5 mg/day for patients weighing 20 kg or more. Once sufficient clinical response has been achieved and maintained, consider gradually lowering dosage to achieve optimal balance of efficacy and safety.
Dosage adjustment
• Hepatic or renal impairment
• Elderly or debilitated patients
Off-label uses
• Tourette syndrome
Contraindications
• Hypersensitivity to drug
Precautions
Use cautiously in:
• renal or hepatic impairment, cardiovascular disease, prolonged QT interval, dysphagia, hyperprolactinemia, hypothermia or hyperthermia, Parkinson's disease, phenylketonuria, tardive dyskinesia, previous diagnosis of breast cancer or prolactin-dependent tumors
• history of seizures, drug abuse, or suicide attempt
• elderly or debilitated patients
• pregnant patients
• breastfeeding patients (use not recommended)
• children (safety not established for Risperdal Consta, Risperdal M-Tab, and Risperdal in children weighing less than 33 lb [15 kg]).
Administration
☞ Do not give powder for injection I.V.
• When reconstituting powder for injection, use only the diluent and needle supplied.
• Shake vial vigorously for a minimum of 10 seconds to ensure homogeneous suspension. When properly mixed, the suspension appears uniform, thick, and milky with visible particles.
• If 2 minutes elapse before giving injection, shake vial vigorously before administering. Give injection within 6 hours of reconstitution.
• Record baseline blood pressure before starting therapy.
• For I.M. use, inject deep into buttock; rotate injection sites between buttocks.
• Be aware that children and adolescents experiencing persistent somnolence may benefit from once-daily Risperdal dose administered at bedtime, from administering half daily dose twice daily, or from reduction of dose.
| Route | Onset | Peak | Duration |
| Oral | 1-2 wk | Unknown | Up to 6 wk |
| I.M. | Unknown | Unknown | Unknown |
Adverse reactions
CNS: aggressive behavior, dizziness, drowsiness, extrapyramidal reactions, headache, increased dreams, longer sleep periods, insomnia, sedation, fatigue, nervousness, agitation, anxiety, tardive dyskinesia, hyperkinesia, akathisia, transient ischemic attack (TIA), cerebrovascular accident (CVA), neuroleptic malignant syndrome
CV: orthostatic hypotension, chest pain, tachycardia, arrhythmias
EENT: vision disturbances, rhinitis, sinusitis, pharyngitis
GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, dry mouth, increased salivation, anorexia
GU: difficulty urinating, polyuria, galactorrhea, dysmenorrhea, menorrhagia, decreased libido
Musculoskeletal: joint or back pain
Respiratory: cough, dyspnea, upper respiratory tract infection
Skin: pruritus, diaphoresis, rash, dry skin, seborrhea, increased pigmentation, photosensitivity
Other: toothache, fever, impaired temperature regulation, weight changes
Interactions
Drug-drug. Antihistamines, opioids, sedative-hypnotics: additive CNS depression
Carbamazepine: increased metabolism and decreased efficacy of risperidone
Clozapine: decreased metabolism and increased effects of risperidone
Levodopa, other dopamine agonists: decreased antiparkinsonian effects of these drugs
Drug-behaviors. Alcohol use: increased CNS depression
Sun exposure: increased risk of photosensitivity
Patient monitoring
☞ Closely monitor neurologic status, especially for neuroleptic malignant syndrome (high fever, sweating, unstable blood pressure, stupor, muscle rigidity, and autonomic dysfunction), extrapyramidal reactions, TIA, CVA, and tardive dyskinesia.
• Monitor blood pressure, particularly for orthostatic hypotension.
• Assess body temperature. Check for fever and other signs and symptoms of infection.
Patient teaching
• Instruct patient to remove orally disintegrating tablet from blister pack, place on tongue immediately, and swallow as tablet dissolves.
• Tell patient to mix oral solution with water, coffee, orange juice, or low-fat milk. Tell him solution isn't compatible with cola or tea.
• Advise patient to use effective bedtime routine to avoid sleep disorders.
☞ Teach patient to recognize and immediately report signs and symptoms of serious adverse reactions, including tardive dyskinesia and neuroleptic malignant syndrome.
• Instruct patient to move slowly when sitting up or standing, to avoid dizziness from sudden blood pressure decrease.
• Tell patient that excessive fluid loss (as from sweating, vomiting, or diarrhea) and inadequate fluid intake increase risk of light-headedness (especially in hot weather).
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Advise female patient to tell prescriber if she is or plans to become pregnant. Caution her not to breastfeed during therapy.
• Advise patient not to drink alcohol.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.
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