Risperidone
Tranquilizer, Sedative/Hypnotic · Benzisoxazole derivative
Indications
Acute and chronic schizophrenia, other psychosis, affective symptoms of schizophrenia.
Dosage
Adults: ORAL: Antipsychotics: Schizophrenia: Over 15 yr, day one, 1 mg twice daily; day two, 2 mg twice daily; day three 3 mg twice daily. Max 8 mg twice daily. Elderly: Initially 0.5 mg twice daily increasing in 0.5 mg increments to 1-2 mg twice daily. Bipolar Disorder: Acute Manic & Mixed Episodes: Monotherapy or adjunct therapy with lithium or valproate: Initial: 2-3 mg daily. Titrate: Increase by 1 mg daily. Max 6 mg/day. Adults: INJECTION: By deep IM injection into the deltoid or gluteal muscle, Patients taking oral risperidone up to 4 mg daily, initially 25 mg IM every 2 wk; Patients taking oral risperidone over 4 mg daily, initially 37.5 mg IM every 2 wk; dose adjusted at intervals of at least 4 wk in steps of 12.5 mg to max 50 mg IM every 2 wk. Children: ORAL: Short-term treatment (up to 6 wk) of persistent aggression in conduct disorder: 5-18 yr and body-weight under 50 kg,…
Administration
Administered by IM into the upper outer quadrant of the gluteal area. Injection should alternate between the two buttocks. Reconstitute with provided diluent only. Do not combine two different dosage strengths into one single administration. It should be administered every 2 weeks by deep IM deltoid or gluteal injection. Each injection should be administered by an expert using an enclosed safety needle. For deltoid administration, use the 1-inch needle, alternating injection between the 2 arms. For gluteal administration, use the 2-inch needle, alternating between the 2 buttocks. Do not administer IV. Stability: After reconstitution, store at room temperature and use within 6 hours.
Adverse Effects
Orthostatic hypotension, reflex tachycardia, extra-pyramidal symptoms. Galactorrhoea, menstrual disturbance. Sexual dysfunction, insomnia, anxiety, agitation, headache, fatigue, dizziness, impaired concentration, weight gain gastrointestinal disturbance, rhinitis, rash, blurred vision, depression, somnolence, RTI, ear infection, dyspnoea, epistaxis, cough, nasal congestion, pharyngolaryngeal pain, GI upset, dry mouth, toothache, priapism, urinary incontinence, UTI, BP change, tachycardia, AV block, amenorrhoea, gynaecomastia, skin reactions, altered LFTs, hyperglycaemia, hyperprolactinaemia, anaemia, conjunctivitis, asthenia, fatigue, muscle spasm, musculoskeletal pain, pain in extremities, pyrexia, oedema. chest pain, flu-like illness. Rarely, neuroleptic malignant syndrome, water intoxication with hyponatraemia, seizures, tardive dyskinesia, intraoperative floppy iris syndrome.
Risk Factor (Pregnancy/Lactation)
Pregnancy: Risk cannot be ruled out. Lactation: Contraindicated or not recommended. Precautions: Elderly. Renal, hepatic, cardiovascular disease. Epilepsy. Parkinsonism, dementia, hyperprolactinaemia, diabetes, bradycardia, hypokalaemia, hypomagnesaemia, family history of QT prolongation. Driving/operating machinery. Monitor for signs of tardive dyskinesia, withdraw if these occur. Monitor for hyperglycaemia and wt gain. Risk factors for stroke or VTE. Monitor patients with history of low WBC count or drug-induced leucopenia/neutropenia. Monitor endocrinological status, sedative effects and for the development of extrapyramidal symptoms and other movement disorders in children. Withdraw gradually.
Interactions
Centrally acting drugs, levodopa, dopamine agonists, drugs that prolong QT interval, alcohol, antihistamines, benzodiazepines, antihypertensives, paliperidone, psychostimulants, paroxetine, fluoxetine and other CYP2D6 inhibitors. Itraconazole, ketoconazole, verapamil, other CYP3A4 and/or P-gp inhibitors and inducers. Carbamazepine, rifampicin, furosemide, anticholinergics.
Advice to Patient
Take with or without meals. Place orodispersible tablet on the tongue and swallow with or without water after it has disintegrated within seconds. Solution may be diluted with water, milk or orange juice. Do not dilute with tea or cola. Contact prescriber if there is difficulty in breathing, severe dizziness, skin rash, yellowing of skin, trembling in fingers, change in gait, unusual muscle or skeletal movements, seizures, increased sleepiness, anxiety, confusion, abnormal thoughts, change in personality, change in menstrual pattern, change in vision, sexual dysfunction, fast heartbeat, chest pain, palpitations, swelling or pain in breasts of both male and female, pain or difficulty on urination. Empty bladder before taking medication. Avoid grapefruit juice, alcohol and caffeine during therapy. Take sufficient amount of fluids (2-3 litres per day) to maintain hydration, unless…
Pharmacokinetics
Following oral administration, the pharmacokinetics of risperidone 9-hydroxyrisperidone in children were found to be similar to values in adults (after adjusting for differences in body weight). Absorption: Oral: Rapid and well absorbed; food does not affect rate or extent. Injection: <1% absorbed initially; main release occurs at approx. 3 weeks and is maintained from 4 to 6 weeks; release ends by 7 weeks. Metabolism: Extensively hepatic. Bioavailability: Oral: 70%; Tablet (relative to solution): 94%; orally-disintegrating tablets and oral solution are bioequivalent to tablet. Injection: Deltoid 1M injection is bioequivalent gluteal IM injection. Half-life elimination: Active moiety (risperidone and its active metabolite 9-hydroxyrisperidone): Oral: 20 hours (mean); prolonged in elderly patients Extensive metabolizers: Risperidone: 3 hours; 9-hydroxyrisperidone: 30 hours. Poor…
Brands with this active ingredient
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