Renuvie

Renuvie

risperidone

Manufacturer:

Medichem

Distributor:

United Lab
Concise Prescribing Info
Contents
Risperidone
Indications/Uses
Schizophrenia in childn 13-17 yr (acute & maintenance treatment in adult). Short-term treatment of acute manic or mixed episodes associated bipolar I disorder (monotherapy in childn & adolescent 10-17 yr; in combination w/ lithium or valproate in adult). Moderate to severe manic episodes associated w/ bipolar disorders in adult. Short-term symptomatic treatment (up to 6 wk) of conduct & other disruptive behavior disorders in childn >5 yr, adolescent & adult w/ subaverage intellectual functioning or mental retardation or average IQ. Irritability associated w/ autistic disorder in child & adolescent 5-16 yr.
Dosage/Direction for Use
Schizophrenia Adult Initial dose: 2 mg once daily or in 2 divided doses. Increase dose at intervals not <24 hr in increments of 1-2 mg/day to recommended dose of 4-8 mg/day. Adolescent 13-17 yr Initial dose: 0.5 mg once daily, either in the morning or evening. Adjust dose at intervals not <24 hr in increments of 0.5-1 mg/day to recommended dose of 3 mg/day. Bipolar Mania Adult Initial dose: 2-3 mg once daily. Increase dose at intervals not <24 hr in increments/decrements of 1 mg/day to recommended dose of 1-6 mg/day. Childn & adolescent 10-17 yr Initial dose: 0.5 mg once daily, either in the morning or evening. Adjust dose at intervals not <24 hr in increments of 0.5-1 mg/day to recommended dose of 2.5 mg/day. Conduct & other disruptive behavior disorders Childn & adolescent 5-18 yr <50 kg Initially 0.25 mg once daily, optimum dose of 0.5 mg once daily; ≥50 kg Initially 0.5 mg once daily, optimum dose of 1 mg once daily. Autism Individualized dosing. Childn & adolescent 5-16 yr <20 kg 0.25 mg/day; ≥20 kg 0.5 mg/day. May increase dose after min of 4 days to recommended dose of 0.5 mg/day in <20 kg & 1 mg/day in ≥20 kg, maintain for a min of 14 days. Consider dose increase at ≥2-wk intervals in increments of 0.25 mg/day in <20 kg or 0.5 mg/day in ≥20 kg. Elderly or debilitated patient, patient w/ severe renal or hepatic impairment & patient either predisposed to hypotension Initially 0.5 mg bid, may increase in increments of not >0.5 mg bid. Increase dosage of >1.5 mg bid should occur at intervals of at least 1 wk.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Neuroleptic malignant syndrome; tardive dyskinesia; history of seizures or other conditions that potentially lower the seizure threshold. Potential for cognitive & motor impairment; possible suicide attempt. Patients w/ CV disease (eg, heart failure, MI or ischemia, conduction abnormalities, dehydration, hypovolemia or cerebrovascular disease); hyperglycemia & DM; preexisting hyperprolactinemia & possible prolactin-dependent tumors; patients at risk for aspiration pneumonia; history of cardiac arrhythmia & congenital long QT syndrome; Parkinson's disease or dementia w/ Lewy bodies. Determine possible risk factors for venous thromboembolism before & during treatment. Monitor wt gain. May cause priapism; thrombotic thrombocytopenic purpura. Preexisting/history of low WBC & history of drug-induced leukopenia/neutropenia; discontinue use in severe neutropenia (ANC <1,000/mm3). May mask signs & symptoms of intestinal obstruction, Reye's syndrome & brain tumor; disruption of body temp regulation eg, hyperthermia or hypothermia. Severe renal & hepatic impairment. Pregnancy. Not to be used during lactation. Childn <13 yr w/ schizophrenia; <10 yr w/ bipolar disorder; <5 yr w/ autistic disorder. Elderly w/ dementia-related psychosis.
Adverse Reactions
Fatigue, asthenia, pyrexia, abnormal feeling, pain, infection, fall, increased body temp, flu, viral infection, malaise, face edema, discomfort, chills, peripheral coldness; tachycardia, chest pain, increased heart rate, syncope, orthostatic hypotension, hypotension, palpitations, HTN, transient ischemic attack, peripheral edema, pitting edema, chest discomfort, sinus bradycardia, sinus tachycardia, AV block 1st degree, Bundle branch block left/right, flushing, ECG abnormal, QT prolongation, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia), cardiac arrest, Torsade de Pointes, atrial fibrillation; vomiting, nausea, constipation, drooling, dry mouth, abdominal pain, upper abdominal pain, dyspepsia, abdominal discomfort, salivary hypersecretion, diarrhea, stomach discomfort, toothache, tongue spasm, gastroenteritis, dysphagia, fecaloma, fecal incontinence, gastritis, lip swelling, cheilitis, aptyalism, thirst, intestinal obstruction, pancreatitis; anemia, granulocytopenia, increased eosinophil count, decreased WBC count, decreased Hb, decreased hematocrit, neutropenia, agranulocytosis, thrombocytopenia; increases in: alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase; jaundice; increased/decreased appetite, polydipsia, anorexia, diabetic coma, hyperglycemia, glucose urine present, diabetic ketoacidosis, DM, hypoglycemia, water intoxication; increases in: wt, blood glucose, blood creatine phosphokinase, blood prolactin; ejaculation failure, ejaculation disorder, ejaculation delayed, decreased libido, anorgasmia, erectile dysfunction, sexual dysfunction, retrograde ejaculation, priapism, inappropriate antidiuretic hormone secretion; back pain, arthralgia, pain in extremity, joint stiffness, buttock pain, abnormal posture, joint swelling, myalgia, neck pain, musculoskeletal chest pain, joint stiffness, muscular weakness, rhabdomyolysis; somnolence, insomnia, sedation, parkinsonism, akathisia, dizziness, postural dizziness, dyskinesia, anxiety, headache, tremor, dystonia, nervousness, lethargy, convulsion, paresthesia, depression, confusional state, depressed level consciousness, cerebrovascular accident, gait disturbance, listless, dysarthria, disturbance in attention, balance disorder, hypersomnia, sluggishness, agitation, blunted affect, sleep disorder, sleep apnea syndrome, unresponsive to stimuli, abnormal coordination, loss of consciousness, speech disorder, hypoesthesia, movement disorder, tardive dyskinesia, cerebral ischemia, NMS, vertigo, mania; cough, productive cough, nasopharyngitis, rhinorrhea, nasal congestion, rhinitis, upper/lower resp tract infection, sinusitis, dyspnea, epistaxis, pharyngolaryngeal pain, sinus congestion, pneumonia, pulmonary congestion, pharyngitis, tonsillitis, bronchitis, bronchopneumonia, tracheobronchitis, wheezing, pneumonia aspiration, dysphonia, resp tract congestion, rales, resp disorder, nasal edema, hyperventilation; rash (erythematous, papular, generalized, maculopapular), hypersensitivity, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, acne, subcutaneous abscess, eczema, cellulitis, erythema, pruritus, localized infection, onychomycosis, acarodermatitis, skin discoloration, skin lesion, skin disorder, anaphylactic reaction, angioedema, alopecia; ear pain, ear infection, otitis media, chronic otitis media, tinnitus, eye infection, blurred vision, blepharospasm, ocular hyperemia, eye discharge, eye rolling, eyelid edema, eye swelling, eyelid margin crusting, dry eye, increased lacrimation, photophobia, glaucoma, reduced visual acuity, conjunctivitis; UTI, urinary incontinence, urinary retention, galactorrhea, enuresis, pollakiura, cystitis, dysuria, irregular menstruation, menstrual disorder, delayed menstruation, amenorrhea, gynecomastia, vag discharge, breast enlargement, breast discomfort, oligomenorrhea.
Drug Interactions
May lead to additive antipsychotic fraction exposure w/ paliperidone. Higher incidence of mortality w/ thiazide diuretics eg, furosemide. Increased risk of sedation w/ centrally-acting drugs (eg, opiates, antihistamines, benzodiazepine) & alcohol. May enhance effects of drugs w/ BP lowering effects. May antagonize effects of levodopa & dopamine agonists. Increased bioavailability w/ cimetidine & ranitidine. Increased plasma conc w/ fluoxetine & paroxetine; CYP3A4 inhibitor (eg, verapamil); phenothiazines, TCAs & some β-blockers. Decreased plasma conc w/ carbamazepine. Decreased efficacy w/ phenytoin, rifampicin & phenobarb. Decreased clearance w/ clozapine. Modestly reduced bioavailability w/ topiramate. May increase peak plasma conc of valproate.
MIMS Class
Antipsychotics
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Renuvie FC tab 1 mg
Packing/Price
30's (P1,650/box, P55/film-coated tab)
Form
Renuvie FC tab 2 mg
Packing/Price
30's (P110/film-coated tab, P3,300/box)
Form
Renuvie FC tab 4 mg
Packing/Price
30's (P210/film-coated tab)
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