Rizem 2 ODT

Rizem 2 ODT

risperidone

Manufacturer:

Jubilant Generics

Distributor:

Emcure Pharma
Concise Prescribing Info
Contents
Risperidone
Indications/Uses
Schizophrenia; moderate to severe manic episodes associated w/ bipolar disorders. Short-term treatment (up to 6 wk) of persistent aggression in patients w/ moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches & when there is risk of harm to self or others. Short-term symptomatic treatment (up to 6 wk) of persistent aggression in conduct disorder in childn from 5 yr & adolescents w/ subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom severity of aggressive or other disruptive behaviors require pharmacologic treatment.
Dosage/Direction for Use
Schizophrenia Adult Initially 2 mg daily, may be increased to 4 mg on the 2nd day & subsequently be maintained unchanged or further individualized if needed. Elderly Initially 0.5 mg bid, can be individually adjusted w/ 0.5 mg bid increment to 1-2 mg bid. Manic episode in bipolar disorder Adult Initially 2 mg once daily. Adjust dose at interval of not <24 hr & in increment of 1 mg daily. Elderly Initially 0.5 mg bid, can be individually adjusted w/ 0.5 mg bid increment to 1-2 mg bid. Persistent aggression in moderate to severe Alzheimer's dementia Initially 0.25 mg bid, can be individually adjusted w/ 0.25 mg bid increment not more frequently than every other day if needed. Max: Not to be used >6 wk. Conduct disorder Childn & adolescent 5-18 yr & 50 kg Initially 0.5 mg once daily, can be individually adjusted w/ 0.5 mg once daily increment not more frequently than every other day if needed, <50 kg Initially 0.25 mg once daily, can be individually adjusted w/ 0.25 mg once daily increment not more frequently than every other day if needed.
Administration
May be taken with or without food: Immediately place tab on the tongue once blister has been opened and allow to disintegrate before swallowing w/ or w/o water.
Special Precautions
Discontinue use in the event of neuroleptic malignant syndrome. Consider discontinuing use if signs & symptoms of tardive dyskinesia appear. Not to be used to treat patients w/ other types of dementias than Alzheimer's. Patients w/ risk factors for stroke; known CV disease (eg, heart failure, MI, conduction abnormalities, dehydration, hypovolemia or cerebrovascular disease); Parkinson's disease or dementia w/ Lewy bodies; preexisting hyperprolactinemia & w/ possible prolactin-dependent tumors; history of seizures or other conditions potentially lowering the seizure threshold. Monitor for symptoms of hyperglycemia (eg, polydipsia, polyuria, polyphagia & weakness). Regularly monitor for worsening of glucose control in patients w/ DM; wt. Concomitant use w/ furosemide or co-treatment w/ other potent diuretics; antihypertensive treatment; medicines prolonging the QT interval. Renal & hepatic impairment. Not to be used during pregnancy. Lactation. Not recommended in childn <18 yr w/ schizophrenia; childn <5 yr w/ conduct disorder. Increased mortality in elderly w/ dementia.
Adverse Reactions
Parkinsonism, headache; insomnia. Increased blood prolactin & wt; tachycardia; akathisia, dizziness, tremor, dystonia, somnolence, sedation, lethargy, dyskinesia; blurred vision; dyspnea, epistaxis, cough, nasal congestion, pharyngolaryngeal pain; vomiting, diarrhea, constipation, nausea, abdominal pain, dyspepsia, dry mouth, stomach discomfort; enuresis; rash, erythema; arthralgia, back pain, pain in extremity; increased/decreased appetite; pneumonia, flu, bronchitis, URTI, UTI; pyrexia, fatigue, peripheral edema, asthenia, chest pain; anxiety, agitation, sleep disorder.
Drug Interactions
Caution w/ medicinal products prolonging QT interval eg, class la (eg, quinidine, disopiramide, procainamide) & III antiarrhythmics (eg, amiodarone, sotalol), TCA (ie, amitriptyline), tetracyclic antidepressants (ie, maprotiline), some antihistaminics, other antipsychotics, some antimalarials (ie, chinice & mefloquine), & medicines causing electrolyte imbalance (hypokalemia, hypomagnesemia), bradycardia, or those inhibiting hepatic metabolism of risperidone. Increased risk of sedation w/ other centrally-acting substances including alcohol, opiates, antihistamines & benzodiazepines. May antagonize effect of levodopa & other dopamine agonists. Clinically significant hypotension w/ antihypertensive treatment. Decreased plasma conc of the active antipsychotic fraction of risperidone w/ carbamazepine & potentially w/ rifampicin, phenytoin & phenobarb. Increased plasma conc w/ fluoxetine & paroxetine & potentially w/ other CYP 2D6 inhibitors eg, quinidine; verapamil. Plasma conc may be increased w/ phenothiazines, TCAs & some β-blockers. Increased bioavailability w/ cimetidine & ranitidine. May lead to additive active antipsychotic fraction exposure w/ paliperidone.
MIMS Class
Antipsychotics
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Rizem 2 ODT orally disintegrating tab 2 mg
Packing/Price
28's
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