Olandus/Olandus ODT

Olanzapine

Olandus 5 Management of schizophrenia. Treatment of moderate to severe mania associated w/ bipolar disorder. Olandus 10 Management of manifestations of psychotic disorder eg, schizophrenia & short-term treatment of acute manic episodes associated w/ bipolar disorder. Olandus ODT 5/Olandus ODT 10 Schizophrenia. Moderate to severe mania associated w/ bipolar disorder. Olandus ODT 15 Short-term treatment of acute manic episodes associated w/ bipolar disorder. Schizophrenia. Prevention of recurrence in patients w/ bipolar disorder.

Olandus 5 tab Adult >18 yr Schizophrenia combination w/ mania, preventing recurrence in bipolar disorder 10 mg daily adjusted to 5-20 mg daily, doses >10 mg daily adjusted to 5-20 mg daily; doses >10 mg daily only after re-assessment. Max: 30 mg daily. Monotherapy for mania 15 mg daily adjusted to 5-20 mg daily, doses >15 mg only after re-assessment. Max: 20 mg daily. Olandus ODT 5/Olandus ODT 10 Adult Schizophrenia Initially 5-10 mg once daily, max: 20 mg/day. Debilitated patient to hypotensive reactions, non-smoking female ≥65 yr 5 mg. Bipolar I disorder (manic or mixed episodes) Initially 10 or 15 mg once a day. Dose increments/decrements of 5 mg once a day is recommended. Maintenance: 5-20 mg/day. Adjunctive treatment to lithium or valproate Initially 10 mg once a day. Adolescent Initially 2.5 or 5 mg once a day, target dose: 10 mg/day. Schizophrenia 2.5-20 mg/day, mean modal dose: 12.5 mg/day. Dose increments/decrements of 2.5 or 5 mg are recommended. Bipolar I disorder (manic or mixed episodes) Initially 2.5 or 5 mg once a day, target dose: 10 mg/day; flexible dose range: 2.5-20 mg/day, mean modal dose: 10.7 mg/day. Dose increments/decrements of 2.5 or 5 mg are recommended. Olandus 10 tab Initially 10 mg daily as a single dose. Adjust dose by 5 mg daily at intervals of not <1 wk to w/in the range of 5-20 mg daily. Doses ≥15 mg daily should be given only after clinical re-assessment. Olandus ODT 15 OD tab Schizophrenia & related disorders 5-10 mg/day as a single daily dose. May be adjusted to 5-20 mg daily. May increase dose >10 mg/day only after appropriate clinical re-assessment. Acute mania associated w/ bipolar disorder 10 or 15 mg once daily as monotherapy or 10 mg once daily in combination therapy w/ lithium or valproate. Dose increments/decrement of 5 mg daily at interval of not <24 hr. Dose range: 5-20 mg/day. Max: 20 mg. Preventing recurrence in bipolar disorder 10 mg once daily. May be adjusted to 5-20 mg/day. Elderly, hepatic &/or renal impairment Starting dose: 5 mg/day.

May be taken with or without food: ODT 5/ODT 10 Tab: Place in the mouth & allow to dissolve completely; it can then be swallowed w/ or w/o liqd. ODT 15 Tab: Place in the mouth & allow to dissolve completely then, swallow w/ saliva & follow w/ a glass of water. Alternatively, disperse in a full glass of water immediately prior administration.

Olandus 5 Hypersensitivity. Pregnancy & lactation. Olandus 10 Lactation. Olandus ODT 5/Olandus ODT 10/Olandus ODT 15 Hypersensitivity.

Olandus 5/Olandus 10 Neuroleptic malignant syndrome & tardive dyskinesia may develop. History of seizures or w/ conditions that potentially lowers seizure threshold eg, Alzheimer's dementia; hepatic impairment, preexisting conditions associated w/ limited hepatic functional reserve, treatment w/ potentially hepatotoxic drugs. May induce orthostatic hypotension associated w/ dizziness, tachycardia, syncope especially during initial dose-titration period. Known CV (history of MI or ischemia, heart failure or conduction abnormalities) & cerebrovascular disease & conditions predisposing to hypotension (dehydration, hypovolemia & treatment w/ antihypertensives), experiencing conditions that may elevate or contribute to core body temp elevation eg, strenuous exercise, extreme heat exposure, concomitant use w/ anticholinergic activity or being subject to dehydration; at risk for aspiration pneumonia; significant prostatic hypertrophy, narrow-angle glaucoma, or history of paralytic ileus. Periodic assessment of transaminases in patients w/ hepatic disease. May be associated to esophageal dysmotility & aspiration. May impair ability to drive or operate machinery. Childn. Olandus 10 Pregnancy. Olandus ODT 5/Olandus ODT 10 Suicide attempt. Neuroleptic malignant syndrome. Regular monitoring of blood glucose level in diabetic patients. Hyperlipidemia. Regular monitoring of wt. Irreversible, involuntary dyskinetic movements may develop. Orthostatic hypotension. Dysphagia in patients w/ Alzheimer's disease. History of seizures. Body temperature regulation. Hyperprolactinemia may lead to decreased bone density. May affect ability to drive & operate machinery. Pregnancy & lactation. Childn <13 yr. Elderly w/ dementia-related psychosis & stroke, transient ischemic attack. Olandus ODT 15 Hyperglycemia & DM, lipid alteration, wt gain. Patients w/ low leukocyte &/or neutrophil counts for any reason, history of drug-induced bone marrow depression/toxicity, bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy & hypereosinophilic conditions or myeloproliferative disease. Possibility of suicide attempt; not for dementia-related psychosis &/or behavioral disturbances; Parkinson's disease. Pregnancy & lactation. Elderly.

Somnolence, wt gain. Olandus 5 Extrapyramidal symptoms including tardive dyskinesia; hyperprolactinemia (usually asymptomatic); increased appetite, peripheral edema, (rare) elevated creatine kinase conc. Olandus 10 Orthostatic hypotension. Olandus ODT 5/Olandus ODT 10 Drowsiness, dizziness, restlessness, unusual behavior, depression, difficulty falling asleep or staying asleep, weakness, difficulty walking, constipation, dry mouth, pain in arms, legs, back or joints, breast enlargement or discharge, late or missed menstrual periods, decreased sexual ability. Olandus ODT 15 Asthenia, fatigue; orthostatic hypotension; constipation, dry mouth, increased appetite; peripheral edema; eosinophilia.

May potentially induce hypotension w/ other centrally acting drugs & alcohol; enhance effects of certain antihypertensive agents. May antagonize the effects of levodopa & dopamine agonists. Metabolism may be mediated to some extent by CYP450 isozyme CYP1A2; concomitant use w/ drugs which inhibit or act as substrate to isozyme may affect plasma conc. May increase clearance by tobacco smoking. Olandus ODT 5/Olandus ODT 10 Potentiated orthostatic hypotension w/ diazepam & alcohol. Increased clearance w/ carbamazepine. Decreased clearance w/ fluvoxamine & fluoxetine. Increased conc w/ fluoxetine, omeprazole & rifampin. Reduced C_max & AUC w/ charcoal. May enhance effects of other antihypertensives. May antagonize effects of L-dopa & dopamine agonists. Olandus ODT 15 Concomitant use w/ medicine known to cause electrolyte imbalance or to increase QT interval. May induce metabolism by smoking or carbamazepine therapy. May decrease clearance w/ fluvoxamine or any other P450-1A2 inhibitor eg, ciprofloxacin.

Antipsychotics

N05AH03 - olanzapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics

Rx