Salveo ODT

Acute & maintenance treatment of schizophrenia & related psychoses in adults & adolescents 13-17 yr. Monotherapy for the acute & maintenance treatment of manic or mixed episodes associated w/ bipolar I disorder in adults & adolescents 13-17 yr. Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated w/ bipolar I disorder in adults. Prevention of recurrence of manic, mixed or depressive episodes in bipolar I disorder. In combination w/ fluoxetine for acute treatment of depressive episodes associated w/ bipolar I disorder in adults & childn 10-17 yr & for acute treatment of treatment-resistant depression in adults.

Schizophrenia Adult ≥18 yr Initially 5-10 mg/day, w/ a target dose of 10 mg/day w/in several days. Dose adjustments if necessary should occur at intervals of not <1 wk in increments/decrements of 5 mg/day. Not indicated in doses >20 mg/day. Maintenance: 10-20 mg/day in patient stabilized for approx 8 wk & followed for relapse for up to 8 mth. Adolescent 13-17 yr Initially 2.5 or 5 mg, w/ a target dose of 10 mg/day. Dose adjustments if necessary are recommended in increments/decrements of 2.5 or 5 mg. Safety & efficacy of doses >20 mg/day have not been evaluated. Patient who is debilitated, w/ predisposition to hypotensive reactions, w/ hepatic impairment, who exhibits a combination of factors that may slow metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, non-smoking status), or who may be pharmacodynamically sensitive to olanzapine Initially 5 mg (as monotherapy) or 2.5-5 mg (in combination w/ fluoxetine 20 mg). Bipolar I disorder (manic or mixed episode) Adult ≥18 yr Monotherapy: Initially 10 or 15 mg/day. Dose adjustments if necessary should occur at intervals of not <24 hr in increments/decrements of 5 mg/day. Maintenance: 5-20 mg/day after achieving responder status for ave duration of 2 wk. Adjunctive treatment to lithium or valproate: Initially 10 mg/day. Maintenance: 5-20 mg/day. Safety of doses >20 mg/day have not been evaluated. Adolescent 13-17 yr Initially 2.5 or 5 mg/day, w/ a target dose of 10 mg/day. Dose adjustments if necessary are recommended in increments/decrements of 2.5 or 5 mg. Safety & efficacy of doses >20 mg/day have not been evaluated. Prevention of recurrence in bipolar I disorder Adult ≥18 yr & those already in remission Initially 10 mg/day. Subsequent daily dose adjustments should be based on clinical status w/in range of 5-20 mg/day. An increase to a dose greater than the starting dose is advised only after appropriate clinical assessment & should occur at intervals of not <24 hr. Depressive episode associated w/ bipolar I disorder Adult ≥18 yr Initially olanzapine 5 mg & fluoxetine 20 mg once daily in the evening. Dose adjustments if necessary can be made based on efficacy & tolerability w/in range of olanzapine 5-12.5 mg & fluoxetine 20-50 mg. Safety of doses above olanzapine 18 mg w/ fluoxetine 75 mg has not been evaluated. Childn & adolescent 10-17 yr Initially olanzapine 2.5 mg & fluoxetine 20 mg once daily in the evening. Safety of doses above olanzapine 12 mg w/ fluoxetine 50 mg has not been evaluated. Treatment-resistant depression Adult ≥18 yr Initially olanzapine 5 mg & fluoxetine 20 mg once daily in the evening. Dose adjustments if necessary can be made based on efficacy & tolerability w/in range of olanzapine 5-20 mg & fluoxetine 20-50 mg. Safety of doses above olanzapine 18 mg w/ fluoxetine 75 mg has not been evaluated. All indications Elderly ≥65 yr, & patient w/ moderate hepatic insufficiency (eg, cirrhosis, Child-Pugh class A or B) Initially 5 mg/day.

May be taken with or without food: Place in the mouth where it will be rapidly dispersed in saliva & can be easily swallowed. Alternatively, disperse in a full glass of water or other beverages (orange juice/apple juice/milk/coffee) immediately before administration.

Hypersensitivity. Patients w/ known risk of narrow-angle glaucoma.

Monotherapy is not indicated for treatment of depressive episodes associated w/ bipolar I disorder & treatment of treatment-resistant depression. Not approved for treatment of patients w/ dementia-related psychosis; patients w/ Alzheimer's disease. Not recommended in treatment of psychosis associated w/ Parkinson's disease. Discontinue treatment if unexplained high fever occurred in patients taking antipsychotics w/o additional clinical manifestations of NMS; hepatitis (including hepatocellular, cholestatic or mixed liver injury); DRESS. Regularly monitor wt. Perform complete fall risk assessments during initiation of treatment & regularly for patients on long-term therapy. Caution in patients experiencing conditions that may contribute to an elevation in core body temp (eg, exercising strenuously, exposure to extreme heat, receiving concomitant medication w/ anticholinergic activity, or being subject to dehydration); w/ history of seizures or w/ conditions that potentially lower seizure threshold eg, Alzheimer's dementia; at risk for aspiration pneumonia; w/ prostatic hypertrophy, narrow-angle glaucoma, or history of paralytic ileus or related conditions; recent history of MI or unstable heart disease; risk of orthostatic hypotension; w/ history or diagnosis of urinary retention, receiving anticholinergics that can affect voiding, & w/ other risk factors for urinary retention (eg, benign prostatic hyperplasia). Potential cognitive & motor impairment. Reports of orthostatic hypotension (particularly during initial dose titration period); sudden cardiac death (very rare); clinically significant QTc prolongations (rare); transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST, & γ-glutamyltransferase (particularly in early treatment); seizures; priapism (rare); several serious cases of urinary retention (some requiring catheterization). Caution when used w/ drugs &/or conditions known to increase QTc interval (eg, elderly, patients w/ congenital long QT syndrome, CHF, heart hypertrophy, hypokalemia or hypomagnesemia). Identify all potential risk factors for VTE before prescribing & perform preventive measures. Perform fasting blood glucose testing at the beginning of & periodically during treatment. Monitor for worsening of glucose control (in patients w/ DM or risk factors for DM eg, obesity, family history of diabetes). Monitor patients treated w/ atypical antipsychotics for symptoms of hyperglycemia. Hyperprolactinemia. Question premenopausal women on menstrual irregularities & investigate those who experience secondary amenorrhea for >6 mth during treatment. Clinical monitoring including baseline & periodic follow-up lipid evaluations is recommended. Frequently monitor CBC during the 1st few mth of therapy in patients w/ history of clinically significant low WBC or drug-induced leukopenia/neutropenia & consider discontinuation at 1st sign of a clinically significant decline in WBC in absence of other causative factors. Carefully monitor patients w/ clinically significant neutropenia for fever or other signs of infection. Consider dose reduction or discontinuation if signs or symptoms of tardive dyskinesia appear. Close supervision & appropriate clinical management of patients at high-risk of suicide should accompany drug therapy. Monitor for signs & symptoms of akathisia. May have antiemetic effect, & olanzapine-induced antiemesis may mask signs of toxicity or symptoms of diseases eg, brain tumors or intestinal obstruction. Should not be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May cause somnolence & dizziness; has the potential to impair ability to drive & use machines. Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for extrapyramidal &/or w/drawal symptoms after delivery. Should be used during pregnancy only if potential benefit justifies potential risk to the fetus. Do not breastfeed during treatment. Safety & efficacy in childn <13 yr have not been established. Exercise caution in the elderly. Increased mortality in elderly w/ dementia-related psychosis.

Somnolence, wt gain, eosinophilia, elevated prolactin, cholesterol, glucose & triglyceride levels, glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia, dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases, rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high γ glutamyltransferase, uric acid & creatine phosphokinase, & edema.

May potentiate orthostatic hypotension w/ ethanol & diazepam. Have additive effect in sedation w/ ethanol. May enhance effects of antihypertensive agents. Concomitant use w/ anti-Parkinsonian drugs is not recommended in patients w/ Parkinson's disease & dementia. Reduced C_max & AUC w/ activated charcoal. Use w/ caution w/ other centrally acting drugs, including alcohol; drugs known to affect QT interval; drugs known to cause electrolyte imbalance; drugs that can cause CNS depression or those that induce hypotension, bradycardia, or resp depression. Slight to moderate increased clearance w/ CYP1A2 inducers. May induce metabolism of olanzapine w/ concomitant smoking. Increased clearance w/ carbamazepine, omeprazole & rifampicin. Decreased clearance w/ fluvoxamine (CYP1A2 inhibitor) & fluoxetine. May antagonize effects of levodopa & dopamine agonists.

Antipsychotics

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

Rx