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Antipsychotics / Mood Stabilizers

asenapine - SAPHRIS®: aripiprazole (Abilify ®):
chlorpromazine (Thorazine ®): Clozapine (Clozaril ®):
fluphenazine (Prolixin ®): haloperidol (Haldol ®):
iloperidone - FANAPT®: loxapine (Loxitane ®):
lurasidone HCL -LATUDA®: --
molindone (Moban ®): olanzepine (Zyprexa ®):
perphenazine (Trilafon ®): pimozide (Orap ®):
quetiapine (Seroquel ®): risperidone (Risperdal ®):
thioridazine (Mellaril ®): thiothixine (Navane ®):
trifluoperazine (Stelazine ®): ziprasidone (Geodon ®):

Other

Lithium (Eskalith CR ® Eskalith ® Lithobid ®) --
Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back    |    New drug index   ]

asenapine - SAPHRIS® top of page

DESCRIPTION
SAPHRIS is a psychotropic agent that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is (3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its molecular formula is C17H16ClNO•C4H4O4 and its molecular weight is 401.84 (free base: 285.8).

Asenapine is a white to off-white powder.

SAPHRIS is supplied for sublingual administration in tablets containing 5-mg or 10-mg asenapine; inactive ingredients include gelatin and mannitol.

INDICATIONS AND USAGE
Schizophrenia
SAPHRIS is indicated for the treatment of schizophrenia. The efficacy of SAPHRIS was established in two 6-week trials and one maintenance trial in adults.

Bipolar Disorder
Monotherapy: SAPHRIS is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Efficacy was established in two 3-week monotherapy trials in adults.

Adjunctive Therapy: SAPHRIS is indicated as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Efficacy was established in one 3-week adjunctive trial in adults

DOSAGE AND ADMINISTRATION
Starting Dose Recommended Dose Maximum Dose
Schizophrenia – acute treatment in adults 5 mg sublingually twice daily 5 mg sublingually twice daily 10 mg sublingually twice daily
Schizophrenia – maintenance treatment in adults 5 mg sublingually twice daily for one week 10 mg sublingually twice daily 10 mg sublingually twice daily
Bipolar mania – adults: monotherapy 10 mg sublingually twice daily 5–10 mg sublingually twice daily 10 mg sublingually twice daily
Bipolar mania – adults: as an adjunct to lithium or valproate 5 mg sublingually twice daily 5–10 mg sublingually twice daily 10 mg sublingually twice daily
Administration: Do not swallow tablet. SAPHRIS sublingual tablets should be placed under the tongue and left to dissolve completely. The tablet will dissolve in saliva within seconds. Eating and drinking should be avoided for 10 minutes after administration.

Administration Instructions
SAPHRIS is a sublingual tablet. To ensure optimal absorption, patients should be instructed to place the tablet under the tongue and allow it to dissolve completely. The tablet will dissolve in saliva within seconds. SAPHRIS sublingual tablets should not be crushed, chewed, or swallowed. Patients should be instructed to not eat or drink for 10 minutes after administration .

Schizophrenia
Usual Dose for Acute Treatment in Adults: The recommended starting and target dose of SAPHRIS is 5 mg given twice daily. In short term controlled trials, there was no suggestion of added benefit with a 10 mg twice daily dose, but there was a clear increase in certain adverse reactions. The safety of doses above 10 mg twice daily has not been evaluated in clinical studies.


Maintenance Treatment: Efficacy was demonstrated with SAPHRIS in a maintenance trial in patients with schizophrenia. The starting dose in this study was 5 mg twice daily with an increase up to 10 mg twice daily after 1 week based on tolerability. While there is no body of evidence available to answer the question of how long the schizophrenic patient should remain on SAPHRIS, patients should be periodically reassessed to determine the need for maintenance treatment.


Bipolar Disorder
Usual Dose for Acute Treatment of Manic or Mixed Episodes Associated with Bipolar I Disorder in Adults:


Monotherapy: The recommended starting dose of SAPHRIS, and the dose maintained by 90% of the patients studied, is 10 mg twice daily. The dose can be decreased to 5 mg twice daily if warranted by adverse effects or based on individual tolerability.

In controlled monotherapy trials, the starting dose for SAPHRIS was 10 mg twice daily. On the second and subsequent days of the trials, the dose could be lowered to 5 mg twice daily, based on tolerability, but less than 10% of patients had their dose reduced. The safety of doses above 10 mg twice daily has not been evaluated in clinical trials.


Adjunctive Therapy: The recommended starting dose of SAPHRIS is 5 mg twice daily when administered as adjunctive therapy with either lithium or valproate. Depending on the clinical response and tolerability in the individual patient, the dose can be increased to 10 mg twice daily. The safety of doses above 10 mg twice daily as adjunctive therapy with lithium or valproate has not been evaluated in clinical trials.


Maintenance Treatment: While there is no body of evidence available to answer the question of how long the bipolar patient should remain on SAPHRIS, whether used as monotherapy or as adjunctive therapy with lithium or valproate, it is generally recommended that responding patients be continued beyond the acute response. If SAPHRIS is used for extended periods in bipolar disorder, the physician should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.


Dosage in Special Populations
In a study of subjects with hepatic impairment who were treated with a single dose of SAPHRIS 5 mg, there were increases in asenapine exposures (compared to subjects with normal hepatic function), that correlated with the degree of hepatic impairment. While the results indicated that no dosage adjustments are required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, there was a 7-fold increase (on average) in asenapine concentrations in subjects with severe hepatic impairment (Child-Pugh C) compared to the concentrations of those in subjects with normal hepatic function. Therefore, SAPHRIS is not recommended in patients with severe hepatic impairment. Dosage adjustments are not routinely required on the basis of age, gender, race, or renal impairment status [see Use in Specific Populations and Clinical Pharmacology].


Switching from Other Antipsychotics
There are no systematically collected data to specifically address switching patients with schizophrenia or bipolar mania from other antipsychotics to SAPHRIS or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized


HOW SUPPLIED
SAPHRIS (asenapine) sublingual tablets are supplied as:

5-mg Tablets
Round, white to off-white sublingual tablets, with "5" on one side.
Child-resistant packaging
Box of 60 6 blisters with 10 tablets NDC 0052-0118-06
Hospital Unit Dose
Box of 100 10 blisters with 10 tablets NDC 0052-0118-90

10-mg Tablets
Round, white to off-white sublingual tablets, with "10" on one side.
Child-resistant packaging
Box of 60 6 blisters with 10 tablets NDC 0052-0119-06
Hospital Unit Dose
Box of 100 10 blisters with 10 tablets NDC 0052-0119-90

5-mg Tablets, black cherry flavor
Round, white to off-white sublingual tablets, with "5" on one side within a circle.
Child-resistant packaging
Box of 60 6 blisters with 10 tablets NDC 0052-2139-03
Hospital Unit Dose
Box of 100 10 blisters with 10 tablets NDC 0052-2139-04

10-mg Tablets, black cherry flavor
Round, white to off-white sublingual tablets, with "10" on one side within a circle.
Child-resistant packaging
Box of 60 6 blisters with 10 tablets NDC 0052-2142-03
Hospital Unit Dose
Box of 100 10 blisters with 10 tablets NDC 0052-2142-04

Storage
Store at 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].

aripiprazole (Abilify ®):  top of page

Dosing (Adults):
Bipolar disorder
(acute manic or mixed episodes): Stabilization: Oral: 30 mg once daily; may require a decrease to 15 mg based on tolerability (15% of patients had dose decreased); safety of doses >30 mg/day has not been evaluated. Maintenance: Continue stabilization dose for up to 6 weeks; efficacy of continued treatment >6 weeks has not been established.

Schizophrenia: Oral: 10-15 mg once daily; may be increased to a maximum of 30 mg once daily (efficacy at dosages above 10-15 mg has not been shown to be increased). Dosage titration should not be more frequent than every 2 weeks.

Supplied: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg tab. 1 mg/ml (150 ml) oral soln.

chlorpromazine (Thorazine ®):  top of page

Low Potency.
Dosing (Adults): Schizophrenia/psychoses: Oral: Range: 30-800 mg/day in 1-4 divided doses, initiate at lower doses and titrate as needed. Usual dose: 200 mg/day. Some patients may require 1-2 g/day. IM, IV: Initial: 25 mg, may repeat (25-50 mg) in 1-4 hours - gradually increase to a maximum of 400 mg/dose every 4-6 hours until patient is controlled. Usual dose: 300-800 mg/day. (Note: Avoid skin contact with oral solution or injection solution; may cause contact dermatitis. IV: Direct or intermittent infusion: Infuse 1 mg or portion thereof over 1 minute.)
Intractable hiccups: Oral, IM: 25-50 mg 3-4 times/day. N/V: Oral: 10-25 mg every 4-6 hours. IM, IV: 25-50 mg every 4-6 hours.

Warnings: 1) Significant hypotension may occur, particularly with parenteral administration. 2) Phenothiazines may cause anticholinergic effects (confusion, agitation, constipation, xerostomia, blurred vision, urinary retention). Therefore, they should be used with caution in patients with decreased gastrointestinal motility, urinary retention, BPH, xerostomia, or visual problems.

Supplied: Tablet: 10 mg, 25 mg, 50 mg, 100 mg, 200 mg. Injection: 25 mg/ml (1, 2 ml).

Clozapine (Clozaril ®):  top of page

DOSING: ADULTS - Schizophrenia: Initial: 12.5 mg once or twice daily; increased, as tolerated, in increments of 25-50 mg/day to a target dose of 300-450 mg/day after 2-4 weeks, may require doses as high as 600-900 mg/day

Reduce risk of suicidal behavior: Initial: 12.5 mg once or twice daily; increased, as tolerated, in increments of 25-50 mg/day to a target dose of 300-450 mg/day after 2-4 weeks; median dose is ~300 mg/day (range: 12.5-900 mg)

IMPORTANT
Termination of therapy: If dosing is interrupted for >/=48 hours, therapy must be reinitiated at 12.5-25 mg/day; may be increased more rapidly than with initial titration, unless cardiopulmonary arrest occurred during initial titration.
In the event of planned termination of clozapine, gradual reduction in dose over a 1- to 2-week period is recommended. If conditions warrant abrupt discontinuation (leukopenia), monitor patient for psychosis and cholinergic rebound (headache, nausea, vomiting, diarrhea).
Patients discontinued on clozapine therapy due to WBC <2000/mm3 or ANC <1000/mm3 should not be restarted on clozapine.

Dosage adjustment for toxicity:
Moderate leukopenia or granulocytopenia (WBC <3000/mm3 and ANC <1500/mm3): Discontinue therapy; may rechallenge patient when WBC >3500/mm3 and/or ANC >2000/mm3. Note: Patient is at greater risk for developing agranulocytosis.
Severe leukopenia or granulocytopenia (WBC <2000/mm3 and/or ANC <1000/mm3): Discontinue therapy and do not rechallenge patient.

Supplied: Tablet: 12.5 mg, 25 mg, 100 mg

fluphenazine (Prolixin ®):  top of page

High Potency.
Dosing (Adults): Psychosis:
Oral: 0.5-10 mg/day in divided doses at 6 to 8 hour intervals; some patients may require up to 40 mg/day.
IM: 2.5-10 mg/day in divided doses at 6 to 8 hour intervals (parenteral dose is 1/3 to 1/2 the oral dose for the hydrochloride salts).

Depot (Long-acting maintenance injections): IM, SQ (decanoate): 12.5 mg every 3 weeks. Conversion from hydrochloride to decanoate IM: 0.5 ml (12.5 mg) decanoate every 3 weeks is approximately equivalent to 10 mg hydrochloride/day.

Supplied: 1 mg, 2.5 mg, 5 mg, 10 mg tab. Oral concentrate: 5 mg/ml (120 ml). Injection (decanoate): 25 mg/ml (5 ml)

haloperidol (Haldol ®):  top of page

High Potency.
Butyrophenone antipsychotic.
Dosing
(Adults): Psychosis: Oral: 0.5-5 mg 2-3 times/day; usual maximum: 30 mg/day.
IM (as lactate): 2-5 mg every 4-8 hours as needed. (decanoate): Initial: 10-20 times the daily oral dose administered at 4-week intervals. Maintenance dose: 10-15 times initial oral dose; used to stabilize psychiatric symptoms.
ICU- Delirium: 2-10 mg IV - may repeat bolus doses every 20-30 minutes until calm then administer 25% of the maximum dose every 6 hours. Monitor ECG and QTc interval. Alternatively: Continuous I.V. infusion: 3 to 25 mg/hour.
Rapid tranquilization
: Oral: 5-10 mg or IM: 5 mg. Average total dose (oral or IM) for tranquilization: 10-20 mg.

Supplied: Tablet: 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg, 20 mg. Oral concentrate: 2 mg/ml (15 ml, 120 ml). Injection (decanoate): 50 mg/ml (1 ml, 5 ml); 100 mg/ml (1 ml, 5 ml). Injection (lactate): 5 mg/ml (1 ml, 10 ml).

iloperidone - FANAPT® top of page

INDICATIONS AND USAGE
FANAPT is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. (1) Efficacy was established in two short-term (4- and 6-week) placebo- and active-controlled studies of adult patients with schizophrenia. (14) In choosing among treatments, prescribers should consider the ability of FANAPT to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate FANAPT slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration.


DRUG INTERACTIONS
The dose of FANAPT should be reduced in patients co-administered a strong CYP2D6 or CYP3A4 inhibitor.

DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION (summary):
The recommended target dosage of FANAPT tablets is 12 to 24 mg/day administered twice daily. This target dosage range is achieved by daily dosage adjustments, alerting patients to symptoms of orthostatic hypotension, starting at a dose of 1 mg twice daily, then moving to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg twice daily on days 2, 3, 4, 5, 6, and 7 respectively, to reach the 12 mg/day to 24 mg/day dose range. FANAPT can be administered without regard to meals.

Usual Dose
FANAPT must be titrated slowly from a low starting dose to avoid orthostatic hypotension due to its alpha-adrenergic blocking properties. The recommended starting dose for FANAPT tablets is 1 mg twice daily. Increases to reach the target dose range of 6-12 mg twice daily may be made with daily dosage adjustments to 2 mg twice daily, 4 mg twice daily, 6 mg twice daily, 8 mg twice daily, 10 mg twice daily, and 12 mg twice daily on days 2, 3, 4, 5, 6, and 7, respectively. Efficacy was demonstrated with FANAPT in a dose range of 6 to 12 mg twice daily. Prescribers should be mindful of the fact that patients need to be titrated to an effective dose of FANAPT. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require similar titration. Prescribers should also be aware that some adverse effects associated with FANAPT use are dose related.

The maximum recommended dose is 12 mg twice daily (24 mg/day); FANAPT doses above 24 mg/day have not been systematically evaluated in the clinical trials.

FANAPT can be administered without regard to meals.


Dosage in Special Populations
Dosage adjustments are not routinely indicated on the basis of age, gender, race, or renal impairment status.

Dosage adjustment for patients taking FANAPT concomitantly with potential CYP2D6 inhibitors: FANAPT dose should be reduced by one-half when administered concomitantly with strong CYP2D6 inhibitors such as fluoxetine or paroxetine. When the CYP2D6 inhibitor is withdrawn from the combination therapy, FANAPT dose should then be increased to where it was before.

Dosage adjustment for patients taking FANAPT concomitantly with potential CYP3A4 inhibitors: FANAPT dose should be reduced by one-half when administered concomitantly with strong CYP3A4 inhibitors such as ketoconazole or clarithromycin. When the CYP3A4 inhibitor is withdrawn from the combination therapy, FANAPT dose should be increased to where it was before.

Dosage adjustment for patients taking FANAPT who are poor metabolizers of CYP2D6: FANAPT dose should be reduced by one-half for poor metabolizers of CYP2D6.

Hepatic Impairment: FANAPT is not recommended for patients with hepatic impairment.


Maintenance Treatment
Although there is no body of evidence available to answer the question of how long the patient treated with FANAPT should be maintained, it is generally recommended that responding patients be continued beyond the acute response. Patients should be periodically reassessed to determine the need for maintenance treatment.


Reinitiation of Treatment in Patients Previously Discontinued
Although there are no data to specifically address re-initiation of treatment, it is recommended that the initiation titration schedule be followed whenever patients have had an interval off FANAPT of more than 3 days.


Switching from Other Antipsychotics
There are no specific data to address how patients with schizophrenia can be switched from other antipsychotics to FANAPT or how FANAPT can be used concomitantly with other antipsychotics. Although immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.

HOW SUPPLIED
FANAPT tablets are available in the following strengths: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg. The tablets are white, round, flat, beveled-edged and identified with a logo “” debossed on one side and tablet strength “1”, “2”, “4”, “6”, “8”, “10”, or “12” debossed on the other side.

loxapine (Loxitane ®):  top of page

Mid Potency.
Dibenzoxazepine antipsychotic. Dosing (Adults): Psychosis: Oral: 10 mg twice daily, increase dose until psychotic symptoms are controlled; usual dose range: 20-100 mg/day in divided doses 2-4 times/day. Dosages > 250 mg/day are not recommended.

Supplied: 5 mg, 10 mg, 25 mg, 50 mg cap.

lurasidone HCL -LATUDA® top of page

INDICATIONS AND USAGE
LATUDA is indicated for the treatment of patients with schizophrenia.

The efficacy of LATUDA in schizophrenia was established in four 6-week controlled studies of adult patients with schizophrenia.

The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration].

DOSAGE AND ADMINISTRATION
Schizophrenia
The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg/day to 120 mg/day. In the 6-week controlled trials, there was no suggestion of added benefit with the 120 mg/day dose, but there was a dose-related increase in certain adverse reactions. Therefore, the maximum recommended dose is 80 mg/day.

Administration Instructions
LATUDA should be taken with food (at least 350 calories).

Dosage in Special Populations
Dosage adjustments are not recommended on the basis of age, gender, and race.

Dose adjustment is recommended in moderate and severe renal impairment patients. The dose in these patients should not exceed 40 mg/day.

Dose adjustment is recommended in moderate and severe hepatic impairment patients. The dose in these patients should not exceed 40 mg/day.

Dosing recommendation for patients taking LATUDA concomitantly with potential CYP3A4 inhibitors: When coadministration of LATUDA with a moderate CYP3A4 inhibitor such as diltiazem is considered, the dose should not exceed 40 mg/day. LATUDA should not be used in combination with a strong CYP3A4 inhibitor (e.g., ketoconazole).

Dosing recommendation for patients taking LATUDA concomitantly with potential CYP3A4 inducers: LATUDA should not be used in combination with a strong CYP3A4 inducer (e.g., rifampin).

HOW SUPPLIED
LATUDA tablets are available in the following shape and color (Table 1) with respective one-sided debossing: 40 mg (white to off-white, round, 'L40'), or 80 mg (pale green, oval, 'L80').

molindone (Moban ®):  top of page

Dosing (Adults): Schizophrenia/psychoses: Oral: 50-75 mg/day increase at 3- to 4-day intervals up to 225 mg/day.

Supplied: 5 mg, 10 mg, 25 mg, 50 mg tab.

olanzepine (Zyprexa ®):  top of page

Atypical antipsychotic.
Dosing (Adults): Schizophrenia: Oral: Usual starting dose: 5-10 mg once daily - increase to 10 mg once daily within 5-7 days, thereafter adjust by 5 mg/day at 1-week intervals, up to a maximum of 20 mg/day. Doses as high as 30-50 mg per day have been used.
Acute mania associated with bipolar disorder: Oral: Mono- therapy: Usual starting dose: 10-15 mg once daily - increase by 5 mg/day at intervals of not less than 24 hours. Maintenance: 5-20 mg/day. Maximum dose: 20 mg/day. Combination therapy (with lithium or valproate): Initial: 10 mg once daily; dosing range: 5-20 mg/day. Agitation (acute, associated with bipolar disorder or schizophrenia): IM: Initial dose: 5-10 mg (a lower dose of 2.5 mg may be considered when clinical factors warrant); additional doses (2.5-10 mg) may be considered; however, 2-4 hours should be allowed between doses to evaluate response (maximum total daily dose: 30 mg, per manufacturer's recommendation).

Supplied: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg tablet. Orally-disintegrating tab (Zydis®): 5, 10, 15, 20 mg. Injection: 10 mg (powder for reconstitution)

Manufacturer:
ZYPREXA® Zydis® (Olanzapine) Orally Disintegrating Tablets
ZYPREXA Zydis, an alternative formulation that dissolves quickly in the mouth, is available in 5, 10, 15, and 20 mg tablets.

* Rapidly dissolves in mouth
* Can be taken with or without water
* Same indications as ZYPREXA tablet
* For use where clinically indicated (for example, patients who have difficulty swallowing pills, those who cheek or spit their medication)
* Bioequivalent to ZYPREXA tablets

ZYPREXA® IntraMuscular
ZYPREXA IntraMuscular is approved for the treatment of agitation associated with schizophrenia and bipolar mania.

Follow the steps below to reconstitute and use ZYPREXA IntraMuscular:

1. Inject 2.1 mL of Sterile Water for Injection into single-packaged vial for up to 10-mg dose.
2. Dissolve contents of vial completely; resulting solution should be clear and yellow.
3. Use solution within 1 hour; discard any unused portion.
4. Refer to table for injection volumes and corresponding doses of ZYPREXA IntraMuscular.
5. Immediately after use, dispose of syringe in approved sharps box.

Recommended dose for agitation in schizophrenia or bipolar mania is 10 mg. If clinically warranted, subsequent doses up to 10 mg may be given to agitated patients with schizophrenia or bipolar mania. However, the efficacy of repeated doses has not been systematically evaluated in controlled clinical trials. The safety of total daily doses greater than 30 mg or of 10 mg injections given more frequently than 2 hours after the initial dose and 4 hours after the second dose has not been evaluated in clinical trials. Maximal dosing (three 10-mg doses administered 2-4 hours apart) may be associated with substantial occurrence of significant orthostatic hypotension; it is recommended that patients requiring subsequent intramuscular injections be assessed for orthostatic hypotension prior to the administration of any subsequent doses. The administration of an additional dose to a patient with a clinically significant postural change in systolic blood pressure is not recommended.

Patients should remain recumbent if drowsy or dizzy after injection until examination has indicated that they are not experiencing postural hypotension and/or bradycardia.

Recommended dose for agitation in special populations is 2.5mg - 5mg.
A dose of  5 mg per injection should be considered for geriatric patients or when other clinical factors warrant. A lower dose of 2.5mg per injection should be considered for patients who otherwise might be debilitated, be predisposed to hypotensive reactions, or be pharmacodynamically sensitive to olanzapine.

perphenazine (Trilafon ®):  top of page

Piperazine phenothiazine.
Dosing (Adults): Schizophrenia/psychoses: Oral: 4-16 mg 2-4 times/day not to exceed 64 mg/day. Nausea/vomiting: Oral: 8-16 mg/day in divided doses up to 24 mg/day.

Supplied: 2 mg, 4 mg, 8 mg, 16 mg tab.

pimozide (Orap ®):  top of page

INDICATIONS:  ORAP (pimozide) is indicated for the suppression of motor and phonic tics in patients with Tourette's Disorder who have failed to respond satisfactorily to standard treatment. ORAP is not intended as a treatment of first choice nor is it intended for the treatment of tics that are merely annoying or cosmetically troublesome. ORAP should be reserved for use in Tourette's Disorder patients whose development and/or daily life function is severely compromised by the presence of motor and phonic tics.

Evidence supporting approval of pimozide for use in Tourette's Disorder was obtained in two controlled clinical investigations which enrolled patients between the ages of 8 and 53 years. Most subjects in the two trials were 12 or older.


Dosing (Adults): Tourette's: In general, treatment with ORAP should be initiated with a dose of 1 to 2 mg a day in divided doses. The dose may be increased thereafter every other day. Most patients are maintained at less than 0.2 mg/kg per day, or 10 mg/day, whichever is less. Doses greater than 0.2 mg/kg/day or 10 mg/day are not recommended.  Note: Sudden unexpected deaths have occurred in patients taking doses >10 mg. Note: An ECG should be performed baseline and periodically thereafter, especially during dosage adjustment.

Supplied: 1 mg, 2 mg tab.

quetiapine (Seroquel ®):  top of page

Atypical antipsychotic.
Dosing (Adults): Schizophrenia/psychosis: Oral: 25-100 mg 2-3 times/day. Usual starting dose 25 mg twice daily, increased in increments of 25-50 mg 2-3 times/day on the second or third day. By the fourth day, the dose should be in the range of 300-400 mg/day in 2-3 divided doses. Further adjustments may be made, as needed, at intervals of at least 2 days in adjustments of 25-50 mg twice daily. Usual maintenance range: 150-750 mg/day. Mania: Oral: Initial: 50 mg twice daily on day 1, increase dose in increments of 100 mg/day to 200 mg twice daily on day 4; may increase to a target dose of 800 mg/day by day 6 at increments of </= 200 mg/day. Usual dosage range: 400-800 mg/day.

Supplied: 25 mg, 100 mg, 200 mg, 300 mg tab.

risperidone (Risperdal ®):  top of page

Atypical antipsychotic.
Dosing (Adults): Bipolar mania: Oral: Recommended starting dose: 2-3 mg once daily; if needed, adjust dose by 1 mg/day in intervals of at least 24 hours. Dosing range: 1-6 mg/day.
Schizophrenia: Oral: Recommended starting dose: 0.5-1 mg twice daily - slowly increase to the optimum range of 3-6 mg/day. May be given as a single daily dose once maintenance dose is achieved. Daily dosages >6 mg does not appear to confer any additional benefit, and the incidence of extrapyramidal symptoms is higher than with lower doses.
IM (Risperdal ® Consta): 25 mg every 2 weeks. Some patients may benefit from larger doses. Maximum dose not to exceed 50 mg every 2 weeks. Dosage adjustments should not be made more frequently than every 4 weeks.

Supplied: Tablet: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg. Oral solution: 1 mg/ml (30 ml). Oral disintegrating tablets (Risperdal M-Tabs): 0.5 mg, 1 mg , 2 mg. Injection (Risperdal® Consta): 25 mg, 37.5 mg, 50 mg.

thioridazine (Mellaril ®): top of page

Low Potency.  Dosing (Adults): Schizophrenia/psychosis: Oral: Initial: 50-100 mg 3 times/day with gradual increments as needed and tolerated. Maximum: 800 mg/day in 2-4 divided doses. Depressive disorders, dementia: Oral: Initial: 25 mg 3 times/day; maintenance dose: 20 to 200 mg/day.

Supplied: 10 mg, 15 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg tablet.

thiothixine (Navane ®): top of page

 High Potency.
Dosing
(Adults): Mild / moderate psychosis: Oral: 2 mg 3 times/day, up to 20-30 mg/day. Severe psychosis: Initial: 5 mg 2 times/day, may increase gradually, if necessary; maximum: 60 mg/day. Rapid tranquilization (administered every 30 to 60 minutes): Oral: 5-10 mg; average total dose for tranquilization: 15-30 mg

Supplied: 1 mg, 2 mg, 5 mg, 10 mg cap.

trifluoperazine (Stelazine ®):  top of page

Piperazine phenothiazine. High Potency.
Dosing (Adults): Schizophrenia/ psychoses: Oral: Outpatient: 1-2 mg twice daily. Hospitalized / well supervised patient: Initial: 2-5 mg twice daily with optimum response in the 15-20 mg/day range; do not exceed 40 mg/day.

Supplied: 1 mg, 2 mg, 5 mg, 10 mg tab.

ziprasidone (Geodon ®):  top of page

Dosing (Adults): Bipolar mania: Oral: Initial: 40 mg twice daily (with food). Adjustment: May increase to 60 or 80 mg twice daily on second day of treatment. Average dose 40-80 mg twice daily.
Schizophrenia
: Oral: Initial: 20 mg twice daily (with food). Adjustment: Increases (if indicated) should be made no more frequently than every 2 days; ordinarily patients should be observed for improvement over several weeks before adjusting the dose.
Maintenance: Range 20-100 mg twice daily; however, dosages >80 mg twice daily are generally not recommended.
Acute agitation (schizophrenia): 10 mg IM every 2 hours or 20 mg every 4 hours (maximum: 40 mg/day). Oral therapy should replace IM administration as soon as possible.

Supplied: 20 mg, 40 mg, 60 mg, 80 mg cap.  20 mg - injection (powder for reconstitution).

Other

Lithium (Eskalith CR ® Eskalith ® Lithobid ®) top of page

Indications: Management of acute manic episodes, bipolar disorders, and depression

Dosage forms: Lithium is a monovalent cation

Lithium carbonate
Tablet or capsule:
300 mg (8.12 mEq lithium)
600 mg (16.24 mEq lithium)

Extended release capsule:
300 mg (8.12 mEq lithium)
450 mg (12.18 mEq lithium)

Lithium citrate
Oral solution: 8 mEq (of lithium) /5 mL

Other:
1) No clinically significant differences exist between lithium-immediate-release capsules and tablets.
2) Both formulations are 95-100% absorbed.
3) Switching among the citrate, capsule, and tablet dosage forms should not result in significantly different 12-hr steady-state levels.
4) Sustained-release formulations were developed to decrease the adverse effects associated with peak and rapidly rising serum lithium concentrations. This difference is restricted to a minority of patients.
5) Switch patients between the immediate-release and sustained-release products on a mg-for-mg basis.

Usual dosage:
900-2000 mg/day (acute mania) with normal renal function.
600 mg/day (prophylaxis).

Literature-Based Dosing vs Kinetic-Based Dosing
Based on kinetic population parameters and modified according to clinical experience
-initial doses = 900-1200mg/day; increased by 300-600mg Q 2-3 days. if decreased renal function, use above guidelines. Test Dose Methods for Inital Dosage (Single Point Method) .
Monitor serum lithium every 4 to 5 days during initial therapy. Drawing Levels: obtain trough level just before next dose (8-12 hours after previous dose). Levels should be obtained twice weekly until both patient's clinical status and levels are stable then levels may be obtained every 1-3 months. Target levels:  Acute mania: 0.6-1.2 mEq/L (SI: 0.6-1.2 mmol/L)
Protection against future episodes in most patients with bipolar disorder: 0.8-1 mEq/L (SI: 0.8-1.0 mmol/L); a higher rate of relapse is described in subjects who are maintained at <0.4 mEq/L (SI: 0.4 mmol/L). Elderly patients can usually be maintained at lower end of therapeutic range (0.6-0.8 mEq/L)

Toxic concentration: >1.5 mEq/L (SI: >2 mmol/L). Adverse effect levels: GI complaints/tremor: 1.5-2 mEq/L.  Confusion/somnolence: 2-2.5 mEq/L. Seizures/death: >2.5 mEq/L

Renal Dosing:
CrCl 10-50 mL/minute: Administer 50-75% of normal dose
CrCl < 10 mL/minute: Administer 25-50% of normal dose
Hemodialysis: 50-100% dialyzable - administer after each dialysis treatment.
Most patients tolerate BID dosing.

Disclaimer

Listed dosages are for - Adult patients ONLY. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. GlobalRPH does not directly or indirectly practice medicine or provide medical services and therefore assumes no liability whatsoever of any kind for the information and data accessed through the Service or for any diagnosis or treatment made in reliance thereon.
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