An atypical antipsychotic - It is used to treat schizophrenia and bipolar disorder, also known as ma... more
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Special Alerts:
[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html and http://www.fda.gov/cder/drug/antidepressants/default.htm.
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Management (alone or in combination with lithium or divalproex sodium) of acute manic episodes associated with bipolar I disorder.
Dosage and Administration
Administration
Oral Administration
Administer orally, generally 2–3 times daily without regard to meals.
When switching from other antipsychotic agents to quetiapine, abrupt discontinuance of previous agent may be acceptable for some patients with schizophrenia, but gradual discontinuance may be appropriate for others. In all cases, minimize period of overlapping antipsychotic administration.
In patients being switched from long-acting (depot) parenteral antipsychotic therapy to oral quetiapine therapy, administer first oral dose in place of next scheduled depot injection of the long-acting preparation.
Periodically reevaluate need for continuing any existing drug therapy for symptomatic relief of adverse extrapyramidal effects.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Available as quetiapine fumarate; dosage is expressed in terms of quetiapine.
Reinitiating therapy: In patients previously treated with quetiapine, dosage titration is not necessary if reinitiated after a drug-free period <1 week; if reinitiated after a drug-free period >1 week, generally titrate dosage as with initial therapy.
Adults
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Schizophrenia
Oral
Initially, 25 mg twice daily.
Increase dosage in increments of 25–50 mg 2 or 3 times daily on the second or third day, as tolerated, to a target dosage of 300–400 mg daily in 2 or 3 divided doses by the fourth day.
Make subsequent dosage adjustments at intervals of not less than 2 days, usually in increments or decrements of 25–50 mg twice daily.
Dosages ranging from 150–750 mg daily were effective in clinical trials. Dosages >300 mg daily usually do not result in greater efficacy, but dosages of 400–500 mg daily have been required in some patients.
Optimum duration of therapy currently not known, but efficacy of maintenance therapy with antipsychotics is well established. Continue therapy in responsive patients as long as clinically necessary and tolerated but at lowest possible effective dosage; reassess need for continued therapy and optimal dosage periodically (e.g., at least annually).
If discontinuance is considered, precautions include slow, gradual dose reduction over many months, more frequent clinician visits, and use of early intervention strategies.
Bipolar Disorder
Acute Mania
Oral
Initially, 100 mg daily in 2 divided doses. Increase dosage (in increments of ≤100 mg daily in 2 divided doses) to 400 mg daily on the fourth day of therapy. Make subsequent adjustments in increments of ≤200 mg daily to reach a dosage of up to 800 mg daily by the sixth day of therapy.
Majority of patients respond to 400–800 mg daily.
Optimum duration not established; efficacy has been demonstrated in two 12-week monotherapy trials and one 3-week adjunct therapy trial. If used for extended periods, periodically reevaluate long-term risks and benefits for the individual patient.
Prescribing Limits
Adults
Schizophrenia
Oral
Safety of dosages >800 mg daily not established.
Bipolar Disorder
Acute Mania
Oral
Safety of dosages >800 mg daily not established.
Special Populations
Hepatic Impairment
Initially, 25 mg daily; increase dosage by 25–50 mg daily according to clinical response and tolerability until an effective dosage is reached.
Renal Impairment
No dosage adjustment necessary.
Patients at Risk of Orthostatic Hypotension
Consider a slower rate of dosage titration and a lower target dosage in geriatric patients and in patients who are debilitated or have a predisposition to hypotensive reactions. Adjust dosage with caution.
Initially, 25 mg twice daily to minimize risk of orthostatic hypotension and associated syncope. If hypotension occurs during dosage titration, return to previous dosage in titration schedule.
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