Quetiapine Dosage

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Usual Adult Dose for:

Usual Geriatric Dose for:

Additional dosage information:

Usual Adult Dose for Schizophrenia

Immediate-release tablets:
Initial Dose: 25 mg orally twice a day.

The dosage may be increased in increments of 25 to 50 mg two times a day or three times a day on the second and third days (as tolerated). By the fourth day a dosage range of 300 mg to 400 mg daily (divided into 2 or 3 doses a day) may be achieved. Additional dosage adjustments (increases or decreases) of 25 to 50 mg twice a day may be made, as needed. However, at least 2 days should pass between the additional dosage adjustments.

Efficacy in schizophrenia has been reported with doses ranging from 150 to 750 mg/day. Maximum clinical effect has been reported at 300 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.

Extended-release tablets:
Initial dose: 300 mg orally once daily without food or with a light meal.
Maintenance dose: 400 to 800 mg orally once daily depending on response and tolerance.
Maximum dose: Doses above 800 mg daily have not been studied.

The dosage of the extended-release tablets may be increased in increments of up to 300 mg daily at intervals as short as 1 day.

The efficacy of quetiapine in long-term use (over 6 weeks) has not been studied in clinical trials. Patients who respond favorably to quetiapine may be continued on the lowest dose which is effective in maintaining their remission. Patients should be periodically reassessed to determine their need for maintenance treatment.

Usual Adult Dose for Bipolar Disorder

Immediate-release tablets:
Mania associated with bipolar I disorder as monotherapy or as adjunct therapy to lithium or divalproex:
Initial Dose: 50 mg orally twice a day

The dose may be increased to 200 mg orally twice daily on day 4 in increments of up to 50 mg twice daily. Further dosage adjustments up to 800 mg per day by day 6 should be in increments of no greater than 200 mg/day. Data has been reported to indicate that the majority of patients responded between 400 mg per day to 800 mg per day. The safety of doses above 800 mg per day has not been evaluated in clinical trials.

Immediate-release tablets:
Depressive episodes associated with bipolar disorder:
Initial dose: 50 mg orally once a day

The dose may be increased to reach 300 mg orally once a day by day 4. Some patients may require a further increase to 600 mg once a day by increasing the daily dose to 400 mg on day 5 and 600 mg on day 8 of treatment. Efficacy was demonstrated in this patient population at both 300 mg and 600 mg per day. However, no additional benefit was observed in patients receiving 600 mg per day as compared to those patients receiving 300 mg per day.

Extended-release tablets:

Bipolar Depression:
(Depressive Episodes Associated with Bipolar Disorder)
Usual dose for Acute Treatment: administer orally once daily in the evening starting with 50 mg per day and increasing doses to reach 300 mg per day by day 4.
Recommended Dosing Schedule: Day 1 - 50 mg, Day 2 - 100, mg, Day 3 - 200 mg, & Day 4 - 300 mg

Bipolar Mania:
Usual dose for Acute Monotherapy or Adjunct Therapy (with lithium or divalproex): administer orally once daily in the evening starting with 300 mg on day 1, 600 mg on day 2, and adjust between 400 mg and 800 mg per day thereafter depending on the clinical response and tolerance of the individual patient.

Bipolar Maintenance:
Continue treatment at the dosage required to maintain symptom remission.
While there is no body of evidence available to specifically address how long patients should remain on quetiapine extended-release tablets, maintenance of efficacy in Bipolar I Disorder has been demonstrated with quetiapine (administered orally twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.

Usual Adult Dose for Depression

As adjunctive therapy to antidepressants for use in the treatment of major depressive disorder:

Extended-release tablets:

Initial dose: 50 mg orally once daily in the evening

On day 3, the dose can be increased to 150 mg once daily in the evening.

Range: 150 mg to 300 mg orally daily. Doses above 300 mg have not been studied.

Usual Geriatric Dose for Schizophrenia

Immediate-release tablets:
Initial Dose: 25 mg orally once a day.

The dose may be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.

Efficacy in schizophrenia has been reported with doses ranging from 150 to 750 mg/day. Maximum clinical effect has been reported at 300 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.

Extended-release tablets:
When an effective immediate-release dose has been reached (above 200 mg), the patient may be switched to the extended-release formulation at an equivalent dose.

The efficacy of quetiapine in long-term use (over 6 weeks) has not been studied in clinical trials. Patients who respond favorably to quetiapine may be continued on the lowest dose which is effective in maintaining their remission. Patients should be periodically reassessed to determine their need for maintenance treatment.

Usual Geriatric Dose for Bipolar Disorder

Extended-release tablets:
Initial dose: 50 mg/day
The dose can be increased in increments of 50 mg/day depending on the response and tolerance of the individual patient.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Immediate-release tablets:
Initial Dose: 25 mg orally once a day.

The dose of the immediate-release tablets should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient. In patients with schizophrenia, once an effective dose has been achieved, the patient may be switched to the extended-release tablets at an equivalent total daily dose.

Quetiapine is metabolized extensively. The mean plasma clearance of the drug has been reported to have been decreased by approximately 30% in patients with hepatic impairment in clinical trials. Therefore patients with liver disease should be monitored carefully during the initial dosing period. A slower rate of dose titration and a lower therapeutic dose may also be appropriate.

Dose Adjustments

A 40% decrease in mean plasma clearance has been reported in patients over 64 years old (when compared to younger patients) in clinical trials. Therefore, elderly patients should be carefully monitored, particularly during the initial dosing period. A slower rate of dose titration and a lower therapeutic dose may also be appropriate.

For the extended-release tablets, in patients requiring less than 200 mg daily during the initial titration, the immediate-release tablets may be used until a target dose is achieved at which time the patient may be switched to the extended-release formulation.

In patients reinitiating therapy who have been off quetiapine for more than one week, the initial dosing schedule should be followed. In patients who have been off quetiapine for less than one week, gradual dose titration may not be necessary and the maintenance dose may be reinitiated.

Precautions

Quetiapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia. Collective data from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including quetiapine, for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug- treated patient than in the placebo- treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

Quetiapine is not approved by the FDA for use in pediatric patients (less than 18 years old).

Dialysis

Data not available

Other Comments

The extended-release tablets should be administered once daily, preferably in the evening without food or with a light meal. The extended-release tablets should be swallowed whole and not split, crushed or chewed.

Patients currently receiving the immediate-release formulation may be switched to the extended-release tablets at the equivalent total daily dose taken once daily

The suggested therapeutically effective quetiapine plasma concentration range is 70 to 170 ng/mL.

Development of hyperglycemia and/or diabetes mellitus is common in patients treated with atypical antipsychotics. Periodic monitoring of fasting plasma glucose is recommended in patients receiving quetiapine.

In patients discontinuing use of quetiapine, gradual withdrawal is recommended. Although rare, withdrawal symptoms (i.e., nausea, vomiting, insomnia) have been reported following abrupt cessation of therapy.

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