pms-Quetiapine

pms-Quetiapine Dosage/Direction for Use

quetiapine

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Full Prescribing Info
Dosage/Direction for Use
Recommended Dose and Dosage Adjustment: pms-QUETIAPINE (quetiapine fumarate immediate-release) can be administered with or without food (see Pharmacology: Pharmacokinetics: Absorption under Actions).
Schizophrenia: The usual starting dose of pms-QUETIAPINE is 25 mg b.i.d., titrated with increments of 25-50 mg b.i.d. per day, as tolerated, to a target dose of 300 mg/day given b.i.d. within four to seven days.
Further dosage adjustments may be indicated depending on the clinical response and tolerability in the individual patient. Dosage adjustments should generally occur at intervals of not less than 2 days, as steady state for quetiapine fumarate would not be achieved for approximately 1-2 days in the typical patient. When adjustments are necessary, dose increments/decrements of 25-50 mg b.i.d. are recommended.
Clinical trials suggest that the usual effective treatment dose will be in the range of 300-600 mg/day (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions). However, some patients may require as little as 150 mg/day. In schizophrenia, the safety of doses above 800 mg/day has not been evaluated.
The need for continuing existing EPS medications should be re-evaluated periodically as quetiapine fumarate has not been associated with treatment-emergent EPS across the clinical dose range.
Bipolar Disorder: Bipolar Mania: Usual Dose: The titration rate, based on the clinical trials (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions) is shown in the following table: See Table 6.

Click on icon to see table/diagram/image

Dosage adjustments should be made depending on the clinical response and tolerability in the individual patient.
Approximately 85% of patients responded between 400 and 800 mg/day, while over 50% of patients responded between 600 and 800 mg/day (the average median dose for responders during the last week of treatment was approximately 600 mg/day). In bipolar mania, the safety of doses above 800 mg/day has not been evaluated.
Bipolar Depression: Usual Dose: The titration rate, based on the clinical trials (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions) is shown in the following table: See Table 7.

Click on icon to see table/diagram/image

Patients in 300 mg fixed dosage arms were continued on quetiapine fumarate 300 mg/day, from day 4 onward. In clinical trials that had a fixed 600 mg dosage arm, quetiapine fumarate was further titrated to 400 mg on Day 5 and up to 600 mg by Day 8, depending on clinical response and tolerability of individual patients. Antidepressant efficacy was demonstrated with quetiapine fumarate at both 300 mg/day and 600 mg/day, however no additional benefit was seen in the 600 mg group during short-term treatment. Thus, a usual target dose of 300 mg/day is recommended.
In bipolar depression, the safety of doses above 600 mg/day has not been evaluated.
Quetiapine fumarate should be administered once daily at bedtime.
Dosing Considerations in Special Populations: Elderly: In clinical trials, 38 patients with schizophrenia or related disorders, 65 years of age or over, were treated with quetiapine fumarate (see Use in the Elderly under Precautions). Given the limited experience with quetiapine fumarate in the elderly, and the higher incidence of concomitant illness and concomitant medication in this population, pms-QUETIAPINE should be used with caution. The mean plasma clearance of quetiapine fumarate was reduced by 30% to 50% in elderly subjects when compared to younger patients. The rate of dose titration may thus need to be slower, and the daily therapeutic target dose lower, than that used in younger patients.
Hepatic Impairment: Quetiapine is extensively metabolized by the liver (see Pharmacology: Pharmacokinetics: Special Populations and Conditions: Hepatic Impairment under Actions). Therefore, pms-QUETIAPINE should be used with caution in patients with mild hepatic impairment, especially during the initial dosing period. Patients with mild hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 to 50 mg/day to an effective dose, depending on the clinical response and tolerance in the individual patient. No pharmacokinetic data are available for any dose of quetiapine fumarate in patients with moderate to severe hepatic impairment. However, should clinical judgement deem treatment with pms-QUETIAPINE necessary, the drug should be used with great caution in patients with moderate or severe hepatic impairment (see Pharmacology: Pharmacokinetics: Special Populations and Conditions: Hepatic Impairment under Actions; Hepatic/Pancreatic: Hepatic Impairment under Precautions).
Renal Impairment: As clinical experience is lacking, caution is advised (see Renal under Precautions).
Missed Dose: If a dose is missed by only a few hours, take it as soon as possible. If most of the day has passed since the missed dose, skip that dose and wait until next scheduled dose. Never take two doses at once.
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