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RIVA-QUETIAPINE is a brand name for Quetiapine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Schizophrenia RIVA-QUETIAPINE (quetiapine fumarate immediate-release) is indicated for: the management of the manifestations of schizophrenia. The antipsychotic efficacy of quetiapine fumarate immediate-release was established in short- term (6-week) controlled inpatient trials (see 14 CLINICAL TRIALS). The efficacy…
Verbatim from this product's HC label. Tap a section to expand.
1. 2 Recommended Dose and Dosage Adjustment, Dosing Considerations in Special Populations. 2. d. 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 immediate-release would not be achieved for approximately 1-2 days in the typical patient. d. are recommended. Clinical trials suggest that the usual effective treatment dose will be in the range of 300-600 mg/day (see 14 CLINICAL TRIALS).
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 immediate-release 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 14 CLINICAL TRIALS) is shown in the table below: Day 1 2 3 4 5 6 BID 100 mg/day 200 mg/day 300 mg/day 400 mg/day Up to 600 mg/day Up to 800 mg/day RIVA-QUETIAPINE - Product Monograph Page 6 of 61 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 14 CLINICAL TRIALS) is shown in the table below: Day 1 2 3 4 Once Daily 50 mg/day 100 mg/day 200 mg/day 300 mg/day Patients in 300 mg fixed dosage arms were continued on quetiapine fumarate immediate- release 300 mg/day, from day 4 onward.
In clinical trials that had a fixed 600 mg dosage arm, quetiapine fumarate immediate-release 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.
). 4% (2/527) on active control drugs. The risk of hypotension and syncope may be reduced by more gradual titration to the target dose (see 4 DOSAGE AND ADMINISTRATION). , dehydration, hypovolemia and treatment with antihypertensive medications) (see 5 OVERDOSAGE).
QT Prolongation:
In clinical trials, quetiapine was not associated with a persistent increase in absolute QT intervals. However, the QT effect was not systematically evaluated in a thorough QT study. In post-marketing experience, there have been cases reported of QT prolongation at therapeutic doses in patients with concomitant illness and in patients taking medicines known to cause electrolyte imbalance or increase QT interval, and with overdose (see 5 OVERDOSAGE)).
As with other antipsychotics, caution should be exercised when quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation. , the elderly, patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalemia, or hypomagnesemia (see
, Musculoskeletal, Rhabdomyolysis 03/2022 7 WARNINGS AND PRECAUTIONS, Psychiatric 03/2022 7 WARNINGS AND PRECAUTIONS, Skin 03/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
4 1 INDICATIONS ...................................................................................................................... 1. Pediatrics ..................................................................................................................
2. Geriatrics .................................................................................................................. 4 2 CONTRAINDICATIONS .......................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ..................................................................................... 1. Dosing Considerations ..............................................................................................
2. Recommended Dose and Dosage Adjustment ......................................................... 4. Administration ........................................................................................................... 5. Missed Dose .............................................................................................................
7 5 OVERDOSAGE ................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 8 7 WARNINGS AND PRECAUTIONS ......................................................................................
1. 1. 2. 3. 4. 1. 2. 1. 3. 4. 5. 2. 3. 4. 5. 6. 7. 1. 2. 3. 38 PART II : SCIENTIFIC INFORMATION .................................................................................... 1. 3. 41 15 MICROBIOLOGY […]
RIVA-QUETIAPINE (quetiapine fumarate immediate-release) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. RIVA-QUETIAPINE - Product Monograph Page 5 of 61
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Antidepressant efficacy was demonstrated with quetiapine fumarate immediate-release 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. RIVA-QUETIAPINE should be administered once daily at bedtime. 1 Special Populations). 1 Special Populations). Given the limited experience with quetiapine fumarate in the elderly, and the higher incidence of concomitant illness and concomitant medication in this population, RIVA- 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.
3 Pharmacokinetics, Special Populations and Conditions). Therefore, RIVA-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.
3 Pharmacokinetics, Special Populations and Conditions).
Renal Impairment:
As clinical experience is lacking, caution is advised (see 7 WARNINGS AND PRECAUTIONS, Renal). 4. Administration RIVA-QUETIAPINE is for oral use only. 3 Pharmacokinetics). 5. 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.