quetiapine fumarate


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quetiapine fumarate

Seroquel, Seroquel XR

Pharmacologic class: Dibenzothiazepine derivative

Therapeutic class: Atypical antipsychotic

Pregnancy risk category C

Action

Unknown. Antipsychotic effects may occur through antagonism of dopamine D2 and serotonin 5-HT2 receptors. Other effects may result partly from antagonism of other receptors, such as histamine H1 and alpha1-adrenergic receptors.

Availability

Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg

Tablets (extended-release): 50 mg, 150 mg, 200 mg, 300 mg, 400 mg

Indications and dosages

Schizophrenia

Adults: Initially, 25 mg P.O. b.i.d., on day 1, increased by 25 to 50 mg given two to three times daily on days 2 and 3 to range of 300 to 400 mg by day 4. Further adjustments can be made in increments of 25 to 50 mg b.i.d. in intervals of not less than 2 days. Recommended dosage range is 150 to 750 mg/day. Or, 300 mg P.O. (extended-release tablet) once daily, preferably in evening; dosage should be titrated to 400 to 800 mg based on response and tolerability. Dosage increases may be done at 1-day intervals at increments of up to 300 mg.

Children and adolescents ages 13 to 17: Immediate-release tablets administered twice daily, with total daily dosage for initial 5 days of therapy as 50 mg P.O. on day 1, 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and 400 mg on day 5. After day 5, adjust dosage within recommended range of 400 to 800 mg/day based on response and tolerability. Make dosage adjustments in increments of no greater than 100 mg/day. Based on response and tolerability, may administer three times daily.

Acute manic episodes associated with bipolar I disorder

Adults: Immediate-release tablets administered twice daily, with total daily dosages as 100 mg P.O. on day 1, 200 mg on day 2, 300 mg on day 3, and 400 mg on day 4. Increase in increments of no more than 200 mg/day up to 800 mg/day by day 6. Recommended dosage range is 400 to 800 mg/day. May be given as monotherapy or as adjunctive therapy with lithium or divalproex. Or, extended-release tablets 300 mg P.O. on day 1,600 mg on day 2, and 400 to 800 mg on day 3. Recommended dosage range is 400 to 800 mg/day.

Children and adolescents ages 10 to 17: Immediate-release tablets administered twice daily, with total daily dosage for initial 5 days of therapy as 50 mg P.O. on day 1,100 mg on day 2, 200 mg on day 3,300 mg on day 4, and 400 mg on day 5. After day 5, adjust dosage within recommended range of 400 to 600 mg/day based on response and tolerability. Adjust dosage in increments of no more than 100 mg/day. Based on response and tolerability, may administer three times daily.

Depression associated with bipolar disorder

Adults: Immediate-release or extended-release tablets administered once daily at bedtime as 50 mg P.O. on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. Maximum dosage is 300 mg/day.

Adjunctive treatment of major depressive disorder

Adults: Initially, 50 mg (extended-release) P.O once daily in the evening on days 1 and 2 and 150 mg (extended-release) P.O. once daily on days 3 and 4 as adjunct to existing antidepressive therapy. Recommended dosage is 150 to 300 mg/day.

Dosage adjustment

• Hepatic impairment
• History of hypotensive reactions
• Elderly or debilitated patients

Off-label uses

• Bipolar disorder
• Mania
• Obsessive-compulsive disorder
• Posttraumatic stress disorder
• Psychosis related to Parkinson's disease

Contraindications

• None

Precautions

Use cautiously in:
• diabetes mellitus, hepatic impairment, cardiovascular disease (including family history of QT-interval prolongation, congestive heart failure, and cardiac hypertrophy), cerebrovascular disease, dehydration, hypovolemia, Alzheimer's dementia, hypothyroidism
• history of seizures, suicide attempt, or hypotensive reactions
• history of cardiac arrhythmias such as bradycardia, hypokalemia or hypomagnesemia, concurrent use of other drugs that prolong the QTc interval, congenital QT-interval prolongation (avoid use)
• concurrent use of drugs known to cause electrolyte imbalance
• elderly or debilitated patients
• pregnant patients
• children (safety not established).

Administration

• Monitor fasting blood lipids before treatment.
• Give immediate-release tablets with or without food; give extended-release tablets without food or with a light meal.

Don't confuse Seroquel with Serzone (an antidepressant).

Adverse reactions

CNS: dizziness, sedation, cognitive impairment, extrapyramidal symptoms, tardive dyskinesia, neuroleptic malignant syndrome, seizures, suicide

CV: tachycardia, palpitations, peripheral edema, ­orthostatic hypotension, hypertension, QT-interval prolongation

EENT: cataracts, ear pain, rhinitis, pharyngitis

GI: constipation, dyspepsia, dry mouth, anorexia

Hematologic: leukopenia

Metabolic: hypothyroidism

Respiratory: cough, dyspnea

Skin: diaphoresis

Other: weight gain, flulike symptoms, acute withdrawal symptoms with abrupt cessation

Interactions

Drug-drug.Antihistamines, opioids, sedative-hypnotics, other CNS depressants: additive CNS depression

Antibiotics (such as gatifloxacin, moxifloxacin), antipsychotics (such as chlorpromazine, thioridazine, ziprasidone), Class 1A antiarrhythmics (such as procainamide, quinidine), Class III antiarrhythmics (such as amiodarone, sotalol), drugs known to prolong QTc interval (such as levomethadyl acetate, methadone, pentamidine): increased risk of prolonged QTc interval

Antihypertensives: increased risk of hypotension

Barbiturates, carbamazepine, corticosteroids, phenytoin, rifampin, thioridazine: increased clearance and decreased efficacy of quetiapine

Dopamine agonists, levodopa: antagonism of these drugs' effects

Erythromycin, fluconazole, itraconazole, ketoconazole, other CYP450-3A4 inhibitors: increased quetiapine effects

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase: asymptomatic elevations

Total cholesterol, triglycerides: increased levels

Urine tricyclic antidepressant assay: false-positive screen

White blood cells: decreased count

Drug-behaviors.Alcohol use: increased CNS effects

Patient monitoring

Monitor neurologic status, especially for signs and symptoms of tardive dyskinesia, suicidal ideation, or neuroleptic malignant syndrome.
• Be aware that patient should undergo lens examination when starting treatment and at 6-month intervals during long-term treatment.
• Monitor blood pressure for orthostatic hypotension.

Monitor patient closely for prolonged QT interval.
• Monitor fasting blood lipids periodically during treatment.

Monitor CBC and differential in patients with preexisting low white blood cell (WBC) count; discontinue drug at first sign of WBC decrease in absence of other causes.

Patient teaching

• Tell patient to take immediate-release tablets with or without food and to take extended-release form preferably in the evening, swallowed whole, without food or with a light meal.
• Instruct patient not to crush, break, or chew extended-release tablets.

Teach patient to recognize and immediately report signs and symptoms of neuroleptic malignant syndrome (such as high fever, sweating, unstable blood pressure, stupor, muscle rigidity, changes in mood or behavior and tardive dyskinesia) and prolonged QT interval.
• Instruct patient to move slowly when sitting up or standing, to avoid dizziness from sudden blood pressure decrease.

Tell patient not to stop taking drug abruptly. Tell him dosage must be tapered.
• Caution patient not to drink alcohol.
• Instruct patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

quetiapine fumarate

Seroquel® Pharmacology An agent used to manage psychotic disorders–eg schizophrenia
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References in periodicals archive ?
2015 Market Research Report on Global Quetiapine Fumarate Industry is a professional and in-depth study on the current state of the Global Quetiapine Fumarate Industry with a focus on the Chinese situation.
The FDA's Psychopharmacologic Drugs Advisory Committee did not define instances in which quetiapine fumarate (Seroquel XR) might be safely prescribed for MDD.
Breckenridge's Quetiapine Fumarate Tablets are supplied under a deal with Medikl, Ltd Cyprus and are manufactured and supplied by Alembic Pharmaceutical's, the ANDA holder.
Quetiapine fumarate appears to have greater safety in overdose than the traditional antipsychotic agents and its toxicity is consistent with its receptor profile.
Under the terms of the agreement, Par has made a payment for the ANDA and for exclusive rights to market, sell and distribute quetiapine fumarate extended-release tablets in the U.
Reddy's Quetiapine fumarate tablets in 25 mg and 50 mg are available in 100 and 500 count bottle sizes, 100 mg, 200 mg and 400 mg are available in 100 count bottle sizes and 300 mg is available in 60 count bottle sizes.
Other risks associated with quetiapine fumarate include but are not limited to neuroleptic malignant syndrome, diabetes mellitus, increased cholesterol and triglycerides, weight gain, increases and decreases in blood pressure, changes in blood counts, changes in ECGs and the formation of cataracts.
SEROQUEL XR, a once-daily, extended-release formulation of quetiapine fumarate, was approved in the US in 2007 for the treatment of schizophrenia in adult patients and in October 2008 for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.
SEROQUEL XR, a once-daily, extended-release tablet formulation of quetiapine fumarate, is approved in the US in adults for (1) add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; (4) long-term treatment of bipolar disorder with lithium or divalproex; and (5) schizophrenia.
TORONTO -- Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that the United States Food and Drug Administration (FDA) has accepted the Company's abbreviated new drug application (ANDA) for a generic formulation of 200mg, 300mg and 400mg strengths of quetiapine fumarate extended-release tablets (sold under the brand name Seroquel XR by AstraZeneca Pharmaceuticals LP).
July 31 /PRNewswire/ -- Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Quetiapine Fumarate Extended-Release Tablets, the generic version of AstraZeneca's SEROQUEL(R) XR, has been accepted for filing by the U.
Efficacy and safety of extended release Quetiapine fumarate (quetiapine XR) monotherapy in patients with generalized anxiety disorder (GAD) [poster].