Quetiapine Fumarate (Page 8 of 14)

8.2 Lactation

Risk Summary

Limited data from published literature report the presence of quetiapine in human breast milk at relative infant dose of <1% of the maternal weight-adjusted dosage. There are no consistent adverse events that have been reported in infants exposed to quetiapine through breast milk. There is no information on the effects of quetiapine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for quetiapine extended-release tablet and any potential adverse effects on the breastfed child from quetiapine extended-release tablet or from the mother’s underlying condition.

8.3 Females and Males of Reproductive Potential

Infertility

Females

Based on the pharmacologic action of quetiapine (D2 antagonism), treatment with quetiapine extended-release tablet may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see WARNINGS AND PRECAUTIONS (5.15)].

8.4 Pediatric Use

Safety and effectiveness of quetiapine extended-release tablet is supported by studies of quetiapine tablet for schizophrenia in adolescent patients 13 to 17 years of age and in bipolar mania in children and adolescent patients 10 to 17 years of age [see CLINICAL STUDIES (14.1 and 14.2)].

In general, the adverse reactions observed in children and adolescents during the clinical trials with quetiapine tablet were similar to those in the adult population with few exceptions. Increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults. Orthostatic hypotension occurred more frequently in adults (4 to 7%) compared to children and adolescents (< 1%) [see WARNINGS AND PRECAUTIONS (5.7) and ADVERSE REACTIONS (6.1)].

Bipolar Depression

The effectiveness of quetiapine extended-release tablet for the treatment of bipolar depression in patients under the age of 18 years has not been established. One 8-week trial was conducted to evaluate the safety and efficacy of quetiapine extended-release tablet in the treatment of bipolar depression in pediatric patients 10 to 17 years of age. The primary objective of the study was to evaluate whether quetiapine extended-release tablet at a dose of 150 to 300 mg/day demonstrated superior efficacy (as measured by change in CDRS-R total score from baseline to end of 8 weeks) compared to placebo in children and adolescents 10 to 17 years of age with bipolar depression. A total of 193 patients with bipolar depression were randomized to placebo or quetiapine extended-release tablet. The primary results of this study did not show a difference between quetiapine extended-release tablet and placebo in decreasing depression symptoms in children and adolescents with bipolar disorder. In this study, patients treated with quetiapine extended-release tablet exhibited metabolic changes, weight gain, increases in blood pressure and increases in heart rate [see WARNINGS AND PRECAUTIONS (5.5, 5.9) and ADVERSE REACTIONS (6.1)].

Some differences in the pharmacokinetics of quetiapine were noted between children/adolescents (10 to 17 years of age) and adults. When adjusted for weight, the AUC and Cmax of quetiapine were 41% and 39% lower, respectively, in children and adolescents compared to adults. The pharmacokinetics of the active metabolite, norquetiapine, were similar between children/adolescents and adults after adjusting for weight [see CLINICAL PHARMACOLOGY (12.3)].

Schizophrenia

The efficacy and safety of quetiapine extended-release tablet in the treatment of schizophrenia in adolescents aged 13 to 17 years is supported by one 6-week, double-blind, placebo-controlled trial with quetiapine tablet [see INDICATIONS AND USAGE (1.1), DOSAGE AND ADMINISTRATION (2.2), ADVERSE REACTIONS (6.1), and CLINICAL STUDIES (14.1)].

Safety and effectiveness of quetiapine extended-release tablet in pediatric patients less than 13 years of age with schizophrenia have not been established.

The safety and effectiveness of quetiapine extended-release tablet in the maintenance treatment of schizophrenia has not been established in patients less than 18 years of age.

Bipolar Mania

The efficacy and safety of quetiapine extended-release tablet in the treatment of bipolar mania in children and adolescents ages 10 to 17 years is supported by one 3-week, double-blind, placebo controlled trial with quetiapine tablet [see INDICATIONS AND USAGE (1.2), DOSAGE AND ADMINISTRATION (2.2), ADVERSE REACTIONS (6.1), and CLINICAL STUDIES (14.2)].

Safety and effectiveness of quetiapine extended-release tablet in pediatric patients less than 10 years of age with bipolar mania have not been established.

The safety and effectiveness of quetiapine extended-release tablet in the maintenance treatment of bipolar disorder has not been established in patients less than 18 years of age.

8.5 Geriatric Use

Sixty-eight patients in clinical studies with quetiapine extended-release tablet were

65 years of age or over. In general, there was no indication of any different tolerability of quetiapine extended-release tablet in the elderly compared to younger adults. Nevertheless, the presence of factors that might decrease pharmacokinetic clearance, increase the pharmacodynamic response to quetiapine extended-release tablet, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period in the elderly. The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients [see DOSAGE AND ADMINISTRATION (2.3) and CLINICAL PHARMACOLOGY (12.3)].

8.6 Renal Impairment

Clinical experience with quetiapine extended-release tablet in patients with renal impairment is limited [see CLINICAL PHARMACOLOGY (12.3)].

8.7 Hepatic Impairment

Since quetiapine is extensively metabolized by the liver, higher plasma levels are expected in patients with hepatic impairment. In this population, a low starting dose of 50 mg/day is recommended and the dose may be increased in increments of 50 mg/day [see DOSAGE AND ADMINISTRATION (2.4) and CLINICAL PHARMACOLOGY (12.3)].

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Quetiapine is not a controlled substance.

9.2 Abuse

Quetiapine extended-release tablet has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of quetiapine extended-release tablet (e.g., development of tolerance, increases in dose, drug-seeking behavior).

10 OVERDOSAGE

10.1 Human Experience

In clinical trials, survival has been reported in acute overdoses of up to 30 grams of quetiapine. Most patients who overdosed experienced no adverse reactions or recovered fully from the reported events. Death has been reported in a clinical trial following an overdose of 13.6 grams of quetiapine alone. In general, reported signs and symptoms were those resulting from an exaggeration of the drug’s known pharmacological effects, i.e., drowsiness, sedation, tachycardia, hypotension, and anticholinergic toxicity including coma and delirium. Patients with pre-existing severe cardiovascular disease may be at an increased risk of the effects of overdose [see WARNINGS AND PRECAUTIONS (5.12)]. One case, involving an estimated overdose of 9600 mg, was associated with hypokalemia and first degree heart block. In post-marketing experience, there were cases reported of QT prolongation with overdose.

10.2 Management of Overdosage

Establish and maintain an airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.

Appropriate supportive measures are the mainstay of management. For the most up-to-date information on the management of quetiapine extended-release tablet overdosage, contact a certified Regional Poison Control Center (1-800-222-1222).

Quetiapine extended-release tablet overdose may lead to gastric bezoar formation and appropriate diagnostic imaging is recommended to further guide patient management. Routine gastric lavage may not be effective in the removal of the bezoar due to gum like sticky consistency of the mass. Endoscopic pharmacobezoar removal has been performed successfully.

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