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AG-QUETIAPINE FUMARATE is a brand name for Quetiapine, supplied as a tablet (immediate release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................ 4 WARNINGS AND PRECAUTIONS ............................................................................... 4…
Verbatim from this product's HC label. Tap a section to expand.
The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Overview of Clinical Trial and Post Market Adverse Drug Reactions The most commonly reported adverse drug reactions in both clinical trials and during post- marketing experience with quetiapine (≥10%) are somnolence dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
Clinical Trial Adverse Drug Reactions The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials.
Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The figures cited, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the populations studied.
9% of placebo-treated patients (n=206). Somnolence, the single most common adverse event leading to withdrawal from quetiapine treatment, led to the withdrawal of four quetiapine- treated patients and no placebo-treated patients. 5% of placebo-treated subjects.
1%). 3% for placebo. Sedation, somnolence and dizziness were the most common adverse events leading to discontinuation in the quetiapine fumarate treatment groups.
Combined Short- and Long-term Controlled Trial Database in Schizophrenia:
In a premarketing controlled clinical trial database of 1710 quetiapine fumarate- treated patients, 5% discontinued due to an adverse event. Somnolence was the single most common adverse event leading to withdrawal of 24 patients from quetiapine fumarate, and was the only adverse event leading to withdrawal that occurred in more than Page 17 of 59 1% of patients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Quetiapine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
, postural hypotension, hypotension, tachycardia, dizziness) accounted for 20% of all subject withdrawals from quetiapine treatment. 9%) quetiapine-treated subjects were withdrawn due to elevated liver enzymes. Four quetiapine-treated subjects were withdrawn because of leucopenia.
Two of these subjects had at least one clinically significant, non-baseline low neutrophil count. Two quetiapine-treated subjects were withdrawn from the trial because of suspected neuroleptic malignant syndrome (NMS). Commonly Observed Adverse Events in Short-Term Placebo-Controlled Clinical Trials Schizophrenia: The following treatment-emergent adverse events, derived from Table 1, commonly occurred during acute therapy with quetiapine fumarate (incidence of at least 5%, and an incidence at least 5% higher than that observed with placebo): somnolence, dizziness, dry mouth, postural hypotension, and elevated ALT levels.
Bipolar Disorder:
Bipolar Mania: In the bipolar mania studies, the following treatment-emergent adverse events commonly occurred during acute therapy with AG-Quetiapine Fumarate (incidence of at least 5%, and an incidence at least 5% higher than that observed with placebo): somnolence, dry mouth, and weight gain.
Bipolar Depression:
In the bipolar depression studies, the following treatment-emergent adverse events commonly occurred during acute therapy with quetiapine fumarate (incidence of at least 5%, and an incidence at least 5% higher than that observed with placebo): dry mouth, somnolence, sedation, dizziness and constipation.
Incidence of Adverse Events in Placebo-Controlled Clinical Trials Certain portions of the discussion below relating to objective or numeric safety parameters are derived from studies in patients with schizophrenia and have not been duplicated for bipolar mania trials.
However, this information is also generally applicable to bipolar mania. Table 1 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy (up to 6 weeks) of schizophrenia in 1% or more of patients treated with quetiapine fumarate (doses of 150 mg/day or more) where the incidence in patients treated with quetiapine fumarate was greater than the incidence in placebo-treated patients.
Page 18 of 59 Table 1 Adverse Events Reported for at least 1% of Quetiapine Fumarate-Treated Subjects (Doses ≥150 mg/day) and for a Higher Percentage of Quetiapine Fumarate-Treated Subjects than Subjects Who Received Placebo in Short-Term, Placebo- Controlled Schizophrenia Phase II- III Trials Body system and COSTART Term Percentage of subjects with adverse events* Quetiapine Fumarate (n = 449) Placebo (n = 202) Whole body Headache 20 17 Abdominal pain 4 1 Back pain 2 1 Fever 2 1 Nervous system Somnolence 18 11 Dizziness 10 4 Digestive system Constipation 9 5 Dry mouth 7 2 Dyspepsia 6 2 Gamma glutamyl transpeptidase increased 2 1 Cardiovascular system Postural hypotension 8 2 Tachycardia 7 5 […]