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ACH-QUETIAPINE FUMARATE XR is a brand name for Quetiapine, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). Transaminase Elevations Asymptomatic, transient and reversible elevations in serum transaminases (primarily ALT) associated with quetiapine fumarate extended-release have been reported. The proportions of patients with transaminase elevations of >3 times the upper limits of the normal reference range in a pool of placebo-controlled trials were approximately 1% for both quetiapine fumarate extended-release and placebo.
During premarketing clinical trials, therapy with quetiapine fumarate immediate-release was associated with elevation of hepatic transaminases, primarily ALT. 2% (3/1892) had elevations to >400 IU/L. No patients had values in excess of 800 IU/L.
None of the quetiapine fumarate immediate- release-treated patients who had elevated transaminase values manifested clinical symptomatology associated with liver impairment. The majority of transaminase elevations were seen during the first two months of treatment.
Most elevations were transient (80%) while patients continued on quetiapine fumarate immediate-release therapy. Of the 101 quetiapine fumarate immediate-release-treated patients whose enzyme levels increased to >120 IU/L, 40 discontinued treatment while their ALT values were still raised.
In 114 quetiapine fumarate immediate-release-treated patients whose baseline ALT was >90 IU/L, only 1 experienced an elevation to >400 IU/L. Precautions should be exercised when using quetiapine in patients with pre-existing hepatic disorders, in patients who are being treated with potentially hepatotoxic drugs, or if treatment- emergent signs or symptoms of hepatic impairment appear.
Hepatic failure, including fatalities, has also been reported very rarely during the post- ACH-Quetiapine Fumarate XR (Quetiapine Fumarate Extended-Release Tablets) Page 19 of 85 marketing period. There have been rare reports of hepatitis in clinical studies.
Rare post- marketing reports of hepatitis (with or without jaundice), in patients with or without prior history, have been received. Very rare cases of hepatic steatosis, cholestatic or mixed liver injury have also been reported in the post-marketing period.
For patients who have known or suspected abnormal hepatic function prior to starting quetiapine, standard clinical assessment, including measurement of transaminase levels is recommended. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data).
Pancreatitis Pancreatitis has been reported in clinical trials and during post marketing experience. Among post marketing reports, while not all cases were confounded by risk factors, many patients had factors which are known to be associated with pancreatitis such as increased triglycerides (see 7 WARNINGS AND PRECAUTIONS - Endocrine and Metabolism), gallstones, and alcohol consumption.
and 14 CLINICAL TRIALS). In MDD, the safety of doses above 300 mg/day has not been evaluated. , antipsychotics), may be dose-related (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). The ACH-Quetiapine Fumarate XR dose should thus be periodically reassessed to achieve and maintain the lowest effective dose.
Furthermore, as the long-term safety of quetiapine fumarate extended-release in MDD has not been systematically evaluated, the physician who elects to use ACH-Quetiapine Fumarate XR in the treatment of MDD should use ACH-Quetiapine Fumarate XR for the shortest time that is clinically indicated.
When long- term treatment is believed to be indicated, the physician must periodically re-evaluate the long- term usefulness of the drug for the individual patient keeping in mind the long-term risks. Switching patients from Quetiapine Fumarate Immediate-Release Tablets to ACH-Quetiapine Fumarate XR Tablets For more convenient dosing, patients who are currently being treated with divided doses of quetiapine fumarate immediate-release formulation may be switched to ACH-Quetiapine Fumarate XR at the equivalent total daily dose taken once daily.
Individual dosage adjustments may be necessary. ACH-Quetiapine Fumarate XR (Quetiapine Fumarate Extended-Release Tablets) Page 8 of 85 Switching patients from other antidepressants For many antidepressants, a gradual taper is recommended prior to complete discontinuation of the drug (physicians should refer to the approved Product Monograph of the specific antidepressant).
There are no systematically collected data to address switching patients from other antidepressants to ACH-Quetiapine Fumarate XR. Generally there should be no need for a wash-out period between stopping an antidepressant and starting ACH-Quetiapine Fumarate XR.
The physician may elect to initiate ACH-Quetiapine Fumarate XR treatment while tapering the antidepressant, however patients may experience additive side effects during the overlap period. Switching patients from other antipsychotics There are no systematically collected data to specifically address switching patients from other antipsychotics to ACH-Quetiapine Fumarate XR, or concerning concomitant administration with other antipsychotics.
, Musculoskeletal - Rhabdomyolysis 02/2022 7 WARNINGS AND PRECAUTIONS, Psychiatric 02/2022 7 WARNINGS AND PRECAUTIONS, Skin 02/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics ................................................................................................................... 2 Geriatrics ...................................................................................................................
5 2 CONTRAINDICATIONS ................................................................................................. 5 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 .............................................................................................................. 9 5 OVERDOSAGE ...........................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Musculoskeletal Rhabdomyolysis Quetiapine may cause rhabdomyolysis at recommended doses, and in the absence of neuroleptic malignant syndrome (NMS). Serious outcomes including compartment syndrome, acute renal failure, and fatalities have been reported.
Consider discontinuing quetiapine if markedly elevated creatine kinase concentrations are observed or myopathy is suspected or diagnosed. Neurologic Neuroleptic Malignant Syndrome Neuroleptic Malignant Syndrome is a potentially fatal symptom complex that has been reported in association with antipsychotic drugs, including quetiapine.
The clinical manifestations of NMS are hyperthermia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.
) and untreated or inadequately treated extrapyramidal signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system pathology.
The management of NMS should include immediate discontinuation of antipsychotic drugs, ACH-Quetiapine Fumarate XR (Quetiapine Fumarate Extended-Release Tablets) Page 20 of 85 including quetiapine, and other drugs not essential to concurrent therapy; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems for which specific treatments are available.
There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered.
The patient should be carefully monitored since recurrences of NMS have been reported. Tardive Dyskinesia (TD) and Extrapyramidal Symptoms (EPS) Tardive Dyskinesia is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic drugs including quetiapine.
Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon estimates to predict which patients are likely to develop the syndrome. In placebo-controlled clinical trials for schizophrenia and bipolar mania the incidence of EPS was no different from that of placebo across the recommended […]
While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.
When switching patients from depot antipsychotics, if medically appropriate, initiate ACH-Quetiapine Fumarate XR therapy in place of next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 Special Populations). Geriatric Use As with other antipsychotics, ACH-Quetiapine Fumarate XR should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration of ACH-Quetiapine Fumarate XR may need to be slower, and the daily therapeutic target dose lower, than that used in younger patients.
1 Special Populations). Given the limited experience with quetiapine fumarate extended-release in the elderly, and the higher incidence of concomitant illness and concomitant medication in this population, ACH-Quetiapine Fumarate ACH-Quetiapine Fumarate XR (Quetiapine Fumarate Extended-Release Tablets) Page 9 of 85 XR should be used with caution.
The mean plasma clearance of quetiapine fumarate immediate- release was reduced by 30% to 50% in elderly subjects when compared to younger patients. , 50 mg/day) of ACH- Quetiapine Fumarate XR. The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerance of the individual patient.
In elderly patients with MDD, initial dosing should begin at 50 mg on Days 1-3, the dose can be increased to 100 mg on Day 4, and 150 mg on Day 8 (see 14 CLINICAL TRIALS). 3 Pharmacokinetics - Special Populations and Conditions). Therefore, ACH-Quetiapine Fumarate XR should be used with caution in patients with mild hepatic impairment, especially during the initial dosing period.
, 50 mg/day) of ACH-Quetiapine Fumarate XR. The dose should be increased daily in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerance in the individual patient. No pharmacokinetic data are available for quetiapine 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 ACH-Quetiapine Fumarate XR is for oral use only.
ACH-Quetiapine Fumarate XR tablets should be […]
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 11 7 WARNINGS AND PRECAUTIONS ................................................................................ 1 Special Populations .................................................................................................
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics ...........................................................................................................
4 Geriatrics ........................................................................................................... 24 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions............................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics .....................................................
3 Less Common Clinical Trial Adverse Reactions ....................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ..............................................................................................................
5 Post-Market Adverse Reactions .............................................................................. 45 9 DRUG INTERACTIONS................................................................................................ 2 Drug Interactions Overview ....................................................................................
3 Drug-Behavioural Interactions ................................................................................ 4 Drug-Drug Interactions............................................................................................ 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions ........................................................................................... 7 Drug-Laboratory Test Interactions .......................................................................... 49 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action .............................................................................................. 2 Pharmacodynamics .................................................................................................
3 Pharmacokinetics .................................................................................................... 51 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 53 12 SPECIAL HANDLING INSTRUCTIONS ...........................................................................
53 PART II: SCIENTIFIC INFORMATION....................................................................................... 54 13 PHARMACEUTICAL INFORMATION ............................................................................ 54 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trial by Indication ........................................................................................ 3 Comparative Bioavailability Studies ........................................................................ 62 15 MICROBIOLOGY […]