Seroquel 25 mg tablet picture

In clinical trials, no additional benefit was seen in the mg group compared to the mg group see section 5. Individual patients may benefit from a mg dose. Doses greater than mg should be initiated by physicians experienced in treating bipolar disorder. In individual patients, in the event of tolerance concerns, clinical trials have indicated that dose reduction to a minimum of mg could be considered. For preventing recurrence in bipolar disorder For preventing recurrence of manic, mixed or depressive episodes in bipolar disorder, patients who have responded to quetiapine for acute treatment of bipolar disorder should continue therapy at the same dose.

It is important that the lowest effective dose is used for maintenance therapy. Elderly As with other antipsychotics, Seroquel should be used with caution in the elderly, especially during the initial dosing period.

The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient.

Efficacy and safety has not been evaluated in patients over 65 years with depressive episodes in the framework of bipolar disorder. Paediatric population Seroquel is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group.

The available evidence from placebo-controlled clinical trials is presented in sections 4. Renal impairment Dosage adjustment is not necessary in patients with renal impairment.

Hepatic impairment Quetiapine is extensively metabolised by the liver. Therefore, Seroquel should be used with caution in patients with known hepatic impairment, especially during the initial dosing period. Concomitant administration of cytochrome P 3A4 inhibitors, such as HIV-protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone, is contraindicated see section 4. Paediatric population Quetiapine is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group.

Clinical trials with quetiapine have shown that in addition to the known safety profile identified in adults see section 4. Changes in thyroid function tests have also been observed in children and adolescents.

Furthermore, the long-term safety implications of treatment with quetiapine on growth and maturation have not been studied beyond 26 weeks. Long-term implications for cognitive and behavioural development are not known. In placebo-controlled clinical trials with children and adolescent patients, quetiapine was associated with an increased incidence of extrapyramidal symptoms EPS compared to placebo in patients treated for schizophrenia, bipolar mania and bipolar depression see section 4.

This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. In addition, physicians should consider the potential risk of suicide-related events after abrupt cessation of quetiapine treatment, due to the known risk factors for the disease being treated.

Other psychiatric conditions for which quetiapine is prescribed can also be associated with an increased risk of suicide related events. In addition, these conditions may be co-morbid with major depressive episodes.

The same precautions observed when treating patients with major depressive episodes should therefore be observed when treating patients with other psychiatric disorders. Patients with a history of suicide related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

A meta analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.

Patients and caregivers of patients should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

In shorter-term placebo controlled clinical studies of patients with major depressive episodes in bipolar disorder an increased risk of suicide-related events was observed in young adult patients younger than 25 years of age who were treated with quetiapine as compared to those treated with placebo 3. A population-based retrospective study of quetiapine for the treatment of patients with major depressive disorder showed an increased risk of self-harm and suicide in patients aged 25 to 64 years without a history of self-harm during use of quetiapine with other antidepressants.

Metabolic risk Given the observed risk for worsening of their metabolic profile, including changes in weight, blood glucose see hyperglycaemia and lipids, which was seen in clinical studies, patients' metabolic parameters should be assessed at the time of treatment initiation and changes in these parameters should be regularly controlled for during the course of treatment.

Worsening in these parameters should be managed as clinically appropriate see also section 4. Extrapyramidal symptoms In placebo controlled clinical trials of adult patients quetiapine was associated with an increased incidence of extrapyramidal symptoms EPS compared to placebo in patients treated for major depressive episodes in bipolar disorder see sections 4. The use of quetiapine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.

This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental. Tardive dyskinesia If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of quetiapine should be considered.

The symptoms of tardive dyskinesia can worsen or even arise after discontinuation of treatment see section 4. Somnolence and dizziness Quetiapine treatment has been associated with somnolence and related symptoms, such as sedation see section 4.

In clinical trials for treatment of patients with bipolar depression, onset was usually within the first 3 days of treatment and was predominantly of mild to moderate intensity. Patients experiencing somnolence of severe intensity may require more frequent contact for a minimum of 2 weeks from onset of somnolence, or until symptoms improve and treatment discontinuation may need to be considered.

Orthostatic hypotension Quetiapine treatment has been associated with orthostatic hypotension and related dizziness see section 4. This could increase the occurrence of accidental injury fall , especially in the elderly population. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.

Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Dose reduction or more gradual titration should be considered if orthostatic hypotension occurs, especially in patients with underlying cardiovascular disease. Sleep apnoea syndrome Sleep apnoea syndrome has been reported in patients using quetiapine. Seizures In controlled clinical trials there was no difference in the incidence of seizures in patients treated with quetiapine or placebo.

No data is available about the incidence of seizures in patients with a history of seizure disorder. As with other antipsychotics, caution is recommended when treating patients with a history of seizures see section 4.

Neuroleptic malignant syndrome Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine see section 4. Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatine phosphokinase. In such an event, quetiapine should be discontinued and appropriate medical treatment given.

Most cases of severe neutropenia have occurred within a couple of months of starting therapy with quetiapine. There was no apparent dose relationship. During post-marketing experience, some cases were fatal. Possible risk factors for neutropenia include pre-existing low white blood cell count WBC and history of drug induced neutropenia. However, some cases occurred in patients without pre-existing risk factors. Patients should be observed for signs and symptoms of infection and neutrophil counts followed until they exceed 1.

Neutropenia should be considered in patients presenting with infection or fever, particularly in the absence of obvious predisposing factor s , and should be managed as clinically appropriate.

Such patients should have a WBC count and an absolute neutrophil count ANC performed promptly, especially in the absence of predisposing factors. Anti-cholinergic muscarinic effects Norquetiapine, an active metabolite of quetiapine, has moderate to strong affinity for several muscarinic receptor subtypes.

This contributes to ADRs reflecting anti-cholinergic effects when quetiapine is used at recommended doses, when used concomitantly with other medications having anti-cholinergic effects, and in the setting of overdose. Quetiapine should be used with caution in patients receiving medications having anti-cholinergic muscarinic effects. Quetiapine should be used with caution in patients with a current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, intestinal obstruction or related conditions, increased intraocular pressure or narrow angle glaucoma see sections 4.

Interactions See section 4. Concomitant use of quetiapine with a strong hepatic enzyme inducer such as carbamazepine or phenytoin substantially decreases quetiapine plasma concentrations, which could affect the efficacy of quetiapine therapy.

In patients receiving a hepatic enzyme inducer, initiation of quetiapine treatment should only occur if the physician considers that the benefits of quetiapine outweigh the risks of removing the hepatic enzyme inducer.

It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer e. Weight Weight gain has been reported in patients who have been treated with quetiapine, and should be monitored and managed as clinically appropriate as in accordance with utilised antipsychotic guidelines see sections 4. Before using this medication , tell your doctor or pharmacist your medical history, especially of: This drug may make you dizzy or drowsy or blur your vision.

Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Talk to your doctor if you are using marijuana. Quetiapine may cause a condition that affects the heart rhythm QT prolongation.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using quetiapine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation.

Talk to your doctor about using quetiapine safely. This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs.

When the weather is hot, drink a lot of fluids and dress lightly.

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