Each a hundred and fifty mg pill contains a hundred and fifty mg quetiapine (as quetiapine fumarate)

For the total list of excipients, see section half dozen.1.

3. Pharmaceutical type
Prolonged-release pill

White, biconvex, rectangular film-coated tablets with embossing “Q 150” on one aspect.

4. Clinical particulars
4.1 Therapeutic indications
Alaquet XL is indicated for:

▪ treatment of psychosis,

▪ treatment of manic depressive illness :

o For the treatment of moderate to severe frenzied episodes in manic depressive illness

o For the treatment of major depressive episodes in manic depressive illness

o For the hindrance of repeat of frenzied or depressed episodes in patients with manic depressive illness WHO antecedently had quetiapine treatment

▪ add-on treatment of major depressive episodes in patients with Major clinical depression (MDD) WHO have had sub-optimal response to antidepressant drug monotherapy (see section five.1). before initiating treatment, clinicians ought to take into account the security profile of quetiapine (see section four.4).

4.2 pharmacological medicine and technique of administration
Posology

Different dosing schedules exist for every indication. It should thus be ensured that patients receive clear data on the acceptable indefinite quantity for his or her condition.

Adults:

For the treatment of psychosis and moderate to severe frenzied episodes in manic depressive illness

Alaquet XL ought to be administered a minimum of one hour before a meal. The daily dose at the beginning of medical aid is three hundred mg on Day one and 600 mg on Day a pair of. The suggested daily dose is 600 mg, but if clinically even the dose could also be inflated to 800 mg daily. The dose ought to be adjusted at intervals the effective dose vary of four hundred mg to 800 mg per day, counting on the clinical response and tolerability of the patient. For maintenance medical aid in psychosis no indefinite quantity adjustment is important.

For the treatment of major depressive episodes in manic depressive illness

Alaquet XL ought to be administered at hour. the whole daily dose for the primary four days of medical aid is fifty mg (Day 1), one hundred mg (Day 2), two hundred mg (Day 3) and three hundred mg (Day 4). The suggested daily dose is three hundred mg. In clinical trials, no further profit was seen within the 600 mg cluster compared to the three hundred mg cluster (see section five.1). Individual patients could have the benefit of a 600 mg dose. Doses bigger than three hundred mg ought to be initiated by physicians older in treating manic depressive illness. In individual patients, within the event of tolerance issues, clinical trials have indicated that dose reduction to a minimum of two hundred mg may well be thought of.

For preventing repeat in manic depressive illness

For preventing repeat of frenzied, mixed or depressive episodes in manic depressive illness, patients WHO have had Alaquet XL for acute treatment of manic depressive illness ought to continue on Alaquet XL at an equivalent dose administered at hour. Alaquet XL dose are often adjusted counting on clinical response and tolerability of the individual patient at intervals the dose vary of three hundred mg to 800 mg/day. it's necessary that rock bottom effective dose is employed for maintenance medical aid.

For add-on treatment of major depressive episodes in MDD:

Alaquet XL ought to be administered before hour. The daily dose at the beginning of medical aid is fifty mg on Day one and a pair of, and a hundred and fifty mg on Day three and four. antidepressant drug impact was seen at a hundred and fifty and three hundred mg/day in short trials as add-on medical aid (with amitriptyline hydrochloride, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, SSRI and venlafaxine - see section five.1) and at fifty mg/day in short monotherapy trials. there's associate degree inflated risk of adverse events at higher doses. Clinicians ought to thus make sure that rock bottom effective dose, beginning with fifty mg/day, is employed for treatment. the requirement to extend the dose from a hundred and fifty to three hundred mg/day ought to be supported individual patient analysis.

Switching from quetiapine immediate-release tablets:

For a lot of convenient dosing, patients WHO square measure presently being treated with divided doses of immediate unharness quetiapine tablets could also be switched to Alaquet XL at the equivalent total daily dose taken once daily. Individual indefinite quantity changes could also be necessary.

Elderly:

As with alternative antipsychotics and antidepressants, Alaquet XL ought to be used with caution within the aged, particularly throughout the initial dosing amount. the speed of dose volumetric analysis of Alaquet XL may have to be slower, and also the daily therapeutic dose lower, than that utilized in younger patients. The mean plasma clearance of quetiapine was reduced by half-hour to five hundredth in aged patients when put next to younger patients. aged patients ought to be started on fifty mg/day. The dose are often inflated in increments of fifty mg/day to a good dose, counting on the clinical response and tolerability of the individual patient.

In aged patients with major depressive episodes in MDD, dosing ought to begin with fifty mg/day on Days 1-3, increasing to one hundred mg/day on Day four and a hundred and fifty mg/day on Day eight. rock bottom effective dose, ranging from fifty mg/day ought to be used. supported individual patient analysis, if dose increase to three hundred mg/day is needed this could not be before Day twenty two of treatment.

Efficacy and safety has not been evaluated in patients over sixty five years with depressive episodes within the framework of manic depressive illness.

Paediatric population:

Alaquet XL isn't suggested to be used in youngsters and adolescents below eighteen years old-time, thanks to a scarcity of knowledge to support use during this age bracket. The accessible proof from placebo-controlled clinical trials is bestowed in sections four.4, 4.8, 5.1 and 5.2.

Renal impairment:

Dosage adjustment isn't necessary in patients with urinary organ impairment.

Hepatic impairment:

Quetiapine is extensively metabolized by the liver. Therefore, Alaquet XL ought to be used with caution in patients with better-known viscus impairment, particularly throughout the initial dosing amount. Patients with viscus impairment ought to be started on fifty mg/day. The dose are often inflated in increments of fifty mg/day to a good dose, counting on the clinical response and tolerability of the individual patient.

Method of administration

Alaquet XL ought to be administered once daily, while not food. The tablets ought to be engulfed whole and not split, chewed or crushed.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section half dozen.1.

Concomitant administration of haemoprotein P450 3A4 inhibitors, like HIV-protease inhibitors, azole-antifungal agents, Ethril, clarithromycin and antidepressant, is contraindicated (see section four.5).

4.4 Special warnings and precautions to be used
As Alaquet XL has many indications, the security profile ought to be thought of with regard to the individual patient's diagnosing and also the dose being administered.

Long-term effectuality and safety in patients with MDD has not been evaluated as add-on medical aid, but long-run effectuality and safety has been evaluated in adult patients as monotherapy (see section five.1).

Paediatric population

Quetiapine isn't suggested to be used in youngsters and adolescents below eighteen years old-time, thanks to a scarcity of knowledge to support use during this age bracket.

Clinical trials with quetiapine have shown that additionally to the better-known safety profile known in adults (see section four.8), sure adverse events occurred at the next frequency in youngsters and adolescents compared to adults (increased appetency, elevations in liquid body substance gonadotropin, vomiting, coryza and syncope) or could have completely different implications for youngsters and adolescents (extrapyramidal symptoms and irritability) and one was known that has not been antecedently seen in adult studies (increases in blood pressure). Changes in thyroid operate tests have additionally been ascertained in youngsters and adolescents.

Furthermore, the long-run safety implications of treatment with quetiapine on growth and maturation haven't been studied on the far side twenty six weeks. long-run implications for psychological feature and activity development aren't better-known.

In placebo-controlled clinical trials with youngsters and adolescent patients, quetiapine was related to associate degree inflated incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for psychosis, bipolar mania and bipolar depression (see section four.8).

Suicide/suicidal thoughts or clinical worsening:

Depression is related to associate degree inflated risk of unsafe thoughts, self-harm and suicide (suicide-related events). This risk persists till important remission happens. As improvement might not occur throughout the primary few weeks or a lot of of treatment, patients ought to be closely monitored till such improvement happens. it's general clinical expertise that the danger of suicide could increase within the early stages of recovery.

In addition, physicians ought to take into account the potential risk of suicide-related events when abrupt surcease of quetiapine treatment, thanks to the better-known risk factors for the unwellness being treated.

Other medical specialty conditions that quetiapine is prescribed may be related to associate degree inflated risk of suicide connected events. additionally, these conditions could also be co-morbid with major depressive episodes. an equivalent precautions ascertained once treating patients with major depressive episodes ought to thus be ascertained once treating patients with alternative medical specialty disorders.

Patients with a history of suicide connected events, or those exhibiting a big degree of unsafe thought before commencement of treatment square measure better-known to be at bigger risk of unsafe thoughts or suicide tries, and may receive careful observation throughout treatment. A meta associate degreealysis of placebo controlled clinical trials of antidepressant drug medication in adult patients with medical specialty disorders showed an inflated risk of unsafe behaviour with antidepressants compared to placebo in patients but twenty five years recent.

Close superintendence of patients and specially those at high risk ought to accompany drug medical aid particularly in early treatment and following dose changes. Patients (and caregivers of patients) ought to be alerted regarding the requirement to observe for any clinical worsening, unsafe behaviour or thoughts and strange changes in behaviour and to hunt medical recommendation forthwith if these symptoms gift.

In shorter-term placebo controlled clinical studies of patients with major depressive episodes in manic depressive illness associate degree inflated risk of suicide-related events was ascertained in young adult patients (younger than twenty five years of age) WHO were treated with quetiapine as compared to those treated with placebo (3.0% vs. 0%, respectively). In clinical studies of patients with MDD the incidence of suicide-related events ascertained in young adult patients (younger than twenty five years of age) was a pair of.1% (3/144) for quetiapine and one.3% (1/75) for placebo.

Metabolic Risk:

Given the ascertained risk for worsening of their metabolic profile, together with changes in weight, glucose (see hyperglycemia) and lipids, that was seen in clinical studies, patients' metabolic parameters ought to be assessed at the time of treatment initiation and changes in these parameters ought to be often controlled for throughout the course of treatment. Worsening in these parameters ought to be managed as clinically acceptable (see additionally section four.8).

Extrapyramidal symptoms:

In placebo controlled clinical trials of adult patients quetiapine was related to associate degree inflated incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for major depressive episodes in manic depressive illness and major clinical depression (see sections four.8 and 5.1).

The use of quetiapine has been related to the event of akathisia, defined by a subjectively unpleasant or distressing restlessness and wish to maneuver typically in the middle of associate degree inability to sit down or stand still. this is often possibly to occur at intervals the primary few weeks of treatment. In patients WHO develop these symptoms, increasing the dose could also be damaging.

Tardive Dyskinesia:

If signs and symptoms of dyskinesia seem, dose reduction or discontinuance of quetiapine ought to be thought of. The symptoms of dyskinesia will worsen or maybe arise when discontinuance of treatment (see section four.8).

Somnolence and dizziness:

Quetiapine treatment has been related to temporary state and connected symptoms, like sedation (see section four.8). In clinical trials for treatment of patients with bipolar depression and major clinical depression, onset was sometimes at intervals the primary three days of treatment and was preponderantly of gentle to moderate intensity. Patients experiencing temporary state of severe intensity could need a lot of frequent contact for a minimum of two weeks from onset of temporary state, or till symptoms improve and treatment discontinuance may have to be thought of.

Orthostatic hypotension:

Quetiapine treatment has been related to postural hypotension and connected lightheadedness (see section four.8) which, like temporary state has onset sometimes throughout the initial dose-titration amount. this might increase the incidence of injury (fall), particularly within the aged population. Therefore, patients ought to be suggested to exercise caution till they're accustomed to the potential effects of the medication.

Quetiapine ought to be used with caution in patients with better-known upset, neural structure unwellness, or alternative conditions predisposing to cardiovascular disease. Dose reduction or a lot of gradual volumetric analysis ought to be thought of if postural hypotension happens, particularly in patients with underlying upset.

Alaquet XL 150 mg prolonged-release tablets

Sleep apnoea syndrome:

Sleep apnoea syndrome has been reported  in patients mistreatment quetiapine. In patients receiving concomitant central systema nervosum depressants and WHO have a history or square measure in danger for sleep apnoea, like people who square measure overweight/obese or square measure male, quetiapine ought to be used with caution.

Seizures:

In controlled clinical trials there was no distinction within the incidence of seizures in patients treated with quetiapine or placebo. No information is out there regarding the incidence of seizures in patients with a history of seizure disorder. like alternative antipsychotics, caution is suggested once treating patients with a history of seizures (see section four.8).

Neuroleptic Malignant Syndrome:

Neuroleptic malignant syndrome has been related to major tranquilliser treatment, together with quetiapine (see section four.8). Clinical manifestations embrace physiological state, altered mental standing, muscular rigidity, involuntary instability, and inflated aminoalkanoic acid phosphokinase. In such an occasion, quetiapine ought to be interrupted and acceptable medical treatment given.

Severe leukopenia and Agranulocytosis:

Severe leukopenia (neutrophil count

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