Instruction for use: Seroquel

Dosage form: film coated tablets

Active substance: Quetiapine*

ATX

N05AH04 Quetiapine

Pharmacological group:

Neuroleptics

The nosological classification (ICD-10)

F20 Schizophrenia: Schizophrenic conditions; Exacerbation of schizophrenia; Schizophrenia; Chronic schizophrenia; Dementia praecox; Bleuler's disease; Psychotic discordant; Dementia early; The febrile form of schizophrenia; Chronic schizophrenic disorder; Psychosis of the schizophrenic type; Acute form of schizophrenia; Acute schizophrenic disorder; Cerebral Organic Insufficiency in Schizophrenia; Acute attack of schizophrenia; Schizophrenic psychosis; Acute schizophrenia; Sluggish schizophrenia; Sluggish schizophrenia with apathoabulic disorders; Acute stage of schizophrenia with excitation

F29 Inorganic psychosis, unspecified: Childhood psychoses; Psychomotor agitation in psychoses; Hallucinatory-delusional disorders; Hallucinatory-delusional syndrome; Intoxication psychosis; Manic-delusional disorders; Manic chronic psychosis; Manic psychosis; Acute psychosis; paranoid psychosis; Paranoid psychosis; Subacute psychosis; Presenile psychosis; Psychosis; Intoxicating psychosis; Psychosis is paranoid; Psychosis in children; Reactive psychosis; Chronic psychosis; Chronic hallucinatory psychosis; Chronic psychosis; Chronic psychotic disorder; Schizophrenic psychosis

F31 Bipolar affective disorder: Mood disorders bipolar; Affective bipolar psychosis; Manic-melancholic psychosis; Intermittent psychosis; Circular psychosis; Cyclophrenia; Bipolar disorders; Bipolar psychosis; Affective insanity; Manic-depressive syndrome; Psycho Manic-Depressive; Depressive episode of bipolar disorder

Composition and release form

Tablets, coated with a coating.

quetiapine (as fumarate) 25 mg; 100 mg; 200 mg

excipients: povidone; dihydrate of dibasic calcium phosphate; ICC; starch (sodium glycolate); lactose monohydrate; magnesium stearate

composition of the shell: iron oxide red (tablets of 25 mg); iron oxide yellow (tablets of 25 and 100 mg); titanium dioxide; hydroxypropylmethylcellulose; polyethylene glycol 400

in a blister of 10 pcs .; in a pack of cardboard 3 or 6 blisters (25 mg tablets); or in a pack of cardboard 3, 6 or 9 blisters (tablets of 100 and 200 mg); or in a pack of cardboard 1 blister (6 tablets of 25 mg, 3 tablets of 100 mg and 1 tablet of 200 mg).

Description of dosage form

Tablet 25 mg: round, 6 mm in diameter, peach color, biconvex, covered with a membrane.

Tablet 100 mg: round, diameter 8.5 mm, yellow, biconvex, covered with a membrane.

Tablet 200 mg: round, 11 mm in diameter, white, biconvex, covered with a membrane.

Pharmachologic effect

Pharmacological action - antipsychotic.

Has a higher affinity for serotonin 5HT2 receptors than dofaminovymi D1- and D2-receptors in the brain, as well as high affinity for histamine and alpha1-adrenergic receptors.

Pharmacokinetics

With plasma proteins binds to 83%. T1 / 2 - about 7 hours. It is excreted in the urine (73%) and with faeces (21%) in the form of inactive metabolites. Biotransformed with the participation of cytochrome P450.

Indications of the Seroquel

Acute and chronic psychoses, including schizophrenia.

Contraindications

Hypersensitivity.

Application in pregnancy and lactation

Perhaps, if the expected effect of therapy exceeds the potential risk to the fetus. For the duration of treatment, breastfeeding should be discontinued.

Dosing and Administration

Inside, regardless of food intake, 2 times a day.

Adults. The daily dose for the first 4 days of therapy is: on the first day - 50 mg, the second day - 100 mg, the third day - 200 mg, 4 day - 300 mg. Beginning from 4 days, the dose should be titrated to the usual effective dosage, ranging from 300 to 450 mg / day. Depending on the clinical effect and individual patient tolerance, the dose may vary from 150 to 750 mg / day.

The elderly. Like other antipsychotics, quetiapine should be used with caution in the elderly, especially during the initial period of therapy. In elderly patients, the initial dose of Seroquel should be 25 mg per day. The dose should be increased daily by 25-50 mg until an effective dose is obtained, which is likely to be less than that of younger patients.

Safety and effectiveness of quetiapine in children and adolescents have not been investigated.

In patients with impaired liver and kidney function, Seroquel therapy should begin at a dose of 25 mg / day. The dose should be increased daily by 25-50 mg until the effective dose is reached.

Overdose

Symptoms: drowsiness, sedation, tachycardia, hypotension.

Treatment: symptomatic; restoration and control of upper airway patency, ensuring adequate oxygenation and ventilation, monitoring and maintaining the cardiovascular system.

Precautionary measures

Care should be taken when combining with other drugs with central activity, with alcohol, as well as in combination with potential inhibitors of biotransformation - ketoconazole, erythromycin, etc.

Special instructions

Do not use during work drivers of vehicles and people whose profession is associated with increased concentration of attention.

Storage conditions of the drug Seroquel

At temperatures not higher than 30 ° C.

Keep out of the reach of children.

Shelf life of the drug Seroquel

3 years.

Do not use after the expiry date printed on the package.