Instruction for use: Ketilept

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

F31.1 Bipolar affective disorder, current episode of mania without psychotic symptoms: Mania in bipolar disorders

F31.2 Bipolar affective disorder, current episode of mania with psychotic symptoms: Manic episode of bipolar disorder; Mania in bipolar disorders

F31.9 Bipolar affective disorder, unspecified: Depressive episode of bipolar disorder

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenodepressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome with psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous Depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

Composition

Tablets covered with a film membrane 1 tab.

active substance:

quetiapine fumarate 28.78 mg; 115.13 mg; 172.7 mg; 230.26 mg; 345.4 mg

(equivalent to 25 mg, 100 mg, 150 mg, 200 mg and 300 mg of quetiapine, respectively)

auxiliary substances: MCC - 9.22 / 36.87 / 55.3 / 73.74 / 110.6 mg; lactose monohydrate - 4/16/24/32/48 mg; sodium carboxymethyl starch (type A) 3,5 / 14/21/28/42 mg; povidone - 3/12/18/24/36 mg; magnesium stearate - 0,75 (3 / 4,5 / 6/9 mg; silicon dioxide colloidal anhydrous - 0,75 (3 / 4,5 / 6/9 mg

composition of the coating (tablets 25 mg): Opadry II33G28523 white (hypromellose 0.8 mg (40%), lactose monohydrate 0.42 mg (21%), macrogol 4000 0.16 mg (8%), titanium dioxide - 0.5 mg (25%), triacetin - 0.12 mg (6%)

composition of the coating (100 mg tablets): Opadry II33G28523 white (hypromellose - 2 mg (40%), lactose monohydrate - 1.05 mg (21%), macrogol 4000 - 0.4 mg (8%), titanium dioxide - 1, 25 mg (25%), triacetin - 0.3 mg (6%)

composition of the coating (150 mg tablets): Opadry II33G28523 white (hypromellose 2.1 mg (40%), lactose monohydrate -1.1025 mg (21%), macrogol 4000 0.42 mg (8%), titanium dioxide - 1,3125 mg (25%), triacetin 0.315 mg (6%), Opadry II33G24283 pink (hypromellose 0.7 mg (40%), iron oxide oxide yellow 0.0105 mg (0.6%), color iron oxide red - 0.032 mg (1.83%), lactose monohydrate - 0.3675 mg (21%), macrogol 4000 - 0.14 mg (8%), titanium dioxide - 0.3981 mg (22.57%) , triacetin - 0.105 mg (6%)

the composition of the coating (tablets 200 mg): Opadry II33G28523 white (hypromellose - 2 mg (40%), lactose monohydrate - 1.05 mg (21%), macrogol 4000 - 0.4 mg (8%), titanium dioxide - 1, 25 mg (25%), triacetin 0.3 mg (6%) Opadry II33G24283 pink (hypromellose 2 mg (40%), iron oxide oxide yellow 0.03 mg (0.6%), iron oxide dye red 0.0915 mg (1.83%) lactose monohydrate 1.05 mg (21%) macrogol 4000 0.4 mg (8%) titanium dioxide 1.1285 mg (22.57%) , triacetin - 0.3 mg (6%)

(300 mg tablet): Opadry II33G28523 white (hypromellose 5.6 mg (40%), lactose monohydrate 2.94 mg (21%), macrogol 4000 1.12 mg (8%), titanium dioxide - 3.5 mg (25%), triacetin - 0.84 mg (6%)

Pharmachologic effect

Pharmacological action - antipsychotic.

Dosing and Administration

Inside, regardless of food intake.

To adults.

Acute and chronic psychoses, including schizophrenia: the drug is prescribed 2 times a day. The total daily dose for the first 4 days of therapy is 50 mg (day 1), 100 mg (day 2), 200 mg (day 3), and 300 mg (day 4).

Beginning from the 4th day, the usual effective daily dose of the preparation Ketilept® is from 300 to 450 mg / day.

Depending on the clinical effect and tolerability in each patient, the dose can be selected (vary) in the range from 150 to 750 mg / day. The maximum recommended daily dose is 750 mg.

For the treatment of acute manic episodes in the structure of bipolar disorder: the drug is prescribed 2 times a day. The total daily dose for the first 4 days of therapy is 100 mg (day 1), 200 mg (day 2), 300 mg (day 3), and 400 mg (day 4).

Further selection of a dose up to 800 mg / day by the 6th day is possible with an increase of no more than 200 mg / day. Depending on the clinical response and tolerability in each patient, the dose can be selected in the range from 200 to 800 mg / day. The usual effective dose is in the range from 400 to 800 mg / day. The maximum recommended daily dose is 800 mg / day.

For the treatment of depressive episodes in the structure of bipolar disorder: Ketilept® is prescribed once a day at night. The daily dose for the first 4 days of therapy is 50 mg (day 1), 100 mg (day 2), 200 mg (day 3), 300 mg (day 4). The recommended dose is 300 mg / day. The maximum recommended daily dose is 600 mg / day.

Elderly patients. The recommended initial dose is 25 mg per day, and then the dose should be increased by 25-50 mg per day to an effective dose, which is usually lower than in young patients. Likewise, a more cautious dose selection and reduced doses are recommended for weakened patients or predisposed to hypotensive reactions.

Children and teenagers. The efficacy and safety of quetiapine in children and adolescents has not been established.

Renal and hepatic insufficiency. It is recommended to begin therapy with 25 mg / day, then daily increase the dose of 25-50 mg to achieve an effective dose, depending on the clinical response of the patient and individual tolerability.

Supportive therapy. To maintain remission, it is advisable to use the lowest dose. Patients should be periodically examined to determine the need for maintenance therapy.

Renewal of interrupted treatment in patients previously treated with quetiapine. With the resumption of therapy less than 1 week after the withdrawal of the drug Ketilept®, the drug can be continued at a dose adequate for maintenance therapy. When the therapy is resumed in patients who have not received Ketilept® for more than 1 week, the rules for initial dose selection should be followed and the effective dose should be set based on the patient's clinical response.

Release form

Tablets, film-coated, 25, 100, 150, 200, 300 mg. For 30 or 60 tablets. in a bottle of brown glass with a PE-cap with a control of the first opening and with an accordion damper, 1 fl. in a cardboard box. Or on 10 tab. in a blister of PVC / PVDC / aluminum foil, 3 or 6 blisters in a cardboard bundle.

Conditions of leave from pharmacies

On prescription.

Storage conditions of the drug Ketilept

At temperatures not higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Ketilept

5 years.

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