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Ketilept pills 100mg №60
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Composition
Film Coated Tablets | 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) | |
Excipients: 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 | |
shell composition (25 mg tablets): Opadry II33G28523 is 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%) | |
shell composition (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%) | |
shell composition (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 dye yellow oxide - 0.0105 mg (0.6%); iron dye red oxide - 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%) | |
shell composition (200 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%); Opadry II33G24283 pink (hypromellose - 2 mg (40%); iron dye yellow oxide - 0.03 mg (0.6%); iron dye red oxide - 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%) | |
shell composition (300 mg tablets): 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.
Dosage and administration
Inside, regardless of the meal.
Adults.
Acute and chronic psychosis, including schizophrenia: the drug is prescribed 2 times a day. The total daily dose in the first 4 days of therapy is 50 mg (1st day), 100 mg (2nd day), 200 mg (3rd day) and 300 mg (4th day).
Starting from the 4th day, the usual effective daily dose of Ketilept ® ranges from 300 to 450 mg / day.
Depending on the clinical effect and tolerance in each patient, the dose can be selected (vary) in the range from 150 to 750 mg / day. The maximum recommended daily dose of 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 in the first 4 days of therapy is 100 mg (1st day), 200 mg (2nd day), 300 mg (3rd day) and 400 mg (4th day).
Further selection of the 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 adjusted in the range from 200 to 800 mg / day. The usual effective dose ranges 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® appoint 1 time per day at night. The daily dose in the first 4 days of therapy is 50 mg (1st day), 100 mg (2nd day), 200 mg (3rd day), 300 mg (4th day). 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 until an effective dose is reached, which is usually lower than in younger patients. Similarly, more careful dose selection and reduced doses are recommended for debilitated patients or those predisposed to hypotensive reactions.
Children and teenagers. The efficacy and safety of quetiapine in children and adolescents has not been established.
Renal and hepatic failure. It is recommended to begin therapy with 25 mg / day, then daily to increase the dose of 25-50 mg to achieve an effective dose, depending on the patient's clinical response and individual tolerance.
Supportive Therapy To maintain remission it is advisable to use the lowest dose. Patients should be examined periodically to determine the need for maintenance therapy.
Resumption of interrupted treatment in patients previously treated with quetiapine. With the resumption of therapy in less than 1 week after discontinuation of the drug Ketilept® the drug can be continued at a dose appropriate for maintenance therapy. When resuming therapy in patients who did not receive Ketilept® more than 1 week, you should follow the rules of the initial dose selection and establish the effective dose according to the clinical response of the patient.
Release form
Tablets, film coated, 25, 100, 150, 200, 300 mg. 30 or 60 table. in a bottle of brown glass with a PE-cap with the control of the first opening and with an accordion absorber, 1 fl. in a carton box. Or 10 tab.in a blister of PVC / PVDH / aluminum foil, 3 or 6 blisters in a carton box.
Pharmacy sales terms
On prescription.
Storage conditions of the drug Ketilept®
At temperatures not above 25 ° C.