Ketilept is an antipsychotic drug.
Release form and composition
Ketilept is produced in the form of coated tablets (biconvex, round, engraved with the letter “E” on one side, with or without odor; depending on the dose: 25 mg - white, with the inscription “201”; 100 mg - white, with the inscription "202"; 150 mg - pink, with the inscription "203"; 200 mg - dark pink, with the inscription "204"; 300 mg - white, with the inscription "205"). 30 pieces each or 60 pcs. in brown glass bottles with a plastic cap with the control of the first opening, 1 bottle in carton packs; on 10 pieces in blisters, 3 or 6 blisters in carton packs.
The composition of 1 tablet includes:
- Active ingredient: quetiapine - 25 mg, 100 mg, 150 mg, 200 mg or 300 mg;
- Auxiliary components: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate, povidone, colloidal (anhydrous) silicon dioxide.
The composition of the shell (tablets by):
- 25 mg, 100 mg, 300 mg: Opadry II33G28523 white (macrogol 4000 - 8%, titanium dioxide - 25%, hypromellose - 40%, lactose monohydrate - 21%, triacetin - 6%);
- 150 mg, 200 mg: Opadry II33G28523 white (macrogol 4000 - 8%, titanium dioxide - 25%, hypromellose - 40%, lactose monohydrate - 21%, triacetin - 6%); Opadry II33G24283 pink (iron dye red oxide –1.83%, triacetin - 6%, hypromellose - 40%, iron dye yellow oxide - 0.6%, lactose monohydrate - 21%, titanium dioxide - 22.57%, macrogol 4000 - eight%).
Indications for use
- Chronic and acute psychosis, including schizophrenia;
- Depressive episodes in the structure of bipolar disorder from moderate to severe severity;
- Manic episodes in the structure of bipolar disorder.
- Children's age (efficacy and safety for this age group have not been studied);
- Hypersensitivity to the drug.
Ketilept should be taken with caution to elderly patients, as well as patients with convulsive seizures in history, liver failure, cerebrovascular and cardiovascular diseases or other conditions that predispose to the development of arterial hypotension.
The efficacy and safety of Ketilepta use in pregnant and lactating women has not been established. The drug should not be used during pregnancy except when the intended benefit to the mother exceeds the risk to the fetus. At the time of taking the drug should be abandoned breastfeeding.
Dosing and Administration
Ketilept is taken orally, regardless of the meal.
Adults with chronic and acute psychosis, including schizophrenia, are usually prescribed: 1 day - 50 mg, 2 day - 100 mg, 3 day - 200 mg, 4 day - 300 mg. Usually, the effective daily dose from the fourth day of treatment is 300-450 mg, however, depending on the tolerance and clinical effect, it can vary in the range of 150-750 mg. The drug is taken 2 times a day.
In the treatment of acute manic episodes in the structure of bipolar disorder in the first 4 days of treatment, Ketilept is prescribed the same way as in the treatment of psychosis. Further selection of the dose is carried out with an increase of not more than 200 mg per day. The daily dose can vary from 200 to 800 mg. Usually the drug is prescribed in an effective dose of 400-800 mg per day, divided into 2 doses.
When depressive episodes in the structure of bipolar disorder Ketilept should be taken 1 time a day before bedtime. In the first 4 days of therapy, the daily dose is increased from 50 mg to 300 mg. The recommended daily intake is 300 mg, the maximum - 600 mg.
Patients with renal and hepatic insufficiency are advised to start treatment with 25 mg per day with a gradual increase of 25-50 mg until an effective dose is reached (determined by the patient’s clinical response and individual tolerance).
Elderly patients should begin treatment with 25 mg per day. Dose gradually to 25-50 mg per day can be increased to an effective, which is usually less than that of young patients. Also, a more careful selection of the dose and the use of reduced doses are recommended for debilitated patients or when they are susceptible to hypotensive reactions.
To maintain remission, the lowest effective dose should be used. Periodically, patients should be examined to determine the need for maintenance therapy.
With the resumption of treatment in less than 7 days after discontinuation of Ketilept, the treatment can be continued in an appropriate dosage for maintenance therapy. When resuming therapy in patients who have not received the drug for more than 1 week, it is necessary to follow the rules of initial dose selection and establish an effective dose based on the clinical response.
Most often during therapy develop: dizziness, drowsiness, tachycardia, dry mouth, constipation, moderate asthenia, dyspepsia and orthostatic hypotension.
As with other antipsychotics, Ketilepta can lead to the development of syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, and peripheral edema.
Also during therapy, disorders may occur on the part of various body systems:
- Immune system: infrequently - hypersensitivity;
- Lymphatic and circulatory system: often - leukopenia; infrequently - eosinophilia; in some cases, neutropenia;
- Nervous system: very often - drowsiness, dizziness; often - fainting, anxiety, headache, tremor, psychomotor agitation; infrequently - epileptic seizures;
- Gastrointestinal: often - constipation, dry mouth, dyspepsia, diarrhea, abdominal pain;
- Metabolism: often - an increase in body weight, increased serum transaminases; very rarely - diabetes, hyperglycemia;
- Respiration and organs of the chest cavity and mediastinum: often - pharyngitis, rhinitis;
- Cardiovascular system: often - tachycardia, orthostatic hypotension;
- Reproductive organs and mammary glands: rarely - priapism;
- Laboratory studies: infrequently - increased levels of gamma-glutamyltransferase (GGT), total cholesterol and triglyceride levels after meals;
- Tissue at the injection site and general disorders: often - peripheral edema, mild asthenia; rarely - neuroleptic malignant syndrome;
- Other: dry skin, pain in the lower back and chest, myalgia, low-grade fever, reduced visual acuity.
Ketilept should be used with caution in patients with cardiovascular diseases and other conditions that are associated with the risk of arterial hypotension (especially at the beginning of therapy) and in elderly patients. The drug should be used under the supervision of a physician with indications of bouts of seizures in history and impaired renal function and liver.
With prolonged use, there is a likelihood of tardive dyskinesia. In this case, the treatment is canceled or the dose taken is reduced.
If malignant neuroleptic syndrome (MNS) develops during treatment, Ketilept should be canceled and appropriate therapy should be prescribed.
Since the drug can lead to drowsiness, patients are not recommended to perform work associated with the need for high speed psychomotor reactions and concentration of attention (including driving vehicles).
Caution should be exercised with the simultaneous use of Ketilept with drugs that prolong the QT interval (especially in elderly patients); with ethanol; with drugs that have a depressant effect on the central nervous system.
With simultaneous use with potential inhibitors of the CYP3A4 isoenzyme (including erythromycin, ketoconazole), side effects and an increase in plasma concentration of Ketilepta are theoretically possible.
During use with thioridazine, clearance of quetiapine may increase.
When combined with rifampicin, carbamazepine, phenytoin and barbiturates, Ketilepta clearance increases and its concentration in blood plasma decreases.
Terms and conditions of storage
Keep out of reach of children at temperature up to 25 ° C.
Shelf life - 5 years.