Rileptid (risperidone) coated tablets 2 mg. №20

Description

Rileptid (risperidone) coated tablets 2 mg. №20

Composition 

active substance: 1 tablet contains risperidone 1 mg or 2 mg, or 3 mg, or 4 mg;

auxiliary substances: lactose monohydrate, corn starch, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silicon dioxide, sodium lauryl sulfate;

shell composition:

• tablets 1 mg: hypromellose, titanium dioxide (E 171), macrogol 400;
• tablets 2 mg: Opadry 0ЗВ220015 (hypromellose, titanium dioxide (E 171), macrogol 400), quinoline yellow (E 104));
• tablets 3 mg and 4 mg: hypromellose, titanium dioxide (E 171), macrogol 400, indigo carmine (E 132), quinoline yellow (E 104).

Medicinal form

Coated tablets.

The main physical and chemical properties:

tablets 1 mg – white or almost white oblong biconvex tablets, covered with a shell, with the engraving “751” and the stylized letter “E” on one side and with a line on the other, odorless or almost odorless;

tablets 2 mg – yellow, oblong biconvex tablets, covered with a shell, with the engraving “752” and the stylized letter “E” on one side and with a line on the other, odorless or almost odorless;

tablets 3 mg – light green, oblong biconvex tablets, covered with a shell, with the engraving “753” and the stylized letter “E” on one side and with a line on the other, odorless or almost odorless;

4 mg tablets are green, oblong, biconvex, film-coated tablets, engraved with “754” and a stylized letter “E” on one side and a line on the other, odorless or almost odorless.

Pharmacotherapeutic group

Antipsychotic drugs.
ATX code N05A X08.

Pharmacological properties

It is an antipsychotic drug (neuroleptic). The active substance selectively (selectively) blocks 5-HT2-serotonergic, D2-dopaminergic receptors of the central nervous system, as well as α1-adrenergic, to a lesser extent, α2-adrenergic and H1-histamine receptors. Eliminates hallucinations, delusions, automatism, reduces aggressiveness, fear.

Indications

Rileptid is used:

• with schizophrenia with pronounced productive (aggressiveness, delirium, hallucinations, thought disorders) or negative symptoms (poor speech, social and emotional detachment);
• in acute / chronic psychoses with pronounced productive or negative symptoms;
• in other psychotic conditions with affective symptoms.

Contraindications

Rileptid does not apply:

• if you are allergic to risperidone;
• with intolerance to excipients.

Application during pregnancy and lactation

Contraindicated.

Method of administration and dosage

Usual dose

Rileptid can be used once or twice a day. Doses greater than 8 mg should be divided into two doses (morning and evening).

To achieve a dose of 0.25-2.5 mg, it is recommended to use risperidone, an oral solution.

Schizophrenia

Adults (up to 65 years old).

Rileptid can be prescribed once or twice a day. You should start taking Rileptid 2 mg per day, on the second day the dose can be increased to 4 mg. After that, the dose can be maintained unchanged or, if necessary, individual dose correction can be continued. For most patients, the recommended dose is 4-6 mg per day. For some patients, a gradual increase in dose or a reduced starting dose may be indicated.

The maximum daily dose of the drug is 10 mg.

Doses greater than 10 mg per day have not been shown to be more effective than lower doses, but may cause extrapyramidal symptoms. Since the safety of doses exceeding 16 mg per day has not been studied, doses exceeding this level should not be used.

Elderly patients (over 65 years of age).

The recommended starting dose is 0.5 mg twice a day. If necessary, the dose can be increased to 1-2 mg twice a day by increasing it by 0.5 mg twice a day. If additional sedation is needed, benzodiazepine can be used at the same time.

Manic episodes in bipolar disorder (adults and children over 10 years of age).

The recommended initial dose of Rileptid is 2 mg once a day, in the evening. The dose can be individually increased by adding 1 mg/day no more often than every 24 hours. The recommended dose range is from 2 to 6 mg per day.

As with other types of symptomatic treatment, with long-term use of Rileptid, it is necessary to periodically review the doses and adjust them during the entire therapy.

There are no data on the effectiveness of risperidone in the treatment of acute bipolar mania lasting more than 12 weeks. If Rileptid is used in combination with normotimic drugs, therapy can be stopped earlier, since the onset of the treatment effect can be expected in the first weeks of therapy. Even after the appearance of the first response to treatment, the possibility of re-emergence of depressive symptoms should be taken into account due to the peculiarities of the course of the disease and side effects of drugs used for treatment, including Rileptid.

Short-term therapy of marked aggression or severe mental symptoms in patients with dementia.

The recommended starting dose is 0.25 mg twice a day. If necessary, the dose can be increased by increasing the dose by 0.25 mg twice a day no more than every other day. For most patients, the optimal dose is 0.5 mg twice a day.

However, for some patients, the effective dose can be increased to 1 mg twice daily. Once the optimal dose is reached, a once-a-day daily dose can be considered.

Cancellation of Rileptid treatment should occur no later than three months after the start of therapy, therapy can be resumed only if behavioral disorders reappear.

Symptomatic treatment of disorders of social behavior or aggressive behavior.

Patients with body weight >50 kg.

The recommended starting dose is 0.5 mg once daily. If necessary, the dose should be adjusted by adding 0.5 mg once a day no more than every other day. The optimal dose for most patients is 1 mg once a day. However, for some patients, no more than 0.5 mg once daily is sufficient to achieve a positive effect, while others may require 1.5 mg once daily.

Patients (children aged 5 years and older and adults) with body weight < 50 kg.

The recommended starting dose is 0.25 mg once a day. If necessary, the dose can be adjusted by adding 0.25 mg once a day no more than every other day. The optimal dose for most patients is 0.5 mg once a day. However, for some patients, no more than 0.25 mg once daily is sufficient to achieve a positive effect, while others may require 0.75 mg once daily.

As with other types of symptomatic treatment, long-term use of Rileptid must be periodically reviewed and adjusted throughout the therapy.

Autism (children aged 5 and over)

The dose should be selected individually, depending on the patient’s condition and clinical response.

Patients with body weight <50 kg

The recommended starting dose is 0.25 mg once daily. From the 4th day, the dose can be increased by 0.25 mg. A dose of 0.5 mg should be maintained and clinical response evaluated on day 14. Dose increases of 0.25 mg at 2-week intervals may only be considered for patients with insufficient clinical response.

Patients with body weight ≥ 50 kg.

The recommended starting dose is 0.5 mg once a day. From the 4th day, the dose can be increased by 0.5 mg. The dose should be maintained at 1 mg and clinical response assessed on day 14. Dose increases of 0.5 mg at 2-week intervals may be considered only for patients with insufficient clinical response.

Rileptid can be used once or twice a day.

For patients who experience drowsiness after taking the drug, it is better to use a daily dose of Rileptid before going to bed.

During clinical trials, approximately two-thirds of children with autism complained of weakness, which was especially noticeable during the initial phase of treatment.

Once an adequate clinical response is achieved, a gradual dose reduction should be considered to achieve the optimal ratio of clinical efficacy and safety.

If severe adverse reactions (eg, extrapyramidal disorders, tardive dyskinesia, or uncontrolled weight gain) occur, the dose of risperidone should be reduced or treatment should be discontinued.

To achieve a dose of 0.25-1 mg, it is recommended to use risperidone in the form of an oral solution.

Overdose

Symptoms: drowsiness, excessive sedation, tachycardia, extrapyramidal disturbances, instability of blood pressure.
Therapeutic measures: gastric lavage, the appointment of sorbents, support of the respiratory and cardiovascular systems, control of electrolyte balance, regulation of the acid-base state.

Side effects:

• Neurological disorders: hyperthermia of central origin, drowsiness, headache, fainting, confusion, akathisia, extrapyramidal disorders (hypokinesia, akinesia, tremor, muscle stiffness), sleep disturbances, insomnia, depression, convulsive seizures, neuroleptic malignant syndrome (shortness of breath) tachypnea, convulsions, tachycardia, arrhythmia, unstable blood pressure, hyperthermia, increased sweating, severe muscle rigidity, involuntary urination, pallor of the skin, fatigue, weakness), tardive dyskinesia.
• Cardiovascular disorders: decrease / increase in blood pressure (including orthostatic hypotension), reflex tachycardia, hypertension, stroke.
• Digestive disorders: constipation, abdominal pain, vomiting, dysphagia, nausea.
• Dermatological disorders: hyperpigmentation, xeroderma, photosensitivity.
• Endocrine disorders: hyperglycemia, hyperprolactinemia, galactorrhea, dysmenorrhea, gynecomastia, amenorrhea.
• Genitourinary disorders: priapism, anorgasmia, erectile dysfunction, ejaculation, dysuria, urinary incontinence, polyuria.
• Hematological disorders: neutro-, thrombocytopenia, thrombocytopenic purpura, anemia.
• Ophthalmic disorders: violation of accommodation, xerophthalmia, decreased visual acuity.
• Others: peripheral edema, weight gain, rhinitis, manifestations of allergies, incl. angioedema, skin rashes, pain in joints / bones / muscles.