Rispaxol (risperidone) coated tablets 4 mg. №60

Description

Rispaxol (risperidone) coated tablets 4 mg. №60

Composition

active ingredient: risperidone;

1 tablet contains 2 mg or 4 mg of risperidone;

excipients: anhydrous lactose, corn starch, magnesium stearate, anhydrous colloidal silicon dioxide, microcrystalline cellulose;

shell:

tablets 2 mg – Opadry Orange OY-8729 (hypromelose, macrogol 400, titanium dioxide (E 171), sunset yellow FCF (E 110), quinoline yellow (E 104)), macrogol 6000, carnauba wax;

tablets 4 mg – Opadry AMB Green 80W21165 (iron oxide (E 172), indigo carmine (E 132), soy lecithin, polyvinyl alcohol, quinoline yellow (E 104), talc, titanium dioxide (E 171), xanthan gum), carnauba wax .

Dosage form

Film-coated tablets.

Basic physical and chemical properties:

2 mg tablets are round, biconvex tablets with a score on one side, coated with an orange film. White at the fault;

tablets 4 mg ̶ round biconvex tablets with a score (into four parts) on one side, green film-coated. White at the fracture site.

Pharmacological group

Antipsychotics.
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 CNS, as well as α1-adrenergic, to a lesser extent – α2-adrenergic and H1-histamine receptors. Eliminates hallucinations, delusions, automatism, reduces aggression, fear.

Indications

Rispaxol coated tablets is used:

• in schizophrenia with pronounced productive (aggression, delusions, hallucinations, thinking disorders) or negative symptoms (poor speech, social and emotional detachment);
• at acute / chronic psychoses with the expressed productive or negative symptomatology;
• in other psychotic states with affective symptoms.

Contraindications

Does not apply Rispaxol coated tablets:

• in case of allergy to risperidone;
• in case of intolerance to excipients.

Use during pregnancy and breastfeeding

Contraindicated.

Method of application and dose

Rispaxol coated tablets is administered orally.

Usual dose

Rispaxol coated tablets can be used 1 or 2 times a day. Doses greater than 8 mg should be divided into two doses (morning and evening).

Schizophrenia

Adults (under 65)

Rispaxol coated tablets can be administered 1 or 2 times a day.

It should be started with 2 mg per day, on the second day the dose can be increased to 4 mg. Thereafter, the dose can be maintained unchanged or, if necessary, adjusted individually. For most patients, the recommended dose is 4-6 mg per day. Some patients may need to gradually increase the dose or reduce the initial dose.

The maximum daily dose of Rispaxol is 10 mg.

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

Elderly patients (from 65 years old)

The recommended starting dose is 0.5 mg twice daily. If necessary, the dose can be increased to 1-2 mg 2 times a day by increasing by 0.5 mg 2 times a day. If additional sedation is needed, a benzodiazepine may be used concomitantly.

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

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

As with other types of symptomatic treatment, with long-term use of risperidone, doses should be periodically reviewed and adjusted throughout therapy. There are no data on the effectiveness of risperidone in the treatment of acute bipolar mania lasting more than 12 weeks. If risperidone is used in combination with mood stabilizers, therapy can be stopped earlier, since the onset of the effect of treatment can be expected in the first weeks of therapy. Even after the first response to treatment, the possibility of recurrence of symptoms of depression should be considered due to the nature of the course of the disease and adverse reactions of drugs that were used for treatment, including risperidone.

Short-term therapy for severe aggression or severe psychiatric symptoms in patients with dementia.

The recommended starting dose is 0.25 mg twice daily. If necessary, the dose can be increased by increasing the dose by 0.25 mg 2 times a day no more than every other day. For most patients, the optimal dose is 0.5 mg 2 times a day. However, for some patients, the effective dose can be increased to 1 mg twice a day. After reaching the optimal dose, you can consider taking a daily dose of 1 time per day.

Cancellation of treatment with risperidone should take place no later than 3 months after the start of therapy, therapy can only be resumed if behavioral disorders reappear.

Symptomatic treatment of social or aggressive behavior disorders

Patients weighing > 50 kg

The recommended starting dose is 0.5 mg once daily. If necessary, the dose should be adjusted by adding 0.5 mg 1 time per 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 1 time per day is sufficient to achieve a positive effect, while others may require 1.5 mg 1 time per day.

Patients (children over 5 years and adults) weighing < 50 kg

The recommended starting dose is 0.25 mg once daily. If necessary, the dose can be adjusted by adding 0.25 mg 1 time per 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 1 time per day is sufficient to achieve a positive effect, while others may require 0.75 mg 1 time per day.

As with other symptomatic treatments, long-term use of risperidone should be periodically reviewed and adjusted throughout therapy.

Autism (children from 5 years old).

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

Patients weighing < 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 assessed on day 14. Dose increases of 0.25 mg at 2-week intervals should only be considered in patients with insufficient clinical response.

Patients with body weight ≥ 50 kg

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

Overdose

Symptoms: drowsiness, excessive sedative effect, tachycardia, extrapyramidal disorders, instability of blood pressure.
Therapeutic measures: gastric lavage, administration of sorbents, support of the respiratory and cardiovascular systems, control of electrolyte balance, regulation of acid-base status.

Side effects:

• Neurological disorders: hyperthermia of central origin, drowsiness, headache, fainting, confusion, akathisia, extrapyramidal disorders (hypokinesia, akinesia, tremor, muscle rigidity), sleep disorders, insomnia, depression, seizures, dyspnea, malignancy tachypnea, convulsions, tachycardia, arrhythmia, unstable blood pressure, hyperthermia, increased sweating, severe muscle rigidity, involuntary urination, pale 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, photosensitization.
• 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: accommodation disorder, xerophthalmia, decreased visual acuity.
• Others: peripheral edema, weight gain, rhinitis, allergies, including angioneurotic edema, skin rash, joint / bone / muscle pain.