Risset (risperidone) coated tablets 4 mg. №20

Description

Risset (risperidone) coated tablets 4 mg. №20

Composition

active substance:
risperidone;

1 tablet contains 1 mg or 2 mg or 3 mg or 4 mg of risperidone;

excipients:

core: lactose monohydrate, microcrystalline cellulose, corn starch, sodium starch glycolate (type A), talc, magnesium stearate;

• tablet coating of 1 mg*: hypromellose, lactose monohydrate, titanium dioxide (E 171), polyethylene glycol, sodium citrate;
• tablet coating of 2 mg: hypromellose*, lactose monohydrate*, titanium dioxide (E 171)*, polyethylene glycol*, sodium citrate*, yellow sunset FCF (E 110);
• tablet coating of 3 mg: hypromellose*, lactose monohydrate*, titanium dioxide (E 171)*, polyethylene glycol*, sodium citrate*, quinoline yellow (E 104);
• coating of 4 mg tablets: hypromellose*, lactose monohydrate*, titanium dioxide (E 171)*, polyethylene glycol*, sodium citrate*, quinoline yellow (E 104), indigo carmine (E 132);

* included in Opadry II 31F58914 white.

Medicinal form

Film-coated tablets.

The main physical and chemical properties:

• tablets of 1 mg: round biconvex tablets of white color, covered with a film shell, on one side divided by a line in half;
• tablets of 2 mg: round biconvex tablets of orange color, covered with a film shell, on one side divided by a line in half;
• tablets of 3 mg: round biconvex tablets of yellow color, covered with a film shell, on one side divided by a line in half;
• tablets of 4 mg: round biconvex tablets of green color, covered with a film shell, on one side divided by a line in half.

Pharmacotherapeutic group

Antipsychotic drugs. Risperidone.
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

Risset tablets 4 mg. 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

Risset tablets 4 mg. does not apply:

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

Application during pregnancy and lactation

Contraindicated.

Method of administration and dosage

Risset tablets 4 mg. is used internally.
The standard dose for adults is 2 mg / day, on the next day the dose is increased to 4 mg / day, on the 3rd day – up to 6 mg / day in one or two doses. In the future, an individual maintenance dose is selected (usually 4–8 mg / day).
The maximum dose is 16 mg / day.
Elderly patients or patients with severe hepatic / renal impairment should be halved.

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 rigidity), sleep disturbances, insomnia, depression, seizures, neuroleptic malignant syndrome (shortness of breath) tachypnea, convulsions, tachycardia, arrhythmia, unstable blood pressure, hyperthermia, increased sweating, severe muscle stiffness, 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.