Rispolept (risperidone) tablets 2 mg. №20

Description

Rispolept (risperidone) tablets 2 mg. №20

Composition

active substance: risperidone;

1 film-coated tablet contains 2 mg of risperidone;

excipients: lactose, monohydrate; corn starch; microcrystalline cellulose; hypromellose; magnesium stearate; colloidal anhydrous silicon dioxide; sodium lauryl sulfate; titanium dioxide (E 171); talc; propylene glycol; orange-yellow S (E 110).

Medicinal form

Coated tablets.

The main physicochemical properties: light orange, elongated, biconvex, film-coated tablet, with the inscriptions “Ris” and “2”, separated by a hyphen.

Pharmacotherapeutic group

Antipsychotic drugs.
ATX code N05A X08.

Pharmacological properties

Risperidone is a selective monoaminergic antagonist with unique properties. It shows high affinity for serotonergic 5-HT2 and dopaminergic D2 receptors. Risperidone also binds to α1-adrenergic receptors and with lower affinity to H1-histaminergic and α2-adrenergic receptors. Risperidone has no affinity for cholinergic receptors. Although risperidone is a potent D2-antagonist, which has been attributed to its efficacy on the productive symptoms of schizophrenia, it does not cause a significant inhibition of motor activity and induces catalepsy to a lesser extent compared to classical antipsychotics. Balanced central antagonism with respect to serotonin and dopamine reduces susceptibility to extrapyramidal side effects and extends the therapeutic effect of the drug to include negative and affective symptoms of schizophrenia.

Indications

Rispolept tablets is used to treat patients suffering from various forms of schizophrenia, as well as patients with the first episode of psychosis and other psychotic disorders, accompanied by the development of severe negative or productive symptoms, such as hostility, suspicion, poor speech, social and emotional withdrawal, impaired thinking, hallucinations.

The drug can be used in the treatment of patients with schizoaffective disorders and a form of schizophrenia, accompanied by the development of affective symptoms: anxiety, fear, depression.

Rispolept tablets is used to prevent the onset of acute psychotic conditions in patients suffering from chronic schizophrenia. In addition, the drug can be used for the prophylaxis and therapy of behavioral disorders in patients with dementia, accompanied by the development of increased aggression, behavior disorders and psychotic symptoms in the patient. Also Rispolept can be used in the complex treatment of bipolar disorders, in which manic episodes are observed.

Contraindications

Rispolept tablets is not used during lactation, for the treatment of children under 15 years of age and hypersensitivity to risperidone.

The drug is prescribed with caution to those who suffer from cardiovascular diseases, impaired cardiac muscle conduction, cerebrovascular accident, Parkinson’s disease and suffered myocardial infarction. Also, it is recommended to refrain from the appointment of Rispolepta if the patient has a history of convulsive syndrome, renal or hepatic failure, drug dependence, intestinal obstruction, brain neoplasms and pregnancy.

Application for pregnancy and lactation

Rispolept is not used to treat pregnant women. If treatment with the drug is necessary for a patient at the lactation stage, it is recommended to refuse breastfeeding.

Method of administration and dosage

To achieve a dosage of 0.25–1.5 mg, use Rispolept in the form of an oral solution. To achieve a dosage of 1 mg, the tablet is divided in half.

Dosage

Schizophrenia:

• Adults
  Rispolept can be prescribed once or twice a day.
  You should start taking Rispolept tablets 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 dose increase or a reduced initial and maintenance dose may be indicated.
  Doses exceeding 10 mg of risperidone per day have not been shown to be more effective than lower doses, but they may cause extrapyramidal symptoms.
  The safety of doses above 16 mg per day has not been studied.
• Elderly patients (from 65 years old).
  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, increasing by 0.5 mg twice a day.
• Children
  It is not recommended to use the drug for children (under the age of 18).

Manic episodes in bipolar disorders:

• Adults
  The recommended starting dose of Rispolept tablets is 2 mg once a day. The dose can be individually increased by adding 1 mg/day no more often than every 24 hours. The recommended dose range is from 1 to 6 mg per day. The use of risperidone in a dose of more than 6 mg per day in patients with manic episodes has not been studied.
  As with other types of symptomatic treatment, the long-term use of Rispolept must be periodically reviewed and adjusted during the entire therapy.
• Elderly patients (from 65 years old).
  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, increasing by 0.5 mg twice a day. Since the experience of use in elderly patients is limited, it is recommended to exercise caution when using.
• Children
  It is not recommended to use the drug for children (under 18 years of age).

Short-term therapy of severe aggression in patients with dementia of the Alzheimer type

The recommended starting dose is 0.25 mg twice a day. Rispolept, oral solution, is the recommended dosage form for a dose of 0.25 mg. 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, an effective dose is 1 mg twice a day.

Rispolept should not be used for more than 6 weeks in patients with severe aggression in Alzheimer’s disease. As with other types of symptomatic treatment, the use of Rispolept must be periodically reviewed and adjusted during the entire therapy.

Symptomatic short-term treatment (up to 6 weeks) of severe aggression in behavioral disorders

Children and adolescents aged 5 to 18 years:

• 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 a day is enough to achieve a positive effect, while others may need 1.5 mg once a day.
• Patients with body weight < 50 kg
  The recommended starting dose is 0.25 mg once a day. Rispolept, oral solution, is the recommended dosage form for a dose of 0.25 mg. 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 a day is enough to achieve a positive effect, while others may need 0.75 mg once a day. As with other types of symptomatic treatment, the use of Rispolept must be periodically reviewed and adjusted during the entire therapy.
• Children
  It is not recommended to use the drug for children under 5 years of age.

Application method

Rispolept is intended for oral use. Eating does not affect the absorption of Rispolept.

At the end of treatment, it is recommended to gradually withdraw the drug. Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia, have been isolated after abrupt discontinuation of high-dose antipsychotics (see Adverse Reactions). Relapses of psychotic symptoms may also occur, and involuntary movements (such as akathisia, dystonia, and dyskinesia) have been reported.

Overdose

When taking Rispolepta in high doses, the patient may experience drowsiness, tachycardia, hypotension and the development of extrapyramidal symptoms. The patient is prescribed gastric lavage, the intake of enerosorbents and symptomatic treatment.

Side effects

When treating with Rispolept, a patient may develop undesirable symptoms from the central nervous system, gastrointestinal tract and cardiovascular system. Also, in some patients with prolonged use of the drug, allergic reactions occur.