Apexidone 4 mg 30 tablets
Apex Pharma
Apex Pharma
Composition
Risperidone — 4 mg in each tablet.
Description
Apexidone 4 mg is a branded formulation whose active substance is risperidone, belonging to the class of atypical antipsychotics. It antagonizes dopamine (D₂) and serotonin (5‑HT₂) receptors, thereby modulating neurotransmitter activity in the brain. The drug exhibits antipsychotic, anxiolytic (calming), mood‑stabilizing, and aggression‑modulating effects.
Indications for Use
Schizophrenia (in adults and adolescents)
Bipolar disorder (including manic episodes)
Behavioral disturbances in patients with dementia
Autism — management of aggression, irritability, self‑injurious behavior (in pediatric practice)
Psychotic states associated with agitation or hallucinations.
Dosage and Administration
The dosage of Apexidone should be tailored to the individual patient and their clinical condition. Typical initial dosage for schizophrenia and bipolar disorder ranges from 2 mg to 4 mg per day. The dose may be gradually increased until the desired effect is achieved. The maximum recommended dose for schizophrenia and bipolar disorder is 16 mg per day.
Contraindications
Hypersensitivity to risperidone or any of its excipients
Concurrent use with paliperidone
Severe hepatic or renal impairment
Severe cardiac disorders (including arrhythmias)
Psychosis associated with dementia in elderly patients
History of neuroleptic malignant syndrome.
Precautions
Monitor blood pressure and heart rate during treatment
Use caution in patients with seizure disorders (e.g., epilepsy)
In patients with hepatic, renal, or cardiac dysfunction, dose adjustments may be required
In elderly patients, risk of thromboembolism may be elevated
Thermoregulatory disturbances are possible
May impair concentration and reaction time — avoid driving or operating machinery
Do not consume alcohol concurrently
Discontinue treatment gradually to avoid withdrawal symptoms.
Adverse Effects
Nervous system
Somnolence, headache, dizziness, anxiety, insomnia, extrapyramidal symptoms (tremor, rigidity, hypersalivation), rarely seizures, very rarely neuroleptic malignant syndrome.
Cardiovascular
Tachycardia, elevated blood pressure, QT prolongation, orthostatic hypotension.
Gastrointestinal
Nausea, constipation, dry mouth, increased appetite, weight gain.
Endocrine
Hyperprolactinemia, possible galactorrhea, amenorrhea, gynecomastia.
Metabolic
Weight gain, disturbances in glucose metabolism.
Allergic
Skin rash, pruritus, edema.
In case of adverse reactions, consult your prescribing physician. In the event of serious reactions, discontinue use immediately and seek medical attention.
Pregnancy and Lactation
Pregnancy
Use of risperidone during pregnancy should be restricted to cases where the expected benefit justifies potential risk to the fetus. Data suggest possible risk of extrapyramidal and withdrawal symptoms in newborns when antipsychotics are used in the third trimester.
Lactation
Risperidone is excreted in breast milk. If treatment is required, breastfeeding should be discontinued.
Storage
Store at a temperature not exceeding 25 °C, in a dry place, protected from light and out of the reach of children. Do not use after the expiration date indicated on the packaging.
Dosage Form
Film‑coated tablets.
Packaging
30 tablets per pack.