Product Information:

RISPERIGET 4mg Tablets contain Risperidone 4mg, a second-generation (atypical) antipsychotic that acts as a potent antagonist at dopamine D₂ and serotonin 5-HT₂A receptors. This higher-strength formulation is typically reserved for moderate to severe psychotic or manic symptoms in patients who have already been titrated to an effective dose under psychiatric supervision.

⚠️ Note: Risperidone doses ≥4mg/day are associated with a higher risk of extrapyramidal side effects (EPS) and metabolic disturbances. Use only when lower doses are insufficient.

Uses of (RISPERIGET 4MG TABLETS):

1. Treatment of schizophrenia in adults (≥18 years) with inadequate response to lower doses
2. Management of severe acute manic or mixed episodes in bipolar I disorder
3. Off-label: Severe aggression or psychosis in treatment-resistant cases (e.g., delusional disorder, schizoaffective disorder)
4. Not indicated for autism or dementia-related psychosis

Key Benefits of (RISPERIGET 4MG TABLETS):

1. Enhanced control of refractory positive symptoms (e.g., persistent hallucinations, delusions)
2. Effective mood stabilization in severe mania
3. Once- or twice-daily dosing for maintenance therapy
4. Predictable pharmacokinetics in stable patients

How To Use (RISPERIGET 4MG TABLETS):

1. Take once or twice daily, with or without food, as directed by your psychiatrist.
2. Swallow whole with water—do not crush or chew.
3. Typical use:
4. Schizophrenia: 4–6mg/day (maximum recommended: 8mg/day)
5. Bipolar mania: 4–6mg/day during acute phase
6. Never initiate therapy at 4mg—always start low (e.g., 1–2mg) and titrate slowly.
7. Do not stop abruptly—taper gradually to avoid rebound psychosis or insomnia.

When Not to Use (RISPERIGET 4MG TABLETS):

Do not use if you have:

1. Hypersensitivity to risperidone or paliperidone
2. History of neuroleptic malignant syndrome (NMS)
3. Dementia-related psychosis in elderly patients (↑ risk of death)
4. Severe cardiovascular disease, cerebrovascular disease, or uncontrolled hypotension
5. Prolonged QT interval or concurrent use of QT-prolonging medications

⚠️ Black Box Warning:

Antipsychotics increase mortality in elderly patients with dementia-related psychosis. RISPERIGET 4mg is not approved for this population.

Side Effects of (RISPERIGET 4MG TABLETS):

Common:

1. Significant sedation, dizziness, fatigue
2. Weight gain, increased appetite
3. Dry mouth, constipation

Serious (more likely at ≥4mg/day):

1. Extrapyramidal symptoms (EPS): Parkinsonism, dystonia, akathisia (restlessness)
2. Hyperprolactinemia: Galactorrhea, amenorrhea, infertility, sexual dysfunction
3. Metabolic effects: Hyperglycemia, dyslipidemia, insulin resistance
4. Orthostatic hypotension (especially during dose escalation)
5. Tardive dyskinesia: Involuntary tongue, lip, or limb movements (may be irreversible)
6. Discontinue and seek emergency care if high fever, muscle rigidity, or altered mental status occurs (signs of NMS).

Dosage: (RISPERIGET 4MG TABLETS):

1. Adults (schizophrenia): 4–6mg/day (max 8mg/day in rare, resistant cases)
2. Bipolar mania: 4–6mg/day during acute phase
3. Elderly or hepatic/renal impairment: Avoid 4mg dose—max 1.5mg/day
4. Adolescents: Generally not prescribed at 4mg; max 3mg/day

Who It’s For (RISPERIGET 4MG TABLETS):

Adults with severe, treatment-resistant schizophrenia or bipolar I mania who have failed lower doses and require intensified therapy under close psychiatric monitoring.

Warnings & Precautions:

1. Not for first-line or initial treatment—use only after titration from lower doses
2. Monitor weight, waist circumference, fasting glucose, HbA1c, and lipids every 3 months
3. Perform regular movement disorder assessments (e.g., AIMS scale)
4. Avoid in elderly patients—high risk of stroke and mortality
5. Counsel patients about metabolic risks and adherence

Drug Interactions:

1. CNS depressants (alcohol, opioids, benzodiazepines): ↑ Sedation and respiratory depression
2. Carbamazepine: May reduce risperidone levels by 50%—monitor closely
3. Fluoxetine, paroxetine: May double risperidone levels—reduce dose if combined
4. Antihypertensives: ↑ Risk of orthostatic hypotension
5. Always inform your psychiatrist about all medications.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiration date. Available by prescription only in Pakistan.