RISPERDAL Tablet / Tablet orally disintegrating / Solution (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Janssen Pharmaceuticals, Inc.

Λέξεις κλειδιά

50458-301 50458-302 50458-300 50458-320 50458-330 50458-350 50458-395 50458-315 50458-325 50458-335 50458-355 50458-305

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1. Indications and Usage

1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), ...

2. Dosage and Administration

Table 1. Recommended Daily Dosage by Indication:   Initial Dose Titration (Increments) Target Dose Effective Dose Range Schizophrenia: adults (2.1) 2 mg 1 to 2 mg 4 to 8 mg 4 to 16 ...

3. Dosage Forms and Strengths

RISPERDAL Tablets are available in the following strengths and colors: 0.25 mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green). All are capsule shaped, and ...

4. Contraindications

RISPERDAL is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL formulation. Hypersensitivity reactions, including ...

5. Warnings and Precautions

5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses ...

6. Adverse Reactions

The following are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of risperidone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Pharmacokinetic-related Interactions The dose of RISPERDAL should be adjusted when used in combination with CYP2D6 enzyme inhibitors (e.g., fluoxetine, and paroxetine) and enzyme inducers (e.g., carbamazepine) ...

8. Use in Specific Populations

8.8 Patients with Parkinsons Disease or Lewy Body Dementia Patients with Parkinsons Disease or Dementia with Lewy Bodies can experience increased sensitivity to RISPERDAL. Manifestations can include confusion, ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including RISPERDAL, during pregnancy. Healthcare providers ...

8.2. Lactation

Risk Summary Limited data from published literature reports the presence of risperidone and its metabolite, 9-hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3% and 4.7% ...

8.3. Females and Males of Reproductive Potential

Infertility Females Based on the pharmacologic action of risperidone (D2 receptor antagonism), treatment with RISPERDAL may result in an increase in serum prolactin levels, which may lead to a reversible ...

8.4. Pediatric Use

Approved Pediatric Indications Schizophrenia The efficacy and safety of RISPERDAL in the treatment of schizophrenia were demonstrated in 417 adolescents, aged 13-17 years, in two short-term (6 and 8 weeks, ...

8.5. Geriatric Use

Clinical studies of RISPERDAL in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients. ...

8.6. Renal Impairment

In patients with moderate to severe (Clcr 59 to 15 mL/min) renal disease, clearance of the sum of risperidone and its active metabolite decreased by 60%, compared to young healthy subjects. RISPERDAL ...

8.7. Hepatic Impairment

While the pharmacokinetics of risperidone in subjects with liver disease were comparable to those in young healthy subjects, the mean free fraction of risperidone in plasma was increased by about 35% because ...

9.1. Controlled Substance

RISPERDAL (risperidone) is not a controlled substance.

9.2. Abuse

RISPERDAL has not been systematically studied in animals or humans for its potential for abuse. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were ...

9.3. Dependence

RISPERDAL has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.

10. Overdosage

10.1 Human Experience Premarketing experience included eight reports of acute RISPERDAL overdosage with estimated doses ranging from 20 to 300 mg and no fatalities. In general, reported signs and symptoms ...

11. Description

RISPERDAL contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. ...

12.1. Mechanism of Action

The mechanism of action of risperidone in schizophrenia is unclear. The drugs therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D2) and serotonin ...

12.2. Pharmacodynamics

Risperidone is a monoaminergic antagonist with high affinity (Ki of 0.12 to 7.3 nM) for the serotonin Type 2 (5HT2), dopamine Type 2 (D2), α1 and α2 adrenergic, ...

12.3. Pharmacokinetics

Absorption Risperidone is well absorbed. The absolute oral bioavailability of risperidone is 70% (CV=25%). The relative oral bioavailability of risperidone from a tablet is 94% (CV=10%) when compared to ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Risperidone was administered in the diet at doses of 0.63, 2.5, and 10 mg/kg for 18 months to mice and for 25 months to rats. These doses are equivalent to approximately 0.2, 0.75, and 3 ...

14. Clinical Studies

14.1 Schizophrenia Adults Short-Term Efficacy: The efficacy of RISPERDAL in the treatment of schizophrenia was established in four short-term (4- to 8-week) controlled trials of psychotic inpatients ...

16.1. How Supplied

RISPERDAL (risperidone) Tablets RISPERDAL (risperidone) Tablets are imprinted JANSSEN on one side and either Ris 0.25, Ris 0.5, R1, R2, R3, or R4 according to their respective strengths. 0.25 mg dark yellow, ...

16.2. Storage and Handling

RISPERDAL Tablets should be stored at controlled room temperature 15°-25°C (59°-77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°-25°C ...

17. Patient Counseling Information

Physicians are advised to discuss the following issues with patients for whom they prescribe RISPERDAL and their caregivers: Orthostatic Hypotension Advise patients and caregivers about the risk of orthostatic ...

BOXED WARNING SECTION

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of ...