RISPERIDONE tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)

Saadav alates:

DIRECT RX

INN (Rahvusvaheline Nimetus):

RISPERIDONE

Koostis:

RISPERIDONE 1 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

1.1 Schizophrenia RISPERIDONE (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), and one long-term maintenance trial in adults [see Clinical Studies ( 14.1)]. 1.2 Bipolar Mania Monotherapy RISPERIDONE is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies ( 14.2)]. Adjunctive Therapy RISPERIDONE adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies ( 14.3)]. 1.3 Irritability Associated with Autistic Disorder Pediatrics RISPERIDONE is indicated for the treatment of irritability assoc

Toote kokkuvõte:

Risperidone Tablets USP, 0.25 mg are dark yellow, round, biconvex film-coated tablets debossed with "Z" on one side and "4" on the other side and are supplied as follows: NDC 68382-112-06in bottle of 30 tablets NDC 68382-112-14 in bottle of 60 tablets NDC 68382-112-16 in bottle of 90 tablets NDC 68382-112-01 in bottle of 100 tablets NDC 68382-112-05 in bottle of 500 tablets NDC 68382-112-10 in bottle of 1000 tablets Risperidone Tablets USP, 0.5 mg are red-brown colored, round, biconvex film-coated tablets debossed with "Z" on one side and "6" on other side and are supplied as follows: NDC 68382-113-06 in bottle of 30 tablets NDC 68382-113-14 in bottle of 60 tablets NDC 68382-113-16 in bottle of 90 tablets NDC 68382-113-01 in bottle of 100 tablets NDC 68382-113-05 in bottle of 500 tablets NDC 68382-113-10 in bottle of 1000 tablets Risperidone Tablets USP, 1 mg are white to off-white, round, biconvex film-coated tablets debossed with "ZC 75" on one side and plain on other side and are supplied as follows: NDC 68382-114-06 in bottle of 30 tablets NDC 68382-114-14 in bottle of 60 tablets NDC 68382-114-16 in bottle of 90 tablets NDC 68382-114-01 in bottle of 100 tablets NDC 68382-114-05 in bottle of 500 tablets NDC 68382-114-10 in bottle of 1000 tablets Risperidone Tablets USP, 2 mg are orange, round, biconvex film-coated tablets debossed with "ZC 76" on one side and plain on other side and are supplied as follows: NDC 68382-115-06 in bottle of 30 tablets NDC 68382-115-14 in bottle of 60 tablets NDC 68382-115-16 in bottle of 90 tablets NDC 68382-115-01 in bottle of 100 tablets NDC 68382-115-05 in bottle of 500 tablets NDC 68382-115-10 in bottle of 1000 tablets Risperidone Tablets USP, 3 mg are yellow, round, biconvex film-coated tablets debossed with "ZC 77"on one side and plain on other side and are supplied as follows: NDC 68382-116-06 in bottle of 30 tablets NDC 68382-116-14 in bottle of 60 tablets NDC 68382-116-16 in bottle of 90 tablets NDC 68382-116-01 in bottle of 100 tablets NDC 68382-116-05 in bottle of 500 tablets NDC 68382-116-10 in bottle of 1000 tablets Risperidone Tablets USP, 4 mg are green, round, biconvex film-coated tablets debossed with "ZC 78" on one side and plain on other side and are supplied as follows: NDC 68382-117-06 in bottle of 30 tablets NDC 68382-117-14 in bottle of 60 tablets NDC 68382-117-16 in bottle of 90 tablets NDC 68382-117-01 in bottle of 100 tablets NDC 68382-117-05 in bottle of 500 tablets NDC 68382-117-10 in bottle of 1000 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container. Keep out of reach of children. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Physicians are advised to discuss the following issues with patients for whom they prescribe RISPERIDONE and their caregivers: Advise patients and caregivers about the risk of orthostatic hypotension, especially during the period of initial dose titration [see WARNINGS AND PRECAUTIONS (5.7)]. Inform patients and caregivers that RISPERIDONE has the potential to impair judgment, thinking, or motor skills. Advise caution about operating hazardous machinery, including automobiles, until patients are reasonably certain that RISPERIDONE therapy does not affect them adversely [see WARNINGS AND PRECAUTIONS (5.9)]. Advise patients and caregivers to notify their physician if the patient becomes pregnant or intends to become pregnant during therapy [see USE IN SPECIFIC POPULATIONS ( 8.1)]. Inform patients and caregivers that risperidone and its active metabolite are present in human breastmilk; there is a potential for serious adverse reactions from RISPERIDONE in nursing infants. Advise patients that the decision whether to discontinue nursing or to discontinue the RISPERIDONE should take into account the importance of the drug to the patient [see USE IN SPECIFIC POPULATIONS ( 8.3)]. Advise patients and caregivers to inform their physicians if the patient is taking, or plans to take, any prescription or over-the-counter drugs, because there is a potential for interactions [see DRUG INTERACTIONS ( 7)]. Advise patients to avoid alcohol while taking RISPERIDONE [see DRUG INTERACTIONS ( 7.2)]. Inform patients and caregivers that treatment with RISPERIDONE can be associated with hyperglycemia and diabetes mellitus, dyslipidemia, and weight gain [see WARNINGS AND PRECAUTIONS ( 5.5)]. Inform patients and caregivers about the risk of tardive dyskinesia [see WARNINGS AND PRECAUTIONS ( 5.4)].

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

RISPERIDONE- RISPERIDONE TABLET, FILM COATED
DIRECT RX
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RISPERIDONE
BOXED WARNING SECTION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIARELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an
increased risk of death. RISPERIDONE (risperidone) is not approved for
the treatment of patients
with dementia-related psychosis. [see Warnings and Precautions ( 5.1)]
INDICATIONS & USAGE SECTION
1.1 Schizophrenia
RISPERIDONE (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), and one long-term
maintenance trial in adults [see Clinical Studies ( 14.1)].
1.2 Bipolar Mania
Monotherapy
RISPERIDONE is indicated for the treatment of acute manic or mixed
episodes associated with Bipolar
I Disorder. Efficacy was established in 2 short-term trials in adults
and one short-term trial in children
and adolescents (ages 10 to 17 years) [see Clinical Studies ( 14.2)].
Adjunctive Therapy
RISPERIDONE adjunctive therapy with lithium or valproate is indicated
for the treatment of acute manic
or mixed episodes associated with Bipolar I Disorder. Efficacy was
established in one short-term trial
in adults [see Clinical Studies ( 14.3)].
1.3 Irritability Associated with Autistic Disorder
Pediatrics
RISPERIDONE is indicated for the treatment of irritability associated
with autistic disorder, including
symptoms of aggression towards others, deliberate self-injuriousness,
temper tantrums, and quickly
changing moods. Efficacy was established in 3 short-term trials in
children and adolescents (ages 5 to
17 years) [see Clinical Studies ( 14.4)].
DOSAGE & ADMINISTRATION SECTION
TABLE 1RECOMMENDED 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 mg
Schizophrenia:
adolescents
(2.2)
0.5 mg
0.5 to 1 mg
3 mg
1 to 6 mg
Bipolar mania: adults (2.2)
2