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Risperidone
Overview
What is Risperidone?
RISPERIDONE contains risperidone, a psychotropic agent 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. Its molecular formula is CHFNO and its molecular weight is 410.49. The structural formula is:
Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.
Each risperidone tablet intended for oral administration contains 0.25 mg or 0.5 mg or 1 mg or 2 mg or 3 mg or 4 mg of risperidone. Additionally each tablet also contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and titanium dioxide. Additionally each 0.25 mg tablet contains iron oxide red and iron oxide yellow, 0.5 mg tablet contains iron oxide red, 2 mg tablet contains FD&C yellow # 6/sunset yellow FCF aluminum lake, 3 mg tablet contains D&C yellow # 10 aluminum lake and 4 mg tablet contains D&C yellow # 10 aluminum lake and FD&C blue # 2/ indigo carmine aluminum lake.
What does Risperidone look like?
What are the available doses of Risperidone?
The round-shaped, film-coated tablets are available in the following strengths, colors and debossing: 0.25 mg - dark yellow and debossed with Z and 4; 0.5 mg - red-brown, debossed with Z and 6; 1 mg - white to off-white and debossed with ZC 75; 2 mg - orange and debossed with ZC 76; 3 mg - yellow and debossed with ZC 77 and 4 mg - green and debossed with ZC 78.
What should I talk to my health care provider before I take Risperidone?
How should I use Risperidone?
Adults
RISPERIDONE (risperidone) is indicated for the acute and maintenance treatment of schizophrenia [see
Adolescents
Due to Janssen Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation's risperidone drug products.
Adults
Usual Initial Dose
RISPERIDONE can be administered once or twice daily. Initial dosing is generally 2 mg/day. Dose increases should then occur at intervals not less than 24 hours, in increments of 1 - 2 mg/day, as tolerated, to a recommended dose of 4 to 8 mg/day. In some patients, slower titration may be appropriate. Efficacy has been demonstrated in a range of 4 to 16 mg/day [see However, doses above 6 mg/day for twice daily dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended. In a single study supporting once-daily dosing, the efficacy results were generally stronger for 8 mg than for 4 mg. The safety of doses above 16 mg/day has not been evaluated in clinical trials.
Maintenance Therapy
While it is unknown how long a patient with schizophrenia should remain on RISPERIDONE, the effectiveness of RISPERIDONE 2 mg/day to 8 mg/day at delaying relapse was demonstrated in a controlled trial in patients who had been clinically stable for at least 4 weeks and were then followed for a period of 1 to 2 years [see Patients should be periodically reassessed to determine the need for maintenance treatment with an appropriate dose.
Adolescents
Due to Janssen Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Dosage and administration information for pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation's risperidone drug product.
Reinitiation of Treatment in Patients Previously Discontinued
Although there are no data to specifically address reinitiation of treatment, it is recommended that after an interval off RISPERIDONE, the initial titration schedule should be followed.
Switching From Other Antipsychotics
There are no systematically collected data to specifically address switching schizophrenic patients from other antipsychotics to RISPERIDONE, or treating patients with concomitant antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some schizophrenic patients, more gradual discontinuation may be most appropriate for others. The period of overlapping antipsychotic administration should be minimized. When switching schizophrenic patients from depot antipsychotics, initiate RISPERIDONE therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
What interacts with Risperidone?
Sorry No Records found
What are the warnings of Risperidone?
Sorry No Records found
What are the precautions of Risperidone?
Sorry No Records found
What are the side effects of Risperidone?
Sorry No records found
What should I look out for while using Risperidone?
Known hypersensitivity to the product ()
What might happen if I take too much Risperidone?
How should I store and handle Risperidone?
Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).Do not refrigerate. Keep the bottle in the outer carton when not in use.The product should be used within three months after it has been opened.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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets 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 67046-653-30 in blister of 30 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 67046-654-30 in blister of 30 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 67046-655-30 in blister of 30 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 67046-656-30 in blister of 30 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 67046-657-30 in blister of 30 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 67046-658-30 in blister of 30 tablets
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of RISPERIDONE, as with other drugs used to treat schizophrenia, is unknown. However, it has been proposed that the drug’s therapeutic activity in schizophrenia is mediated through a combination of dopamine Type 2 (D) and serotonin Type 2 (5HT) receptor antagonism.
RISPERIDONE is a selective monoaminergic antagonist with high affinity (Ki of 0.12 to 7.3 nM) for the serotonin Type 2 (5HT), dopamine Type 2 (D), α and α adrenergic, and H histaminergic receptors. RISPERIDONE acts as an antagonist at other receptors, but with lower potency. RISPERIDONE has low to moderate affinity (Ki of 47 to 253 nM) for the serotonin 5HT, 5HT, and 5HT receptors, weak affinity (Ki of 620 to 800 nM) for the dopamine D and haloperidol-sensitive sigma site, and no affinity (when tested at concentrations >10 M) for cholinergic muscarinic or βand β adrenergic receptors.
Non-Clinical Toxicology
Known hypersensitivity to the product ()Drug Interactions:
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERIDONE is not approved for the treatment of dementia-related psychosis
BOXED WARNING ]
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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