Note: Ingredients listed on restricted chemical lists
EC/CAS
9005-25-8
Name of the chemical
Starch
Concentration
<10
General Information
Version
010A
Revision date
2015-11-05
Product name
RISPERIDONE TABLETS, USP
Product Synonyms
Formulated Product Risperidone Tablets USP, 0.25 mg Risperidone Tablets USP, 0.5 mg Risperidone Tablets USP, 1 mg Risperidone Tablets USP, 2 mg Risperidone Tablets USP, 3mg Risperidone Tablets USP, 4 mg
1.2.2. Uses advised against
No other uses are advised
Manufacturer Name
Zhejiang Huahai Pharmaceutical Co Ltd
Emergency telephone
008657685016474
Icons in SDS
Company Information
company name
Zhejiang Huahai Pharmaceutical Co Ltd
e-mail address of the competent person responsible for the Safety Data Sheet
leikewei@huahaipharm.com
GHS Information
Signal word
Danger
Section 2
SECTION 2: Hazards identification
OSHA defined hazards Classification of the substance or mixture
Physical hazards
Not classified
Health hazards
Not classified
Environmental hazards
Not classified
2.2 Label elements
INDICATIONS AND USAGE Risperidone is an atypical antipsychotic indicated for: • Treatment of schizophrenia. • As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder . • Treatment of irritability associated with autistic disorder. WARNINGS AND PRECAUTIONS • Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis: Risperidone is not approved for use in patients with dementia-related psychosis. • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of Risperidone and close monitoring. • Tardive dyskinesia: Consider discontinuing Risperidone if clinically indicated. • Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. •Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes. • Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. • Weight Gain: Significant weight gain has been reported. Monitor weight gain. • Hyperprolactinemia: Prolactin elevations occur and persist during chronic administration. • Orthostatic hypotension: For patients at risk, consider a lower starting dose and slower titration. • Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts in patients with a history of clinically significant low white blood cell count (WBC). Consider discontinuing Risperidone if a clinically significant decline in WBC occurs in the absence of other causative factors. • Potential for cognitive and motor impairment: Use caution when operating machinery. • Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. Hazard(s) not otherwise classified (HNOC) Available hazard identification for Active Pharmaceutical Ingredient (API) alone
Signal word
Danger
Hazard statements
H301 Toxic if swallowed.
Precautionary statements
P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/ physician.
Storage
Store at controlled room temperature, 20° to 25°C (68° to77°F) [see USP]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.
Disposal
Offer surplus and non-recyclable solutions to a licensed disposal company. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber.
Further information
No additional information
2.1 Classification of the substance or mixture
Physical hazards: Not classified. Health hazards: Not classified. OSHA defined hazards: Not classified. Environment hazards: Not classified.
