16. HOW SUPPLIED/STORAGE AND HANDLING
Risperidone Tablets, 0.25 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n28 on the other and are available in:
bottles of 100 NDC 58165-028-01
bottles of 500 NDC 58165-028-02
blisters (10 x 15 tablets cards) NDC 58165-028-03.
Risperidone Tablets, 0.5 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n29 on the other and are available in:
bottles of 100 NDC 58165-029-01
bottles of 500 NDC 58165-029-02
blisters (10 x 15 tablets cards) NDC 58165-029-03.
Risperidone Tablets, 1 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n30 on the other and are available in:
bottles of 100 NDC 58165-030-01
bottles of 500 NDC 58165-030-02
blisters (10 x 15 tablets cards) NDC 58165-030-03.
Risperidone Tablets, 2 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n31 on the other and are available in:
bottles of 100 NDC 58165-031-01
bottles of 500 NDC 58165-031-02
blisters (10 x 15 tablets cards) NDC 58165-031-03.
Risperidone Tablets, 3 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n32 on the other and are available in:
bottles of 100 NDC 58165-032-01
bottles of 500 NDC 58165-032-02
blisters (10 x 15 tablets cards) NDC 58165-032-03.
Risperidone Tablets, 4 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n33 on the other and are available in:
bottles of 100 NDC 58165-033-01
bottles of 500 NDC 58165-033-02
blisters (10 x 15 tablets cards) NDC 58165-033-03.
Storage and Handling
Risperidone Tablets should be stored at controlled room temperature 15°-25°C (59°-77°F).
Protect from light and moisture.
Keep out of reach of children.
17. PATIENT COUNSELING INFORMATION
Physicians are advised to discuss the following issues with patients for whom they prescribe risperidone:
17.1 Orthostatic Hypotension
Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration [see Warnings and Precautions (5.7)].
17.2 Interference with Cognitive and Motor Performance
Since risperidone has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that risperidone therapy does not affect them adversely [see Warnings and Precautions (5.9)].
17.3 Pregnancy
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations (8.1)].
17.4 Nursing
Patients should be advised not to breast-feed an infant if they are taking risperidone [see Use in Specific Populations (8.3)].
17.5 Concomitant Medication
Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Drug Interactions (7)].
17.6 Alcohol
Patients should be advised to avoid alcohol while taking risperidone [see Drug Interactions (7.1)].
Revised May 2010
Risperidone Tablets are manufactured by:
ratiopharm inc.
Canada J7J 1P31 800 337 2584
PRINCIPAL DISPLAY PANEL
150 TABLETS
NDC 58165-029-03
risperidone tablets
0.5 mg
Rx only
ratiopharm
Each tablet contains: 0.5 mg of risperidone.
DOSAGE: See accompanying package insert.
Store at 15-25°C (59-77°F). See USP Controlled Room Temperature. Protect from light and moisture.
KEEP OUT OF THE REACH OF CHILDREN.
This unit-dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be used.
Manufactured by: ratiopharm inc. ,Mirabel, Canada J7J 1P3
RISPERIDONE risperidone tablet, coated |
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RISPERIDONE risperidone tablet, coated |
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RISPERIDONE risperidone tablet, coated |
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RISPERIDONE risperidone tablet, coated |
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RISPERIDONE risperidone tablet, coated |
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RISPERIDONE risperidone tablet, coated |
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Revised: 05/2010 Ratiopharm Inc
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