Risperidone (Page 12 of 12)

17.4 Nursing

Inform patients and caregivers that risperidone and its active metabolite are present in human breast milk; 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) ].

17.5 Concomitant Medication

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)].

17.6 Alcohol

Advise patients to avoid alcohol while taking risperidone [see Drug Interactions (7.2) ].

17.8 Metabolic Changes

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)].

17.9 Tardive Dyskinesia

Inform patients and caregivers about the risk of tardive dyskinesia [see Warnings and Precautions (5.4) ].

Rx Only

Manufactured by:
Silarx Pharmaceuticals, Inc. Carmel, NY 10512

Rev. 11/14

USING YOUR RISPERIDONE ORAL SOLUTION, USP DISPENSING-SYRINGE AND BOTTLE

Each 1mL contains: 1mg of risperidone in an aqueous solution.

Use this product as indicated below, unless directed otherwise by your Physician.

IMPORTANT: Please read these instructions before using risperidone oral solution.

1. Remove cap by pressing down and turning it counter-clockwise. See Figure 1.Figure
2. While holding the bottle firmly, insert plastic bottle adapter completely into neck of the open bottle. See Figure 2.
Figure
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3. Insert the tip of syringe firmly into opening of plastic bottle adapter. See figure 3.
Figure
(click image for full-size original)
4. Invert the entire unit (bottle with syringe) upside down as shown in Figure 4.5. While holding the bottle and outer barrel of syringe, pull the plunger down slowly to the level (see markings on side) that equals the dosage prescribed by your doctor. See Figure 4
Figure
(click image for full-size original)
6. Turn the entire unit right side up and remove the syringe slowly from the plastic bottle adapter being careful not to depress the plunger. See Figure 5.7. Empty the entire contents into 3 to 4 ounces (100 mL) of a beverage by pushing the plunger down inside the syringe. Stir the mixture thoroughly before consuming. Risperidone is compatible with water, coffee, orange juice, or low-fat milk. IT IS NOT COMPATIBLE with cola or tea.
Figure
(click image for full-size original)

Manufactured by:
Silarx Pharmaceuticals, Inc Carmel, NY 10512

Rev. 11/14

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container
(click image for full-size original)
Carton
(click image for full-size original)
RISPERIDONE risperidone solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54838-563
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
SORBITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54838-563-30 30 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202386 01/30/2015
Labeler — Lannett Company, Inc. (161630033)

Revised: 01/2015 Lannett Company, Inc.

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