Risperdal

[Risperidone]

Co-Administration of RISPERDAL ® with Certain Other Medications
Co-administration of carbamazepine and other enzyme inducers ( e. g. , phenytoin, rifampin, phenobarbital) with risperidone would be expected to cause decreases in the plasma concentrations of active moiety ( the sum of risperidone and 9-hydroxyrisperidone) , which could lead to decreased efficacy of risperidone treatment. The dose of risperidone needs to be titrated accordingly for patients receiving these enzyme inducers, especially during initiation or discontinuation of therapy with these inducers ( see CLINICAL PHARMACOLOGY and PRECAUTIONS) .
Fluoxetine and paroxetine have been shown to increase the plasma concentration of risperidone 2.5-2.8 fold and 3-9 fold respectively. Fluoxetine did not affect the plasma concentration of 9-hydroxyrisperidone. Paroxetine lowered the concentration of 9-hydroxyrisperidone an average of 13% . The dose of risperidone needs to be titrated accordingly when fluoxetine or paroxetine is co-administered ( see CLINICAL PHARMACOLOGY and PRECAUTIONS) .

Directions for Use of RISPERDAL ® M-TAB Orally Disintegrating Tablets
RISPERDAL ® M-TAB Orally Disintegrating Tablets are supplied in blister packs of 4 tablet units each. .

Tablet Accessing

Text Continues Below

---

Do not open the blister until ready to administer. For single tablet removal, separate one of the four blister units by tearing apart at the perforations. Bend the corner where indicated. Peel back foil to expose the tablet. DO NOT push the tablet through the foil because this could damage the tablet.

Tablet Administration

Using dry hands, remove the tablet from the blister unit and immediately place the entire RISPERDAL ® M-TAB Orally Disintegrating Tablet on the tongue. The RISPERDAL ® M-TAB Orally Disintegrating Tablet should be consumed immediately, as the tablet cannot be stored once removed from the blister unit. RISPERDAL ® M-TAB Orally Disintegrating Tablets disintegrate in the mouth within seconds and can be swallowed subsequently with or without liquid. Patients should not attempt to split or to chew the tablet.

HOW SUPPLIED

RISPERDAL ® ( risperidone) tablets are imprinted JANSSEN , and either Ris and the strength 0.25 , 0.5 , or R and the strength 1 , 2 , 3 , or 4 . 0.25 mg dark yellow tablet: bottles of 60 NDC 50458-301-04, bottles of 500 NDC 50458-301-50, hospital unit dose packs of 100 NDC 50458-301-01. 0.5 mg red-brown tablet: bottles of 60 NDC 50458-302-06, bottles of 500 NDC 50458-302-50, hospital unit dose packs of 100 NDC 50458-302-01.
1 mg white tablet: bottles of 60 NDC 50458-300-06, blister pack of 100 NDC 50458-300-01, bottles of 500 NDC 50458-300-50.
2 mg orange tablet: bottles of 60 NDC 50458-320-06, blister pack of 100 NDC 50458-320-01, bottles of 500 NDC 50458-320-50.
3 mg yellow tablet: bottles of 60 NDC 50458-330-06, blister pack of 100 NDC 50458-330-01, bottles of 500 NDC 50458-330-50.
4 mg green tablet: bottles of 60 NDC 50458-350-06, blister pack of 100 NDC 50458-350-01.
RISPERDAL ® ( risperidone) 1 mg/ mL oral solution ( NDC 50458-305-03) is supplied in 30 mL bottles with a calibrated ( in milligrams and milliliters) pipette. The minimum calibrated volume is 0. 25 mL, while the maximum calibrated volume is 3 mL.

Tests indicate that RISPERDAL ® ( risperidone) oral solution is compatible n the following beverages: water, coffee, orange juice, and low-fat milk; it is NOT compatible with either cola or tea, however.
RISPERDAL ® M-TAB ( risperidone) Orally Disintegrating Tablets are etched on one side with R0.5 , R1 , and R2 , respectively, and are packaged in blister packs of 4 ( 2 X 2) tablets.
0.5 mg light coral, round, biconvex tablets: 7 blister packages per box, NDC 50458-395-28, long-term care packaging of 30 tablets NDC 50458-395-30.
1 mg light coral, square, biconvex tablets: 7 blister packages per box, NDC 50458-315-28, long-term care packaging of 30 tablets NDC 50458-315-30.
2 mg light coral, round, biconvex tablets: 7 blister packages per box, NDC 50458-325-28.
Storage and Handling
RISPERDAL ® 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.
RISPERDAL ® 1 mg/ mL oral solution should be stored at controlled room temperature 15 ° -25 ° C ( 59 ° -77 ° F) . Protect from light and freezing.

Keep out of reach of children.
RISPERDAL ® M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15 ° -25 ° C ( 59 ° -77 ° F) .
Keep out of reach of children.

7503226
US Patent 4,804,663
December 2003
© Janssen 2003

RISPERDAL ® tablets are manufactured by:
JOLLC, Gurabo, Puerto Rico or
Janssen-Cilag, SpA, Latina, Italy

RISPERDAL ® oral solution is manufactured by:
Janssen Pharmaceutica N. V.
Beerse, Belgium

RISPERDAL ® M-TAB Orally Disintegrating Tablets are manufactured by:
JOLLC, Gurabo, Puerto Rico

RISPERDAL ® tablets, RISPERDAL ® M-TAB Orally Disintegrating Tablets, and oral solution are distributed by:

Janssen Pharmaceutica Products, L. P. Titusville, NJ 08560

Page:  << Prev | 1 | 2 | 3 | 4 | 5