Imatinib Mesylate (Page 9 of 9)

15 REFERENCES

OSHA Hazardous Drugs. OSHA. [Accessed on 20-September- 2013, from

http://www.osha.gov/SLTC/hazardousdrugs/index.html]

16 HOW SUPPLIED/STORAGE AND HANDLING


Each film-coated tablet contains 100 mg or 400 mg of imatinib free base.

  • 100 mg Tablets

Yellow, circular, biconvex, film coated tablet debossed with “472” on one side and breakline on the other side.
Bottles of 30 with child-resistant closure ……………… NDC 47335-472-83
Bottles of 90 with child-resistant closure ……………… NDC 47335-472-81
Bottles of 100 with child-resistant closure …………….. NDC 47335-472-88
Bottles of 500……………………………… ……….. NDC 47335-472-13

  • 400 mg Tablets

Yellow, ovaloid shaped, biconvex, film coated tablet debossed with “475” on one side and breakline on the other side.
Bottles of 30 with child-resistant closure ……………… NDC 47335-475-83
Bottles of 100 with child-resistant closure …………….. NDC 47335-475-88
Bottles of 500 ……………………………… …….…… NDC 47335-475-13
Unit-dose blister pack of 30 (3×10) tablets … …….…… NDC 47335-475-64
Storage and Handling
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature]. Protect from moisture.
Dispense in a tight container, USP.
Do not crush imatinib mesylate tablets. Avoid direct contact of crushed tablets with the skin or mucous membranes. If such contact occurs, wash thoroughly as outlined in the references. Avoid exposure to crushed tablets.

17 PATIENT COUNSELING INFORMATION

Dosing and Administration

Advise patients to take imatinib mesylate tablets exactly as prescribed, not to change their dose or to stop taking imatinib mesylate tablets unless they are told to do so by their doctor. If the patient missed a dose of imatinib mesylate tablets, the patient should take the next scheduled dose at its regular time. The patient should not take two doses at the same time. Advise patients to take imatinib mesylate tablets with a meal and a large glass of water [see Dosage and Administration (2.1)].

Fluid Retention and Edema

Inform patients of the possibility of developing edema and fluid retention. Advise patients to contact their health care provider if unexpected rapid weight gain occurs [see Warnings and Precautions (5.1)].

Hepatotoxicity

Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their health care provider if signs of liver failure occur, including jaundice, anorexia, bleeding, or bruising [see Warnings and Precautions (5.4)].

Pregnancy and Breastfeeding

Advise patients to inform their doctor if they are or think they may be pregnant. Advise women of reproductive potential to avoid becoming pregnant while taking imatinib mesylate tablets. Female patients of reproductive potential taking imatinib mesylate tablets should use highly effective contraception during treatment and for fourteen days after stopping treatment with imatinib mesylate tablets [see Use in Specific Populations (8.3)]. Avoid breastfeeding during treatment and for 1 month after the last dose [see Use in Specific Populations (8.2)].

Drug Interactions

Imatinib mesylate tablets and certain other medicines, such as warfarin, erythromycin, and phenytoin, including over-the-counter medications, such as herbal products, can interact with each other. Advise patients to tell their doctor if they are taking or plan to take iron supplements. Avoid grapefruit juice and other foods known to inhibit CYP3A4 while taking imatinib mesylate tablets [see Drug Interactions (7)].

Pediatric

Advise patients that growth retardation has been reported in children and pre-adolescents receiving imatinib mesylate tablets. The long term effects of prolonged treatment with imatinib mesylate tablets on growth in children are unknown. Therefore, closely monitor growth in children under imatinib mesylate tablets treatment [see Warnings and Precautions (5.11)].

Driving and Using Machines

Advise patients that they may experience side effects, such as dizziness, blurred vision, or somnolence during treatment with imatinib mesylate tablets. Therefore, caution patients about driving a car or operating machinery [see Warnings and Precautions (5.13)].

Manufactured by:

Sun Pharmaceutical Industries Ltd.

Halol-Baroda Highway,

Halol-389 350, Gujarat, India.

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512
PJPI0610B

ISS. 08/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel -Label — 100 mg
NDC 47335-472-81
Imatinib Mesylate Tablets
100 mg*
Rx only
90 Tablets SUN PHARMA

spl-imatinib-100
(click image for full-size original)

Principal Display Panel -Label — 400 mg
NDC 47335-475-83
Imatinib Mesylate Tablets
400 mg*
Rx only
30 Tablets
SUN PHARMA

spl-imatinib-400
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-472-81
Imatinib Mesylate Tablets
100 mg*
Rx only
90 Tablets SUN PHARMA

spl-imatinib-100-mg
(click image for full-size original)

NDC 47335-475-83
Imatinib Mesylate Tablets
400 mg*
Rx only
30 Tablets
SUN PHARMA

spl-imatinib-400-mg
(click image for full-size original)
IMATINIB MESYLATE imatinib mesylate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-472
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMATINIB MESYLATE (IMATINIB) IMATINIB 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
MANNITOL
COPOVIDONE K25-31
CROSPOVIDONE (120 .MU.M)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FERRIC OXIDE RED
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND (circular) Size 9mm
Flavor Imprint Code 472
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-472-83 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:47335-472-88 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:47335-472-13 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:47335-472-81 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078340 02/01/2016
IMATINIB MESYLATE imatinib mesylate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-475
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMATINIB MESYLATE (IMATINIB) IMATINIB 400 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
MANNITOL
COPOVIDONE K25-31
CROSPOVIDONE (120 .MU.M)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FERRIC OXIDE RED
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL (ovaloid) Size 20mm
Flavor Imprint Code 475
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-475-83 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:47335-475-88 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:47335-475-13 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:47335-475-64 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (47335-475-64)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078340 02/01/2016
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (47335-472), ANALYSIS (47335-475), MANUFACTURE (47335-472), MANUFACTURE (47335-475)

Revised: 08/2020 Sun Pharmaceutical Industries, Inc.

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