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CAMPTOSAR- irinotecan hydrochloride injection, solution


  1. Patient Information
  2. Revised: 3/2019document Id:

Patient Information 

  • Patients and caregivers should be informed of gastrointestinal complications, such as nausea, vomiting, abdominal cramping, and diarrhea. Patients should have loperamide readily available to begin treatment for late diarrhea (generally occurring more than 24 hours after administration of CAMPTOSAR). Begin loperamide at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normal. One dosage regimen for loperamide is 4 mg at the first onset of late diarrhea and then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 hours. Loperamide is not recommended to be used for more than 48 consecutive hours at these doses, because of the risk of paralytic ileus. During the night, the patient may take 4 mg of loperamide every 4 hours. Patients should contact their physician if any of the following occur: diarrhea for the first time during treatment; black or bloody stools; symptoms of dehydration such as lightheadedness, dizziness, or faintness; inability to take fluids by mouth due to nausea or vomiting; or inability to get diarrhea under control within 24 hours.
  • Patients should be warned about the potential for dizziness or visual disturbances which may occur within 24 hours following the administration of CAMPTOSAR.
  • Explain the significance of routine blood cell counts. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever or infection.
  • CAMPTOSAR may cause fetal harm. Advise patients to avoid becoming pregnant while receiving this drug.
  • Patients should be alerted to the possibility of alopecia.
  • Contains sorbitol.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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LAB-0134-22.0

PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Label

NDC 0009-7529-03
Single Use: Discard unused portion

Camptosar
irinotecan HCl injection

100 mg/5 mL
(20 mg/mL)

For Intravenous Use Only
CytosafeVial
Caution: Cytotoxic Agent

PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Label

PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Carton

NDC 0009-7529-03

Single Use: Discard unused portion
Camptosar

irinotecan hydrochloride
injection

100 mg/5 mL
(20 mg/mL)

For Intravenous Use Only

CytosafeVial
Caution: Cytotoxic Agent

Pfizer Injectables

Rx only

PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Carton
CAMPTOSAR
irinotecan hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0009-7529
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRINOTECAN HYDROCHLORIDE(UNII: 042LAQ1IIS) (IRINOTECAN - UNII:7673326042)IRINOTECAN HYDROCHLORIDE20 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0009-7529-021 in 1 CARTON06/14/199606/01/2013
12 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2NDC:0009-7529-011 in 1 CARTON06/14/199609/01/2013
25 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
3NDC:0009-7529-041 in 1 CARTON06/14/1996
32 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
4NDC:0009-7529-031 in 1 CARTON06/14/1996
45 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
5NDC:0009-7529-051 in 1 CARTON06/14/1996
515 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02057106/14/1996
Labeler -Pharmacia and Upjohn Company LLC (618054084)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer (Perth) Pty Limited757868963ANALYSIS(0009-7529) , MANUFACTURE(0009-7529) , PACK(0009-7529)

Revised: 3/2019document Id: 

02b55806-a85e-4561-a708-b484ecd81f8fSet id: e518dfc6-7e93-4fee-a66c-51e1ab71c056Version: 25Effective Time: 20190306Pharmacia and Upjohn Company LLC



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