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Laboratory Tests 
Periodic platelet counts, hematocrits and tests for occult blood in stool are recommended during the 
entire course of heparin use (see DOSAGE AND ADMINISTRATION). 
Drug Interactions 
Platelet Inhibitors 
Drugs such as acetylsalicylic acid, dextran, phenylbutazone, ibuprofen, indomethacin, dipyridamole, 
hydroxychloroquine and others that interfere with platelet-aggregation reactions (the main hemostatic 
defense of heparinized patients) may induce bleeding and should be used with caution in patients 
receiving heparin sodium. 
Other Interactions 
Digitalis, tetracyclines, nicotine or antihistamines may partially counteract the anticoagulant action of 
heparin sodium. 


NDA 17-037/S-158 
Page 18 
Carcinogenesis, Mutagenesis, Impairment Of Fertility 
No long-term studies in animals have been performed to evaluate the carcinogenic potential of heparin 
sodium. Also, no reproduction studies in animals have been performed concerning mutagenesis or 
impairment of fertility. 
Pregnancy 
Teratogenic Effects—Pregnancy Category C
Animal reproduction studies have not been conducted with heparin sodium. It is also not known 
whether heparin sodium can cause fetal harm when administered to a pregnant woman or can affect 
reproduction capacity. Heparin sodium should be given to a pregnant woman only if clearly needed. 
Nonteratogenic Effects 
Heparin does not cross the placental barrier. 
Nursing Mothers 
Heparin is not excreted in human milk. 
Pediatric Use 
Safety and effectiveness in pediatric patients have not been established. Not for use in neonates (see 
WARNINGS). 
Geriatric Use 
A higher incidence of bleeding has been reported in patients over 60 years of age, especially women 
(see CLINICAL PHARMACOLOGY and PRECAUTIONSGeneral). 

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