Hydralazine tablet use in specific populations: Difference between revisions

Revision as of 19:59, 10 March 2014

Hydralazine
HYDRALAZINE tablet^® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
How Supplied/Storage and Handling
Labels and Packages
HYDRALAZINE injection^® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
How Supplied/Storage and Handling
Labels and Packages
Clinical Trials on Hydralazine
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

USE IN SPECIFIC POPULATIONS

Pregancy

Teratogenic Effects

Pregnancy Category C

Animal studies indicate that hydralazine is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones.

There are no adequate and well-controlled studies in pregnant women. Although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydralazine should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Nursing Mothers

Hydralazine has been shown to be excreted in breast milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of hydralazine in pediatric patients. The usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. Dosage may be increased gradually over the next 3 to 4 weeks to a maximum of 7.5 mg/kg or 200 mg daily.^[1]

References

↑ "HYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.]". Retrieved 10 March 2014.

[dailymed.nlm.nih.gov-1] "HYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.]". Retrieved 10 March 2014.

[1]

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 ==USE IN SPECIFIC POPULATIONS==
-===Carcinogenesis, Mutagenesis, Impairment of Fertility===
-In a lifetime study in Swiss albino mice, there was a statistically significant increase in the incidence of lung tumors ([[adenomas ]]and [[adenocarcinomas]]) of both male and female mice given hydralazine continuously in their drinking water at a dosage of about 250 mg/kg per day (about 80 times the maximum recommended human dose). In a 2-year carcinogenicity study of rats given hydralazine by gavage at dose levels of 15, 30, and 60 mg/kg/day (approximately 5 to 20 times the recommended human daily dosage), microscopic examination of the liver revealed a small, but statistically significant, increase in benign neoplastic nodules in male and female rats from the high-dose group and in female rats from the intermediate-dose group. Benign interstitial cell tumors of the testes were also significantly increased in male rats from the high-dose group. The tumors observed are common in aged rats and a significantly increased incidence was not observed until 18 months of treatment. Hydralazine was shown to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one of two rats and one rabbit hepatocyte in vitro DNA repair studies. Additional in vivo and in vitro studies using lymphoma cells, germinal cells, and fibroblasts from mice, bone marrow cells from Chinese hamsters and fibroblasts from human cell lines did not demonstrate any mutagenic potential for hydralazine.
+===Pregancy===
-The extent to which these findings indicate a risk to man is uncertain. While long-term clinical observation has not suggested that human cancer is associated with hydralazine use, epidemiologic studies have so far been insufficient to arrive at any conclusions.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = HYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ddbbdb09-3202-42d7-bbb0-08331dde2f54 | publisher =  | date =  | accessdate = 10 March 2014 }}</ref>
+====Teratogenic Effects====
+'''Pregnancy Category C'''
+Animal studies indicate that hydralazine is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones.
+There are no adequate and well-controlled studies in pregnant women. Although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydralazine should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
+===Nursing Mothers===
+Hydralazine has been shown to be excreted in breast milk.
+===Pediatric Use===
+Safety and effectiveness in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of hydralazine in pediatric patients. The usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. Dosage may be increased gradually over the next 3 to 4 weeks to a maximum of 7.5 mg/kg or 200 mg daily.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = HYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ddbbdb09-3202-42d7-bbb0-08331dde2f54 | publisher =  | date =  | accessdate = 10 March 2014 }}</ref>
 ==References==