Meitheal Pharmaceuticals (Meitheal) is pleased to announce the official launch of hydrALAZINE Hydrochloride Injection, USP:
- 71288-205-02: hydrALAZINE Hydrochloride Injection, USP 20mg per mL SDV
INDICATIONS AND USAGE
HydrALAZINE Hydrochloride Injection, USP is an antihypertensive indicated for severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
Contraindications
Hydralazine Hydrochloride is contraindicated in patients with hypersensitivity to hydralazine; and in patients with coronary artery disease and those with mitral valvular rheumatic heart disease.
Warnings and Precautions
Simulation of lupus erythematosus Hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis, necessitating discontinuation unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary.
Use caution in patients with suspected coronary artery disease Myocardial stimulation produced by hydralazine can cause anginal attacks and ECG changes of myocardial ischemia including myocardial infarction. Use with caution in patients with suspected coronary artery disease.
Potential impact to cardiovascular inadequacies The “hyperdynamic” circulation caused by hydralazine may accentuate specific cardiovascular inadequacies. For example, hydralazine may increase pulmonary artery pressure in patients with mitral valvular disease. The drug may reduce the pressor responses to epinephrine. Postural hypotension may result from hydralazine but is less common than with ganglionic blocking agents. It should be used with caution in patients with cerebral vascular accidents.
Potential impact to renal function In hypertensive patients with normal kidneys who are treated with hydralazine, there is evidence of increased renal blood flow and a maintenance of glomerular filtration rate. In some instances where control values were below normal, improved renal function has been noted after administration of hydralazine. However, as with any antihypertensive agent, hydralazine should be used with caution in patients with advanced renal damage.
Peripheral neuritis Peripheral neuritis, evidenced by paresthesia, numbness, and tingling, has been observed. Published evidence suggests an antipyridoxine effect, and that pyridoxine should be added to the regimen if symptoms develop.
Laboratory Test Considerations
Complete blood counts and antinuclear antibody titer determinations are indicated before and periodically during prolonged therapy with hydralazine even though the patient is asymptomatic. These studies are also indicated if the patient develops arthralgia, fever, chest pain, continued malaise, or other unexplained signs or symptoms.
Blood dyscrasias have been reported. Discontinue treatment with hydralazine hydrochloride if any of the following blood dyscrasias are reported: reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, and purpura.
Drug Interactions
MAO inhibitors should be used with caution in patients receiving hydralazine.
When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydralazine, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydralazine injection are used concomitantly.
Use in Specific Populations
Pregnancy: 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 hydrochloride in children.
Adverse Reactions
Adverse reactions observed with hydralazine hydrochloride include headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, and angina pectoris.
To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Prescribing Information for hydrALAZINE Hydrochloride Injection, USP by clicking on the following link.
Learn more about who we are and what we do at: www.meithealpharma.com.
