Hydralazine Hydrochloride Injection, Usp

Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.

When there is urgent need, therapy in the hospitalized patient may be initiated intramuscularly or as a rapid intravenous bolus injection directly into the vein. Hydralazine hydrochloride injection should be used only when the drug cannot be given orally. The usual dose is 20 to 40 mg, repeated as necessary.

Certain patients (especially those with marked renal damage) may require a lower dose. Blood pressure should be checked frequently. It may begin to fall within a few minutes after injection, with the average maximal decrease occurring in 10 to 80 minutes. In cases where there has been increased intracranial pressure, lowering the blood pressure may increase cerebral ischemia. Most patients can be transferred to oral hydralazine hydrochloride within 24 to 48 hours.

The product should be used immediately after the vial is opened. It should not be added to infusion solutions. Hydralazine hydrochloride injection may discolor upon contact with metal; discolored solutions should be discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Discard unused portion.

Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.

Hydralazine Hydrochloride Injection, USP is a colorless solution and is supplied as follows:

Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and

intramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile, nonpyrogenic colorless solution.

Each mL contains:

Active: Hydralazine Hydrochloride, USP, 20 mg

Preservatives: Methylparaben, NF, 0.65 mg; Propylparaben, NF, 0.35 mg

Inactives: Propylene Glycol, USP, 103.6 mg; Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (3.4 to 4.4)

and Water for Injection.

Hydralazine Hydrochloride, USP is 1-hydrazinophthalazine monohydrochloride, and its structural formula is:

Molecular Formula C₈H₈N₄•HCl

Hydralazine Hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly

soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular

weight of 196.64.

General

Myocardial stimulation produced by hydralazine can cause anginal attacks and ECG changes of myocardial ischemia. The drug has been implicated in the production of myocardial infarction. It must, therefore, be used with caution in patients with suspected coronary artery disease.

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.

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, 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.

(For Intramuscular or Intravenous Use)

meitheal®

Rx only

In a few patients hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydralazine should be discontinued 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 (see PRECAUTIONS, Laboratory Tests ).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Sterile, Nonpyrogenic.

The container closure is not made with natural rubber latex.

meitheal®

Mfd. for Meitheal Pharmaceuticals

Chicago, IL 60631 (USA)

©2023 Meitheal Pharmaceuticals Inc.

Mfd. by Kindos Pharmaceuticals Co., Ltd.

Chengdu, China 611731

November 2023

Acute Toxicity:      No deaths due to acute poisoning have been reported.

                             Highest known dose survived: adults, 10 g orally.

                             Oral LD₅₀ in rats: 173 and 187 mg/kg.

NDC 71288-205-01

Rx Only

hydrALAZINE Hydrochloride  Injection, USP

20 mg per mL

For Intramuscular or Intravenous Use

1 mL Single-Dose Vial

NDC 71288-205-02

Rx Only

hydrALAZINE Hydrochloride Injection, USP

20 mg per mL

For Intramuscular or Intravenous  Use

25 x 1 mL Single-Dose Vials

General

Myocardial stimulation produced by hydralazine can cause anginal attacks and ECG changes of myocardial ischemia. The drug has been implicated in the production of myocardial infarction. It must, therefore, be used with caution in patients with suspected coronary artery disease.

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.

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, 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.

(For Intramuscular or Intravenous Use)

meitheal®

Rx only

In a few patients hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydralazine should be discontinued 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 (see PRECAUTIONS, Laboratory Tests ).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Sterile, Nonpyrogenic.

The container closure is not made with natural rubber latex.

meitheal®

Mfd. for Meitheal Pharmaceuticals

Chicago, IL 60631 (USA)

©2023 Meitheal Pharmaceuticals Inc.

Mfd. by Kindos Pharmaceuticals Co., Ltd.

Chengdu, China 611731

November 2023

Acute Toxicity:      No deaths due to acute poisoning have been reported.

                             Highest known dose survived: adults, 10 g orally.

                             Oral LD₅₀ in rats: 173 and 187 mg/kg.

Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and

intramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile, nonpyrogenic colorless solution.

Each mL contains:

Active: Hydralazine Hydrochloride, USP, 20 mg

Preservatives: Methylparaben, NF, 0.65 mg; Propylparaben, NF, 0.35 mg

Inactives: Propylene Glycol, USP, 103.6 mg; Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (3.4 to 4.4)

and Water for Injection.

Hydralazine Hydrochloride, USP is 1-hydrazinophthalazine monohydrochloride, and its structural formula is:

Molecular Formula C₈H₈N₄•HCl

Hydralazine Hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly

soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular

weight of 196.64.

Hydralazine Hydrochloride Injection, USP is a colorless solution and is supplied as follows:

Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.

Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.

When there is urgent need, therapy in the hospitalized patient may be initiated intramuscularly or as a rapid intravenous bolus injection directly into the vein. Hydralazine hydrochloride injection should be used only when the drug cannot be given orally. The usual dose is 20 to 40 mg, repeated as necessary.

Certain patients (especially those with marked renal damage) may require a lower dose. Blood pressure should be checked frequently. It may begin to fall within a few minutes after injection, with the average maximal decrease occurring in 10 to 80 minutes. In cases where there has been increased intracranial pressure, lowering the blood pressure may increase cerebral ischemia. Most patients can be transferred to oral hydralazine hydrochloride within 24 to 48 hours.

The product should be used immediately after the vial is opened. It should not be added to infusion solutions. Hydralazine hydrochloride injection may discolor upon contact with metal; discolored solutions should be discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Discard unused portion.

NDC 71288-205-01

Rx Only

hydrALAZINE Hydrochloride  Injection, USP

20 mg per mL

For Intramuscular or Intravenous Use

1 mL Single-Dose Vial

NDC 71288-205-02

Rx Only

hydrALAZINE Hydrochloride Injection, USP

20 mg per mL

For Intramuscular or Intravenous  Use

25 x 1 mL Single-Dose Vials