HYDRALAZINE HYDROCHLORIDE (Page 2 of 2)

OVERDOSAGE

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.

Signs and Symptoms: Signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing.

Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock.

Treatment: There is no specific antidote.

The gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. An activated charcoal slurry may be instilled if conditions permit. These manipulations may have to be omitted or carried out after cardiovascular status has been stabilized, since they might precipitate cardiac arrhythmias or increase the depth of shock.

Support of the cardiovascular system is of primary importance. Shock should be treated with plasma expanders. If possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia.

Tachycardia responds to beta blockers. Digitalization may be necessary, and renal function should be monitored and supported as required.

No experience has been reported with extracorporeal or peritoneal dialysis.

DOSAGE AND ADMINISTRATION

Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels.

The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE.

In a few resistant patients, up to 300 mg of hydrALAZINE daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.

HOW SUPPLIED

HydrALAZINE Hydrochloride Tablets, USP

10 mg — round, convex, pink film-coated tablet engraved with HP above 1 on one side and plain on the other side

NDC 23155-001-01 Bottles of 100 w/ CRC

NDC 23155-001-10 Bottles of 1000

25 mg — round, convex, pink film-coated tablet engraved with HP above 2 on one side and plain on the other side

NDC 23155-002-01 Bottles of 100 w/ CRC

NDC 23155-002-10 Bottles of 1000

50 mg — round, convex, pink film-coated tablet engraved with HP above 3 on one side and plain on the other side

NDC 23155-003-01 Bottles of 100 w/ CRC

NDC 23155-003-10 Bottles of 1000

100 mg — round, convex, pink film-coated tablet engraved with HP above 4 on one side and plain on the other side

NDC 23155-004-01 Bottles of 100 w/ CRC

NDC 23155-004-10 Bottles of 1000

Dispense in a tight, light-resistant container as defined in the USP.

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

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Distributed by:

Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816

1-866-901-DRUG (3784)

51U000000172US05

Revised: 08/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydralazine Hydrochloride Tablets, USP, 10 mg, 100 count

Hydralazine Hydrochloride Tablets, USP, 25 mg, 100 count

Hydralazine Hydrochloride Tablets, USP, 50 mg, 100 count

Hydralazine Hydrochloride Tablets, USP, 100 mg, 100 count

HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-001 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE STARCH, CORN MAGNESIUM STEARATE MINERAL OIL TITANIUM DIOXIDE SODIUM LAURYL SULFATE FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED

Product Characteristics Color PINK Score no score Shape ROUND Size 7mm Flavor Imprint Code HP;1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-001-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:23155-001-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA086242 04/06/2007

HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-002 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE STARCH, CORN MAGNESIUM STEARATE MINERAL OIL TITANIUM DIOXIDE SODIUM LAURYL SULFATE FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED

Product Characteristics Color PINK Score no score Shape ROUND Size 8mm Flavor Imprint Code HP;2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-002-10 1000 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:23155-002-01 100 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA086242 04/06/2007

HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-003 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE STARCH, CORN MAGNESIUM STEARATE MINERAL OIL TITANIUM DIOXIDE SODIUM LAURYL SULFATE FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED

Product Characteristics Color PINK Score no score Shape ROUND Size 10mm Flavor Imprint Code HP;3 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-003-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:23155-003-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA086242 04/06/2007

HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-004 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 100 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE STARCH, CORN MAGNESIUM STEARATE MINERAL OIL TITANIUM DIOXIDE SODIUM LAURYL SULFATE FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED

Product Characteristics Color PINK Score no score Shape ROUND Size 11mm Flavor Imprint Code HP;4 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-004-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:23155-004-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA086242 04/06/2007

Labeler — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)

Establishment
Name	Address	ID/FEI	Operations
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.		189630168	ANALYSIS (23155-001), ANALYSIS (23155-002), ANALYSIS (23155-003), ANALYSIS (23155-004), LABEL (23155-001), LABEL (23155-002), LABEL (23155-003), LABEL (23155-004), MANUFACTURE (23155-001), MANUFACTURE (23155-002), MANUFACTURE (23155-003), MANUFACTURE (23155-004), PACK (23155-001), PACK (23155-002), PACK (23155-003), PACK (23155-004)

Establishment
Name	Address	ID/FEI	Operations
Sumitomo Chemical Company Ltd.		711530311	API MANUFACTURE (23155-001), API MANUFACTURE (23155-002), API MANUFACTURE (23155-003), API MANUFACTURE (23155-004)

Revised: 08/2021 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.