Hydralazine (Page 2 of 2)

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.

ADVERSE REACTIONS

Adverse reactions with hydrALAZINE are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency.

Common

headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris.

Less Frequent

Digestive

constipation, paralytic ileus.

Cardiovascular

hypotension, paradoxical pressor response, edema.

Respiratory

dyspnea.

Neurologic

peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety.

Genitourinary

difficulty in urination.

Hematologic

blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly.

Hypersensitive Reactions

rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis.

Other

nasal congestion, flushing, lacrimation, conjunctivitis.

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 hydrochloride tablets.

In a few resistant patients, up to 300 mg of hydrALAZINE hydrochloride tablets 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 are available as:

25 mg orange, round, uncoated, biconvex tablet debossed ‘C43’ on one side and plain on other side
Bottles of 100 NDC 75834-126-01
Bottles of 1,000 NDC 75834-126-00
50 mg orange, round, uncoated, biconvex tablet debossed ‘C45’ on one side and plain on other side
Bottles of 100 NDC 75834-127-01
Bottles of 1,000 NDC 75834-127-00
100 mg orange, round, uncoated, biconvex tablet debossed ‘C47’ on one side and plain on other side
Bottles of 100 NDC 75834-128-01

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

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required)

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Manufactured for : Nivagen Pharmaceuticals, Inc.
Sacramento, CA 95827
Toll free number : 1-877-977-0687

Manufactured by : Cadila Pharmaceuticals Ltd.
1389, Dholka, Dist. Ahmedabad, Gujarat State, India.

August 2016

OETA0026

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

Rx only

NDC 75834-126-01

HydrALAZINE
Hydrochloride
Tablets USP
25 mg

100 TABLETS

NIVAGEN PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL -- 25 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

Rx only

NDC 75834-127-01

HydrALAZINE
Hydrochloride
Tablets USP
50 mg

100 Tablets

NIVAGEN PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL -- 50 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

Rx only

NDC 75834-128-01

HydrALAZINE
Hydrochloride
Tablets USP
100 mg

100 Tablets

NIVAGEN PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL -- 100 mg Tablet Bottle Label
(click image for full-size original)
HYDRALAZINE hydralazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-126
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
MANNITOL
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code C43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75834-126-01 100 TABLET in 1 BOTTLE None
2 NDC:75834-126-00 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203845 02/15/2017
HYDRALAZINE hydralazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-127
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
MANNITOL
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75834-127-01 100 TABLET in 1 BOTTLE None
2 NDC:75834-127-00 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203845 02/15/2017
HYDRALAZINE hydralazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-128
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
MANNITOL
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code C47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75834-128-01 100 TABLET in 1 BOTTLE None
2 NDC:75834-128-00 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203845 02/15/2017
Labeler — Nivagen Pharmaceuticals, Inc. (052032418)

Revised: 02/2022 Nivagen Pharmaceuticals, Inc.

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.