Hydralazine Hydrochloride (Page 2 of 2)

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.

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 LD 50 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 hydrochloride tablets 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, convex, unscored tablets, debossed with “PLIVA 327” on one side and plain on the other side. They are available as follows:
Overbagged with 10 tablets per bag, NDC 55154-5689-0

50 mg

Orange, round, convex, unscored tablets, debossed with “PLIVA 328” on one side and plain on the other side. They are available as follows:
Overbagged with 10 tablets per bag, NDC 55154-5085-0

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

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured in Czech Republic by:
TEVA CZECH INDUSTRIES s.r.o.
Opava-Komarov, Czech Republic

Manufactured for:
TEVA PHARMACEUTICALS USA, Inc.
North Wales, PA 19454

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

Distributed by: Cardinal Health

Dublin, OH 43017

L41452980324

L41577230224

S-11344 R3
4/20

Package/Label Display Panel

Hydralazine Hydrochloride Tablets, USP

25 mg

10 Tablets

Bag Label
(click image for full-size original)

Package/Label Display Panel

Hydralazine Hydrochloride Tablets, USP

50 mg

10 Tablets

Bag Label
(click image for full-size original)
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5689(NDC:51079-075)
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
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 PLIVA;327
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5689-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the BAG (55154-5689-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088467 05/13/2011
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5085(NDC:51079-076)
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
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 9mm
Flavor Imprint Code PLIVA;328
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5085-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the BAG (55154-5085-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088468 05/13/2011
Labeler — Cardinal Health 107, LLC (118546603)

Revised: 03/2024 Cardinal Health 107, LLC

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