Hydralazine Hydrochloride (Page 2 of 2)

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when hydrALAZINE is administered to a nursing woman.

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.

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.[/S]

HOW SUPPLIED

HydrALAZINE Hydrochloride Tablets, USP

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

NDC 67046-270-07 blisterpacks of 7

NDC 67046-270-14 blisterpacks of 14

NDC 67046-270-15 blisterpacks of 15

NDC 67046-270-20 blisterpacks of 20

NDC 67046-270-21 blisterpacks of 21

NDC 67046-270-28 blisterpacks of 28

NDC 67046-270-30 blisterpacks of 30

NDC 67046-270-60 blisterpacks of 60

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

NDC 67046-280-07 blisterpacks of 7

NDC 67046-280-14 blisterpacks of 14

NDC 67046-280-15 blisterpacks of 15

NDC 67046-280-20 blisterpacks of 20

NDC 67046-280-21 blisterpacks of 21

NDC 67046-280-28 blisterpacks of 28

NDC 67046-280-30 blisterpacks of 30

NDC 67046-280-60 blisterpacks of 60

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

Store at 20°-25°C (68°-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.

MANUFACTURED FOR: Heritage Pharmaceuticals Inc Eatontown, NJ 077241-866-901-DRUG (3784)

Issued: 10/13

Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Rev: Original—2017.10.02—NJW

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hydral25
(click image for full-size original)
hydral50
(click image for full-size original)

HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-270(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
HYPROMELLOSES
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:67046-270-07 7 TABLET, FILM COATED in 1 BLISTER PACK None
2 NDC:67046-270-14 14 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:67046-270-15 15 TABLET, FILM COATED in 1 BLISTER PACK None
4 NDC:67046-270-20 20 TABLET, FILM COATED in 1 BLISTER PACK None
5 NDC:67046-270-21 21 TABLET, FILM COATED in 1 BLISTER PACK None
6 NDC:67046-270-60 60 TABLET, FILM COATED in 1 BLISTER PACK None
7 NDC:67046-270-28 28 TABLET, FILM COATED in 1 BLISTER PACK None
8 NDC:67046-270-30 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086242 10/02/2017
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-280(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
HYPROMELLOSES
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:67046-280-07 7 TABLET, FILM COATED in 1 BLISTER PACK None
2 NDC:67046-280-14 14 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:67046-280-15 15 TABLET, FILM COATED in 1 BLISTER PACK None
4 NDC:67046-280-20 20 TABLET, FILM COATED in 1 BLISTER PACK None
5 NDC:67046-280-21 21 TABLET, FILM COATED in 1 BLISTER PACK None
6 NDC:67046-280-28 28 TABLET, FILM COATED in 1 BLISTER PACK None
7 NDC:67046-280-30 30 TABLET, FILM COATED in 1 BLISTER PACK None
8 NDC:67046-280-60 60 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086242 10/02/2017
Labeler — Contract Pharmacy Services-PA (945429777)
Establishment
Name Address ID/FEI Operations
Coupler Enterprises Inc. 945429777 repack (67046-270), repack (67046-280)

Revised: 12/2018 Contract Pharmacy Services-PA

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.