Hydralazine Hydrochloride (Page 2 of 2)

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 & 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 Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘293’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-293-01 Bottles of 500 Tablets NDC 67877-293-05 Bottles of 1000 Tablets NDC 67877-293-10
25 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘292’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-292-01 Bottles of 500 Tablets NDC 67877-292-05 Bottles of 1000 Tablets NDC 67877-292-10
50 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘291’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-291-01 Bottles of 500 Tablets NDC 67877-291-05 Bottles of 1000 Tablets NDC 67877-291-10
100 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘290’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-290-01 Bottles of 500 Tablets NDC 67877-290-05

Dispense in a tight, light-resistant container.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

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

Manufactured by:
ALKEM LABORATORIES LIMITED
H.O.: ALKEM HOUSE,
Senapati Bapat Marg, Lower Parel,
Mumbai — 400 013, INDIA
Distributed by:
Ascend Laboratories
Parsippany, NJ 07054
Revised: December,2017
PT 1368-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HydrALAZINE Hydrochloride Tablets, USP 10 mg — Container Label
NDC 67877-293-01
HydrALAZINE
Hydrochloride
Tablets, USP
10 mg
Rx Only
100 Tablets

100s-10mg
(click image for full-size original)


HydrALAZINE Hydrochloride Tablets, USP 25 mg — Container Label
NDC 67877-292-05
HydrALAZINE
Hydrochloride
Tablets, USP
25 mg
Rx Only
500 Tablets
500s-25mg
(click image for full-size original)

HydrALAZINE Hydrochloride Tablets, USP 50 mg — Container Label

NDC 67877-291-10
HydrALAZINE
Hydrochloride
Tablets, USP
50 mg
Rx Only
1000 Tablets
1000s-50mg
(click image for full-size original)

HydrALAZINE Hydrochloride Tablets, USP 100 mg — Container Label
NDC 67877-290-01
HydrALAZINE
Hydrochloride
Tablets, USP
100 mg
Rx Only
100 Tablets
100s-100mg
(click image for full-size original)

HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-293
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C YELLOW NO. 6
SILICON DIOXIDE
STEARIC ACID
MANNITOL
POVIDONE K30
Product Characteristics
Color ORANGE (Light Orange) Score no score
Shape ROUND (Circular biconvex) Size 6mm
Flavor Imprint Code 293
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-293-01 100 TABLET in 1 BOTTLE None
2 NDC:67877-293-05 500 TABLET in 1 BOTTLE None
3 NDC:67877-293-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200737 05/24/2010
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-292
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C YELLOW NO. 6
POVIDONE K30
SILICON DIOXIDE
STEARIC ACID
MANNITOL
Product Characteristics
Color ORANGE (Light Orange) Score no score
Shape ROUND (Circular biconvex) Size 8mm
Flavor Imprint Code 292
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-292-01 100 TABLET in 1 BOTTLE None
2 NDC:67877-292-05 500 TABLET in 1 BOTTLE None
3 NDC:67877-292-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200737 05/24/2010
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-291
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C YELLOW NO. 6
POVIDONE K30
SILICON DIOXIDE
STEARIC ACID
MANNITOL
Product Characteristics
Color ORANGE (Light Orange) Score no score
Shape ROUND (Circular biconvex) Size 10mm
Flavor Imprint Code 291
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-291-01 100 TABLET in 1 BOTTLE None
2 NDC:67877-291-05 500 TABLET in 1 BOTTLE None
3 NDC:67877-291-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200737 11/24/2009
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-290
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C YELLOW NO. 6
POVIDONE K30
SILICON DIOXIDE
STEARIC ACID
MANNITOL
Product Characteristics
Color ORANGE (Light Orange) Score no score
Shape ROUND (Circular biconvex) Size 12mm
Flavor Imprint Code 290
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-290-01 100 TABLET in 1 BOTTLE None
2 NDC:67877-290-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200737 05/24/2010
Labeler — Ascend Laboratories, LLC (141250469)
Establishment
Name Address ID/FEI Operations
Alkem Laboratories Limited 915628612 MANUFACTURE (67877-290), MANUFACTURE (67877-291), MANUFACTURE (67877-292), MANUFACTURE (67877-293)

Revised: 12/2017 Ascend Laboratories, LLC

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