Hydralazine Hydrochloride (Page 2 of 2)

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.
  • Hypersensitivity 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.

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, round, unscored tablets debossed with ‘H’ on one side and ‘38’ on the other side.

25 mg — Orange, round, unscored tablets debossed with ‘H’ on one side and ‘39’ on the other side.

50 mg — Orange, round, unscored tablets debossed with ‘H’ on one side and ‘40’ on the other side.

100 mg — Orange, round, unscored tablets debossed with ‘H’ on one side and ‘41’ on the other side.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-1062-150 MG30 Tablets in a Blister PackORANGE31722-521

Protect from light.

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

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854

By: Hetero Drugs Limited
2005566-00
Jeedimetla, Hyderabad- 500 055, India

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

PACKAGE LABEL

Label Image for 53808-1062 50mg

Label Image for 50mgLabel Image for 50mg
HYDRALAZINE HYDROCHLORIDE
hydralazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-1062(NDC:31722-521)
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
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 H;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-1062-1 30 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040901 11/01/2014
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-1062)

Revised: 01/2015 State of Florida DOH Central Pharmacy

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