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
| HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride tablet, film coated | |||||||||||||||||||||||||||||||||||||||||
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| HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride tablet, film coated | |||||||||||||||||||||||||||||||||||||||||
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| 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
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