Finished product reference
Hydralazine Hydrochloride
Tablet · Oral · 50 mg
- List code
- 634
Indications
INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.
Dosage and administration (summary)
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.
Contraindications
CONTRAINDICATIONS Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.
Warnings and precautions
WARNINGS In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests .)
Storage and supply
HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP are available as: 25 mg – Round, peach, core tablet, debossed EP over 102 on one side and plain on the reverse side. NDC 82804-081-30 Bottles of 30 NDC 82804-081-60 Bottles of 60 NDC 82804-081-90 Bottles of 90 NDC 82804-081-72 Bottles of 120 Dispense in a tight, light-resistant container as define…
Source: Hydralazine Hydrochloride (Hydralazine Hydrochloride) — US FDA prescribing information, 2025-07-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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