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What is hydralazine 25 mg used for?

In the pharmaceutical industry, Hydralazine Hydrochloride 25 mg is a potent direct-acting peripheral vasodilator. As a pharmacist, I categorize this as a specialized antihypertensive that works exclusively on the smooth muscles of the arterial system rather than the venous system.

Primary Clinical Uses

  • Essential Hypertension: Used as an adjunctive therapy for high blood pressure, typically when first-line agents like ACE inhibitors or Calcium Channel Blockers are insufficient.

  • Hypertensive Emergency/Urgency: Frequently used in hospital settings for the rapid reduction of dangerously high blood pressure.

  • Chronic Heart Failure (CHF): Often used in a specific fixed-dose combination with Isosorbide Dinitrate (particularly in self-identified Black patients) to reduce mortality and hospitalizations.

  • Preeclampsia and Eclampsia: One of the preferred agents for managing severe hypertension during pregnancy due to its established safety profile for the fetus.

Mechanism of Action

Hydralazine works by directly relaxing the smooth muscles of the arterioles.

Vascular Relaxation: It interferes with the movement of calcium ions within the smooth muscle cells of the arterial walls.

Peripheral Resistance Reduction: By causing the arteries to widen (vasodilation), it significantly reduces peripheral vascular resistance.

Blood Pressure Drop: The heart can pump blood more easily against lower resistance, leading to a decrease in systemic blood pressure.

Reflex Tachycardia: Because it causes rapid vasodilation, it often triggers a “reflex” increase in heart rate, which is why it is commonly prescribed alongside a Beta-blocker.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Hydralazine 25 mg is a high-precision product with specific technical requirements:

  • API Stability: Hydralazine is susceptible to oxidation and can interact with certain tablet excipients (specifically those containing lactose or certain metals). As a WHO-GMP manufacturer, we utilize stabilized formulations to prevent the formation of “Hydrazones.”

  • Dose Titration: Since patients often start at 10 mg or 25 mg and titrate up to 50 mg, we ensure our 25 mg tablets have high breaking strength and friability standards to allow for precise dosing.

  • Stability for Export: We utilize Alu-Alu blister packaging to protect the API from moisture and light, ensuring a 24–36 month shelf life for export to Zone IVb regions (Africa, SE Asia).

  • B2B & Dossier Support: We provide comprehensive CTD/eCTD Dossiers to support international registration against the innovator (Apresoline). This is a staple for cardiovascular specialty distributors.

Hydralazine Tablets