In the pharmaceutical industry, Hydralazine is a potent direct-acting vasodilator that is considered a first-line agent for managing severe hypertension in pregnancy. As a pharmacist and manufacturer, I view this as a “Critical Care” molecule, specifically used to prevent complications like stroke or eclampsia.
At your WHO-GMP facility in Mumbai, you likely handle this in 25 mg and 50 mg tablets, as well as 20 mg/mL vials for injection, which is the preferred form for acute hypertensive emergencies.
Administration Protocols in Pregnancy
The method of delivery is strictly determined by the severity and urgency of the blood pressure reading:
1. Acute Hypertensive Crisis (Emergency)
When blood pressure is dangerously high (e.g., $\ge$ 160/110 mmHg), Hydralazine is administered intravenously (IV) or intramuscularly (IM).
-
IV Bolus: A common starting dose is 5 mg to 10 mg given slowly over several minutes.
-
Repeat Dosing: If the target blood pressure is not reached, doses can be repeated every 20 minutes.
-
IV Infusion: In some clinical settings, it may be given as a continuous infusion titrated to the patient’s response.
2. Chronic Management
For non-emergency long-term management, oral tablets are used.
-
Typical Dose: Often started at 10 mg four times daily, gradually increasing as needed.
-
Combination Therapy: It is frequently used alongside other agents like Methyldopa or Labetalol.
Mechanism: Arteriolar Vasodilation
Hydralazine works by directly relaxing the smooth muscles of the blood vessels.
Selective Action: It primarily affects the arterioles (resistance vessels) rather than the veins.
Calcium Interference: It is thought to interfere with calcium movements within the vascular smooth muscle, preventing contraction.
Result: This leads to decreased peripheral vascular resistance, which lowers blood pressure while increasing heart rate and cardiac output (reflex tachycardia).
The Pharmacist’s “Technical Warning”
As you promote your firm on digital platforms, providing these technical nuances is essential for professional authority:
-
Fetal Monitoring: Because Hydralazine can cause a rapid drop in maternal blood pressure, it may reduce placental blood flow; continuous fetal heart rate monitoring is recommended during IV administration.
-
Side Effects: Common reactions include headache, palpitations, and a lupus-like syndrome with long-term high-dose use.
-
Reflex Tachycardia: Due to the drop in pressure, the heart may beat faster; sometimes a beta-blocker is added to control the heart rate.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
-
The “Emergency Portfolio” USP: On your marketplace, highlight your Hydralazine 20mg Vials as an essential “Maternal Health Emergency” product. This attracts high-volume orders from international hospital networks and NGOs.
-
Stability & Packaging: Hydralazine is light-sensitive and can react with certain metals. We utilize Amber-colored glass vials and Alu-Alu blister packaging for tablets to ensure a 36-month shelf life in Zone IVb tropical regions.
-
Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders and for bidding on WHO pre-qualification programs.