Description

Hydralazine Tablets (25mg / 50mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Hydralazine Hydrochloride Tablets in India. Hydralazine is a direct-acting Vasodilator used for the management of Essential Hypertension (high blood pressure), often in combination with other antihypertensives. It is also a critical component (when combined with Isosorbide Dinitrate) in the treatment of Heart Failure in specific patient populations who cannot tolerate ACE inhibitors.

We offer Contract Manufacturing (Third Party) services for this classic cardiovascular drug. Hydralazine is sensitive to light and contact with metal. Our WHO-GMP certified facility in Mumbai utilizes specialized Non-Metallic Contact Parts during compression and opaque Film Coating to ensure the tablet remains stable and does not discolor. Healthy Inc manages the export logistics, supplying cardiology centers and pharmacy chains across the USA, Africa, and the Caribbean.

2. Product Specifications

3. Manufacturing Technology

Stability against metal and light.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Metal Chelation Prevention: Hydralazine can react with trace metals (like iron) in manufacturing equipment to form colored impurities. We use Passivated Stainless Steel (316L) and specific chelating agents (like EDTA) in the formulation to prevent this reaction.

  • Sugar/Film Coating: The core tablet is bitter and light-sensitive. We apply a robust Sugar Coating or Opaque Film Coating to protect the API from photodegradation and mask the metallic taste.

  • Content Uniformity: We ensure precise blending to guarantee that every tablet contains exactly 25mg or 50mg, which is critical for titration in heart failure patients.

• The Exporter: Healthy Inc

  • Heart Failure Kits: We can support the packaging of “Combination Kits” (Hydralazine + Isosorbide Dinitrate) for markets where the fixed-dose combination (BiDil generic) is not available or too expensive.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for Hydrazine (a toxic degradation product) to ensure it remains below stringent safety limits (ppm levels).

5. Why Use Hydralazine?

It relaxes the arteries to lower the pressure.

• Mechanism: Hydralazine exerts a direct relaxing effect on the vascular smooth muscle, preferentially dilating Arterioles (small arteries) rather than veins. This lowers peripheral resistance, making it easier for the heart to pump blood and immediately lowering blood pressure.

• Key Indications:

  • Severe Hypertension: Used when first-line drugs (ACEs, ARBs, CCBs) fail to control BP.

  • Hypertensive Crisis: (Oral maintenance after IV).

  • Heart Failure: Used with nitrates to reduce afterload (resistance) and preload (volume) in the heart.

  • Pre-eclampsia: Used in pregnancy (safe profile) to control high blood pressure.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Hydralazine Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Apresoline?

  A: Apresoline is the brand name (Novartis). We manufacture the Generic Equivalent (Hydralazine HCl), which acts exactly the same.

• Q: Can it cause Lupus?

  A: Yes. Long-term use of high doses (>200mg/day) can cause Drug-Induced Lupus Erythematosus (DILE) (joint pain, fever, rash). This is reversible if the drug is stopped.

• Q: Does it cause headaches?

  A: Yes. Like nitrates, it causes vasodilation which can lead to throbbing headaches and palpitations (reflex tachycardia). These usually improve with time or by adding a beta-blocker.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Hypertension: Start 10mg four times daily, increase gradually to 25-50mg four times daily.

• Heart Failure: Start 10-25mg 3-4 times daily (target 75mg QID).

• Administration: Take with food (improves bioavailability).

9. Side Effects and Precautions

• Lupus-Like Syndrome: Warning: Monitor for joint pain, fever, and ANA titers (blood test) every 6 months.

• Cardiac: Can precipitate angina or heart attack in patients with coronary artery disease due to reflex tachycardia (heart racing). Often prescribed with a Beta-Blocker to prevent this.

• Peripheral Neuritis: Numbness in hands/feet (treatable with Vitamin B6).

• Hypotension: Postural hypotension (dizziness when standing).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. (Tablets may turn yellow if exposed).