Description

Clonidine Tablets (100mcg / 200mcg / 300mcg)

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 Clonidine Hydrochloride Tablets in India. Clonidine is a centrally acting Alpha-2 Adrenergic Agonist used primarily for the treatment of Hypertension (high blood pressure). Due to its unique mechanism of calming the central nervous system, it is also extensively used off-label and in specific formulations for ADHD (Attention Deficit Hyperactivity Disorder), Opioid Withdrawal Management, and menopausal hot flashes.

We offer Contract Manufacturing (Third Party) services for this potent low-dose medication. Clonidine is dosed in micrograms (mcg), requiring extreme precision during manufacturing to ensure safety. Our WHO-GMP certified facility in Mumbai utilizes advanced Geometric Dilution blending techniques and automated weight checking to guarantee absolute content uniformity. Healthy Inc manages the export logistics, supplying rehabilitation centers, psychiatric clinics, and hospitals across the USA, Europe, and Russia.

2. Product Specifications

3. Manufacturing Technology

Micro-dosing with macro-precision.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: A single tablet contains as little as 0.1mg of active drug. To prevent “hot spots” (overdosed tablets), we use a validated Multi-Stage Blending process where the active ingredient is progressively mixed with larger amounts of excipients (Lactose/Starch) to ensure a homogeneous mix.

  • Hardness Control: Clonidine tablets are often split to taper doses. We engineer the tablets with optimal hardness to allow for clean breaking along the score line without crumbling.

  • Direct Compression: We utilize specialized direct compression grades of excipients to maintain stability and prevent segregation of the active ingredient during the tableting process.

• The Exporter: Healthy Inc

  • Rehab Kits: We can supply bulk packs specifically designed for addiction treatment centers where daily observed therapy (DOT) is practiced.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

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

• Uniformity of Dosage Units: We perform rigorous statistical testing (AV value) to confirm every tablet in the batch delivers the correct microgram dose.

5. Why Use Clonidine?

Calms the nerves to lower the pressure.

• Mechanism: Clonidine stimulates Alpha-2 Adrenergic Receptors in the brainstem (medulla oblongata). This tricks the brain into thinking catecholamine levels are too high, causing it to reduce the sympathetic outflow (fight-or-flight signals) to the heart and blood vessels. The result is relaxed vessels and lower blood pressure.

• Key Indications:

  • Resistant Hypertension: Used when other drugs fail.

  • ADHD: Improves attention and reduces impulsivity (often used for sleep in ADHD kids).

  • Opioid Withdrawal: Reduces the physical symptoms of withdrawal (sweating, agitation, tremors) by dampening the sympathetic overactivity.

  • Tourette’s Syndrome: Reduces tics.

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 Clonidine Tablets?

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

• Q: Is it Catapres?

  A: Catapres is the brand name (Boehringer Ingelheim). We manufacture the Generic Equivalent (Clonidine HCl), which works exactly the same.

• Q: Can I stop taking it suddenly?

  A: NEVER. Sudden withdrawal causes Rebound Hypertension—a dangerous spike in blood pressure that can cause a stroke. You must taper the dose slowly over several days.

• Q: Does it make you sleepy?

  A: Yes. Sedation and drowsiness are very common. It is often taken at bedtime for this reason.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Hypertension: Start 0.1mg twice daily. Max 2.4mg/day (rarely needed).

• Opioid Withdrawal: 0.1mg to 0.2mg every 4-6 hours (monitor BP before each dose).

• ADHD: 0.1mg at bedtime (titrated up).

• Administration: Swallow with water. Can be taken with or without food.

9. Side Effects and Precautions

• Common: Dry mouth (very common), drowsiness, dizziness, constipation.

• Cardiovascular: Bradycardia (slow heart rate) and hypotension.

• Rebound Effect: Agitation, tremor, and rapid BP rise if missed doses occur.

• Interaction: Increases sedation with Alcohol, Benzodiazepines, and Opioids. Beta-blockers can worsen rebound hypertension if stopped concurrently.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.