Description

Cinnarizine Tablets (15mg / 25mg / 75mg)

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 Cinnarizine Tablets in India. Cinnarizine is a dual-action agent: a Piperazine Antihistamine and a selective Calcium Channel Blocker. It is the global drug of choice for the prevention and treatment of Motion Sickness (travel sickness) and the management of Vertigo and balance disorders (such as Meniere’s disease).

We offer Contract Manufacturing (Third Party) services for this vestibular sedative. Cinnarizine is highly lipophilic (fat-soluble) and requires specific formulation techniques to ensuring consistent absorption. Our WHO-GMP certified facility in Mumbai utilizes advanced granulation processes to optimize the disintegration time, ensuring the drug is released rapidly to provide quick relief before nausea sets in. Healthy Inc manages the export logistics, supplying travel clinics, naval suppliers, and pharmacy chains across Europe, Southeast Asia, and Africa.

2. Product Specifications

3. Manufacturing Technology

Stabilizing the inner ear, stabilizing the tablet.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Solubility Enhancement: Cinnarizine dissolves poorly in water but well in acid. We use specific disintegrants that create an optimal micro-environment in the stomach, ensuring the tablet breaks down completely even in patients with low stomach acid (a common issue in the elderly who use this drug for vertigo).

  • Forte Formulation: For the 75mg (Cinnarizine Forte) dosage, we use high-compressibility binders to keep the tablet size manageable while ensuring it is robust enough to withstand shipping without crumbling.

  • Uniformity: We employ automated mixing and validation protocols to ensure the active ingredient is evenly distributed, preventing dose variation which could lead to excessive sedation.

• The Exporter: Healthy Inc

  • Travel Packs: We specialize in “Travel Rescue Packs” (small blisters of 10 or 20 tablets) designed for retail sale at airports, ferry terminals, and travel clinics.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 45 minutes in 0.1M HCl.

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

• Related Substances: We strictly monitor for impurities to ensure safety and stability.

5. Why Use Cinnarizine?

Stops the spinning, calms the stomach.

• Mechanism:

  • Calcium Channel Blockade: Cinnarizine inhibits the influx of calcium into the “hair cells” of the vestibular system (inner ear). This reduces the sensitivity of the balance center to motion, preventing the brain from receiving “spinning” signals.

  • Antihistamine: It blocks H1 receptors in the vomiting center of the brain, preventing nausea.

  • Peripheral Vasodilation: It improves blood flow to the inner ear (and legs), helping with tinnitus and cramps.

• Key Indications:

  • Motion Sickness: Prevents seasickness, carsickness, and airsickness.

  • Vertigo & Meniere’s Disease: Reduces dizziness, tinnitus (ringing ears), and nausea associated with inner ear disorders.

  • Peripheral Vascular Disease: (Adjunct) Improves circulation in Raynaud’s phenomenon or intermittent claudication.

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 Cinnarizine Tablets?

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

• Q: Is it Stugeron?

  A: Stugeron is the brand name (Janssen). We manufacture the Generic Equivalent (Cinnarizine), which is bioequivalent.

• Q: When should I take it for travel?

  A: 2 hours before. It takes time to work. Take the first dose 2 hours before your journey starts for the best protection.

• Q: Does it make you sleepy?

  A: Yes. Drowsiness is a common side effect. Avoid driving or operating machinery after taking it.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Motion Sickness:

  • Adults: 25mg taken 2 hours before travel. Repeat 15mg every 8 hours if needed.

  • Children (5-12 yrs): Half the adult dose.

• Vertigo / Balance Disorders: 25mg three times daily OR 75mg (Forte) once/twice daily.

• Peripheral Vascular Disease: 75mg two to three times daily.

• Administration: Take after meals to reduce gastric irritation.

9. Side Effects and Precautions

• CNS: Drowsiness (very common), lethargy, weight gain.

• Parkinsonism: Warning: Long-term use in elderly patients can cause tremors, muscle rigidity, or “mask-like” face (Drug-Induced Parkinsonism). Monitor elderly patients closely and stop if movement issues appear.

• Contraindications: Parkinson’s Disease (can worsen symptoms) and severe depression.

• Interaction: Alcohol enhances the sedative effect.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.