Description

Aceclofenac & Thiocolchicoside Tablets

Healthy Inc is a specialized global supplier and exporter of advanced orthopedic, rheumatological, and acute pain management therapeutics. We provide ultra-high-purity, kinetically synchronized Aceclofenac (100 mg) & Thiocolchicoside (4 mg / 8 mg) Film-Coated Tablets, manufactured in WHO–GMP certified, high-capacity oral solid dosage facilities. This “Dual-Action Musculoskeletal Synergy” is a massive-volume, premium export to orthopedic trauma centers, physiotherapy networks, sports medicine clinics, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally trusted, short-term intervention for acute, painfully restricted spinal muscle spasms and severe joint inflammation.

Product Overview

This advanced FDC masterfully combines Aceclofenac, a highly potent, COX-2 preferring non-steroidal anti-inflammatory drug (NSAID), with Thiocolchicoside, a rapidly acting, plant-derived central muscle relaxant.

The “Pain-Spasm Cycle Eradication” Specialist:

• Mechanism 1 (The Peripheral Blockade – Aceclofenac): When a muscle or joint is injured, it floods the area with prostaglandins, causing severe pain and swelling. Aceclofenac aggressively inhibits the Cyclooxygenase (COX) enzymes (preferentially COX-2) right at the site of the trauma, shutting down this inflammatory cascade with significantly better gastrointestinal tolerability than older drugs like Diclofenac.
• Mechanism 2 (The Central Blockade – Thiocolchicoside): In response to the pain, the spinal cord sends hyperactive reflex signals causing the surrounding muscles to lock up in a severe spasm. This spasm causes more pain, creating a vicious cycle. Thiocolchicoside binds to GABA-A and glycine receptors in the spinal cord, physically interrupting these hyperactive motor signals and instantly relaxing the contracted muscle without causing severe, paralyzing sedation.
• The Synergistic Advantage: Taking these drugs separately leads to poor patient compliance. By combining them, the patient receives immediate relief from both the structural inflammation and the neurological contracture in a single dose, allowing for rapid mobilization and effective physical therapy.

Product Composition & Strength

We supply this product as a Precision-Blended Film-Coated Tablet, packed in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute stability of the semi-synthetic Thiocolchicoside component.

*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically to align with the strict 7-day acute dispensing limits).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Orthopedic Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Synchronized Dissolution Profiling: Combining a bulky NSAID with a micro-dosed muscle relaxant requires highly sophisticated blending. Our facilities utilize advanced high-shear granulation and strictly validated HPLC multipoint dissolution testing to guarantee that both the Aceclofenac and the Thiocolchicoside are released into the gastric fluid simultaneously, ensuring the dual-action effect hits the bloodstream at the exact same time.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of acute, painful musculoskeletal contractures:

• Acute Spinal Pathologies: Severe lumbago (lower back pain), sciatica, torticollis (wry neck), and cervical syndrome.
• Orthopedic Trauma & Post-Operative Pain: Relief of severe muscle spasms following traumatic injury, joint dislocations, or orthopedic surgery.
• Note: It is strictly NOT indicated for chronic conditions, osteoarthritis maintenance, or neurological spasticity.

Dosage & Administration

Recommended Dosage (Strictly as per EMA and Global Orthopedic Guidelines):

• Standard Adult Dosing: One tablet (100mg/4mg or 100mg/8mg) taken twice daily (every 12 hours).
• Administration (GASTRIC PROTECTION RULE): Because of the NSAID (Aceclofenac) component, these tablets MUST be taken with or immediately after a full meal with a glass of water to minimize the risk of gastric irritation or ulceration.
• THE 7-DAY LIMITATION (CRITICAL COMPLIANCE): Due to potential genotoxic risks associated with the Thiocolchicoside metabolite, oral treatment must be strictly limited to a maximum of 7 consecutive days.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX EQUIVALENT (Aneuploidy & Genotoxicity): The Thiocolchicoside component can cause aneuploidy (an abnormal number of chromosomes in dividing cells) at high doses or prolonged exposure, leading to theoretical risks of teratogenicity and impaired male fertility. The strict 7-day dosing limit is absolute. It is strictly contraindicated in pregnancy and lactation.
• NSAID Cardiovascular & Gastrointestinal Risks: Aceclofenac carries the standard NSAID warnings. It may cause an increased risk of serious cardiovascular thrombotic events (MI and stroke) and severe gastrointestinal adverse events (bleeding, ulceration, and perforation of the stomach). It is contraindicated in patients with active peptic ulcers or severe heart failure.
• Seizure Risk: Thiocolchicoside may lower the seizure threshold. It is contraindicated in patients with epilepsy or a history of seizure disorders.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Orthopedic and Analgesic Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for acute trauma centers in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.