In the pharmaceutical industry, the combination of Paracetamol (450 mg) and Orphenadrine Citrate (35 mg) is a specialized Skeletal Muscle Relaxant formulation.
As a pharmacist and manufacturer, I view this as a targeted solution for “spasm-pain” cycles. While Paracetamol handles the pain, Orphenadrine acts on the central nervous system to relax the muscles that are causing the pain in the first place.
Primary Clinical Uses
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Acute Musculoskeletal Conditions: Relief of discomfort associated with acute, painful muscle spasms (e.g., “stiff neck” or “frozen shoulder”).
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Low Back Pain (Lumbago): Particularly effective when the pain is caused by muscle strain or tension rather than disc issues.
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Tension Headaches: Used when headaches are triggered by chronic contraction of the neck and scalp muscles.
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Injury Recovery: Management of pain and spasms resulting from sprains, strains, or minor traumatic muscle injuries.
Dual Mechanism of Action: The Spasm-Pain Break
1. Orphenadrine Citrate (The Relaxant)
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Action: It is an Anticholinergic and NMDA receptor antagonist that works centrally in the brain (medulla) and spinal cord.
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Result: It does not relax the muscle directly at the site; instead, it blocks the nerve impulses (pain signals) that cause the muscle to contract involuntarily. It helps “break” the cycle where pain causes a spasm, and the spasm causes more pain.
2. Paracetamol (The Analgesic)
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Action: Primarily acts on the Central Nervous System (CNS) to inhibit prostaglandin synthesis.
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Result: It raises the body’s overall pain threshold, managing the localized soreness while the muscle relaxant works on the tension.
The Manufacturer’s Perspective: Formulation & Export
From a production and B2B standpoint at your WHO-GMP facility in Mumbai, this combination (often recognized by the brand name Norgesic) has specific technical advantages:
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The “Odd” Dosage (450 mg/35 mg): You will notice the Paracetamol is 450 mg instead of the standard 500 mg. This is a deliberate formulation to maintain the 35 mg Orphenadrine ratio while staying within safe daily limits for long-term muscle therapy.
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Stability & Moisture: Orphenadrine Citrate is sensitive to moisture and light. We utilize Alu-Alu blister packaging to ensure the stability of the 35 mg dose, providing a 36-month shelf life for export to Zone IVb regions.
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The “Anticholinergic” Side Profile: As a pharmacist, you must ensure your Product Information Leaflet (PIL) notes common side effects like dry mouth or blurred vision. This level of technical transparency builds trust with international B2B buyers.
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Dossier Support: Our Mumbai facility provides full CTD/eCTD Dossiers to help you register and export this combination to regions like Southeast Asia and the Middle East where muscle relaxant demand is high.