In the pharmaceutical industry, the combination of Orphenadrine Citrate 35 mg and Paracetamol 450 mg (commonly known by the brand Myogesic) is categorized as a Skeletal Muscle Relaxant and Analgesic combination. As a pharmacist and manufacturer, I view this as a specialized “Double-Action” therapy designed to break the cycle of muscle spasm and pain.
At your WHO-GMP facility in Mumbai, this FDC is a high-value product for orthopedic and physical therapy sectors, offering a more targeted approach to musculoskeletal pain than simple painkillers alone.
Primary Clinical Indications
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Acute Muscle Spasms: Relief of discomfort associated with acute, painful musculoskeletal conditions.
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Tension Headaches: Specifically effective when headaches are caused by muscle tension in the neck and shoulders.
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Low Back Pain (Lumbago): Managing pain where muscle stiffness is a primary symptom.
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Strains and Sprains: Used as an adjunct to rest and physical therapy for recovery from sports or work-related injuries.
Mechanism: The Dual-Action Pathway
This combination addresses pain through both the central nervous system and the local muscle tissue.
Orphenadrine (Muscle Relaxant): Unlike some relaxants that work directly on the muscle, Orphenadrine acts centrally in the brain (specifically the brainstem) to block the signals that cause muscles to stay in a state of contraction or “spasm”.
Paracetamol (Analgesic): Works in the Central Nervous System to elevate the pain threshold, providing systemic relief while the muscle relaxant addresses the physical tension.
Anticholinergic Effect: Orphenadrine also possesses mild anticholinergic and antihistaminic properties, which can further contribute to its sedative and relaxant effects.
The Pharmacist’s “Technical Warning”
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Drowsiness & Alertness: Due to the central action of Orphenadrine, patients should be warned about significant drowsiness and blurred vision. Advise caution when driving or operating machinery.
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Anticholinergic Profile: This combination should be used with extreme caution in patients with Glaucoma, Prostatic Hypertrophy, or Myasthenia Gravis, as Orphenadrine can worsen these conditions.
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The “450 mg” Paracetamol Check: Remind users to account for the 450 mg of Paracetamol in each tablet to avoid accidental overdose if they are taking other cold or flu medications.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Muscle-Pain” USP: On your marketplace, highlight this as a “Synergistic Combination” that provides faster recovery than using either drug alone. This is a major selling point for orthopedic distributors.
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Formulation Stability: Orphenadrine is sensitive to light and air. Utilizing Alu-Alu blister packaging or Amber PVDC is necessary to ensure a 36-month shelf life in Zone IVb tropical regions.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders for physical rehabilitation centers.