In the pharmaceutical industry, Prochlorperazine Maleate 5 mg is a potent first-generation antipsychotic belonging to the phenothiazine class. However, as a pharmacist and manufacturer, you will recognize that at this specific 5 mg dose, its primary clinical utility shifted long ago from psychiatry to gastroenterology and neurology as a highly effective antiemetic and vestibular suppressant.
Primary Clinical Uses
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Nausea and Vomiting: Used for the prevention and treatment of severe nausea and vomiting induced by surgery, radiation, or toxins.
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Vertigo and Meniere’s Disease: Specifically indicated for controlling the “spinning” sensation (vertigo) associated with inner ear disorders.
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Migraine Relief: Frequently used in emergency departments to treat acute migraine attacks, often combined with analgesics to stop both the pain and the associated vomiting.
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Short-term Anxiety: Occasionally used for the short-term management of non-psychotic anxiety.
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Schizophrenia: While higher doses are required for psychosis, the 5 mg strength serves as a titration or maintenance dose for some patients.
Mechanism of Action: Dopamine $D_2$ Blockade
Prochlorperazine works primarily by targeting the brain’s “vomit center.”
CTZ Inhibition: It blocks Dopamine $D_2$ receptors in the Chemoreceptor Trigger Zone (CTZ) of the brain. This stops the chemical signals that trigger the urge to vomit.
Anticholinergic Effects: It also possesses weak antihistaminic and moderate anticholinergic activity, which helps reduce vestibular (inner ear) sensitivity, effectively treating vertigo.
Alpha-Adrenergic Blockade: It has some alpha-blocking activity, which can contribute to its sedative effect.
The Manufacturer’s Perspective: Formulation & Export
From a production and global trade standpoint at your WHO-GMP facility in Mumbai, Prochlorperazine 5 mg offers specific technical USPs for your firm:
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The “MD” (Mouth Dissolving) Advantage: For your digital platform, a major selling point is the Orally Disintegrating Tablet (ODT) or Mouth Dissolving (MD) formulation. Patients who are vomiting cannot easily swallow water; a 5 mg tablet that dissolves on the tongue is a superior B2B product.
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Photosensitivity: The API is highly sensitive to light. At our facility, we utilize Alu-Alu or Amber-colored PVC/PVDC blisters to prevent degradation and ensure a 36-month shelf life.
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The “EPS” Profile: As a pharmacist, you must ensure your Product Information Leaflet (PIL) includes warnings about Extrapyramidal Side Effects (like dystonia). This technical transparency is essential for export to highly regulated markets.
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B2B & Dossier Support: We provide full CTD/eCTD Dossiers to support international registration against the innovator (Stemetil).