Description
Prochlorperazine Maleate Tablets (5 mg / 10 mg)
Healthy Inc is a specialized global supplier and exporter of advanced antiemetic, vestibular, and central nervous system (CNS) therapeutics. We provide ultra-high-purity, fast-acting Prochlorperazine Maleate Film-Coated Tablets (5 mg / 10 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Phenothiazine Dopamine Antagonist” is a massive-volume, essential export to oncology wards, ENT clinics, psychiatric networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally trusted, rapid-onset intervention for severe nausea, debilitating vertigo, and acute psychiatric exacerbations.
Product Overview
This formulation contains Prochlorperazine (as the highly stable Maleate salt), a potent first-generation phenothiazine that exerts profound, targeted depressant actions on specific regulatory centers within the brain.
The “Antiemetic & Vestibular” Specialist:
- Mechanism 1 (The CTZ Nausea Blockade): Severe nausea (whether from chemotherapy, toxins, or radiation) is triggered by the Chemoreceptor Trigger Zone (CTZ) in the brain. Prochlorperazine aggressively binds to and blocks the Dopamine (D2) receptors in the CTZ. By cutting off this chemical communication, it physically stops the brain from sending the signal to the stomach to vomit, providing rapid, overwhelming antiemetic relief.
- Mechanism 2 (Vestibular Labyrinth Suppression): In conditions like Meniere’s disease or acute labyrinthitis, the inner ear sends chaotic, dizzying signals to the brain. Prochlorperazine effectively suppresses these vestibular pathways, halting the sensation of spinning and the severe nausea that accompanies acute vertigo attacks.
- Mechanism 3 (Psychiatric CNS Stabilization): At higher dosages, its broad blockade of postsynaptic mesolimbic dopamine receptors in the brain makes it a highly effective antipsychotic, capable of rapidly tranquilizing acute mania and managing schizophrenia.
Product Composition & Strength
We supply this product as a Precision-Blended Film-Coated or Uncoated Tablet, packed in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the stability of the active phenothiazine compound.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Prochlorperazine Maleate USP/Ph.Eur. | 5 mg | Global Standard: Standard adult dose for acute nausea, vomiting, and vertigo management. |
| Prochlorperazine Maleate USP/Ph.Eur. | 10 mg | High-Dose Therapy: Severe, refractory emesis and acute psychiatric/schizophrenia management. |
| Excipients | Lactose Monohydrate / Maize Starch / Sodium Starch Glycolate / Magnesium Stearate | Diluent / Binder / Superdisintegrant (Engineered for ultra-fast gastric breakdown to prevent emesis rejection) |
*Pack Sizes: 10×10 Blisters (Optimized specifically for acute hospital dispensing and short-term retail pharmacy regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Hospital Procurement Boards, and ENT/Oncology Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antiemetics/Psychotropics) |
| CAS Number | 84-02-6 (Prochlorperazine Maleate) |
| Dosage Form | Tablet (Immediate Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the sensitive phenothiazine from light degradation and environmental humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Light (CRITICAL). |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Rapid Gastric Disintegration Engineering: The greatest challenge in oral antiemetic therapy is ensuring the drug is absorbed before the patient vomits the tablet back up. Our 5 mg and 10 mg formulations utilize advanced superdisintegrants (like Sodium Starch Glycolate) combined with optimized compression forces to guarantee the tablet physically shatters and dissolves within minutes of reaching the stomach fluids, ensuring rapid systemic absorption and immediate clinical relief.
Therapeutic Indications (Human Use)
Indicated for the targeted, rapid management of severe neurological and vestibular distress:
- Severe Nausea & Vomiting: Prevention and treatment of severe nausea and vomiting induced by radiation therapy, chemotherapy, toxins, or post-operative recovery.
- Vestibular Disorders: Management of severe dizziness and vertigo associated with Meniere’s syndrome and labyrinthitis.
- Psychiatry: Management of schizophrenia, acute mania, and severe generalized anxiety (short-term).
Dosage & Administration
Recommended Dosage (Strictly as per Physician Guidelines):
- Adults (Nausea/Vomiting/Vertigo): 5 mg to 10 mg taken 3 to 4 times daily. (Some severe vertigo protocols initiate with 20 mg).
- Adults (Psychiatry): 15 mg to 20 mg daily in divided doses, titrated upward strictly under psychiatric supervision.
- Administration: Take with a full glass of water. Can be taken with food to minimize gastric irritation. Avoid alcohol entirely, as it causes massive, dangerous CNS depression.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Elderly Patients with Dementia): Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (largely from cardiovascular or infectious events). Prochlorperazine is strictly not approved for the treatment of patients with dementia-related psychosis.
- Extrapyramidal Symptoms (EPS) & Dystonia: Because it blocks dopamine, it frequently causes severe, terrifying (but reversible) muscle spasms, particularly in the neck, jaw, and eyes (acute dystonic reactions), as well as intense motor restlessness (akathisia). This is especially common in pediatric and adolescent patients.
- Tardive Dyskinesia (TD): Long-term use can cause permanent, irreversible involuntary movements of the face, tongue, and jaw. Use must be strictly limited to the shortest duration necessary.
- Neuroleptic Malignant Syndrome (NMS): A rare, potentially fatal complex characterized by extreme hyperthermia, severe muscle rigidity, altered mental status, and autonomic instability. Requires immediate emergency cessation of the drug.
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 Antiemetic and CNS Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for oncology wards 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.
