Description

Promethazine Hydrochloride Injection

Healthy Inc is a specialized global supplier and exporter of essential anti-allergic and antiemetic therapies. We provide high-purity Promethazine Hydrochloride Injection (25 mg/ml / 50 mg/ml), manufactured in WHO–GMP certified sterile facilities. This “Multi-Receptor Antagonist” is a mandatory export to emergency departments, surgical wards, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a critical agent for severe allergic reactions, motion sickness, and pre- or post-operative sedation and nausea control.

Product Overview

This formulation contains Promethazine Hydrochloride, a phenothiazine derivative that acts primarily as a potent first-generation H1 receptor antagonist (antihistamine).

The “Versatile Antagonist” Specialist:

• Mechanism (Broad Blockade): While it competitively blocks histamine at H1 receptors to stop the allergic cascade (vasodilation, capillary permeability), its phenothiazine structure also provides significant anticholinergic, sedative, and weak antidopaminergic effects.
• Surgical Utility: Frequently used in the perioperative setting. It provides conscious sedation, reduces anxiety, dries up oral and respiratory secretions (anticholinergic effect), and prevents post-operative nausea and vomiting (PONV).
• Emergency Adjunct: Acts as a vital adjunctive therapy to Epinephrine (Adrenaline) in the treatment of anaphylaxis after the acute symptoms have been controlled.

Product Composition & Strength

We supply this product as a Sterile, Clear, Colorless to Faint Yellow Solution in glass ampoules.

*Pack Sizes: Tray of 10 Ampoules, 50 Ampoules, or 100 Ampoules.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

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

• Oxidation Prevention: Promethazine is extremely sensitive to oxidation and light, which turns the solution blue or brown. Our formulation uses a robust Sodium Metabisulfite antioxidant system, and ampoules are sealed under a nitrogen blanket to eliminate oxygen, ensuring a stable 36-month shelf life.
• pH Precision: The solution is buffered to an optimal pH (4.0 to 5.5) to ensure maximum tissue compatibility during deep intramuscular administration.

Therapeutic Indications (Human Use)

Indicated for the management of allergic conditions, nausea, and sedation:

• Allergic Reactions: Type 1 hypersensitivity, uncomplicated allergic conditions, and as an adjunct in anaphylaxis.
• Antiemetic: Active treatment and prophylaxis of nausea and vomiting (including post-operative).
• Sedation: Preoperative, postoperative, and obstetric (during labor) sedation.
• Motion Sickness: Prevention and treatment.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

• Route: Deep Intramuscular (IM) Injection is the PREFERRED route.
• Allergies / Nausea (Adults): 25 mg IM, repeated every 2 to 4 hours if necessary.
• Sedation (Adults): 25 mg to 50 mg IM at nighttime or pre-operatively.
• Intravenous (IV) Administration Warning: If IV must be used, it must be diluted (e.g., to a concentration of 2.5 mg/ml) and administered extremely slowly through a large-bore vein.
• Contraindicated Routes: NEVER administer Subcutaneously (SC) or Intra-arterially.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Pediatric Respiratory Depression): CONTRAINDICATED in children under 2 years of age. Fatal respiratory depression has occurred. Use with extreme caution in children over 2 years.
• BLACK BOX WARNING (Severe Tissue Injury): Improper IV injection, intra-arterial injection, or perivascular extravasation can cause severe tissue necrosis and gangrene, frequently requiring surgical intervention or amputation. Stop injection immediately if patient reports pain at the site.
• CNS Depression: Profound sedation. Do not mix with alcohol, barbiturates, or other CNS depressants.

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 Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Antihistamine and Sedative Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement 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.