Amoxicillin Sodium Injection 500mg

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Description

Amoxicillin Sodium Injection 500mg

Healthy Inc is a specialized global supplier and exporter of essential beta-lactam antibiotics. We provide high-purity Amoxicillin Sodium Injection (500mg), sourced from WHO–GMP certified sterile injectable facilities. This “Universal Respiratory Shield” is a top export to general hospitals, maternity wards, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the trusted first-line therapy for community-acquired pneumonia and ENT infections in adults.


Product Overview

This formulation contains Amoxicillin Sodium, a semi-synthetic penicillin with excellent tissue penetration and a safety profile superior to many other antibiotic classes.

The “Standard of Care” Specialist:

  • Mechanism (Bactericidal): Amoxicillin is a cell-wall active antibiotic. It binds irreversibly to Penicillin-Binding Proteins (PBPs), which are enzymes responsible for cross-linking the peptidoglycan layer of the bacterial cell wall. This inhibition weakens the wall, leading to rapid cell lysis (bursting) and bacterial death.
  • Pregnancy Safety: Unlike Tetracyclines or Fluoroquinolones, Amoxicillin is Pregnancy Category B, making it the antibiotic of choice for treating infections in pregnant women.
  • Spectrum: Broad coverage against Gram-positive organisms (Streptococcus pneumoniae, Enterococcus faecalis) and susceptible Gram-negatives (H. influenzae, E. coli, Helicobacter pylori).

Product Composition & Strength

We supply this product as a Sterile Dry Powder for Injection in glass vials. It must be reconstituted with Sterile Water for Injection prior to use.

Active Ingredient Strength (Standard Adult Dose) Therapeutic Role
Amoxicillin Sodium USP/BP Equivalent to 500 mg Amoxicillin Broad Spectrum Antibiotic
Excipients None (Pure Sterile Powder)

*Pack Sizes: Tray of 10 Vials, 50 Vials, or Box of 1/10 Vials with Water for Injection (WFI).


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code 3004.10.10 (Medicaments containing penicillins)
Dosage Form Powder for Injection (Dry Fill)
Packaging Type I Glass Vial (Sterile) with Flip-off Seal
Storage Store below 25°C. Keep Dry. Reconstituted solution must be used immediately (within 1 hour).
Certificates WHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

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

  • Sterile Crystallization: Amoxicillin Sodium is hygroscopic and sensitive to degradation. Our manufacturing utilizes advanced sterile crystallization processes in humidity-controlled environments (RH < 25%) to ensure the powder remains free-flowing and chemically stable inside the vial.
  • Rapid Solubility: The particle size distribution is optimized to ensure instant dissolution in Water for Injection, providing a clear, particle-free solution essential for safe intravenous administration.

Therapeutic Indications (Human Use)

Indicated for the treatment of moderate infections in adults and adolescents:

  • Respiratory Tract: Acute exacerbations of chronic bronchitis, Lobar and Bronchopneumonia.
  • ENT Infections: Severe Sinusitis, Otitis Media, and Pharyngitis.
  • Genitourinary Tract: Cystitis, Urethritis, and Pyelonephritis (in pregnancy).
  • Dental Infections: Severe dental abscess with spreading cellulitis.
  • Prophylaxis: Prevention of bacterial endocarditis in patients undergoing surgery.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

  • Route: Intramuscular (IM) or Slow Intravenous (IV) Injection (over 3-4 mins).
  • Adults: 500 mg every 8 hours. In severe infections, dose may be increased to 1 g every 6 hours.
  • Renal Impairment: Dose reduction required if Glomerular Filtration Rate (GFR) < 30 ml/min.
  • Reconstitution: Dissolve 500mg vial in 5ml Sterile Water for Injection. Shake vigorously.

Safety Warnings (CRITICAL):

  • Penicillin Allergy (ANAPHYLAXIS): CONTRAINDICATED in patients with a history of penicillin hypersensitivity. A standard sensitivity test (AST) must be performed before the first dose.
  • Infectious Mononucleosis: Do not use in patients with Mono (Glandular Fever) as it almost always causes a non-allergic maculopapular rash.
  • Cross-Sensitivity: Caution in patients allergic to Cephalosporins (10-15% cross-reactivity).

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 Sterile 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.

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