Description
Tobramycin & Dexamethasone Ophthalmic Suspension
Healthy Inc is a specialized global supplier and exporter of advanced anti-infectives, ophthalmology, and high-potency steroid therapeutics. We provide ultra-high-purity, kinetically balanced Tobramycin & Dexamethasone FDC Eye Drops, manufactured in WHO–GMP certified, high-precision sterile ophthalmic facilities. This “Aminoglycoside Antibiotic & Potent Corticosteroid” combination is a strategic export to surgical eye centers, retail pharmacies, and government health ministries, serving as the globally preferred intervention for steroid-responsive inflammatory ocular conditions where bacterial infection is present or highly probable.
Product Overview
This formulation operates as a “Dual-Action Eradication and Suppression System.” It physically targets the bacterial replication machinery while chemically interrupting the body’s aggressive inflammatory response that leads to ocular tissue damage.
Mechanism 1 (The Protein Inhibitor – Tobramycin): An aminoglycoside that physically binds to the 30S ribosomal subunit of bacteria. This causes a misreading of the genetic code, halting protein synthesis and leading to the death of pathogens, including Pseudomonas aeruginosa, Staphylococci, and Streptococci.
Mechanism 2 (The Inflammatory Switch – Dexamethasone): A potent corticosteroid that physically inhibits the release of arachidonic acid. This prevents the formation of prostaglandins and leukotrienes, providing immediate relief from intense redness, swelling, and ocular heat.
Mechanism 3 (Enhanced Ocular Tolerance): Tobramycin is physically engineered to be less toxic to the corneal epithelium than Gentamicin, making this combination preferred for patients with sensitive or compromised eye surfaces.
Product Composition & Strength
We supply this product as a Sterile, Buffered Ophthalmic Suspension, optimized for high ocular bioavailability and rapid symptom relief.
| Active Ingredient | Strength (w/v) | Primary Clinical Function |
| Tobramycin USP/BP | 0.3% (3mg/mL) | The Antibiotic: Eradicates common and resistant bacteria. |
| Dexamethasone USP/BP | 0.1% (1mg/mL) | The Potent Steroid: Stops severe redness and swelling. |
| Excipients | Tyloxapol / Benzalkonium Chloride | The Sterile Matrix: pH-balanced (pH 5.0–6.0). |
Technical & Logistics Specifications
HS Code: 3004.32.00 (Medicaments containing Adrenal Cortical Hormones / Ophthalmic)
CAS Numbers: 32986-56-4 (Tobramycin) / 50-02-2 (Dexamethasone)
Dosage Form: Sterile Eye Drops (Ophthalmic Suspension)
Packaging: Sterile LDPE Dropper Bottles (5ml). Our specialized ophthalmic packaging ensures 24-month stability in Zone IVb tropical climates.
Manufacturing Authority & Compliance
Aseptic Filling Excellence: Our manufacturing process utilizes Class 100 (ISO 5) Sterile Filling Lines. This ensures the solution is 100% free from microbial contaminants, a non-negotiable requirement for ocular safety.
Hormonal Segregation: We utilize Dedicated Steroid Manufacturing Blocks to ensure zero cross-contamination with non-hormonal products, meeting the strictest international B2B safety standards for global export.
Primary Indications
Ophthalmology: Treatment of Infected Bacterial Conjunctivitis, Keratitis, and Blepharitis where inflammation is severe.
Post-Operative Care: Prevention of infection and management of inflammation following Cataract Surgery or corneal procedures.
Trauma: Reduction of swelling and prevention of infection following minor ocular injury or foreign body removal.
Dosage & Administration
Standard Regimen: Typically 1 to 2 drops in the affected eye(s) every 4 to 6 hours. In the initial 48 hours, the dosage may be increased to 1 drop every 2 hours.
Administration: Shake well before use. Apply to the conjunctival sac. To minimize systemic absorption, apply pressure to the tear duct for 1 minute after instillation.
Duration: Typically used for 7 days.
Safety Warning: For Ophthalmic Use Only. Vision Warning: May cause temporary blurred vision; do not drive until vision is clear. IOP Monitoring: Prolonged use (over 10 days) requires monitoring of Intraocular Pressure (IOP) to prevent steroid-induced glaucoma. Contraindication: Do not use in viral (Herpes), fungal, or tuberculosis eye infections.
Global Export & Contract Manufacturing
Healthy Inc is a premier Ophthalmic and Anti-Infective Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-volume sterile ophthalmic FDCs. Whether you are a Surgical Eye Hospital in the Middle East or a B2B Pharma Marketplace partner in Africa, the CIS, or LATAM, we ensure secure, WHO-GMP compliant delivery.
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