GMP Certified / Tobramycin Dexamethasone Eye Drops

• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 5ml
• Model NO.: eye drops
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Tobramycin Dexamethasone Eye Drops
Strength	5ml
Packing	1 tube/box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Tobramycin Dexamethasone Eye Drops

Character:
This product is white or quasi-white suspension liquid.

Indications:
1. Ophthalmic inflammatory lesions that respond to adrenal corticosteroids and bacterial infection or risk of infection on the eye surface;
2. Eye hormones are used in eyelid, bulbar conjunctivitis, cornea, anterior segment of eyeball tissue and some infectious conjunctivitis and other inflammatory diseases that can accept hormones, which can reduce edema and inflammation. They are also suitable for chronic anterior uveitis, chemical, radiation, burn and foreign body penetrating corneal injury;
3. Compound preparations with anti-infective ingredients can be used in areas where the risk of ocular surface infection is high and where the potential risk of a large number of bacteria present in the eye is expected;
The special anti-infective agents in this product are effective against some common eye bacteria and pathogens:
Staphylococcus aureus and Staphylococcus epidermidis (thrombin positive and negative), including penicillin-resistant strains.
Streptococcus: Group A beta hemolytic streptococcus, some non-hemolytic streptococcus, and some pneumococcus.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus Mirabilis, Morganella mosani, most common strains of Proteus, Haemophilus influenzae, Moraxella lacunaris, Haemophilus ebersii, Acinetobacter calcinetobacter, and some Neisseria SPP.

Matters needing attention:
1. Can not be used for eye injection. Some patients may be allergic to topically used aminoglycosides and should stop taking them if allergy occurs;
2. Long-term use of ocular hormones can lead to glaucoma, damage to the optic nerve, vision loss, visual field loss, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored during use, even in children who have difficulty measuring intraocular pressure and in uncooperative patients. Long-term use of the hormone can suppress the host's immune response and may increase the chance of secondary serious eye infections. The use of hormones in some lesions that cause thinning of the cornea and sclera may lead to perforation of the eyeball. In acute suppurative eye lesions, hormones can mask the infection and aggravate the existing infection.
3. The possibility of corneal fungal infection should be considered after long-term use of hormones. As with other antibiotics, long-term use can lead to overgrowth of non-sensitive microorganisms, including fungi. As soon as a double infection occurs, appropriate treatment must be initiated. Fluorescein corneal staining and slit-lamp biomicroscopy should be performed when multiple treatments are required or when clinical judgment suggests a double infection.
4. The carcinogenicity or mutagenicity of this product has not been studied and evaluated. No adverse effects on fecundity were found in the subcutaneous injection of tobramycin 50mg and 100mg/kg/ day.
5. Medications should be kept out of reach of children.
6. Cross allergy can occur with other aminoglycoside antibiotics.
7. In order to prevent the concentration of dexamethasone detected in athletes' urine samples from exceeding the relevant regulations, athletes are requested to use this product with caution.
8. Do not touch the mouth of the bottle to any surface, as this will contaminate the liquid in the bottle. Contact lenses should not be worn during use of this product.

Pharmacology and toxicology:
1. Adrenocortical hormone can inhibit the inflammatory response caused by various factors, and may also delay wound healing. Adrenal corticosteroids inhibit the body's defense against infection, and if this inhibition is clinically significant, antibiotics should be considered. Dexamethasone is a powerful corticosteroid;
2. The antibiotic component (tobramycin) contained in the mixture has anti-sensitive microbial activity. Experimental studies have shown that tobramycin is effective against the following microbial sensitive strains:
Staphylococcus aureus and Staphylococcus epidermidis (thrombin positive and negative), including penicillin-resistant strains.
Streptococcus: Group A beta hemolytic streptococcus, some non-hemolytic streptococcus, and some pneumococcus. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus Mirabilis, Morganella morgeni, most common strains of Proteus, Haemophilus influenzae, Haemophilus ebergii, Moraxella lacunaris, Acinetobacter calc acetate, and some Neisseria SPP.
3. Drug susceptibility tests of bacteria showed that some gentamicin-resistant microorganisms were still sensitive to tobramycin. No strains with significant resistance to tobramycin have been found. However, with the extension of use time, drug-resistant bacteria may appear;
4. There is no information on the degree of systemic absorption of this product after use. However, we all know that there is systemic absorption after topical use of drugs in the eye. If Dianbisu eye drops are administered at the maximum dose (2 drops per eye every 2 hours) in the first 48 hours and complete systemic absorption occurs (this is unlikely), the equivalent of 2.4 mg of dexamethasone daily. The usual physiological replacement is 0.75 mg per day. Given 2 drops per eye every 4 hours for the first 48 hours, the dosage of dexamethasone would be 1.2 mg per day.

Storage:
Store at 8 ~ 27ºC.