Optidex T

Drugs , Eye, Nose and Ear / October 16, 2016

Class: Eye, Nose and Ear
Dosage Form: Eye Drops
Description: Antimicrobial and anti-inflammatory eye drops
Stock: Available
Manufacturer: Jamjoom Pharma

Composition:

Each ml contains:
Tobramycin……………………………………………………3 mg
Dexamethasone………………………………………………1 mg
Benzalkonium chloride (preservative)………….0.06 mg

Properties:

Dexamethaose is a corticosteroid with anti-inflammatory properties. It is about 25 times more potent than hydrocrotisone in its anti-inflammatory action. Tobramycin is an aminogylcoside anitbiotic, which is active against many strains of gram negative bacteria, inlcuding Pesudomonase aeuroginosa.

Indications:

For the treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral diseases.
Dexamethasone in suspension is indicated for inflammatory conditions of the palpebral and bulbar conjuctiva, cornea and anterior segment of the globe. Also indicated in chronic anterior uveiti, corneal injury from chemical, radiation or thermal burns, or from penetration of foreign bodies. Postoperative management of contract, glaucoma and strabismus.
Tobramycin is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the group of beta-hemolytic species, some non-hemolytic species, and some streptococci pneumoniae, pseudomonas aeuroginosa, escheria coli, klebsiella penumoniae, enterobacter aerogenes, proteus mirabilis, morganella morganii, most porteus vulgaris strains, haemophilus influenzae and H. aegyptius, moraxella lacunata, and acinetobacter calcoaceticus and some neisseria species.

Contraindicatons:

Optidex T is contraindicated in:

 

  • Hypersensitivity to any of the components
  • Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia , varicella, and many other viral disease of the cornea and conjunctiva
  • Mycobacterial infection of the eye
  • Fungal infections of the eye
  • Following uncomplicated removal of a corneal foreign body
  • Glaucoma

 

Side Effects:

Prolonged topical use of corticosteroids may bring about glaucoma, affecting the optic nerve, causing alterations in the vision. If Optidex T is administered for mroe than ten days, ocular pressure should be regularly monitored by the physician.
Prolonged use of corticosteroids may increase risk of secondary ocular infections, masking of an acute infection. As with other antibiotics, prolonged use may bring about the growth of resistant organisms. Treatment should not be withdrawn too early, in order to avoid a renewed outbreak of the infection.
Delayed wound healing, posterior subcapsular cataract formation.
Use in Children: The safety and effectiveness of this preparation for children has not been established.

Dosage and Administration:

The following is generally recommended:

  • Instill one to two drops of the suspension into the conjunctival sac every 4 to 6 hours
  • During the initial 24 to 48 hours the frequency may be increased to one or two drops every 2 hours
  • Treatment should not be discontinued prematurely
  • Shake well before use
  • Should not be used more than one month after opening of the bottle

Pregnancy and Lactation:

It is not known whether it can cause fetal harm when administered to a pregnant women. Also, it is not known whether the components of this preparation are excreted in human milk; because many drugs are excreted in human milk, use with caution in nursing women.
Category C: should only be given if potential benefit justifies the potential risk to the fetus.

Warnings:

Not for injection into the eye.
This ophthalmic product contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses, therefore this product not be used while wearing these lenses. These lenses should be removed before application of this produc and not re-inserted earlier than 15 minutes after use.

Packaging:

 

5 ml suspension in LDPE bottle.

 

Storage:

Store at room temperature, below 25°C.

 

 

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