PYRIMON eye drops
Dexamethasone BP 0.1%w/v
Chloramphenicol BP 1%w/v
Chloramphenicol is an antibiotic originally isolated from Streptomyces venezuelae. Chloramphenicol is usually bacteriostatic in action. Chloramphenicol inhibits protein synthesis in susceptible organisms by binding to 50S ribosomal sub-units Chloramphenicol is active against most gram-positive and gram-negative bacteria, Rickettsia, Chlamydia (psittacosis-lymphogranuloma organisms) and Mycoplasma. The drug is inactive against fungi.
In general, susceptible organisms are inhibited in vitro by Chloramphenicol concentrations of 0.1-20mcg/mL; concentrations of 0.1-12 mcg/mL inhibit most susceptible strains of Escherichia coli Haemophilus influenzae, Moraxella lacunata, Staphylococci, Streptococci and Pneumococci. Following topical application to the eye, Chloramphenicol may be absorbed into the aqueous humor. Studies in patients with cataracts suggest that the degree of penetration varies with the dosage form and the frequency of application.
Dexamethasone is a synthetic fluorinated corticosteroid. Following topical application to the conjunctiva, corticosteroids inhibit the inflammatory response to mechanical, chemical or immunologic agents. Although their precise mechanism of action is unknown, corticosteroids inhibit edema, fibrin deposition, capillary dilation and migration of leukocytes and phagocytes in the acute inflammatory response. Following topical instillation of corticosteroids into the conjunctival sac, the drugs are absorbed into the aqueous humor, and systemic absorption occurs. However, because topical ophthalmic corticosteroid dosage is less than when the drugs are given systemically, clinical evidence of systemic absorption usually does not occur.
Infections of cornea, sclera and uveal tract; allergic conditions of the eye, conjunctivitis, episcleritis and scleritis; blepharitis, following traumatic, chemical and thermal injuries of the eye.
Dosage and administration
1 or 2 drops to be instilled in the eye 2 to 4 times a day or more often, or as directed by the physician
The prolonged use of antibiotics may occasionally result in overgrowth of non-susceptible organisms, including fungi. If new infections appear during medication, the drug should be discontinued and appropriate measures should be taken.
The possibility of fungal infections of the cornea should be considered after long term steroid dosing. If superinfection occurs, appropriate therapy should be initiated.
There are no adequate and well-controlled studies in pregnant women. The preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Not for injection into the eye
Do not touch the nozzle tip to any surface, since this may contaminate the solution. If irritation persists or increases discontinue the use and consult the physician. Bone marrow hypoplasia including aplastic anemia and death has been reported following local application of Chloramphenicol Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.
Prolonged use of steroids may results in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub-capsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Prolonged use may suppress the host response and thus increases the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
The preparation is contraindicated in patients with Epithelial herpes simplex keratitis vaccinia, varicella and many other viral diseases of the cornea and conjunctiva, Mycobacterial infection of the eye, fungal diseases of ocular structures, and in patients who are hypersensitive to the drug or to any other ingredient in the formulation. The use of this combination is always contraindicated after removal of a corneal foreign body.
Transient burning or stinging may occur when Chloramphenicol is applied topically to the eye. Hypersensitivity or inflammatory reactions including contact conjunctivitis, itching or burning, angioneurotic edema, urticaria and vesicular and/or maculopapular dermatitis have occurred rarely following topical application of Chloramphenicol in patients who are sensitive to the drug or other ingredients in the formulations.
The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage; posterior sub-capsular cataract formation and delayed wound healing.