Occumycine for anterior segment of the eye in patients in whom corticosteroid therapy

Ophthalmic solution

Composition :

Each 1 ml contains:
Active substance: Chlotamphenicol 5mg and Dexamethasone sodium phosphate 1 mg.
Excipients : Hydroxypropylmethyl cellulose , Boric acid, Borax, PoIyeth)1ene glycol 400, Water for lnjection.
Preservative : Benzalkonium chloride 0.10 mg .

Indications / Potential uses :

Inflammation of the anterior segment of the eye in patients in whom corticosteroid therapy is indicated and there is either concurrent infection with bacte ria susceptible to chloramphenicol or ahigh risk of such infection chloramphenicol should only be used if the pathogen proves to be resistant to all other antibiotios

Dosage and Administration :

1 drop, instilled into the conjunctival sac 3-5 times daily .
in accte cases: up to 1 drop per hour Due to the possibility of adverse systemic effects, caution is required when administering
corticosteroids to infants under 2 years of age. Occumycine must not be used in neonates

Contraindications :

– Hypersensitivity to either of the active substances or to any 0f the excipients.
– Corneal lesions and ulcerative processes, herpes simplex and other virtual infections, mycosis .
– Glaucoma.
– Severe hepatic dysfunction and severe blood disorders due to bone marrow depression.
– Family history of bone marrow depression.

Warnings and Precautions :

– Occumycine contains the preservative benzalkonium chloride, which may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior t0 application and wait at east 15 minutes before reinsertion. Benzalkonium chloride is known t0 discolour soft contact lenses.
– In those diseases causing thinning of the cornea or sclera, perforations may occur with the chronic use of steroids.
– Caution should be exercised when ophthalmic steroids (sucn as Dexamethasone) are used concomitantly with anti-inflammatory drugs.
– Treatment with chloramphenicol-even in the eye can result in very rare cases of aplastic anemia or other blood dyscrasias. This irreversible disease can occor even after weeks or months. Therefore a careful risk / benefit assessment must be made in each case. It should only be used when other drugs ineffective and / or are contraindicated.
– The application 01 Occumyclne can lead to secondary infections. Corticosteroids may mask. or exacerbate these infections. longer (>2 weeks) use of corticosteroids may have a pathological intraocular pressure increase resulted. Sensitive patients must therefore regularly check the intraocular pressure.
– longer, more intense treatment, the formation or worsening of posterior subcapsular cataracts have resufted.
– Occumycine should not be used longer than 10 days. If after 3 days of treatment, no improvement is achieved, other therapeutic measures are to be considered.
– The use of steroids invnediatety after cataract surgery may delay healing and increase the formation of bubbles
– In patients with diabetes mellitus caution must be taken, as these patients have an increased tendency to glaucoma and I or cataracts.
– In general, caution is required when administering corticosteroids to Infants under 2 years 0f age.

Note for contact lens wearers :

In general, however contact lenses should not be worn
during treatment because of the risk 01 spreading the infection.

Interactions :

– concomitant use of ophthalmic steroids (such as Dexamethasone) and non- steroidal anti-inflammatory drugs in patients with significant Pre-existing corneal epithelium defect or corneal  inflanvnation may increase the risk of developing corneal complica-
tions (erosions, ulcers, perforations), therefore caution should be used.
– Occumyclne should no! be used concurrently with bactericidal substances (penicillins cephalosporins, gentamicin, tetracyciines, polymyxin S, vancomycin or sulphadiazine) because bacteriostatic antibiotics can inhibitlhose with a bactericidal action. In addition, as a
precaution, Occumyclne should not be used in patients undergoing systemic treatment with drugs that suppress hematopoiesis such as sulphonyJureas, coumarin derivatives, hydantoins or methotrexate.

Pregnancy and lactation :

– There have been no controlled studies in pregnat women .
– Occomycine should not be used during pregnancy .
– In addition Occumycine should not be used by women who are breastfeeding

Effects on abillity to drive and use machines :

Temporary blurring-or other impairment-of vision may adversely effect the patient’s ability 10 00ve or use machines. Patients should not carry out these activities until such disturbances have subsided.

Adverse effects :

Occumycine is a combination 0f dexamethasone and chloramphenicol, that is why you may experience unwanted effects 0f these drugs. Post-marketing experience gives no evidence of potentiation 0f toxic effects of the two components or more than
additive toxicity.

Blood and lymphatic effects :

After application of eye preparations containing
chloramphenicol isolated cases of irreversible blood dysaasias (aplastic anemia pancytopenia ,leucopenia, thrombocytopenia ,agranulocytosis have been reported severity and timing of the onset of these irreversible and disturbances did not correlate with the dose

Overdose :

There have been no known cases 0f overdosage involving topical use. Measures should be taken t0 delay absorption in case 0f inadvertent oral ingestion. There is no specific antidote.

Storage :

store at temperature 2-8 c and should be used within one month after opening at temperature 2-8 c

keep out of the reach of children

Packing :

Carton box containing white plastic (LDPE)
dropper bottle of 5ml solution with transparent (HDPE)
nozzle and white (HDPE) cap + insert leaflet

Produced by :

10 of ramadan for pharmaceutical industries and diagnostic products for pharco pharmaceuticals

أوكيوميسين لعلاج التهاب الجزء الامامى من العين فى المرضى الذين يوصى بعلاجهم بالكورتيكوستيرويد