COMPOSITION

Eye Drops
a) Pulv. : Chloramphenicolum 25 mg - Acid. boric - Natr. carbonas
b) Solv.: Alcohol phenoxyethyl. - Hypromellos. - Natr. phosphas 12 aq. - Natr. phosphas acid. 2 aq. - Aqua ad iniectabilia q.s. pro 5 ml

Eye ointment
Chloramphenicolum 10 mg - Paraffin. liquid. - Vaselin. q.s. pro 1 g.

Dermal cream
Chloramphenicolum 10 mg - Alcohol cetylic. - Natr. laurylsulfas - Cera alba - Propylenglycol. - Chlorocresol. - Aurant. flor. essent. synth. derog. 42/836 - Monokal. phosphas - Dinatr. phosphas - Aqua purificata q.s. pro 1 g.

PROPERTIES

Chloramphenicol is a broad spectrum antibiotic active against Gram-positive and Gram-negative cocci and bacilli, spirocheta (treponema and leptospira), rickettsia, chlamydia, mycoplasma and actinomyceta. Pseudomonas is not sensitive; resistant strains of Staphylococci can appear sometimes. After local use, some systemic absorption can be noticed.

INDICATIONS

Local antibiotic treatment of infections caused by sensitive germs.

Ophthalmic drops and ointment
Blepharitis, styes, dacryocystitis, conjunctivitis, keratitis. In case of intracorneal abscess or rosacea keratitis, the use of the eye drops or ointment is associated with a systemic treatment.
Postsurgical infections: while changing the bandage, a local application of ophthalmic ointment is recommended.

Dermal cream
Dermatosis and infected eczema, abscesses, furuncles, impetigo, periungual infections, sycosis barbae etc… Infected surgical or traumatic wounds, infected burns. Chloramphenicol is not to be used in minor infections or in prophylaxis against bacterial infections.

DOSAGE AND ADMINISTRATION

Eye drops
Prepare the solution right before use:
- 1. Open both vials.
- 2. Pour the solution over the powder then attach the dropper.
- 3. Shake well in order to mix the two phases. The dropper can be maintained attached to the vial during all the treatment. The small caplet should cover the dropper after each use.
- 4. For application: incline the vial, press slightly to get the desired number of drops. It is recommended to shake the vial before each application. After cautiously washing the eye, instill 2 drops in the conjunctival sac, 3 to 6 times daily.

Eye ointment
After proceeding with wound detersion, the product can be applied 3 to 4 times in 24 hours. Its prolonged action prevents nocturnal applications. The healthy eye will be treated similarly to the affected one in order to avoid contamination.

Dermal cream
Clean the wound, spread a thick layer of cream on a piece of sterile gauze, apply on the lesion 1 to 3 times daily. Intensive, prolonged or intermittent cures should be avoided.

CONTRAINDICATIONS

The use of Chloramphenicol is contraindicated in patients who manifested hypersensitivity reactions to this drug in the past. Diseases that can mask a hemopathy or require a prolonged treatment forbid Chloramphenicol use.

ADVERSE EFFECTS

Very rarely a local treatment with Chloramphenicol can cause a hematopoietic hypoplasia or aplasia (aplastic or hypoplastic anemia, granulocytopenia, thrombocytopenia), sometimes irreversible.

PRECAUTIONS

Intensive, prolonged or intermittent cures should be avoided. The association of Chloramphenicol with sulphamide or any other product that could cause bone marrow depression is forbidden.

PREGNANCY AND LACTATION

Intensive use during pregnancy, especially during the first trimester, is not recommended

STORAGE

Store the eye ointment and the dermal cream at cool (8-15 C degrees). Since the mode of preparation of the eye drops do not exclude contamination, we suggest the solution to be used within two weeks from preparation. The expiry date is the first day of the month printed near the group EX on the package.

SUPPLIED

Eye Drops: Box containing 1 vial of powder, 1 vial of diluent (5 ml), and a dropper.

Eye Ointment: Box containing 1 tube of 2.5 g.

Dermal Cream: Box containing a tube of 20 g.

AVAILABILITY

- in Belgium: Over the counter in pharmacies
- in Luxembourg: Obtainable on medical prescription.