INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CHLOROMYCETIN REDIDROPS 0,5%
CHLOROMYCETIN OPHTHALMIC OINTMENT 1%
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CHLOROMYCETIN REDIDROPS 0,5%
CHLOROMYCETIN OPHTHALMIC OINTMENT 1%

(1)        Chloromycetin Redidrops 0,5% (eye drops)
(2)        Chloromycetin Ophthalmic Ointment 1%

COMPOSITION:
(1) Chloromycetin Redidrops 0,5% - each mL contains:
  Chloramphenicol 5 mg
  Preservative: Phenylmercuric nitrate 0,022% m/v
(2) Chloromycetin Ophthalmic Ointment 1% - each gram contains:
  Chloramphenicol 10 mg
  Base:        liquid paraffin
        polyethylene

PHARMACOLOGICAL CLASSIFICATION:
A: 15.1 Ophthalmic Preparations with antibiotics and/or sulphonamides.

PHARMACOLOGICAL ACTION:
Chloramphenicol, a broad spectrum antibiotic originally isolated from Streptomyces venezuelae, is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes. Chloramphenicol is absorbed systemically from the eye, and toxicity has been reported following chronic exposure.

INDICATIONS:
Chloromycetin is indicated in the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms. Bacteriological studies should be performed to determine the causative organisms and their sensitivity to chloramphenicol.

CONTRA-INDICATIONS:
These products are contra-indicated in persons sensitive to any of their components.
The use of chloramphenicol during pregnancy is best avoided. Chloramphenicol is excreted in breast milk; use is not recommended during lactation because of the possibility of adverse effects on the nursing infant.

WARNINGS:
Blood dyscrasias, including aplastic anaemia, may be associated with the use of chloramphenicol. Adequate blood tests should be carried out during prolonged or intermittent therapy.
Bone marrow hypoplasia following the prolonged topical use of chloramphenicol eye drops has been reported.
Chloromycetin is considered unsafe in patients with acute porphyria.
Ophthalmic ointments may retard corneal wound healing.

DOSAGE AND DIRECTIONS FOR USE:
Chloromycetin Redidrops 0,5%: Instil 2-3 drops in the eye every 2-3 hours. Discard 30 days after opening.
Chloromycetin Ophthalmic Ointment 1%: A small amount of ointment is placed in the eye every three hours.
N.B. With both these preparations, administration should be continued day and night for the first 48 hours after which the interval between applications may be increased. Treatment should be continued for at least 48 hours after the eye appears normal.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
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.
In all except very superficial infections, the topical use of Chloramphenicol should be supplemented by appropriate systemic medication.
Signs of local irritation with subjective symptoms of itching or burning, angioneurotic oedema, urticaria, vesicular and maculopapular dermatitis have been reported in patients sensitive to chloramphenicol and are causes for discontinuing the medication. Similar sensitivity reactions to other materials in topical preparations may also occur.
If irritation, pain, swelling, lacrimation, or photophobia occur after undesired eye contact, the exposed eye(s) should be washed out with water for at least 15 minutes. If symptoms persist, a doctor should be consulted.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-Effects and Special Precautions".
Treatment: Symptomatic and supportive.

IDENTIFICATION:
(1) Chloromycetin Redidrops 0,5%: A bright, colourless to faint yellow, aqueous solution, practically clear and practically free from particles.
(2) Chloromycetin Ophthalmic
Ointment 1%:		 A smooth, uniform, translucent, greasy ointment.

PRESENTATION:
Chloromycetin Redidrops 0,5%: Plastic bottle containing 10 mL solution.
Chloromycetin Ophthalmic Ointment 1%: Tubes of 3,5 g.

STORAGE INSTRUCTIONS:
Chloromycetin Redidrops 0,5%: Store between 2° and 8°C.
Chloromycetin Ophthalmic Ointment 1%: Store in a cool place (below 25°C).
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBERS:
Chloromycetin Redidrops 0,5%:         H1216 (Act 101/1965)
Chloromycetin Ophthalmic Ointment1%:         H1217 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Laboratories (Pty) Ltd
102 Rivonia Road
SANDTON, 2196

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
31 January 1975

Updated on this site: February 2005
Source: Pharmaceutical Industry

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