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

Logo CHLORAMEX OPHTHALMIC OINTMENT

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CHLORAMEX OPHTHALMIC OINTMENT
(OINTMENT)

COMPOSITION:
Each 1 gram contains:
Chloramphenicol 10 mg

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

PHARMACOLOGICAL ACTION:
Chloramex is a broad-spectrum antibiotic with bacteriostatic and bactericidal properties (depending on concentration) against a wide range of pathogenic organisms, including Gram-positive and Gram-negative bacteria, rickettsiae and the trachoma virus. Amongst bacteria it produces a bacteriostatic action in high concentration against Pseudomonas aeruginosa (Ps. pyocyaneus). It is thus effective against nearly all organisms which cause infections of the eye and eyelid. Bacterial resistance to topical administration is rare.

INDICATIONS:
Superficial infections of the eye and eyelid, including conjunctivitis, uveitis, corneitis, blepharitis and trachoma.

CONTRA-INDICATIONS:
History of a previous blood dyscrasia.

DOSAGE AND DIRECTIONS FOR USE:
Eye infections:
Draw down the lower lid and squeeze a small amount into the corner of the eye and massage gently over the eye surface. Apply four times daily.
Eyelid infections: Apply four times daily to the infected area with the finger tip.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Systemically administered chloramphenicol has caused both fatal and non-fatal blood dyscrasias, such as agranulocytosis and aplastic anaemia in a small percentage of cases. It is not considered advisable to use the ointment in patients with a previous history of such a dyscrasia. For ophthalmic use only.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None.

IDENTIFICATION:
Chloramex Ophthalmic Ointment is a yellowish ointment packed in applicator-nozzle metal tubes.

PRESENTATION:
Applicator-nozzle tubes of 3,5 g.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C). Keep the tube tightly closed.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H 1193 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMACARE LIMITED –(Co. Reg. No. 04/00252/06)
7 Fairclough Road, Korsten, PORT ELIZABETH, 6020

PUBLICATION DATE OF THIS PACKAGE INSERT:
2 February 1982
CODE 308027 A433                LH&SEL-K6512 C98

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