Threolone

/ Abic

A thin layer of the ointment is to be applied 2 – 4 times daily on the infected area.
Threolone should not be applied near the eyes.
Patients should be instructed to return to the physician if no improvement in their condition occurs after 4 – 5 days of treatment.

Infected eczema, pruritic lesions, angular stomatitis, impetigo, external otitis and pyoderma, and other skin infections caused by organisms sensitive to
chloramphenicol.

Known hypersensitivity to any ingredient of the preparation.
Topical corticosteroids are contraindicated in tuberculosis of the skin, herpes
simplex, vaccinia, and varicella.
This preparation should not be applied in the external auditory canal of patients with perforated eardrum.
Because of the chloramphenicol component, patients with a known personal or
family history of blood dyscrasias including aplastic anaemia should avoid use of this product.
This preparation is not intended for ophthalmic use.

For Prednisolone
Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected.
Visual disturbance
Visual disturbance may be reported with systemic topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use if systemic and topical corticosteroids.

Paediatric population
In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur even without occlusion. In infants, the napkin may act as an occlusive dressing, and increase absorption.
General
* Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.
* As with all corticosteroids prolonged application to the face is undesirable.

For Choramphenicol
* Chloramphenicol toxicity has been reported following chronic exposure.
* Discontinue promptly if sensitization or irritation occurs.
* The use of chloramphenicol may occasionally result in overgrowth of non-susceptible organisms, including fungi. If any new infection appears
during treatment, the antibiotic should be discontinued and appropriate measures taken.

* Prolonged or frequent intermittent use of topical chloramphenicol should be avoided, because of the possibility of absorption and of hypersensitivity reactions. It may also increase the likelihood of sensitization and emergence of resistant organisms. Chloramphenicol should be reserved for use only for infections for which it is specifically indicated.
* Chloramphenicol does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.
* Bone marrow hypoplasia, including aplastic anaemia and death, has been rarely reported following topical use of chloramphenicol.
Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.
* Where the ointment is used on a long-term or intermittent basis, it may be advisable to perform a routine blood profile before therapy and at
appropriate intervals thereafter to detect haemopoietic abnormalities.

Excipient with known effect
This medicine contains lanolin anhydrous (wool fat), that may cause local skin reactions (e.g. contact dermatitis).
See prescribing information for full details.

For Corticosteroids: The following local adverse reactions have been reported infrequently with topical corticosteroids: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
For Chloramphenicol: Transient burning or stinging sensations may occur with the use of chloramphenicol ophthalmic preparations. More serious side effects include bone marrow depression and rarely aplastic anaemia, angioneurotic oedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis have been reported and are causes for discontinuation.
It should be noted that these adverse reactions may occur more frequently with
occlusive dressings, tightfitting diapers or plastic pants.

The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided

Pregnancy
Corticosteroids:
There are no adequate and well-controlled studies in pregnant women on
teratogenic effects from topically applied corticosteroids. Therefore, topical
corticosteroids should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Infants born to mothers who have been treated during pregnancy with large
amounts of corticosteroids, or for prolonged periods of time, should be observed carefully for signs of hypoadrenalism.
Chloramphenicol: The safety of topical chloramphenicol in pregnancy has not been established. Chloramphenicol may be absorbed systemically following the use of ophthalmic preparations and may cross the placenta and appear in breast milk.
Breastfeeding
Corticosteroids: It is not known whether topical application of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore, caution should be exercised when topical corticosteroids are applied to nursing mothers.
Chloramphenicol: The safety of topical chloramphenicol in lactation has not been established. Chloramphenicol may be absorbed systemically following the use of ophthalmic preparations and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during pregnancy and lactation.