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IMEX Ointment

COMPOSITION
100 gram IMEX contains 3.0 g Tetracycline as an active ingredient. As excipients, White
vaseline, medium chain triglyceride, Titanium dioxide, Brown iron oxide, Red iron oxide
exist.
PHARMACOLOGICAL PROPERTIES
According to common belief about acne pathogenesis among physician, acne formation is
associated with clogging of pilosebaceous gland follicles. This occurs as a result of defective
keratinization of follicles.
It has been proven that Tetracycline is effective against to all factors involving in acne
development:
– Reduction of lipase in Propionibacterium acnes
– Inhibition of chemotaxis of polymorph nuclear lymphocytes
– Blockage of free oxygen radicals’ release from polymorph nuclear lymphocytes
– Antagonism of calmodulin activity

Following topical application tetracycline should be available between 0.05 microgram/ml –
100 microgram/ml in the affected area,.
It was demonstrated that tetracycline’s follicular concentration was equal to 64
microgram/ml or greater, after topical Imex administration.
Severe acne forms are characterized with persistent inflammatory nodules, which end up
with scars that cause dysmorphosis. Histological examinations of these lesions indicated that
intense lymphocytic and granuloma formation. It was believed that granuloma stimulation
arises from Propionibacterium acnes. Tetracycline’s well known effect probably may be
related partially to its antigranuloma activity. It was shown that in vitro inhibition of
granuloma formation is due to Protein Kinase C inhibition.
Antibiotics (ampicillin, cefalotin, erythromycin and clindamycin) that have no effects on
granuloma either have no effects or little effects on Protein Kinase C.
It has been determined that Imex’s active ingredient tetracycline does not penetrate into
corium even in the highest concentration. Since Imex does not contain penetration mediator,
it is not possible to be absorbed and to have systemic effect.
INDICATIONS
Topical acne treatment, particularly inflammatory forms.
CONTRAINDICATION
Imex should not be used in individuals who have a known hypersentivity to tetracycline.

WARNINGS / PRECAUTIONS
Imex should not be used after expiry date.
According to current knowledge, it is recommended that patients should take following
precautions in addition to medical treatment:
• Skin should be cleaned regularly but not vigorously with non-alkaline soap preferably.
• In spite of comedones can be cleaned; do not mechanically remove acne with signs of inflammation and pustules, in order to avoid scar formation. • Do not apply make-up or use face powder, in order to avoid re-clog of sebaceous glands.
USE IN PREGNANACY AND LACTATION
Although there is no information about teratogenic effect and sign of Imex’s usage, no
clinical studies have been conducted with Imex in pregnant and nursing women. Therefore,
as with all other products, it is not recommended to use in pregnant women.
UNDESIRABLE EFFECTS
By this time, no significant side effects have been reported with the use of Imex. It is well
tolerated by patients.
IN CASE UNDESIRABLE EFFECTS, PLEASE CONSULT YOUR DOCTOR.
DRUG INTERACTIONS
No drug incompatibilities have been reported with topical use of Imex.
METHOD OF ADMINISTRATION
Unless, prescribed otherwise by physician, apply daily 1- 3 times to the affected skin area,
gently massage to allow its penetration.
OVERDOSE
There is no knowledge about overdose of Imex Ointment.
STORAGE CONDITIONS
Keep it at room temperature under 25 °C.
Keep out of the reach and sight of the children and store it in its package.
COMMERCIAL PRESENTATION AND CONTENT OF CONTAINER
IMEX ointment presented in 20 gram aluminum tubes.
REGISTRATION OWNER AND IMPORTER
ASSOS İlaç, Kimya, Gıda Ürünleri Üretim, Tic. Ltd. Şti,
ÜMRANİYE 34773, İSTANBUL
MANUFACTURER
Merz Pharmaceuticals, GmbH, Frankfurt, Germany
REGISTRATION NUMBER: 26.11.2001, 111/25
AVAILABLE WTH PRESCRIPTION

Source: http://www.assospharma.com/english/documents/imex-ointment.pdf