(Metronidazole Gel)
Composition:
Metronidazole 7.5mg in an aqueous gel containing methylhydroxybenzoate 0.8mg/g,
propyl hydroxybenzoate 0.2mg/g, propylene glycol, Carbomer 940 and disodium
edetate.
Actions:
Metronidazole is an antiprotozoal (tricho-moniasis, amoebiasis, giardiasis) and
anaerobic antibacterial agent. However, the mechanisms by which Rozex acts in
reducing inflammatory lesions of rosacea are unknown, but may include an
antibacterial and/or anti-/inflammatory effect.
Pharmacokinetics:
The absorption of
metronidazole following topical administration is negligible. Studies on the
topical administration of 1 gram of Rozex (7.5mg of metronidazole) to the face
of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per
mL in one patient. This concentration is approximately 100 times less than
concentrations afforded by a single 250mg tablet. The serum metronidazole
concentrations were below the detectable limits of the assay at the majority of
time points in all patients.
Indications:
The treatment of inflammatory papules, pustules and erythema of rosacea.
Conta-indications:
Contra-/indicated in individuals with a history of hyper-sensitivity to
metronidazole, parabens or other ingredients of the formulation
Precautions:
Rozex has been reported to irritate the eyes (watering); therefore, contact
with the eyes should be avoided. If a reaction suggesting local irritation
occurs, patients should be directed to use the medication less frequently,
discontinue use temporarily or discontinue use until further instructions.
Metronidazole is a nitroimidazole and should be used with care in patients with
evidence of or history of, blood dyscrasia.
Use in
Pregnancy:
Category B2. There is no experience to date with the use of Rozex in pregnancy.
Use in Lactation:
Metronidazole blood levels from topical application are significantly lower
than those achieved after oral metronidazole. A decision should be made to
discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.
Interactions with Other Drugs:
Drug
interactions are less likely with topical administration but should be kept in
mind when Rozex is prescribed for patients who are receiving anticoagulant
treatment.
Adverse Reaction:
Adverse reactions reported with Rozex include eye irritation (watering) if the
gel is applied too closely to this area, transient redness, mild dryness,
burning and skin irritation.
Dosage and Administration:
Adult: Apply and rub in a thin film of gel twice daily, morning and evening, to
entire affected areas after washing.
Elderly: The dosage recommended in the elderly is the same as that
recommended in adults.
Children: Not recommended.
Areas to be treated should be cleansed before application of
Rozex. Patients may use cosmetics after application of the product.
Significant therapeutic results should be noted within three
weeks. Clinical studies have demonstrated continuing improvement through nine
weeks of therapy.
Storage: Store below 25&C (room temperature).
Pack: Tube 15g, 20g, 30g.
LINK: http://www.medsafe.govt.nz/search.htm