Nadixa Cream %0.1 30 Gr ingredient Nadifloxacin

FORMULA: 1 g of cream contains 10 mg of nadifloxacin.
Auxiliary materials; White soft paraffin, light liquid paraffin, stearyl alcohol, cetyl alcohol, polyoxyethylene
5 cetyl ether, polyoxyethylene 20 cetyl ether, sodium hydroxide, diethanolamine, disodium edetate, glycerin,
benzalkonium chloride, pure water.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties:
Aerobic, including nadifloxacin, Propionibacterium acnes and Staphylococcus epidermidis
A broad antibacterial activity against gram-positive, aerobic Gram-negative and anaerobic bacteria
lt; / RTI & gt; spectrum of a bactericidal kinolonide.
Nadifloxacin against methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive
A high antibacterial activity with similar potency to Staphylococcus aureus (CNSA)
It showed. It has also been observed that the drug is also effective against the new MRSA resistant to the quinolone.
Nadifloxacin did not show cross-resistance to other new quinolones.
The bactericidal effect of nadifloxacin, DNA gyrase (topoisomerase II) and topoisomerase IV bacterial
& lt; / RTI & gt; These enzymes are responsible for the replication of bacterial DNA,
transcription and repair.
It is metabolized by oxidation and conjugation processes.
No cross resistance of nadifloxacin against other new quinolones was observed.
Pharmacokinetic properties:
Following the application of the cream-in-water emulsion, the amount of absorption of nadifloxacin is not known precisely
but it is known that the absorption is not complete.
Following absorption, both unchanged nadifloxacin and its metabolites were detected in urine and faeces.
The degree of absorption depends on the presence of a solid Stratum Corneumun.
Nadifloxacin is often metabolised by oxidation and conjugation.
Following systemic absorption, it has a widespread and rapid distribution, but because tissue levels are rapidly falling,
it is not expected to cause a problem such as accumulation in the body.
It has been observed in most patients that the levels of nadifloxacin in circulation are below the limit of detection.
INDICATIONS:
Nadixa is indicated for the topical treatment of acne vulgaris, which is dominated by creams, papules and pustules.
CONTRAINDICATIONS:
Nadixa, Nadifloxacin or any of the adjuvants in the formulation.
should not be used in people known to be sensitive.
WARNINGS / PRECAUTIONS:
Nadixa cream reliability and efficacy have not been adequately studied in children under 14 years of age. Therefore,
it is not recommended for use in this age group of patients.
Avoid contact with eyes and other mucous membranes. If there is contact, the eyes or
the mucous membrane should be washed with plenty of warm water. Prevent accidental application to other areas
, the hands should be washed after applying the cream.
In patients treated with other systemically administered quinolones, sensitivity to light
reactions are known to develop.
Various studies in animal and human Nadifloxacin has been shown to have phototoxic or photoallergic effects
, the cream base can maximize its effect on photosensitivity.
In addition, while Nadixa is in use, long-term exposure to sunlight or artificial UV light
no experience is available. For this reason, patients treated with Nadixa artificial UV
(UV lamps, sunbath, solarium) and, if possible, exposed to sunlight
should avoid.
If sensitization or severe irritation develops, use of the drug should be discontinued.
The medication should not be applied to damaged skin (cuts and abrasions).
Any of the safety of simultaneous use with other acne treatments (eg, benzoyl peroxide)
Since there is no data available, Nadixa should only be used in the form of monotherapy

Warnings for pregnant women and lactating women:
Pregnancy category: B
There are no controlled studies on the effects of nadifloxacin in pregnant women. with animals
work done, teratogenic risk or other toxic effect on the fetus / embryo or animal
it has proven that there is no effect on the postnatal development of the offspring. During pregnancy,
Nadixa, however, believes that the expected benefit for the mother is that it is against the potential risks
should be used after careful evaluation. It is known that nadifloxacin passes to human
and for this reason, Nadixa cream should not be used during breastfeeding. During breastfeeding
women, Nadixa cream should not apply to your breasts in any way.
Effect on driving and using machinery:
Pharmacodynamic profile and acquired clinical experience, Nadiflexoxine use of vehicle and machine
No effect on its ability is expected.
SIDE EFFECTS / ADVERSE EFFECTS:
During treatment with Nadixa, it has been observed that changes in the skin may cause irritation to the skin. These include itching,
burning sensation, erythema, contact dermatitis and urticaria. Rarely, deride
Hypopigmentation has also been reported.
If sensitivity or severe irritation develops, treatment should be discontinued.
"WE HAVE COMPLETED YOUR DOCTOR WITH AN UNEXPECTED EFFECT"
DRUG INTERACTIONS AND OTHER INTERACTIONS:
Following administration of Nadixa cream, the absorption of Nadifloxacin through human skin is very slow,
it is very unlikely to interact with other drugs administered concurrently from the systemic route.
The efficacy of systemically administered drugs may be affected by topical Nadixa administration
There is no evidence to show.
Because Nadixa cream can cause irritation to the skin, peeling agents, astringents and aromatic agents
and products containing irritants such as alcohol may lead to an increase in internal irritation.
DOSAGE AND ADMINISTRATION:
Nadixa cream, the areas to be applied carefully cleaned, then, after the morning and bedtime
it should be applied in a thin layer twice a day, first. Contact with eyes and lips
care must be taken. To prevent contamination, a cotton / cloth piece of Nadixa Cream
. Nadixa should not be used in occult conditions. The duration of treatment is usually 8
week, but may be extended up to a maximum of 12 weeks if deemed necessary.
MEASURES TO BE OBTAINED FROM OVERDOSE:
Nadixa cream is designed for topical application, not for oral use. Repeated and
overapplications do not accelerate or advance therapeutic healing and, on the other hand,
It carries the risk of redness and discomfort.
If Nadixa cream is mistakenly ingested and the amount received is not too low, a suitable gastric lavage
should be considered.
STORAGE CONDITIONS:
Store at room temperature below 25 ° C.
We keep them in places and in their packaging where children can not and can not reach them.
COMMERCIAL REPRESENTATION AND PACKAGE EXPLORATION:
30 g aluminum tube