Each gram contains: Nadifloxacin 10 mg.
Nadifloxacin is a synthetic quinolone with potent broad-spectrum antibacterial activity.
Pharmacology: Nadifloxacin is an antimicrobial drug for the topical treatment of defined forms of acne. Nadifloxacin is a synthetic bactericidal quinolone with a broad spectrum of antibacterial activity against aerobic Gram-positive, aerobic Gram-negative and anaerobic bacteria, including Propionibacterium acnes and Staphylococcus epidermidis. Nadifloxacin has shown a high antibacterial activity against methicillin-resistant Staphylococcus aureus (MRSA), with similar strength to methicillin sensitive Staphylococcus aureus (MSSA). It is also effective against recently emerged MRSA quinolone-resistant.
Mechanism of Action: The bactericidal action of Nadifloxacin results from the inhibition of the DNA gyrase (topoisomerase II) and topoisomerase IV bacterial enzymes. These enzymes are essential for the replication, transcription and repair of bacterial DNA.
The metabolism is produced by oxidation and conjugation processes. No cross-resistances of Nadifloxacin to other new quinolones have been observed.
Topical treatment of mild or moderate inflammatory forms of acne vulgaris (papulopustular acne, grade I-II).
Nadifloxacin cream should be applied on a clean and dry affected areas twice a day, once in the morning and again before retiring to bed. Extra care should be exercised when applying Nadifloxacin cream near the eyes and lips. To avoid infections, Nadifloxacin Cream should be applied using a swab. Nadifloxacin should not be used under occlusive conditions. The duration of the treatment is, in general, up to 8 weeks but can be extended up to a maximum of 12 weeks if this is considered as acceptable from a medical point of view.
Nadifloxacin is intended for topical use and not for oral administration. Repeated and excessive applications do not accelerate or improve the therapeutical recovery and, on the other hand, they bear a risk of marked reddishness and discomfort. In case of involuntary oral ingestion and unless the quantity of Nadifloxacin accidentally ingested was small, a suitable method of gastric lavage should be considered.
Nadifloxacin is contraindicated in cases of known hypersensitivity to Nadifloxacin or any of the excipients of the formulation.
The safety and effectiveness of Nadifloxacin have not been studied enough in children younger than 14 years. Therefore, it is advisable not to use it in patients of this age group.
Contact with eyes and other mucous membranes should be avoided. In case of contact, wash the eyes or mucous membrane with abundant warm water. Wash hands after the application of the cream to avoid the accidental application to other areas.
It is known that photosensitivity reactions have been developed in patients treated with other quinolones systemically administered. Although several studies in animals and humans have shown that Nadifloxacin has no phototoxic or photoallergic effect, the cream base can maximize the effect over the photosensitivity. In addition, there is no experience regarding the prolonged exposition to solar light or artificial UV light when Nadifloxacin is used. Therefore, patients under treatment with Nadifloxacin should avoid the exposition to artificial UV radiation (UV lamps, solar beds, solarium) and avoid when possible the exposition to solar light.
If there is sensitization or severe irritation, discontinue the use of the product.
The drug should not be applied to damaged skin (cuts and grazes).
Effects on Ability to Drive and Use Machines: Neither the pharmacodynamic profile, nor the clinical experience suggest that Nadifloxacin could have any effect on the ability to drive and use machines.
There are no data from controlled clinical trials regarding the effects of Nadifloxacin in pregnant women. Studies with animals have proved that there is no teratogenic risk or any other foetus/embryo toxic effects or effects to the postnatal development of the litter. During pregnancy, Nadifloxacin should only be used after careful evaluation of the expected benefit for the mother against the potential risks to the child development. It is known that Nadifloxacin is excreted with human milk and for that reason Nadifloxacin should not be used during the nursing period. Women during nursing period should not apply, in any circumstance, Nadifloxacin on their breast.
During the treatment with Nadifloxacin it has been observed that skin alterations or irritation can be produced. These are shown as pruritus, burning sensation, erythema, contact dermatitis and urticaria. Skin hypopigmentation is also described in rare reports. The treatment should be discontinued in case of sensitivity or severe irritation.
The absorption of Nadifloxacin after the application of Nadifloxacin to the human skin is very low and therefore, the interaction with other drugs concomitantly administered by systemic route is very unlikely. There is no evidence that shows that the effectiveness of systemically administered drugs could be influenced by the topical use of Nadifloxacin. Nadifloxacin can produce skin irritation and thus it is possible that its use together with peeling agents, astringents and products containing irritant substances as aromatic agents and alcohols, can result in an increase in skin irritation.
Store at temperatures not exceeding 30°C.
D10AF05 - nadifloxacin ; Belongs to the class of topical antiinfective preparations used in the treatment of acne.
Nadiquin cream 1% w/w
10 g x 1's
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