Monograph: |
Nadifloxacin
Clinical Pharmacology:
Nadifloxacin is a synthetic quinolone with potent broad-spectrum anti-bacterial activity.
It is intended for the treatment of acne vulgaris caused by Propionibacterium acnes and other superficial bacterial skin infections like folliculitis.
Mechanism of action : It inhibits enzyme DNA gyrase that is involved in bacterial DNA synthesis and replication, thus inhibiting the bacterial multiplication.
Antibacterial spectrum : In vitro anti-bacterial activity of nadifloxacin has shown that it has a potent and broad-spectrum activity against aerobic Gram-positive, Gram-negative and
anaerobic bacteria, including Propionibacterium acnes and Staphylococcus epidermidis.
The drug activity is bactericidal. Nadifloxacin has shown potent anti-bacterial activity against methicillin resistant Staphytococcus aureus (MRSA) that was similar to the
potency against methicillin-sensitive Staphylococcus aureus(MSSA). The drug has also been found to be active against new quinolone-resistant MRSA. Nadifloxacin has not
shown cross-resistance with other new quinolones.
Pharmacokinetics:
It has been shown that after a single topical application of 10 gm Nadifloxacin 1 % cream to normal human skin on the back, the highest plasma concentration was reported to be minimal with an elimination half-life of 19.4 hours. The percentage of urinary excretion of the drug was negligible over 48 hour post-dosing.The repeated administration study has shown that the plasma concentration reached a steady-state on Day 5 when Nadifloxacin 1 % cream was applied at 5 g twice daily to normal individuals for a period of 7 days. The plasma concentration reached was still minimal at 8 hours post-final dosing with an elimination half-life of 23.2 hours & the urinary excretion rate was negligible on Day 7.
Indications:
Treatment of Acne vulgaris (Inflammatory stage) & treatment of superficial bacterial skin infections like folliculitis (caused by susceptible bacteria).
Dosage and Administration:
Nadifloxacin cream should be applied to the lesions twice daily.
Contraindications:
Known hypersensitivity to nadifloxacin or any of the ingredients of the cream.
Warnings & Precautions:
Keep out of reach of children. The drug is intended for topical (dermal) application on and is not intended for ophthalmologic use. The drug should not be applied to the cornea or conjunctiva. As a rule, susceptibility testing should be performed prior to actual use of this drug to estimate nadifloxacin susceptibility. To minimize the chance that resistant micro-organism will develop as a result of the therapy. The treatment duration should be
the shortest feasible. This drug should be discontinued if the desired therapeutic effect not achieved at the recommended dose within four weeks for acne vulgaris & within one week for superficial bacterial skin infections like folliculitis. Photosensitivity has been reported in patients taking orally synthetic quinolone antibacterial agents.
Use in Pregnancy & Lactation
The safety of this drug for use in pregnancy has not been established. (Clinical experience in pregnant women is insufficient)
Use in Premature babies, Newborns, and Infants .
The safety of this drug in premature babies, newborns, and infants has not been established.(Clinical experience in these patients is insufficient)
Adverse Reactions:
Pruritus, irritation, redness, papules, feeling of facial warmth, increased sweating, contact dermatitis, dryness of the skin and hot flushes may infrequently occur.
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