NADIBACT Cream/Gel (Nadifloxacin 1%)

Table of Content

NADIBACT cream/gel contains nadifloxacin 1%, the only fluroquinolone for topical use. It inhibits the enzyme DNA gyrase, which is involved in bacterial DNA synthesis and replication, thus inhibiting the bacterial multiplication. It has got potent bactericidal activity and additional anti-inflammatory property.

In vitro studies of nadifloxacin showed a potent and broad spectrum antibacterial activity against aerobic Gram-positive, Gram-negative and anaerobic bacteria, including Propionibacterium acnes and Staphylococcus epidermidis. Nadifloxacin showed potent antibacterial activity against methicillin-resistant Staphylococcus aureus (MRSA), which was similar to potency against methicillin-sensitive Staphylococcus aureus (MSSA). The drug was also active against quinolone resistant MRSA. Nadifloxacin does not show cross resistance with other quinolones.

NADIBACT cream/gel is indicated for treatment of acne vulgaris and superficial bacterial infections of skin. It should be applied to the lesions twice daily. In case of acne, it should be applied after washing the face. Though these products are used in both indications, preferably NADIBACT cream should be used in bacterial infection and gel should be used in acne.

With NADIBACT cream/gel mild and transient side effects like itching, erythema and swelling may occur at the site of application.

NADIBACT cream and gel both are available in a 10 g lamitube pack.

Composition

NADIBACT cream

Nadifloxacin ..........................1% w/w

In a cream base

NADIBACT gel

Nadifloxacin ..........................1% w/w

In a gel base

Dosage Form

Cream and gel

Pharmacology

Pharmacodynamics

Nadifloxacin is a synthetic quinolone with potent broad-spectrum antibacterial activity. It is bactericidal in nature. Nadifloxacin inhibits the enzyme DNA gyrase that is involved in bacterial DNA synthesis and replication, thus inhibiting bacterial multiplication.

In vitro studies of nadifloxacin showed potent and broad-spectrum antibacterial activity against aerobic Gram-positive, Gram-negative and anaerobic bacteria, including Propionibacterium acnes and Staphylococcus epidermidis. Nadifloxacin showed potent antibacterial activity against methicillin-resistant Staphylococcus aureus (MRSA), which was similar to potency against methicillin-sensitive Staphylococcus aureus (MSSA). The drug was also active against quinolone-resistant MRSA. Nadifloxacin does not show cross-resistance with other quinolones.

Pharmacokinetics

Following a single topical application of 10 gm nadifloxacin 1% cream/gel to normal human back skin, the highest plasma concentration was determined to be 1.7 ng/ml with an elimination half-life of 19.4 hours. Approximately 0.09% of the administered dose was excreted in the urine over 48 hours post-dosing. The plasma concentration reached a steady state on day 5 of the repeated administration study when nadifloxacin 1% cream/gel was applied in the dose of 5 g twice daily to normal healthy individuals for a period of 7 days. The plasma concentration reached a peak of 4.1 ng/ml at 8 hours post-final dosing with an elimination half-life of 23.2 hours. The urinary excretion rate reached 0.16% on day 7.

Indications

Treatment of acne vulgaris

Treatment of bacterial skin infections

Dosage and Administration

NADIBACT Cream/Gel should be applied to the lesions twice daily. In case of acne, it should be applied after washing the face.

Contraindications

NADIBACT Cream/Gel is contraindicated in those patients with a history of hypersensitivity reactions to any of its components.

Warnings and Precautions

General

As a rule, susceptibility testing should be performed prior to the actual use of this drug to estimate nadifloxacin susceptibility. To minimize the chance that resistant microorganisms will develop as a result of therapy, the treatment duration should be the shortest feasible.

This drug is intended for topical (dermal) application only and is not intended for ophthalmologic use. The drug should not be applied to the cornea or conjunctiva.

This drug should be discontinued if the desired therapeutic effect is not achieved at the recommended dose.

Pregnancy

The safety of this drug for use during pregnancy has not been established (clinical experience in pregnant women is insufficient).

Paediatric Use

The safety of this drug in children younger than 14 years has not been studied or established.

Undesirable Effects

Mild and transient side effects like itching and erythema may occur at the site of application. Other side effects like flushes, papules, feeling of facial warmth, increased sweating, contact dermatitis, and dryness of the skin may infrequently occur. These local side effects are very rare and occur in less than 5% of the patients.

Shelf-Life

2 years

Storage and Handling Instructions

Store in a cool, dry place.

Packaging Information

NADIBACT Cream: Tube of 10g

NADIBACT Gel: Tube of 10g

Last Updated: Nov 2013
Last Reviewed: Aug 2015