Heilongjiang Tianlong Pharmaceutical Co.Ltd

Instruction for Usage of Ofloxacin Gel

Please read the instruction carefully and use the product under the advice of doctor

Warning: Those allergic to this product and quinolones are forbidden to use.

【Name】Ofloxacin Gel

【Pin yin】Yangfushaxing Ningjiao

【Composition】The main ingredients of this product is ofloxacin.

Chemical name: (±) -9- fluorine -2, 3- dihydro -3- methyl -10- (4-methyl -1- piperazinyl) -7- oxo -7H- pyridine (1, 2, 3, -de) – [1, 4] benzoxazine -6- carboxylic acid

 Chemical structural formula: 

 Molecular formula: C18H20FN3O4

  Molecular weight: 361.38

【Description】Light yellow to light yellow-green transparency semisolid gel.

【Indication】For bacterial infection of skin and soft tissue diseases, such as folliculitis, boil swelling, trauma caused by sensitive bacteria,traumatic infection and eczema infection.  .【Specification】10g: 50mg

【Dosage and Administration】 External application. 2 times/day. Patients with purulent secretion, use after clean the disease tissue with saline.

【Adverse Reactions】So far, there was little literature reference recorded adverse reaction of this product for dermatologic. However, local irritation or local or systemic allergic reactions are not clear.

【Taboo】Those allergic to this product and quinolones are forbidden to use.

【Matters Needing Attention】

  1. Same as other anti-infective drugs, extension use may cause overgrowth of non sensitive microorganisms, including fungi. So this product should avoid long-term use.

  2. Quinolones administered even once only, may have an allergic reaction, some reactions with cardiovascular collapse, loss of consciousness, angioedema (including pharynx, throat and facial edema), airway obstruction, dyspnea, urticaria, itching etc. Discontinue use and consult a doctor if rash or other allergic reactions occur.

  3. Patients with Severe liver and kidney dysfunction should be used with caution.

  4. Please put this product in the place where children can not contact.

【Pregnant and Lactant Women Medication】

There is no adequate controlled study of pregnant women, therefore for pregnant women, use only if the potential benefit of the drug is greater than the risk to the fetus. Ofloxacin can be excreted by human milk, so breastfeeding women should be used with caution.

【Pediatric Medication】

The efficacy and safety of children use this product has not yet been confirmed. Immature animals oral take quinolones cause joint disease.

【Agedness Medication】 Not clear.

【Drug Interactions】The drug interactions of this product are not clear. However, it has been proved that some quinolones systemic administration can increase the blood concentration of theophylline, interfere with the metabolism of caffeine, increase oral anticoagulation drug warfarin and its ramification. If taken with cyclosporine, patients may have a transient increase in serum creatinine.

【Overdose】Not clear.

【Pharmacology and Toxicology】

This product has broad-spectrum antibacterial function, particularly; it has a high antibacterial activity against aerobic gram negative bacilli, and has good antibacterial activity in following bacteria: most of the Enterobacteriaceae including citrobacter, aerobacter cloacae and enterobacter aerogenes such enterobacter, escherichia coli, klebsiella, bacterium termo, salm, shigella, vibrio, yersinia, etc. It also has antibacterial activity against multi drug resistant bacteria. It has certain antibacterial activity against penicillin resistant neisseria gonorrhoeae, haemophilus influenzae and Mora. It has antibacterial activity against most of pseudomonas, such as pseudomonas aeruginosa, etc. This product has antibacterial activity against methicillin sensitive staphylococcus, and has only moderate antibacterial activity against streptococcus pneumoniae, streptococcus mutans and enterococcus faecalis. It has a good anti microbial effect on chlamydia trachomatis, mycoplasma, legionella, and has antibacterial activity against mycobacterium tuberculosis and atypical mycobacteria, and poor antibacterial activity against anaerobic bacteria. Ofloxacin is a bactericide, which results in the death of bacteria by inhibiting the synthesis and duplication of DNA in the subunit A of bacterial DNA helicase.

【Pharmacokinetics】

The pharmacokinetics of ofloxacin in dermatologic is not clear. Protein binding rate of ofloxacin was 20%-25% when systematic administration. Ofloxacin absorbed into the blood mainly in the form of kidney excretion, a small amount (3%) in the liver metabolism, rarely in urine metabolites, small amount of archetype excreted from the stool. Ofloxacin can pass through the placenta barrier, but also through the secretion of milk.

【Storage】Sealed. Protected from light.

【Package】Packaging in pharmaceutical polyethylene-aluminum composite pipeline, 10g/pipe   1pipe/box

【Shelf Life】24 months