Ofloxacin Injection/infusion 100ml:200mg
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Name: Ofloxacin Injection
Structural formula: C18H20FN3O4
Mol wt: 361.38
Description the product is slightly yellow and green pellucid liquid.
Pharmacology and toxicity
Broad spectrum aerobicidal quinolone antibiotic. In vitro ofloxacin can resist all of the G- Bacteria effectively. It also has effect on the resistance of G+ Bacteria. But it has lower sensibility for the anaerobic bacteria. As a kind of bactericidal agent, ofloxacin can inhibit DNA screw enzyme, preventing them from the metabolism, and lead to bacteria dead.
After administering the medicine distributes widely to all kinds of tissues and body liquids, the concentration in the tissues usually exceed the concentration in the plasma. The products can pass through the placental barrier, the binding rate with protein is about 20%~25%. Most of the product is mainly excreted with the original shape, about 3% is excreted through the liver. The metabolism in the urine is very little; and little is excreted in feces with the original shape, after 24hours and 48hours the total excretion quantity is about 1.6% and 3.9% of the total administration dosage; the product can also be excreted through latex.
Used to treat the following infections caused by the sensitive bacteria:
1.Urinary tract infections, including simple and complicated urinary tract infections, bacteroidal prostatitis, or cervicitis.
2.Respiratory tract infections, including bronchitic and pneumonia caused by the sensitive G- .
5.Bone & joint infections
6.Skin & soft Tissue infections
7.General infection including blood poisoning
Administration and dosage By drip phleboclysis. The general dose for the adult is as follows:
1. Bronchitic and pneumonia: 0.3g/time (according to ofloxacin) , twice every day, and the course of treatment is 7,14days.
2.Acute simple urinary tract infections: 0.2g/time, and twice every day, the course of treatment is 5,7days; complicated urinary tract infection, 0.2g/time, twice every day, and the course of treatment is 10,14days.
3.Prostatitis: 0.3g/time, twice every day, the course of treatment is 6 weeks; cervicitis and nonspecific urethritis caused by the chlamydia , 0.3g/time, twice every day, the course of treatment is 7~14days.
4.Simple clap, with the single dose 04g/time.
5.Typhia: 0.3g every time, with interval 12hours, the course of treatment is 10,14days. For the patients with the more acute infection, the dose can be increased to 0.4g/time, and twice every day.
1.Gastrointestinal reaction: including diarrhea stomach pain or cramps, dysentery, nausea, and vomiting.
2.Centre nerve system reaction: including dizzy, headache, drowsiness, and sleepless.
3.Allergic reaction including tetter, skin pruritus; photosensitivity reaction on few patients
4.The following system may happen on patients occasionally, include;
(1) falling sickness, insanity , restlessness, confusion, delusions and tremors
(2) blood in urine, fever, skin rash
(4) crystalluria, the symptom happen when used with large dose.
5. During the course of treatment few patients may have the following symptoms such as blood serum aminopherase increase, blood urea mitrogen increase, and white cell in the blood picture decrease. But the symptoms are low-grade and temporary.
Forbid to use the medicine for the patients allergic to this medicine and other quinolone drugs.
1. The administration time with the dosage 100ml is not less than 30mins.
2. At present drug resistance of coliform is usual for quinolone drug. Urine breeding sample should be kept before the administration and adjust the administration according to sensitivity test result to the medicine.
3. Administering with high dose or PH of urine>7 may lead to crystalluria. To avoid this, suggest the patients drinking a lot of water and assuring to excrete the urine 1200ml during 24hours.
4.For the patients with renal failure, adjust the administration dose according to the renal function.
5.Moderate to heavy photosensitivity reaction may happen when using the quinolone drugs. So avoid unnecessary or prolonged exposure to sunlight. Stop using the medicine if the aforementioned symptom happens.
6.Hypohepatia may lead to the medicine elimination decreased and concentration of medicine in the plasma increased, especially for the patients with the renal and liver failure. So when using for the patients with the liver and kidney diseases, the abovementioned factors must be taken into account and the dose should be adjusted.
7.Avoid using the medicine for the patients with the disease of central nerve system such as epilepsy or history of epilepsy. If the indication exist, make decision whether or not use after a good thought.
Indication for women in pregnant and suckle
Test on animal do not confirm that the quinolone drug can lead to malformation, but study of administration for the pregnant women have no definite conclusion. Seeing that the medicine may lead to joint affection, thus forbid to use this medicine for the women in pregnant and women in suckle stop sucking when used with this medicine.
Indications for the children
Safety of ofloxacin for the infants and the children younger than 18years old is uncertain. But when used for some kinds of infant animals, the administration may cause joint affection. So the medicine is not available for the infants and the children younger than 18 years old.
Indications for the elder patients
Because this injection partly is excreted via kidney, administer decreased dosage for most of the elder patients with the disease of renal failure.
1. Urine absifier can decrease the solubility of ofloxacin in the urine and lead to the crystalluria and renal disease.
2.Administering combined with the hyphylline drug may lead to significantly decreased liver elimination of hyphylline, prolonged T1/2 of blood elimination, and increased drug concentration in the plasma, along with hyphylline intoxication symptoms such as nausea, vomiting, tremors, restlessness, excitement, twitch, heart-throb, and etc. So when using with the hyphylline drug, measure the drug concentration in the plasma and adjust the dosage.
3.When used with Cicrosporin, oflxacin can make the drug concentration in the plasma of the latter increase. During this course, monitor the concentration and adjust the dose.
4.When used with the anticoagulants, ofloxacin can increase the effect of the latter. But during this course monitor the prothrombase time.
5.Bednzoic acid can decrease 50% of the secrete of ofloxacin via renal tubule, so when the above two kinds of medicine are combined for use, toxicity could be produced for the high concentration of ofloxacin in the plasma.
6.Ofloxacin may interfere the metabolism of the caffeine, which may lead to decreased caffeine elimination, prolonged T1/2 of blood elimination. That may also produce the toxicity for the central nerve system.
100ml: Ofloxacin 0.2g and Sodium Chloride 0.9g
Light-resistant and store in well-closed containers.
Packed in glass bottle
Validity Two years