Actions of Ofloxacine Aguettant in details
Pharmacokinetics: Drug concentrations in serum (in subjects with tympanostomy tubes and perforated tympanic membranes), in otorrhea and in mucosa of the middle ear (in subjects with perforated tympanic membranes) were determined following otic administration of Ofloxacine Aguettant solution. In two single-dose studies, mean Ofloxacine Aguettant serum concentrations were low in adult patients with tympanostomy tubes, with and without otorrhea, after otic administration of 0.3% solution [4.1 ng/mL (n=3) and 5.4 ng/mL (n=5), respectively]. In adults with perforated tympanic membranes, the maximum serum drug level of Ofloxacine Aguettant detected was 10 ng/mL after administration of a 0.3% solution. Ofloxacine Aguettant was detectable in the middle ear mucosa of some adult subjects with perforated tympanic membranes (11 out of 15 subjects). The variability of Ofloxacine Aguettant concentration in the middle ear mucosa was high. The concentrations ranged from 1.2-602 mcg/g after otic administration of a 0.3% solution. Ofloxacine Aguettant was present in high concentrations in otorrhea (389-2850 mcg/g, n=13) 30 min after otic administration of a 0.3% solution in subjects with chronic suppurative otitis media and perforated tympanic membranes. However, the measurement of Ofloxacine Aguettant in the otorrhea does not necessarily reflect the exposure of the middle ear to Ofloxacine Aguettant.
Microbiology: Ofloxacine Aguettant has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Ofloxacine Aguettant exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial topoisomerase. DNA gyrase is an essential enzyme which controls DNA topology and assists in DNA replication, repair, deactivation and transcription. Cross-resistance has been observed between Ofloxacine Aguettant and other fluoroquinolones. There is generally no cross-resistance between Ofloxacine Aguettant and other classes of antibacterial agents eg, β-lactams or aminoglycosides.
Ofloxacine Aguettant has been shown to be active against most strains of the following microorganisms, both in vitro and clinically in otic infections :
Gram-Positive Aerobes: Staphylococcus aureus and Streptococcus pneumoniae.
Gram-Negative Aerobes: Haemophilus influenzae, Proteus mirabilis, Moraxella catarrhalis and Pseudomonas aeruginosa.
How should I take Ofloxacine Aguettant?
Take Ofloxacine Aguettant only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
Ofloxacine Aguettant comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take Ofloxacine Aguettant with or without food.
Drink plenty of fluids while you are being treated with Ofloxacine Aguettant. Drinking extra water will help to prevent some unwanted effects of Ofloxacine Aguettant.
If you are also using antacids containing aluminum or magnesium (such as Maalox®, Mylanta®), multivitamins (with calcium, iron, or zinc), didanosine (Videx®), or sucralfate (Carafate®), take these medicines at least 2 hours before or 2 hours after you take Ofloxacine Aguettant. These medicines may keep Ofloxacine Aguettant from working properly.
Keep using Ofloxacine Aguettant for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Dosing
The dose of Ofloxacine Aguettant will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Ofloxacine Aguettant. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For treatment of infection:
- Adults—200 to 400 milligrams (mg) every twelve hours for 3 to 14 days, depending on the medical problem being treated. Prostatitis is usually treated for six weeks. Gonorrhea is usually treated with a single oral dose of 400 mg.
- Children—Use and dose must be determined by your doctor.
- For treatment of infection:
Missed Dose
If you miss a dose of Ofloxacine Aguettant, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Ofloxacine Aguettant administration
Use Ofloxacine Aguettant otic exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Do not use this medication in the eyes or take it by mouth. Ofloxacine Aguettant otic is intended for use in the ears only.
In general, Ofloxacine Aguettant otic should be used as follows:
- Warm the drops slightly by holding the bottle in the hands for 1 or 2 minutes. Administration of cold drops into the ear may cause dizziness.
- Have another person administer the drops whenever possible. Have the affected person lie on their side or tilt the ear up to make administering a drop easier.
- Gently shake the drops just before administration.
- For adults, gently hold the earlobe up and back. For children, gently hold the earlobe down and back. This will allow the drops to run into the ear canal. Carefully instill the prescribed number of drops in the first ear.
- Keep the ear tilted for at least 5 minutes to allow the medication to penetrate the ear.
- If the patient being treated has ear tubes, the doctor may recommend gently pressing the tragus (part of the ear in front of the opening of the ear canal) four to five times in a pumping motion after administration of the drops. This may allow the drops to pass through the tubes into the middle ear. Follow the doctor's instructions.
- Repeat the process in the other ear if prescribed.
Ofloxacine Aguettant ear drops are usually used twice a day, about 12 hours apart. Follow your doctor's instructions.
Use all of the medication that has been prescribed. Symptoms may begin to improve before the condition is completely treated. If you do not use all of the medication prescribed, the condition could return or worsen.
It is important to use Ofloxacine Aguettant otic regularly to get the most benefit.
Notify your doctor if the condition does not improve or appears to worsen.
Avoid getting water inside of the affected ear(s) during treatment with Ofloxacine Aguettant. Care should be used while bathing, and swimming may not be recommended. Talk to your healthcare provider.
Store Ofloxacine Aguettant otic at room temperature, away from moisture, heat, and direct light. Keep the bottle properly capped.
Ofloxacine Aguettant pharmacology
Pharmacokinetics:
Serum, urine and tear concentrations of Ofloxacine Aguettant were measured in 30 healthy women at various time points during a ten-day course of treatment with Ofloxacine Aguettant Ophthalmic Solution. The mean serum Ofloxacine Aguettant concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum Ofloxacine Aguettant concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days. Maximum serum Ofloxacine Aguettant concentrations after ten days of topical ophthalmic dosing were more than 1000 times lower than those reported after standard oral doses of Ofloxacine Aguettant.
Tear Ofloxacine Aguettant concentrations ranged from 5.7 to 31 mcg/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9.2 mcg/g.
Corneal tissue concentrations of 4.4 mcg/mL were observed four hours after beginning topical ocular application of two drops of Ofloxacine Aguettant Ophthalmic Solution every 30 minutes. Ofloxacine Aguettant was excreted in the urine primarily unmodified.
Microbiology:
Ofloxacine Aguettant has in vitro activity against a broad range of gram-positive and gram-negative aerobic and anaerobic bacteria. Ofloxacine Aguettant is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacine Aguettant is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting DNA gyrase, an essential bacterial enzyme which is a critical catalyst in the duplication, transcription, and repair of bacterial DNA.
Cross-resistance has been observed between Ofloxacine Aguettant and other fluoroquinolones. There is generally no cross-resistance between Ofloxacine Aguettant and other classes of antibacterial agents such as beta-lactams or aminoglycosides.
Ofloxacine Aguettant has been shown to be active against most strains of the following organisms both in vitro and clinically, in conjunctival and/or corneal ulcer infections as described in the section.
*Efficasy for this organism was studied in fewer than 10 infection
The safety and effectiveness of Ofloxacine Aguettant Ophthalmic Solution in treating ophthalmologic infections due to the following organisms have not been established in adequate and well-controlled clinical trials. Ofloxacine Aguettant Ophthalmic Solution has been shown to be active in vitro against most strains of these organisms but the clinical significance in ophthalmologic infections is unknown.
Clinical Studies:
Conjunctivitis: In a randomized, double-masked, multicenter clinical trial, Ofloxacine Aguettant Ophthalmic Solution was superior to its vehicle after 2 days of treatment in patients with conjunctivitis and positive conjunctival cultures. Clinical outcomes for the trial demonstrated a clinical improvement rate of 86% (54/63) for the Ofloxacine Aguettant treated group versus 72% (48/67) for the placebo treated group after 2 days of therapy. Microbiological outcomes for the same clinical trial demonstrated an eradication rate for causative pathogens of 65% (41/63) for the Ofloxacine Aguettant treated group versus 25% (17/67) for the vehicle treated group after 2 days of therapy. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.
Corneal Ulcers: In a randomized, double-masked, multi-center clinical trial of 140 subjects with positive cultures, Ofloxacine Aguettant Ophthalmic Solution treated subjects had an overall clinical success rate (complete reepithelialization and no progression of the infiltrate for two consecutive visits) of 82% (61/74) compared to 80% (53/66) for the fortified antibiotic group, consisting of 1.5% tobramycin and 10% cefazolin solutions. The median time to clinical success was 11 days for the Ofloxacine Aguettant treated group and 10 days for the fortified treatment group.
References
- DailyMed. "OFLOXACIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- EPA DSStox. "Ofloxacin: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
