Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U), DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)
Rebel Distributors Corp
CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN 3 mg in 1 mL
AURICULAR (OTIC)
PRESCRIPTION DRUG
CIPRODEX® Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Media in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus , Streptococcus pneumoniae , Haemophilus influenzae , Moraxella catarrhalis , and Pseudomonas aeruginosa . Acute Otitis Externa in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . CIPRODEX® Otic is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. Use of this product is contraindicated in viral infections of the external canal including herpes simplex infections. The safety and efficacy of CIPRODEX® Otic have been established in pediatric patients 6 months and older (937 patients) in adequate and well-controlled clinical trials. Although no data are available
CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension is supplied as follows: 7.5 mL fill in a DROP-TAINER® system. The DROP-TAINER® system consists of a natural polyethylene bottle and natural plug, with a white polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package. NDC 21695-969-75, 7.5 mL fill Storage: Store at controlled room temperature, 15°C to 30°C (59°F to 86°F). Avoid freezing. Protect from light.
New Drug Application
CIPRODEX- CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION Rebel Distributors Corp ---------- PATIENT INFORMATION CIPRODEX® (CI-PRO-DEX) (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE. What is CIPRODEX® Otic? CIPRODEX® Otic is an antibiotic/steroid combination product in a sterile suspension used to treat: • Middle Ear Infection with Drainage Through a Tube in Children 6 months and older: A middle ear infection is a bacterial infection behind the eardrum. People with a tube in the eardrum may notice drainage from the ear canal.\ • Outer Ear Canal Infection in Patients 6 months and older: An outer ear canal infection, also known as "Swimmer's Ear", is a bacterial infection of the outer ear canal. The ear canal and the outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal. Who should NOT use CIPRODEX® Otic? • Do not use this product if allergic to ciprofloxacin or to other quinolone antibiotics. • Do not use this product if allergic to dexamethasone or to other steroids. • Do not give this product to pediatric patients who are less than 6 months old. How often should CIPRODEX® Otic be given? CIPRODEX® Otic ear drops should be given 2 times each day (about 12 hours apart, for example, 8 AM and 8 PM) in each infected ear unless the doctor has instructed otherwise. The best times to use the ear drops are in the morning and at night. It is very important to use the ear drops for as long as the doctor has instructed, even if the symptoms improve. If CIPRODEX® Otic ear drops are not used for as long as the doctor has instructed, the infection may return. What if a dose is missed? If a dose of CIPRODEX® Otic is missed, it should be given as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not use a double dose unless the doctor has instructed you to do so. If the infection is not improved after Perskaitykite visą dokumentą
CIPRODEX- CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION REBEL DISTRIBUTORS CORP ---------- CIPRODEX® (CIPROFLOXACIN 0.3% AND DEXAMETHASONE 0.1%) STERILE OTIC SUSPENSION DESCRIPTION CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension contains the synthetic broad-spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti- inflammatory corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of CIPRODEX® Otic contains ciprofloxacin hydrochloride (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a fluoroquinolone is available as the monohydrochloride monohydrate salt of 1- cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-qui nolinecarboxylic acid. The empirical formula is C H FN O ·HCl·H O and the structural formula is: Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-di ene-3,20-dione, is an anti- inflammatory corticosteroid. The empirical formula is C H FO and the structural formula is: CLINICAL PHARMACOLOGY PHARMACOKINETICS: Following a single bilateral 4-drop (total dose = 0.28 mL, 0.84 mg ciprofloxacin, 0.28 mg dexamethasone) topical otic dose of CIPRODEX® Otic to pediatric patients after tympanostomy tube insertion, measurable plasma concentrations of ciprofloxacin and dexamethasone were observed at 6 hours following administration in 2 of 9 patients and 5 of 9 patients, respectively. 17 18 3 3 2 22 29 5 Mean ± SD peak plasma concentrations of ciprofloxacin were 1.39 ± 0.880 ng/mL (n=9). Peak plasma concentrations ranged from 0.543 ng/mL to 3.45 ng/mL and were on average approximately 0.1% of peak plasma concentrations achieved with an oral dose of 250-mg [1]. Peak plasma concentration Perskaitykite visą dokumentą