Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP, is a sterile white to off white homogenous suspension supplied as 7.5 mL fill in a system consisting of a 10 mL LDPE natural bottle, 30 µL LDPE natural nozzle and a HDPE white opaque screw-on cap with tamper evident ring for tamper evident feature. It is available as follows: 7.5 mL in a 10 mL Container: NDC 53746-831-53 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Protect from light.; PRINCIPAL DISPLAY PANEL NDC 53746-831-53 Ciprofloxacin and Dexamethasone Otic Suspension, USP 0.3%/0.1% (7.5 mL) Rx only Container Label Amneal Pharmaceuticals LLC NDC 53746-831-53 Ciprofloxacin and Dexamethasone Otic Suspension, USP 0.3%/0.1% (7.5 mL) Rx only Carton Label Amneal Pharmaceuticals LLC 1 2
- 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP, is a sterile white to off white homogenous suspension supplied as 7.5 mL fill in a system consisting of a 10 mL LDPE natural bottle, 30 µL LDPE natural nozzle and a HDPE white opaque screw-on cap with tamper evident ring for tamper evident feature. It is available as follows: 7.5 mL in a 10 mL Container: NDC 53746-831-53 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Protect from light.
- PRINCIPAL DISPLAY PANEL NDC 53746-831-53 Ciprofloxacin and Dexamethasone Otic Suspension, USP 0.3%/0.1% (7.5 mL) Rx only Container Label Amneal Pharmaceuticals LLC NDC 53746-831-53 Ciprofloxacin and Dexamethasone Otic Suspension, USP 0.3%/0.1% (7.5 mL) Rx only Carton Label Amneal Pharmaceuticals LLC 1 2
Overview
Ciprofloxacin and Dexamethasone Otic Suspension, USP contains the quinolone antimicrobial, ciprofloxacin hydrochloride, USP, combined with the corticosteroid, dexamethasone USP, in a sterile, preserved suspension for otic use. Each mL of ciprofloxacin and dexamethasone otic suspension, USP contains ciprofloxacin hydrochloride, USP (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone, USP, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are acetic acid, boric acid, edetate disodium (as dihydrate), hydroxyethyl cellulose, sodium acetate trihydrate, sodium chloride, tyloxapol and water for injection, USP. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a quinolone antimicrobial is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. The molecular formula is C 17 H 18 FN 3 O 3 ·HCl·H 2 O. The molecular weight is 385.82 g/mol and the structural formula is: Figure 1: Structure of Ciprofloxacin Dexamethasone USP, (11β,16α)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The molecular formula is C 22 H 29 FO 5 . The molecular weight is 392.46 g/mol and the structural formula is: Figure 2: Structure of Dexamethasone structure 1 structure 2
Indications & Usage
Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. Ciprofloxacin and dexamethasone otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . ( 1 )
Dosage & Administration
Ciprofloxacin and dexamethasone otic suspension is for otic use (ears) only, not for ophthalmic use, or for injection. ( 2.1 ) Shake well immediately before use. ( 2.1 ) Instill four drops into the affected ear twice daily, for seven days. ( 2.2 ) 2.1 Important Administration Instructions Ciprofloxacin and dexamethasone otic suspension is for otic use (ears) only, and not for ophthalmic use, or for injection. Shake well immediately before use. 2.2 Dosage For the Treatment of Acute Otitis Externa (age 6 months and older) The recommended dosage regimen is as follows: Four drops [equivalent to 0.14 mL of ciprofloxacin and dexamethasone otic suspension, (consisting of 0.42 mg ciprofloxacin and 0.14 mg dexamethasone)] instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.
Warnings & Precautions
Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones. Discontinue use if this occurs with use of ciprofloxacin and dexamethasone. ( 5.1 ) Prolonged use may result in overgrowth of non-susceptible bacteria and fungi. ( 5.2 ) 5.1 Hypersensitivity Reactions Ciprofloxacin and dexamethasone otic suspension should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal, or facial edema), airway obstruction, dyspnea, urticaria, and itching. 5.2 Potential for Microbial Overgrowth with Prolonged Use Prolonged use of ciprofloxacin and dexamethasone otic suspension may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy. 5.3 Continued or Recurrent Otorrhea If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition, such as cholesteatoma, foreign body, or a tumor.
Contraindications
Ciprofloxacin and dexamethasone otic suspension 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 and fungal otic infections. Ciprofloxacin and dexamethasone otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. ( 4 ) Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections. ( 4 )
Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]. Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions (5.2) ]. Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phases II and III clinical trials, a total of 537 patients were treated with ciprofloxacin and dexamethasone otic suspension with AOE. The reported adverse reactions are listed below: Acute Otitis Externa The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic membranes. Adverse Reactions Incidence (N = 537) Ear pruritus 1.5% Ear debris 0.6% Superimposed ear infection 0.6% Ear congestion 0.4% Ear pain 0.4% Erythema 0.4% The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling). 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of ciprofloxacin and dexamethasone otic suspension. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.
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