What is Pabi-Dexamethason used for?

Ciprofloxacin/Dexamethasone is indicated for the treatment of the following infections in adults and children (see section 4.2). See section 5.1 for commonly susceptible species. • Acute otitis externa (AOE) Consideration should be given to official guidance on the appropriate use of antibacterial agents.

What is the active ingredient in Pabi-Dexamethason?

Dexamethasonum (Dexamethasonum)

What pharmaceutical form is Pabi-Dexamethason available in?

Pabi-Dexamethason: Tabletki 500 mcg (doustna)

Is Pabi-Dexamethason OTC or prescription only?

Pabi-Dexamethason requires a doctor's prescription.

What are the side effects of Pabi-Dexamethason?

Summary of the safety profile In 5 clinical studies involving 976 patients, ciprofloxacin/dexamethasone was administered twice daily. This included 439 patients participating in 3 clinical studies with acute otitis media with tympanostomy tubes and 537 patients participating in 2 clinical studies with acute otitis externa. No serious otic or systemic undesirable effects related to ciprofloxacin/dexamethasone were reported in any of the clinical studies. In clinical trials, the

Who should NOT take Pabi-Dexamethason?

Hypersensitivity to ciprofloxacin, to other quinolones, to dexamethasone or to any of the excipients listed in section 6.1. Viral (i.e., varicella, herpes simplex) and fungal otic infections.

Does Pabi-Dexamethason interact with other medications?

No interaction studies have been performed. Following topical otic administration in paediatric patients with patent tympanostomy tubes, low plasma concentrations were observed for ciprofloxacin (≥ 0.50 ng/ml in only 4 of 25 patients) and for dexamethasone (≥ 0.05 ng/ml in 14 of 24 patients) at 6 hours post-dose. It is concluded that clinically relevant drug-drug pharmacokinetic interactions for ciprofloxacin or dexamethasone through protein binding, or involving P450 metabolis

Can Pabi-Dexamethason be used during pregnancy?

Pregnancy Since no animal reproduction studies and no adequate or well controlled studies in pregnant women have been conducted with the combination of ciprofloxacin and dexamethasone, this medicine should not be used during pregnancy unless clearly necessary and only if the potential benefit justifies the potential risk to the foetus (see Section 5.3). Breast-feeding Ciprofloxacin and corticosteroids, as a class, appear in milk following oral administration. It is not known wh

What precautions should be taken with Pabi-Dexamethason?

Any unused product or waste material should be disposed of in accordance with local requirements.

What ATC class does Pabi-Dexamethason belong to?

Pabi-Dexamethason: ATC H02AB02. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Pabi-Dexamethason

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pabi-Dexamethason — Description, Dosage, Side Effects | PillsCard

ATC Classification : Pharmacotherapeutic group: OTOLOGICALS, Corticosteroids and anti-infectives in combination. ATC-Code: S02CA06 Mechanisms of Action: These ear drops contain the fluoroquinolone, ciprofloxacin as the antibacterial agent.‍‍‍‍‍‍‍ The bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination. The mechanism of action of dexamethasone, a corticosteroid is not fully understood. However, it is known that corticosteroids bind to receptors in the cytoplasm, translocate to the nucleus, with subsequent binding to corticosteroid responsive elements on corticosteroid responsive genes. Corticosteroids are known to increase the transcription of anti-inflammatory proteins as well as inhibiting the expression of multiple inflammatory genes. Dexamethasone has an anti-inflammatory activity that is approximately 25 times more potent than hydrocortisone. Mechanism of Resistance : In-vitro resistance to ciprofloxacin can be acquired through a stepwise process by target site mutation in both DNA gyrase and topoisomerase IV. The degree of cross-resistance between ciprofloxacin and other fluoroquinolones that results is variable. Single mutations may not result in clinical resistance, but multiple mutations generally result in clinical resistance to many or all active substances within the class. Impermeability and/or active substance of efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance. All in-vitro mechanisms of resistance are commonly observed in clinical isolates. Resistance mechanisms that inactivate other antibiotics such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may affect susceptibility to ciprofloxacin. Plasmid-mediated resistance encoded by qnr-genes has been reported. Susceptibility testing breakpoints: Currently, minimal inhibitory concentration (MIC) breakpoints as established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) take into consideration drug concentrations achievable systemically following oral or intravenous administration of the antibiotic. These Susceptible/Resistant (S/R in mg/L) breakpoints are used in every day clinical laboratory practice to predict clinical efficacy. However, when ciprofloxacin is used by ototopical administration, higher concentrations could be achieved in the ear and the drug activity influenced by the physiochemical characteristics at this site of administration. EUCAST breakpoints are not adequate for a topical antibiotic but these recommendations that follow are consistent for a general use. EUCAST S/R Recommended Breakpoints for Ciprofloxacin (version 10.0-2020.01.01)) Microorganisms Susceptible (S) Resistant (R) Staphylococcus species S ≤ 0.001 mg/L R > 1 mg/L Haemophilus influenzae S ≤ 0.06 mg/L R > 0.06 mg/L Moraxella catarrhalis S ≤ 0.125 mg/L R > 0.125 mg/L Pseudomonas aeruginosa S ≤ 0.001 mg/L R > 0.5 mg/L The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. Acute Otitis Externa (AOE) Commonly susceptible species Aerobic Gram-positive microorganisms: Staphylococcus aureus (methicillin- susceptible) Aerobic Gram-negative microorganisms: Pseudomonas aeruginosa Species for which acquired resistance may be a problem Aerobic Gram-positive microorganisms: Staphylococcus aureus ( methicillin-resistant) The above information is based on microbiological surveillance studies performed at various sites in Europe and data obtained in the U.S.A. and Canadian clinical studies.

Pabi-Dexamethason

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