Cetraxal Plus

Cetraxal Plus

Manufacturer:

Hyphens

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Ciprofloxacin, fluocinolone acetonide.
Description
Each ml of solution contains 3 mg of ciprofloxacin (as hydrochloride monohydrate) and 0.25 mg of fluocinolone acetonide.
Excipients/Inactive Ingredients: 0.6 mg methyl parahydroxybenzoate (E218) per ml, 0.3 mg propyl parahydroxybenzoate (E216) per ml, povidone-K-90-F, diethylene glycol ether, glycereth-26 (compound of glycerine and ethylene oxide), 1N hydrochloric acid and/or 1N sodium hydroxide (to adjust pH), purified water.
Action
Pharmacotherapeutic Group: Otological preparations: corticosteroids and antiinfectives in combination. ATC Code: S02CA03.
Pharmacology: Fluocinolone acetonide: Fluocinolone acetonide is a synthetic fluorinated corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids.
Ciprofloxacin: Mechanism of Action: As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair and recombination.
Pharmacokinetics: Auricular use: Given the concentration of the formulation as drops and the maximum daily dose to be administered, topical application in the ear is unlikely to result in pharmacokinetically or clinically relevant systemic levels of ciprofloxacin.
The absorption of fluocinolone acetonide after topical administration is generally low, and varies ostensibly according to the application site. There are no data on absorption following ototopical application.
Toxicology: Preclinical Safety Data: The toxicity of ciprofloxacin has been deeply studied. Adverse effects on CNS and potential to damage cartilage as well as tendons have been described in human and preclinical studies. However, these toxic effects have been observed after oral or IV administration at doses that cannot be achieved after otic administration.
Regarding fluocinolone acetonide, reversible hypothalamic-pituitary-adrenal (HPA) axis suppression has occurred in some patients receiving topical corticosteroid at total doses higher than 2 g. However, no HPA axis suppression has been described after otically administered corticosteroids. Considering the low total dose after the treatment with Cetraxal Plus, it is unlikely that the systemic exposure of this drug could lead to measurable changes in cortisol levels.
Since no relevant signs of ototoxicity were observed after intratympanic administration of Cetraxal Plus during 28 days in guinea pigs, the ototopical use of this product should be considered safe and no risk for hearing loss should be expected with its clinical use.
Microbiology: Ciprofloxacin: Mechanism of Resistance: The mutation in genes encoding ciprofloxacin targets (gyr A, gyrN, parC, parE) represent the main mechanism of ciprofloxacin resistance in P. aeruginosa. Another mechanism of resistance described is overexpression of the efflux pumps, in particular Mex (Multiple EffluX) gene. The single mutations do not necessarily result in clinical resistance, but multiple mutations generally result in clinical resistance. Nevertheless, the high concentration of delivered antibiotic, when topical administration is used, is always well above the MIC of the relevant organisms. This makes the emergence of bacterial resistance extremely improbable. The possibility for the emergence of resistance seems to be vastly lower when topical routes of administration are used as compared with drugs that are administered systemically.
Breakpoints: Prevalence of resistance may vary according to geographical zone and weather for the selected microorganisms. Local information on resistance should be available, particularly in the case of serious infections. This information only provides an approximate orientation as to the probability of the microorganism being sensitive to this antibiotic.
Based on present data the following table represents susceptibility of ciprofloxacin to the leading pathogens in the approved indication. (See table.)

Click on icon to see table/diagram/image
Indications/Uses
Cetraxal Plus is indicated in adults and in children for the local treatment of acute otitis externa with an intact tympanic membrane caused by susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.
Dosage/Direction for Use
Auricular use.
Adults:
Instill 4-6 drops into the affected external ear canal every 8 hours. The duration of the treatment will be 8 days.
Paediatric patients: The dosage in children is the same as for adults.
The safety and efficacy of Cetraxal Plus have been established in paediatric patients 7 years and older in adequate and well controlled clinical trials. Although no clinical data are available on patients less than seven years there are no known safety concerns or differences in the disease process in this population that would preclude use of this product in children of two years and older (see Precautions).
Renal/hepatic impairment: No dosage adjustment is deemed necessary.
Elderly patients: No dosage adjustment is deemed necessary.
Instruction for correct use of the product: The solution should be warmed before its use, by holding the bottle in the hand for several minutes. This will avoid the discomfort that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled pulling several times on the auricle. This position should be maintained for around 5 minutes to facilitate penetration of the drops into the ear.
Repeat, if necessary, for the opposite ear.
To prevent contamination of the dropper tip in order to limit bacterial risks, care should be taken not to touch the auricle or the external ear canal and surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. Keep the bottle until the completion of the treatment.
Overdosage
No case of overdose has been reported.
Topically applied fluocinolone may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may appear. (See Adverse Reactions.)
If the preparation is accidentally swallowed, treatment will include gastric emptying by induced vomiting or gastric lavage, the administration of activated charcoal and antacids containing magnesium or calcium.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Contraindications
Hypersensitivity to the active substance ciprofloxacin or to fluocinolone or any member of the quinolone class of antimicrobial agents or to any of the excipients.
Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.
Special Precautions
Consideration should be given to official guidance on the appropriate use of antibacterial agents. This medicinal product is for auricular use, not for ophthalmic use, inhalation or injection. This medicine should not be swallowed or injected.
Safety and efficacy of Cetraxal Plus have not been established in children younger than seven years, but there are no known safety concerns or differences in disease process to preclude use in children over two years old, since there is no experience with fluocinolone in children younger than two years old.
The safety and efficacy of Cetraxal Plus ear drops solution have not been studied in the presence of a perforated tympanic membrane. Therefore, Cetraxal Plus ear drops solution should be used with caution in patients with known or suspected perforation, or where there is a risk of perforation of the tympanic membrane.
Cetraxal Plus 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. Serious acute hypersensitivity reactions may require immediate emergency treatment.
Growth of Resistant Organisms with Prolonged Use: As with other antibiotic preparation, the use of this product may result in overgrowth of non-susceptible organisms, including bacterial strains, yeast and fungi. If superinfection occurs, discontinue use and appropriate therapy should be initiated. If after one week of therapy some signs and symptoms persist, further evaluation is recommended to reassess the disease and the treatment.
Some patients taking systemic quinolones have shown moderate to severe skin sensitivity to sun. Due to the site of administration, it is unlikely that this product may show photoallergic reactions.
Corticosteroids, such as fluocinolone, may be absorbed in sufficient amounts to cause systemic corticosteroids effects, if applied to large areas, to broken skin or under occlusive dressings.
Manifestations of hypercortisolism (Cushing's Syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids. If either of the previously mentioned are observed, withdraw the drug gradually by reducing the frequency of application. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency.
Cetraxal Plus may cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate (see Adverse Reactions).
Effects on the Ability to Drive and Use Machines: In view of the route of administration and the conditions of use, taking into account the safety profile of Cetraxal Plus, this medicine may have no influence on the ability to drive and use machines.
Use In Pregnancy & Lactation
Pregnancy: Data available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism or foetus (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide.
Before administering the medicine, an assessment should be made on the benefits of the treatment outweighing the possible risk.
Breastfeeding: Ciprofloxacin is excreted in breast milk. Although a significant systemic absorption of ciprofloxacin is not expected after an auricular administration (see Pharmacology: Pharmacokinetics under Actions), an exposure to ciprofloxacin cannot be ruled out.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cetraxal Plus is administered to a nursing woman.
Adverse Reactions
MedDRA terminology has been used to classify reported adverse reactions: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data).
General disorders and administration site conditions: Uncommon: application site pruritus, application site hyperesthesia.
Immune system disorders: Not known: allergic reactions (see Precautions).
Drug Interactions
Specific drug interaction studies have not been conducted with Cetraxal Plus. However, due to low plasma level anticipated after application in the ear (see Pharmacology: Pharmacokinetics under Actions), it is unlikely that ciprofloxacin or fluocinolone may show clinically meaningful systemic interaction with other drugs.
It is recommended not to use other ear preparations concomitantly. If more than one medicine needs to be administered by this route, it is advised to administer them apart.
Caution For Usage
Instructions for Use and Handling: Not applicable.
Incompatibilities: Not applicable.
Storage
Store below 30°C.
Shelf-Life: 24 months.
After First Opening: 1 month.
ATC Classification
S02CA05 - fluocinolone acetonide and antiinfectives ; Belongs to the class of combinations of corticosteroids and antiinfectives used in the treatment of ear diseases.
Presentation/Packing
Ear drops soln (transparent, limpid solution) 10 mL.
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