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FRAKIDEX Ophthalmic ointment Tube/5g

Laboratoire Chauvin

FRAKIDEX Ophthalmic ointment Tube/5g

CIP / EAN code: 3400932645213

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Product information

Find indications, dosage and precautions in the sections below.

Automatic English translation of the French VIDAL document. Original numerical values and units are retained, including decimal commas.

VIDAL
Medicines
Update of 10/07/2025

FRAKIDEX®
framycetin, dexamethasone


Forms and presentations

Eye drops in solution:  Bottle of 5 mL.
Ophthalmic ointment:  Tube of 5 g.


Composition

Eye drops: per vial
Framycetin (INN) sulfate 
31 500 IU
Dexamethasone (INN) sodium phosphate 
5 mg
Excipients: benzalkonium chloride, sodium citrate, polysorbate 80, sodium hydroxide and/or dilute hydrochloric acid, purified water.

Excipient with known effect: this medicine contains 0,50 mg of benzalkonium chloride per unit volume (5 mL).

Ophthalmic ointment: per tube
Framycetin (INN) sulfate 
15 750 IU
Dexamethasone (INN) sodium phosphate 
5 mg
Excipients: liquid paraffin/petrolatum mixture (65/35%).

Indications

Eye drops and ointment:
Local anti-inflammatory and antibacterial treatment of the eye and its adnexa for the ointment:
  • following ophthalmic surgery,
  • infections due to germs sensitive to framycetin with an inflammatory component.
Official recommendations concerning the appropriate use of antibacterial agents should be taken into account.

Dosage and administration

Dosage
Eye drops:
Instil 1 drop into the lower conjunctival sac:
  • every hour at the start of treatment in severe acute conditions;
  • 3 to 6 times a day in other cases for an average of 7 days.
A longer treatment may be prescribed, under strict ophthalmological supervision.
Systemic absorption may be reduced by nasolacrimal occlusion or by closing the eyelids for 2 minutes. This method may help to reduce systemic adverse effects and increase local efficacy.
Ointment:
1 to 3 applications per day.
Apply an amount equivalent to a grain of wheat of ointment into the lower conjunctival sac of the diseased eye or eyes and, if necessary, on the edge of the eyelid.
Duration of treatment: on average 7 days.
A longer treatment may be prescribed under strict ophthalmological supervision.

Method of administration:
Eye drops:
Ophthalmic use.
Patients are advised:
  • to wash their hands thoroughly before instillation,
  • not to touch the eye or eyelids with the tip of the bottle,
  • to recap the bottle carefully after use.
Ointment:
Ophthalmic use.
Pull the eyelid downward while looking upward and place the ointment between the eyelid and the eyeball.
Do not touch the eye or eyelids with the tip of the tube.
Recap the ointment tube carefully after use.

Paediatric population:

In the absence of data, use of Frakidex in the paediatric population is not recommended.


Contraindications

This medicine is contraindicated in cases of:
  • Hypersensitivity to the active substances or to any of the excipients listed in section Composition.
  • Dendritic epithelial herpetic keratitis, mycotic keratitis, epidemic viral keratoconjunctivitis at an early stage.

Warnings and precautions


Warnings:

Do not swallow.

In case of hypersensitivity, treatment must be stopped.

Repeated and/or prolonged instillations (eye drops) or applications (ointment) may result in a non-negligible systemic passage of the corticosteroid.

Repeated and/or prolonged instillations (eye drops) or applications (ointment) may cause ocular hypertension in some patients and/or delayed wound healing.

Precautions for use

In the absence of rapid improvement or in case of prolonged treatment, regular medical monitoring including bacteriological tests with study of the germ's sensitivity allows detection of resistance to the product and possible adjustment of treatment.

As with all ophthalmic preparations containing a corticosteroid, prolonged use requires particularly careful ophthalmological monitoring of the cornea, intraocular pressure and the lens.

Indeed, visual disturbances may occur during systemic or local corticosteroid therapy. In case of blurred vision or the onset of any other visual symptom during corticosteroid therapy, an ophthalmological examination is required to look in particular for cataract, glaucoma, or a rarer lesion such as central serous chorioretinopathy, as described with the administration of systemic or local corticosteroids.

In case of concomitant treatment with another eye drop, respect an interval of 15 minutes between the 2 instillations.

Wearing contact lenses is not recommended during treatment (risk of adsorption of the preservative and active ingredients). Furthermore, in case of inflammation/infection of the eye, wearing contact lenses is not recommended for the entire duration of treatment.

Athletes' attention is drawn to the fact that this medicinal product contains an active ingredient (dexamethasone) that may induce a positive reaction in tests carried out during anti-doping controls.

Cushing's syndrome and/or inhibition of adrenal function associated with systemic absorption of ophthalmic dexamethasone may occur after intensive continuous or long-term treatment in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In this case, treatment must be discontinued gradually.

Eye drops:
This medicine contains 0,50 mg of benzalkonium chloride per unit volume (5 mL).
Benzalkonium chloride may be absorbed by soft contact lenses and change their colour. Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Benzalkonium chloride is known to cause eye irritation, dry eye syndrome symptoms, and may affect the tear film and the surface of the cornea. This medicine should be used with caution in patients with dry eye and those at risk of corneal damage. Patients should be monitored in case of prolonged use.
If abnormal sensation, tingling, or pain in the eyes occurs after using this medicine, a doctor must be consulted.

Interactions

Drug interactions
In case of concomitant treatment with another eye drop, respect an interval of 15 minutes between the 2 instillations.
Although the amount of dexamethasone passing into the systemic circulation is low after ocular application, the interactions observed with systemically administered dexamethasone should be taken into account.

Not recommended:
  • Medicines causing torsades de pointes (astemizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine): torsades de pointes (hypokalaemia is a predisposing factor, as are bradycardia and a pre-existing long QT interval).
    Use substances that do not carry the disadvantage of causing torsades de pointes in case of hypokalaemia.
  • CYP3A4 inhibitors (including ritonavir and cobicistat) may decrease the clearance of dexamethasone, resulting in increased effects and inhibition of adrenal function/Cushing's syndrome. The combination should be avoided, unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid effects.

Requiring precautions for use:
  • Systemic acetylsalicylic acid and, by extension, other salicylates: decreased salicylaemia during corticosteroid treatment and risk of salicylate overdose after its discontinuation, due to increased elimination of salicylates by corticosteroids.
    Adjust salicylate doses during the combination and after discontinuation of corticoid treatment.
  • Antiarrhythmics causing torsades de pointes (amiodarone, bretylium, disopyramide, quinidine-like agents, sotalol): torsades de pointes (hypokalaemia is a predisposing factor, as are bradycardia and a pre-existing long QT interval).
    Prevent hypokalaemia and correct it if necessary; monitor the QT interval. In case of torsades, do not administer antiarrhythmics (electrical overdrive pacing).
  • Oral anticoagulants: possible impact of corticosteroid therapy on the metabolism of the oral anticoagulant and on that of coagulation factors. Haemorrhagic risk specific to corticosteroid therapy (gastrointestinal mucosa, vascular fragility) at high doses or during prolonged treatment exceeding 10 days.
    When the combination is justified, reinforce monitoring: biological check at 8e day, then every 15 days during corticotherapy and after its discontinuation.
  • Other hypokalaemic agents (hypokalaemic diuretics alone or in combination, stimulant laxatives, amphotericin B IV): increased risk of hypokalaemia through additive effect.
    Monitor serum potassium and correct if necessary, especially in cases of digitalis therapy.
  • Digitalis glycosides: hypokalemia favoring the toxic effects of digitalis glycosides.
    Monitor serum potassium, correct if necessary, and possibly perform an ECG.
  • Parenteral heparins: aggravation by heparin of the haemorrhagic risk specific to corticosteroid therapy (gastrointestinal mucosa, vascular fragility) at high doses or during prolonged treatment exceeding 10 days.
    The combination must be justified; reinforce monitoring.
  • Enzyme inducers (carbamazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampicin): decreased plasma levels and efficacy of corticosteroids due to increased hepatic metabolism. The consequences are particularly significant in patients with Addison's disease and in transplantation.
    Clinical and biological monitoring, adjustment of the corticosteroid dosage during the combination and after discontinuation of the enzyme inducer.
  • Insulin, metformin, sulfonylureas: elevated blood glucose, sometimes with ketosis (decreased glucose tolerance caused by corticosteroids). Inform the patient and reinforce blood and urine self-monitoring, especially at the start of treatment. Adjust the antidiabetic dose as needed during corticosteroid treatment and after its discontinuation.
  • Isoniazid (described for prednisolone): decreased plasma levels of isoniazid. Proposed mechanism: increased hepatic metabolism of isoniazid and decreased metabolism of glucocorticoids.
    Clinical and biological monitoring.
  • Gastrointestinal topicals: magnesium, aluminium and calcium salts, oxides and hydroxides (described for prednisolone and dexamethasone): decreased digestive absorption of glucocorticoids.
    Take gastrointestinal topicals at a distance from glucocorticoids (more than 2 hours if possible).

To be taken into account:
  • Antihypertensives: decreased antihypertensive effect (sodium and water retention by corticosteroids).
  • Interferon alfa: risk of inhibition of the action of interferon.
  • Praziquantel: possible decrease in plasma concentrations of praziquantel.
  • Live attenuated vaccines: risk of generalised disease, possibly fatal. This risk is increased in subjects already immunosuppressed by the underlying disease.
    Use an inactivated vaccine where one exists (poliomyelitis).
Particular problems with INR imbalance:

Many cases of increased activity of oral anticoagulants have been reported in patients receiving antibiotics. A marked infectious or inflammatory context, age and general condition of the patient appear to be risk factors. In these circumstances, it is difficult to distinguish between the infectious disease and its treatment in the occurrence of the INR imbalance. However, certain classes of antibiotics are more involved: these include fluoroquinolones, macrolides, cyclines, cotrimoxazole and certain cephalosporins.


Fertility, pregnancy and breastfeeding

In case of ocular administration, systemic absorption is not negligible. However, compared with an eye drop form, systemic absorption from an ointment form is probably very low.

The presence of framycetin determines the course of action in case of pregnancy and breastfeeding.

Pregnancy:

Studies carried out in animals with aminoglycosides have demonstrated damage to the cochleovestibular apparatus and renal function in several species.

In clinical practice, a few cases of cochleovestibular damage have been described with certain aminoglycosides.

Consequently, the use of this medicine is not recommended during pregnancy. This element does not constitute the systematic argument for advising termination of pregnancy, but leads to an attitude of caution and targeted prenatal monitoring (ears, kidneys).


Breastfeeding:

The passage of aminoglycosides into breast milk is poorly known but probably low.

Absorption of these substances through the digestive tract of the newborn is considered negligible. Their presence in the newborn's intestine may cause destruction of the digestive flora and lead to the occurrence of candidiasis or diarrhoea. In addition, the oto-nephrotoxicity of aminoglycosides constitutes an additional potential risk.

Consequently, the use of this medicine during breastfeeding is not recommended.


Driving and using machines

Eye drops:
Vision may be blurred immediately after instillation.
Ointment:
In case of significant ocular discomfort related to adhesion of the ointment form, it is recommended to wait for the symptoms to disappear before driving a vehicle or using a machine.

Adverse effects

Risk of cutaneous-conjunctival hypersensitivity reaction.

Eye disorders:

  • Possibility of transient local irritation:
    • pruritus and swelling of the eyelids and conjunctival erythema (ointment);
    • discomfort, tearing, burning, conjunctival hyperaemia (eye drops).
  • With prolonged use: risk of corticosteroid-induced ocular hypertension, lens opacification, superficial keratitis due to the presence of corticosteroid.
  • In case of corneal or scleral ulceration, corticosteroids may delay healing and promote superinfection.
  • Eye drops: a few rare cases of corneal calcification have been reported in association with the use of drops containing phosphates in certain patients with severely damaged corneas.
  • Frequency not determined: blurred vision (see Warnings and Precautions for Use).

Endocrine disorders:

  • Frequency not determined: Cushing's syndrome, inhibition of adrenal function (see Warnings and Precautions for Use).
Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.


Overdose

No cases of overdose have been reported. However, repeated instillations (eye drops) or applications (ointment) over a prolonged period may lead to a non-negligible systemic absorption of the active ingredients, corticosteroid-induced ocular hypertension, lens opacification, superficial keratitis, and delayed wound healing.

As with all ophthalmic preparations containing a corticosteroid, prolonged use requires particularly careful ophthalmological monitoring of the cornea, intraocular pressure and the lens: cases of corneal thinning and cases of cataract have been reported after prolonged treatment with certain topical corticosteroids.


Pharmacodynamics

Pharmacotherapeutic class: Corticosteroid and anti-infective in combination for topical use (S: sensory organs), ATC code: S01CA01.

Dexamethasone is a steroidal anti-inflammatory agent.

Framycetin is a bactericidal antibiotic of the aminoglycoside family.

Antibacterial activity spectrum of framycetin:
The prevalence of acquired resistance can vary according to geography and time for certain species. It is therefore useful to have information on local resistance prevalence, especially for the treatment of severe infections. These data can only provide guidance on the probabilities of the susceptibility of a bacterial strain to this antibiotic.
When the variability of resistance prevalence in France is known for a bacterial species, the frequency of acquired resistance in France (> 10 %; extreme values) is indicated in parentheses:
Susceptible species:
  • Aerobic Gram-positive: Corynebacterium, Listeria monocytogenes, Staphylococcus methicillin-S.
  • Aerobic Gram-negative: Acinetobacter (50-75 %) essentially Acinetobacter baumannii, Branhamella catarrhalis, Campylobacter, Citrobacter freundii (20-25 %), Citrobacter koseri, Enterobacter aerogenes (?), Enterobacter cloacae (10-20 %), Escherichia coli (15-25 %), Haemophilus influenzae (25-35 %), Klebsiella (10-15 %), Morganella morganii (10-20 %), Proteus mirabilis (20-50 %), Proteus vulgaris (?), Providencia rettgeri (?), Salmonella (?), Serratia (?), Shigella (?), Yersinia (?).
Moderately susceptible species (in vitro of intermediate susceptibility):
  • Aerobic Gram-negative: Pasteurella.
Resistant species:
  • Gram-positive aerobes: enterococci, Nocardia asteroides, Staphylococcus spp. methicillin-R* , Streptococcus.
  • Aerobic Gram-negative: Alcaligenes denitrificans, Burkholderia, Flavobacterium sp., Providencia stuartii, Pseudomonas aeruginosa, Stenotrophomonas maltophilia.
  • Anaerobes: strict anaerobic bacteria.
  • Others: Chlamydia, mycoplasmas, rickettsiae.
*  The frequency of methicillin resistance is approximately 30 to 50 % of all staphylococci and is found mainly in hospital settings.

Note: This spectrum corresponds to that of the systemic forms of antibiotics belonging to the aminoglycoside family. With the local pharmaceutical presentations, the concentrations obtained in situ are much higher than plasma concentrations. Some uncertainties remain regarding the kinetics of the concentrations in situ, depend on the local physicochemical conditions that may modify the activity of the antibiotic, and on the stability of the product in situ.

Eye drops: when used topically, framycetin penetrates the cornea poorly.


Pharmacokinetics

When used topically, framycetin penetrates the cornea poorly.


Storage conditions

Shelf life before opening:
2 years.

Store at a temperature below 25 °C.

After 1re opening of the eye drop bottle:
15 days.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

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


Prescription, supply and reimbursement

LIST I
Marketing authorisation (AMM) 3400934734953 (1997, SPC rev 11.04.2022) eye drops.
3400932645213 (1998, SPC rev 13.06.2023) ointment.
   
Price: 1,59 euros (eye drops 5 mL).
1,35 euros (ointment 5 g).
Social Security reimbursement at 30%. Collect.


CHAUVIN Laboratory
416, rue Samuel-Morse. CS 99535. 34961 Montpellier
Tel: 04 67 12 30 30

Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.