Dexa-Gentamicin

Dexamethasone sodium phosphate, gentamicin sulfate.

Eye drops: 1 ml isotonic solution contains 1.0 mg Dexamethasone sodium phosphate, 5.0 mg Gentamicin sulfate (= 3.0 mg Gentamicin).
Eye oint: 1 g ointment contains 0.3 mg Dexamethasone, 5.0 mg Gentamicin sulfate (=3.0 mg Gentamicin).
Excipients/Inactive Ingredients: Eye drops: Benzalkonium chloride (preservative) 0.05 mg/ml, Sodium chloride, monobasic potassium phosphate, dibasic potassium phosphate, water for injections.
Eye oint: White vaseline, liquid paraffin, wool fat.

Pharmaco-therapeutic group: Dexa-Gentamicin is active against inflammations or hypersensitivities to certain substances (allergies) of the eye. ATC-Code: S01CA01.
Pharmacology: Eye oint: Dexa-Gentamicin is a combination of gentamicin sulfate, as antibiotic drug with a broad spectrum activity against gram negative and gram positive germs and dexamethasone, an anti-inflammatory and antiallergic active drug.
Topically applied gentamicin is absorbed by conjunctiva and cornea and is detectable in the aqueous humor 15 minutes after application.
Using gentamicin on intact mucous membrane of the eye, no detectable amounts of gentamicin are to be expected in serum. Dexamethasone poorly penetrate an intact corneal epithelium. The penetration is significantly elevated in eyes with inflammed or lesioned mucosal membranes.
Gentamicin is active against a wide variety of pathogenic gram-negative and gram-positive bacteria. The gram-negative bacteria which are sensitive to gentamicin include certain strains of Pseudomonas aeruginosa, Staphylococcus aureus, indole-positive and indole-negative Proteus species, Escherichia coli, Haemophilus influenzae and Haemophilus aegyptius and Neisseria species, including Neisseria gonorrhoeae.
The gram-positive bacteria against which gentamicin is active induce coagulase-positive and coagulase-negative staphylococci, inclusive of certain strains that are resistant to penicillin, group-A beta-hemolytic and nonhemolytic streptococci and Diplococcus pneumoniae.
Pharmacodynamics: Eye drops: Antibiotic: The bactericidal action of Gentamicin is based on an irreversible inhibition of the bacterial protein synthesis.
Gentamicin elicits rapid bacterial action by acting directly on the bacterial ribosome, where it disrupts the normal cycle of ribosomal function. Additionally, Gentamicin includes misreading of the genetic code of the mRNA template, leading to incorporation of incorrect amino acids into the growing polypeptide chain.
Corticosteroid: The corticosteroid's method of action is not yet completely known. The corticosteroids are thought to act by controlling the rate of synthesis of proteins important for chemotactic and immunologic reactions.
Modifications of the leukocyte's and macrophage's functions seem to have an influence on the suppression of inflammatory and allergic reactions.
Pharmacokinetics: Eye drops: Antibiotic: Systemically available Gentamicin has a half-life of plasma elimination of 2 to 3 hours in healthy adults and is excreted unchanged by the kidneys. Topically applied, Gentamicin is absorbed by conjunctiva and cornea and is detectable in the aqueous humour 15 minutes after application. Using Gentamicin on intact mucous membranes of the eye, no detectable amounts of Gentamicin are to be expected in serum.
Corticosteroid: Dexamethasone sodium phosphate and Dexamethasone poorly penetrate an intact corneal epithelium. The penetration is significantly elevated in eyes with inflammed or lesioned mucosal membranes.
Systemically absorbed Dexamethasone is bound to proteins to 80%. It is excreted by the kidneys (as glucuronide) with a half-life of 3 to 4 hours.

Dexa-Gentamicin Eye Ointment is used with inflammations of the anterior eye together with an infection with gentamicin-sensitive germs or in case of a risk of bacterial infection and with allergic inflammations of the anterior eye (Eye drops); conjunctiva and the eye lid (Eye oint) with bacterial superinfection.

The following statements apply to Dexa-Gentamicin unless otherwise prescribed by the physician. Observe these instructions for use, otherwise the patient will not fully benefit from Dexa-Gentamicin (for Eye drops).
Always use this medicine exactly as the doctor has told. Check with the doctor or pharmacist if not sure.
The treatment with Dexa-Gentamicin should normally not extend beyond a period of two weeks.
The exact duration of treatment should be determined by the doctor.
Consult the doctor if the patient has the impression that the effect of Dexa-Gentamicin is too strong or too weak.
Special advise: None.
Eye drops: If not otherwise prescribed by the doctor, the recommended dose is 1 drop 4-6 times daily into the conjunctival sac.
Avoid any contact of the bottle tip with the eyes or skin. Unscrew the cap covering the nozzle.
Tilt head back, gently pull down the lower eye lid and apply one drop into the conjunctival sac by gently squeezing the bottle. Slowly close the eyes. Close the bottle carefully after use.
Apply Dexa-Gentamicin eye drops regularly over the day.
Eye oint: The recommended dose is 4 - 6 times daily a 1 cm strip of eye ointment into the conjunctival sac (1 cm strip of eye ointment corresponds to 0.1 mg gentamicin sulphate and 0.006 mg dexamethasone).
Eye ointments should always be used avoiding a contact of the tip of the tube with the eye or skin. Remove the cap, tilt the head slightly back, retract the lower eye lid slightly from the eye and gently squeeze out a small strip of ointment into the conjunctival sac. Slowly close the eye lids.
Close the tube carefully after use.
During the treatment with Dexa-Gentamicin Eye Ointment the patient must not wear contact lenses.

No special measures have to be taken. Even if a child drinks the solution or eats the ointment, there will be no risk of intoxication.
For further questions on the use of this medicine please ask the doctor or pharmacist.

Dexa-Gentamicin should not be used when the following conditions and diseases occur: If the patient is allergic to dexamethasone sodium phosphate or gentamicin sulfate or one of the other ingredients; if the patient suffers from a superficial herpes-simplex-infection of the cornea (herpes corneae superficialis); in case of injuries and ulcerations of the cornea; in case of an increased intraocular pressure (closed- and open-angle glaucoma); in case of tuberculous infections of the eye; in case of fungal as well as solely bacterial infections of the eye.
Eye oint: Contraindicated following uncomplicated removal of a corneal foreign body.

Contact lenses should not be worn during treatment with Dexa-Gentamicin.
Prolonged use of topical antibiotics or corticosteroids may give rise to overgrowth of nonsusceptible microorganisms and fungi. Should this occur, or if irritation or hypersensitivity to Dexa-Gentamicin develops, discontinue use of this preparation and institute appropriate therapy.
Cross-allergenicity among aminoglycosides or corticosteroids has been demonstrated.
Talk to the doctor or pharmacist before using Dexa-Gentamicin.
Talk to the doctor if the patient experiences swelling and weight gain around the trunk and in the face as these are usually the first manifestations of a syndrome called Cushing's syndrome. Suppression of the adrenal gland function may develop after stopping a long-term or intensive treatment with Dexa-Gentamicin. Talk to the doctor before stopping the treatment.
These risks are especially important in children and patients treated with a drug called ritonavir or cobicistat.
Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Contact a doctor if the patient experiences blurred vision or other visual disturbances.
Eye drops: Benzalkonium chloride may cause eye irritations.
Avoid contact with soft contact lenses. Benzalkonium chloride may cause discoloration of soft contact lenses. Contact lenses have to be removed before using the eye drops and have to be inserted not earlier than 15 minutes after application.
Eye oint: Ophthalmic ointment may retard corneal healing.
Wool fat may cause local irritation of the skin (e.g. contact dermatitis).
Driving and using machines: Eye drops: No special precautions are required.
Eye oint: After the use of Dexa-Gentamicin eye ointment, the ointment film causes temporarily blurred vision, affecting reaction time. Therefore the patient must not drive, operate machines or work without stable footing shortly after applying Dexa-Gentamicin Eye Ointment.
Use in Pregnancy & Lactation: Eye oint: There are no controlled clinical data about the use of Dexa-Gentamicin Eye Ointment in pregnancy and lactation. Therefore, it should only be used after a very careful benefit-risk analysis of the treating physician.
Use in Children: Safety and effectiveness of the eye drops in children below the age of 8; and eye ointment in children less than six years of age have not been established yet.

If the patient is pregnant or breast-feeding, thinking may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Dexa-Gentamicin eye drops should not be used in the first trimenon, and during the further course of pregnancy (Eye drops); later (Eye oint) only after a careful benefit-risk-assessment by a doctor.
Glucocorticoids, among them dexamethasone sodium phosphate (Eye drops); dexamethasone (Eye oint) pass into breast milk. A harmful effect to the infant has not been reported until now. Nevertheless, the necessity of the treatment during breast-feeding should be precisely evaluated. Because of the low absorption of the active substance into systemic circulation no side effects on the infant caused by gentamicin are to be expected.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
For the assessment of side effects the following frequencies of occurrence are defined: Very common: more than 1 of 10 treated patients; Common: 1 to 10 of 100 treated patients; Uncommon: 1 to 10 of 1000 treated patients; Rare: 1 to 10 of 10,000 treated patients; Very rare: less than 1 of 10,000 treated patients; Not known: frequency of the basis of the available data not assessable.
Hormone problems: Not known: Growth of extra body hair (particularly in women), muscle weakness and wasting, purple stretch marks on body skin, increased blood pressure, irregular or missing periods, changes in the levels of protein and calcium in the body, stunted growth in children and teenagers and welling and weight gain of the body and face (called 'Cushing's syndrome') (see Precautions).
Eye Disorders: Very rarely there is the possibility of allergic reactions and uncommonly of a temporary burning in the eye.
With prolonged use, corticosteroids like dexamethasone may cause an increase of intraocular pressure in certain patients which improves after termination of treatment. Long term treatment with these substances may cause irreversible lens opacity (Eye drops); irreversible cataract formation (Eye oint), especially in children.
Furthermore: herpes simplex keratitis, perforation of the cornea in an existing inflammation of the cornea, fungal infections (e.g. Candida albicans), aggravation of bacterial infections of the cornea, dropping of the upper eye lid, pupil dilatation. After injuries of the cornea the use of Dexa-Gentamicin may lead to disorders in wound healing. Very rarely hypersensitive reactions (contact allergies) with itching, swelling of the eye lid (oedema) or eczema of the eye lid (vesiculation, weeping) were observed.
Not known: vision, blurred.
Eye drops: In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
Not known: vision, blurred.
If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
By reporting side effects the patient can help provide more information on the safety of this medicine.
If side effects occur: Stop to apply Dexa-Gentamicin and consult an ophthalmologist soon.

Tell the doctor or pharmacist if the patient is taking, have recently taken or might take any other medicines, including medicines obtained without prescription.
There are no clinical relevant interactions with gentamicin known.
An additional increase of the intraocular pressure may be caused by concomitant use of atropine and other anti-cholinergic drugs.
Gentamicin is incompatible with amphotericin B, heparin, sulfadiazine, cephalotin and cloxacillin. Concomitant local application of gentamicin and one of these substances may cause visible precipitates in the conjunctival sac.
Tell the doctor if the patient is using ritonavir or cobicistat, as this may increase the amount of dexamethasone in the blood.
Advice: Note that this is also valid for recently used medicines. If the patient is using additionally other eye drops or eye ointments, the patient should wait 15 minutes between two applications. Eye ointments should always be applied at last.

Dexa-Gentamicin can be used up to 4 weeks after first opening.
Do not store above 25° C.
Store the bottle in the folding carton to protect the content from light (Eye drops).
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer in use. These measures will help protect the environment.

Eye Antiseptics with Corticosteroids

R01AD53 - dexamethasone, combinations ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.

POM