Lotemaxin plus (Drops) Instructions for Use

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Bausch & Lomb Incorporated (USA)

ATC Code

S01CA (Corticosteroids in combination with antimicrobial drugs)

Active Substances

Tobramycin (Rec.INN registered by WHO)

Loteprednol (Rec.INN registered by WHO)

Dosage Form

Lotemaxin plus

Eye drops 5 mg+3 mg/1 ml: bottle 5 ml with a dropper tip

Dosage Form, Packaging, and Composition

Eye drops as a suspension from white to milky white in color.

Excipients: povidone, benzalkonium chloride 50% solution, disodium edetate dihydrate, glycerol, tyloxapol, water for injection, sulfuric acid, sodium hydroxide.

5 ml – polyethylene bottles (1) with a dropper tip and a polypropylene cap – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial and anti-inflammatory action for topical application in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology; anti-inflammatory agents in combination with antimicrobial agents; corticosteroids in combination with antimicrobial agents

Pharmacological Action

Loteprednol has a structure similar to other glucocorticoids. However, it lacks a ketone group at the 20-position.

Glucocorticoids suppress the inflammatory response to various triggering factors and are thought to slow down healing processes.

They have an anti-edematous effect, inhibit the processes of fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, collagen deposition, and scar formation caused by inflammation.

Glucocorticoids may cause an increase in intraocular pressure.

Tobramycin is an antibiotic of the aminoglycoside group.

It is active against the following pathogens: staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains; streptococci, including some species of group A beta-hemolytic streptococci, some species of non-hemolytic streptococci, as well as Streptococcus pneumoniae; Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most strains of Proteus vulgaris, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some species of the genus Neisseria.

Pharmacokinetics

When instilled into the conjunctival sac, the systemic absorption of loteprednol and tobramycin is limited.

Indications

Treatment of inflammatory diseases of the eye for which glucocorticoid therapy is indicated, and in the presence of or risk of superficial bacterial eye infection: blepharoconjunctivitis, giant papillary conjunctivitis, allergic conjunctivitis, postoperative inflammation after ophthalmic surgery; acute anterior uveitis.

Dosage Regimen

Shake the bottle well before each use to resuspend the medication.

Instill one drop into the conjunctival sac of the affected eye or both eyes, depending on the clinical indication.

For postoperative inflammation, apply one to two drops into the operated eye four times daily, beginning 24 hours after surgery and continuing throughout the first two weeks of the postoperative period.

For steroid-responsive inflammatory conditions with a risk of bacterial infection, the typical dosage is one to two drops instilled into the affected eye(s) every four to six hours.

During the initial 24 to 48 hours, the dosing frequency may be increased to every one to two hours, as deemed necessary by the physician based on the severity of inflammation.

Do not discontinue therapy prematurely. Taper the dosage frequency gradually as instructed by your physician following clinical improvement to avoid rebound inflammation.

The total duration of treatment should not exceed the period prescribed. Do not use for more than 10 days without reassessment and monitoring of intraocular pressure by an ophthalmologist.

Avoid allowing the dropper tip to contact any surface, including the eye, to prevent contamination of the suspension.

Adverse Reactions

Nervous system disorders common – headache.

Eye disorders common – burning and stinging in the eyes after instillation, blurred vision, conjunctivitis, lacrimation, eye pain, meibomitis, corneal staining, eyelid redness, eyelid edema; uncommon – increased intraocular pressure, foreign body sensation in the eye, asthenopia, keratitis.

Gastrointestinal disorders uncommon – nausea.

Skin and subcutaneous tissue disorders common – rash.

Contraindications

Hypersensitivity to loteprednol or tobramycin, to glucocorticosteroids or to antibiotics of the aminoglycoside group; viral diseases of the cornea and conjunctiva, including herpes simplex epithelial keratitis (dendritic keratitis), varicella, and post-vaccination reaction; pregnancy, breastfeeding period; age under 18 years.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Long-term use of glucocorticoids may lead to an increase in intraocular pressure and the development of glaucoma with damage to the optic nerve, decreased visual acuity, and narrowing of the visual fields.

Glucocorticoids should be used with caution in patients with glaucoma.

This agent should be used for 10 days or more only with monitoring of intraocular pressure.

The use of glucocorticoids may lead to the formation of posterior subcapsular cataract.

The use of glucocorticoids in the postoperative period after cataract extraction may slow down the healing process and increase the incidence of macular edema.

In diseases causing thinning of the cornea or sclera, cases of their perforation have been reported with the use of topical glucocorticoid preparations.

The decision to use this agent and to extend therapy should be made by the physician only after examination of the patient’s eye using magnifying optics, such as biomicroscopy (slit-lamp examination) and, if necessary, staining with fluorescein solution.

Long-term use of glucocorticoids may suppress the body’s immune response and, consequently, increase the risk of secondary eye infection.

In acute purulent eye infections, glucocorticoids may promote their development or mask their manifestations.

If the clinical picture does not improve after 2 days of therapy, the patient should be re-examined and the treatment tactics should be reconsidered.

Patients are advised to consult a doctor immediately if pain, increased redness, itching, or inflammation occurs during treatment.

In patients with a history of herpes simplex virus infection, treatment with glucocorticoids should be carried out with great caution.

The use of ophthalmic preparations containing glucocorticoids may prolong and increase the severity of many viral eye infections (including infection caused by the herpes simplex virus).

Fungal infection of the cornea develops particularly frequently with prolonged topical use of glucocorticoids.

The possibility of fungal invasion should be considered in every case of persistent corneal ulceration during the use of glucocorticoids.

If necessary, a culture test should be performed.

Some patients develop a hypersensitivity reaction to aminoglycosides with their topical application.

In case of hypersensitivity development, the drug should be discontinued and appropriate treatment should be prescribed.

Effect on ability to drive vehicles and operate machinery

If the patient experiences temporary visual disturbances, it is recommended to refrain from driving vehicles and operating machinery until visual function is sufficiently restored.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.