Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Lotemax 0.5% w/v Eye Drops, Suspension
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Loteprednol etabonate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Lotemax is an eye drop suspension. Lotemax is used to treat inflammation of the eye, after surgery. Sometimes the eye may become inflamed (red and painful). Loteprednol etabonate is one of a group of medicines called corticosteroids. It acts by reducing inflammation and eases the symptoms. Because it is used in low doses directly where it is needed, its action is only at this place.
2.
What you need to know before you take it
e Lotemax
Do not use Lotemax: if you are allergic to the active substance (loteprednol) or any of the other ingredients of this medicine (listed in section 6). if you have been allergic to any other corticosteroid. if you have eye diseases caused by viruses such as herpes simplex, vaccinia, and varicella. if you have eye diseases caused by mycobacterium and fungi. if you are breast-feeding. Warnings and precautions Tell your doctor if you already have glaucoma. Contact your doctor if you experience blurred vision or other visual disturbances. Tell your doctor if pain develops, or if redness, itching, or inflammation gets worse. See your doctor if your symptoms do not get better within 2 days. He/she may want to re-evaluate your condition. You should not use Lotemax longer than 10 days without having the pressure in your eye checked by your doctor. Long-term use of Lotemax or other eye drops that contain steroids, may result in glaucoma or raised pressure in the eye, which can cause damage to the optic nerve, problems with vision, and cataracts.
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Long-term use of Lotemax or other eye drops that contain steroids, may lower your ability to fight infections and may increase your chance of getting an eye infection including herpes simplex. Using steroid eye drops like Lotemax may make viral diseases of the eye worse and last longer. Contact lenses Wearing contact lenses is not recommended after cataract surgery. If you normally wear contact lenses, your doctor will recommend you use glasses for a time following cataract surgery. This is to allow your eyes to recover from the procedure. Your doctor will advise you when you can use contact lenses again (see also "(Lotemax contains benzalkonium chloride"). Other medicines and Lotemax Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially, tell you doctor if you use:
- medicines known as anticholinergics (used to treat a variety of conditions, e.g. gastrointestinal cramps, muscular spasms, urge incontinence or asthma)
- eye drops for the treatment of high pressure in the eye. Some medicines may increase the effects of Lotemax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is possible that you may still receive Lotemax, but it is also possible that an alternative may be used. Lotemax should not be used when breast-feeding. Driving and using machines Eye drops can cause your vision to be blurred. This usually passes quickly. Do not drive or use machines until your vision is clear. Lotemax contains benzalkonium chloride This medicine contains 0.0152 mg benzalkonium chloride in each dosage unit (2 drops) which is equivalent to 0.20 mg/1 ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
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How to take it
Lotemax
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for adults and elderly is one to two drops four times daily. Treatment with Lotemax normally begins 24 hours after surgery and continues for two weeks.
Use in adults
- Shake Lotemax well before using.
- Look upwards and gently pull down the lower eyelid of the affected eye(s).
- Apply one to two drops of Lotemax into the gap between your eyeball and eyelid, four times a day or as directed by your doctor.
- Do not allow the tip of the dropper to touch any surface because this may contaminate the medicine.
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- The bottle should be closed immediately after use.
- Your doctor will tell you how long your treatment with Lotemax will last.
- Do not stop treatment without talking with your doctor. Use in children and adolescents Lotemax should not be used in children and adolescents until further data becomes available. If you use more Lotemax than you should Tell your doctor or a pharmacist. If you forget to use Lotemax Do not take a double dose to make up for a forgotten dose. Wait until the next dose and then continue as before. If you stop using Lotemax Always use this medicine exactly as your doctor has told you. Do not stop using Lotemax without speaking to your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following symptoms: redness, itching or swelling of the membrane covering the white part of the eye and/or eyelid(s) or general symptoms such as difficulty breathing, difficulty swallowing, flushing or redness of the face and swelling of the face or tongue you should stop using this medicine and seek immediate medical advice. These could be the signs of severe allergic reaction. •
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As you may need urgent medical treatment, you should also contact your doctor immediately if you notice any of the following side effects: Worsened pain in the eye, especially when exposed to bright light and redness in the eye whilst using this medicine. This may be a result of inflammation of the coloured part of the eye, called iritis – uncommon side effect (may affect up to 1 in 100 people). Lump or thickening in an area of the breast, change in the size, shape or feel of a breast, swelling or lump in your armpit or a change in the shape of your nipple. These may be symptoms of breast cancer, which is rare side effect (may affect up to 1 in 1,000 people). Involuntary muscle contraction (muscle twitching) – rare side effect (may affect up to 1 in 1,000 people). Nervousness – rare side effect (may affect up to 1 in 1,000 people). Noise (ringing) in the ears (tinnitus) – rare side effect (may affect up to 1 in 1,000 people). Chest pain – rare side effect (may affect up to 1 in 1,000 people).
The side effects listed below may also occur during treatment with this medicine: Common side effects (may affect up to 1 in 10 people):
- Effects in the eye: Corneal defect, eye discharge, ocular discomfort, dry eye, tearing, foreign body sensation in eyes, eye redness, ocular itching, burning sensation at the site of instillation and rise in intra-ocular pressure.
- General side effects: headache. Uncommon side effects (may affect up to 1 in 100 people):
- Effects in the eye: abnormal vision, conjunctiva swelling, conjunctivitis, eye irritation, eye pain, fine elevations on the conjunctiva, light sensitivity, ocular inflammation, inflammation of the cornea and conjunctiva, ocular infection and lens opacification.
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•
General side effects: fatigue, running nose and sore throat.
Rare side effects (may affect up to 1 in 1,000 people):
- General side effects: migraine, taste change, sensation of vertigo, numbness, chills, fever and pain, cough, urinary tract infection or inflammation, urticaria, rash, dry skin, eczema, diarrhoea, nausea and vomiting, weight gain. Not known: frequency cannot be estimated from the available data:
- Effects in the eye: blurred vision. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: United Kingdom Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland HPRA Pharmacovigilance Website: www.hpra.ie By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Lotemax
Keep this medicine out of the sight and reach of children. Store the container in an upright position. Do not store above 25oC. Do not freeze. Do not use this medicine after the expiry date which is stated on the carton and bottle after expiry. The expiry date refers to the last day of that month. Throw away any solution 28 days after opening. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.> DO NOT USE IF PROTECTIVE SEAL IS BROKEN
6.
Contents of the pack and other information
What Lotemax contains –
The active ingredient is Loteprednol Etabonate. Each ml contains 5 mg (0.5%) Loteprednol Etabonate. The other ingredients are Disodium Edetate, Glycerol, Povidone, Purified Water and Tyloxapol. Benzalkonium Chloride (0.01%) is added as a preservative. Sodium Hydroxide and/or Hydrochloric Acid are added to adjust the pH.
What Lotemax looks like and contents of the pack Lotemax is a milky-white eye-drops suspension. Lotemax is available in bottles containing 2.5 mL, 5 mL or 10 mL. Not all pack sizes may be marketed.
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Marketing Authorisation Holder IE: Dr. Gerhard Mann chem.-pharm. Fabrik GmbH Brunsbütteler Damm 165/173 13581 Berlin Germany UK: BAUSCH + LOMB IRELAND LIMITED 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24 PPT3 Ireland Manufacturer Dr. Gerhard Mann chem.-pharm. Fabrik GmbH Brunsbütteler Damm 165/173 13581 Berlin Germany Bausch Health Poland sp. z o.o. ul. Przemysłowa 2 35-959 Rzeszów Poland Bausch Health Poland sp. z. o. o. ul .Kosztowska 21 41-409 Mysłowice Poland BAUSCH + LOMB IRELAND LIMITED 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24 PPT3 Ireland
This leaflet was last revised in: August 2022
Other sources of information For any information about this medicine, please contact Bausch & Lomb, 106 London Road, Kingston-Upon-Thames, Surrey, KT2 6TN, UK. Lotemax is a registered trademark of Bausch & Lomb Incorporated or its affiliates. ©Bausch & Lomb Incorporated
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Frequently asked questions about Lotemax 0.5% w/v Eye Drops, Suspension
How do I take Lotemax 0.5% w/v Eye Drops, Suspension?
Lotemax 0.5% w/v Eye Drops, Suspension comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Lotemax 0.5% w/v Eye Drops, Suspension?
The active substance in Lotemax 0.5% w/v Eye Drops, Suspension is loteprednol etabonate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Lotemax 0.5% w/v Eye Drops, Suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Lotemax 0.5% w/v Eye Drops, Suspension without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: loteprednol etabonate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of post-operative inflammation following ocular surgery.
4.2. Posology and method of administration
Posology
Adults and elderly
One to two drops four times daily beginning 24 hours after surgery and continuing throughout the post-operative period.
The duration of treatment should not exceed 2 weeks.
Paediatric Population
Lotemax should not be used in the paediatric age group until further data become available.
Method of administration
Ocular use
Shake the bottle vigorously before using the eye drops.
This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. The bottle should be closed immediately after use.
4.3. Contraindications
Lotemax is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures; untreated purulent acute infections which, similar to other infectious diseases, can be masked and worsened by corticoids, 'red eye' with unknown diagnosis and infection caused by amoeba.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other corticosteroids.
4.4. Special warnings and precautions for use
Prolonged use of corticosteroids may result in ocular hypertension or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma.
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.
Prolonged use of corticosteroids may suppress the host response and may increase the possibility of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
Long term treating with corticosteroids can cause fungal disease. Fungal disease should be considered in the differential diagnosis when a corneal ulcer persists.
In general patients should not wear contact lenses after cataract surgery, unless contact lens wearing is medically indicated.
If signs and symptoms fail to improve after two days, the patient should be re-evaluated. If this product is used for 10 days or longer, intraocular pressure should be monitored.
Lotemax contains benzalkonium chloride
This medicinal product contains 0.0152 mg benzalkonium chloride in each dosage unit (2 drops) which is equivalent to 0.20 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should remove contact lenses before using this medicine and put them back 15minutes afterwards.
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Lotemax should be used with caution in dry eye patients and in patients where the cornea may be compromised.
Patients should be monitored in case of prolonged use.
4.5. Interaction with other medicinal products and other forms of interaction
Since loteprednol etabonate is not detected in plasma following the topical administration of Lotemax, it is not expected to affect the pharmacokinetics of systemically administered medicinal products. However, the low potential of ocular loteprednol etabonate eye drops to increase the intraocular pressure may be adversely affected by systemically administered medicinal products with anticholinergic activity. In patients receiving concomitant ocular hypotensive therapy, the addition of loteprednol etabonate may increase intraocular pressure and decrease the apparent ocular hypotensive effect of these medicinal products.
Concurrent administration of cycloplegics may increase the risk of raised intraocular pressure.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweights the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
4.6. Fertility, pregnancy and lactation
Pregnancy
For Lotemax no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown and Lotemax should not be used in pregnancy unless clearly necessary.
Breastfeeding
It is not known whether loteprednol etabonate is excreted in human milk. Excretion of loteprednol etabonate in breast milk has not been investigated in animal studies. Therefore, the use of loteprednol etabonate is contraindicated in lactating women.
Fertility
There are no clinical data concerning the loteprednol etabonate influence on the fertility in humans.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
If there are any transient effects on vision, the patient should be advised to wait until these subside before driving or operating machinery.
4.8. Undesirable effects
Reactions associated with ophthalmic steroids include elevated intraocular pressure in steroid responsive patients, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
Ocular adverse reactions occurring in patients treated with loteprednol etabonate ophthalmic suspension in clinical studies included the following:
All undesirable effects have been classified as follows very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), or very rare (<1/10,000), not known (cannot be estimated from the available data).
Eye disorders
Common:
Corneal defect, eye discharge, ocular discomfort, dry eye, epiphora, foreign body sensation in eyes, conjunctival hyperaemia and ocular itching.
Uncommon:
Abnormal vision, chemosis, keratoconjunctivitis, conjunctivitis, iritis, eye irritation, eye pain, conjunctival papillae, photophobia and uveitis.
Not known:
Vision blurred (see also section 4.4).
Some of these events were similar to the underlying ocular disease being studied
Non-ocular events possibly related to treatment occurring in patients included:
Infections and infestations
Uncommon:
Pharyngitis
Rare:
Urinary tract infection and urethritis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rare:
Breast neoplasm
Psychiatric disorders
Rare:
Nervousness
Nervous system disorders
Common:
Headache
Rare:
Migraine, taste perversion, dizziness, paresthesia
Ear and labyrinth disorders
Rare:
Tinnitus
Respiratory, thoracic and mediastinal disorders
Uncommon:
Rhinitis
Rare:
Cough
Gastrointestinal disorders
Rare:
Diarrhoea, nausea and vomiting
Skin and subcutaneous tissue disorders
Rare:
Face oedema, urticaria, rash, dry skin and eczema
Musculoskeletal and connective tissue disorders
Rare:
Twitching
General disorders and administration site conditions
Common:
Instillation site burning
Uncommon:
Asthenia
Rare:
Chest pain, chills, fever and pain
Investigations
Rare:
Weight gain
In a summation of controlled, randomised studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mmHg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No case of overdose has been reported. Acute overdosage is unlikely to occur via the ophthalmic route.
💬 Ask about this leaflet
Ask anything about Lotemax 0.5% w/v Eye Drops, Suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.