LOMIDE Eye drops, solution (2020)
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Περιεχόμενα
1. Name of the medicinal product
LOMIDE Lodoxamide trometamol 0.1% Eye Drops.
2. Qualitative and quantitative composition
Each mL of Lomide Eye Drops contains the active ingredient lodoxamide trometamol 0.178%w/v equivalent to lodoxamide 0.1%. <u>Excipient with known effect:</u> Benzalkonium chloride 0.007% as a preservative. ...
3. Pharmaceutical form
Sterile preserved eye drops, solution.
4.1. Therapeutic indications
Lomide Eye Drops 0.1% are indicated in the treatment of non-infectious allergic conjunctivitis (vernal conjunctivitis, giant papillary conjunctivitis and seasonal allergic conjunctivitis). The aetiologic ...
4.2. Posology and method of administration
Adults and children of 4 years and older One drop in each eye four times a day at regular intervals. Patients should be advised that the effect of therapy with Lomide Eye Drops is dependent upon its administration ...
4.3. Contraindications
Hypersensitivity to lodoxamide or any of the excipients listed under section 6.1.
4.4. Special warnings and precautions for use
Lomide Eye Drops are not for injection. Patients should be advised that effect of therapy with Lomide Eye Drops is dependent upon administration at regular intervals. The recommended frequency of administration ...
4.5. Interaction with other medicinal products and other forms of interaction
No specific drug interaction studies, either with ophthalmic or systemic medications, have been conducted. Limited concomitant medications, however, were permitted during the clinical studies and no interactions ...
4.6. Fertility, pregnancy and lactation
Pregnancy CATEGORY B1. Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect ...
4.7. Effects on ability to drive and use machines
Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving ...
4.8. Undesirable effects
During clinical studies of Lomide Eye Drops, the most frequently reported ocular adverse experiences were transient burning, stinging, or discomfort upon instillation, which occurred in 13% of patients. ...
4.9. Overdose
Due to the characteristics of this preparation, toxic effects are unlikely following an ocular overdose of this product. In the event of an ocular overdose, flush from the eye with lukewarm water. In case ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> ophthalmologicals; Antiallergics <b>ATC Code:</b> S01GX05 Mechanism of action Lodoxamide trometamol is a mast cell stabiliser that inhibits the in vivo Type-I, IgEmediated ...
5.2. Pharmacokinetic properties
The disposition of <sup>14</sup>C-lodoxamide was studied in six healthy adult volunteers receiving a 3 mg (50 μCi) oral dose of lodoxamide. Urinary excretion was the major route of elimination (83%). The ...
5.3. Preclinical safety data
Pregnancy Studies in animals have not shown evidence of an increased occurrence of fetal damage. Reproduction studies with lodoxamide trometamol administered orally to rats and rabbits in doses of 100 ...
6.1. List of excipients
Mannitol Hypromellose Sodium citrate dihydrate Citric acid monohydrate Tyloxapol Disodium edetate dihydrate Benzalkonium chloride Hydrochloric acid Sodium hydroxide Purified water
6.2. Incompatibilities
Unknown.
6.3. Shelf life
24 months.
6.4. Special precautions for storage
Store below 25°C. Do not freeze. Discard container 4 weeks after opening.
6.5. Nature and contents of container
10 mL or 5 mL DROP-TAINER bottle dispenser.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
Novartis New Zealand Limited, PO Box 99102, Newmarket, Auckland 1149, New Zealand
9. Date of first authorization / renewal of the authorization
25 July 1996
10. Date of revision of the text
30 June 2020
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