Welcome to our comprehensive guide on FML Liquifilm Ophthalmic, an effective medication used for the treatment of corticosteroid-responsive inflammation in the eyes. In this article, we will provide detailed information about the active ingredient, qualitative and quantitative composition, therapeutic indications, posology, contraindications, special warnings and precautions, undesirable effects, pharmacological properties, and more. Whether you are a healthcare professional or a patient seeking information about FML Liquifilm Ophthalmic, this guide aims to provide you with the necessary knowledge to understand and utilize this medication effectively.
1. Active Ingredient and Company
FML Liquifilm Ophthalmic contains the active ingredient fluorometholone. It is manufactured by AbbVie Ltd, a renowned pharmaceutical company known for its commitment to producing high-quality medications.
2. Qualitative and Quantitative Composition
Each milliliter of FML Liquifilm Ophthalmic eye drops suspension contains 1 mg of Fluorometholone. It also contains excipients such as benzalkonium chloride, disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, and other phosphate buffers. For a complete list of excipients, please refer to section 6.1 of the product information.
3. Pharmaceutical Form
FML Liquifilm Ophthalmic is available as eye drops in suspension form. The suspension is a white, microfine liquid that is easy to administer.
4. Therapeutic Indications
FML Liquifilm Ophthalmic is primarily used for the treatment of corticosteroid-responsive inflammation in various parts of the eye, including the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. It effectively reduces inflammation and provides relief from associated symptoms.
5. Posology and Method of Administration
FML Liquifilm Ophthalmic is intended for topical ophthalmic use only. It should be applied as drops into the conjunctival sac. Before use, it is important to shake the bottle well to ensure proper suspension of the medication. The recommended posology is to instill 1-2 drops into the conjunctival sac 2-4 times daily. During the first 24 to 48 hours of treatment, the dose may be safely increased to 2 drops at one-hour intervals. It is crucial not to withdraw the treatment too early, especially in chronic conditions. In such cases, the withdrawal of treatment should be carried out by gradually decreasing the frequency of applications. It is important to note that the safety and efficacy of FML Liquifilm Ophthalmic in children aged 2 years or less have not been established.
FML Liquifilm Ophthalmic is contraindicated in individuals with hypersensitivity to the active substance (fluorometholone) or any of the excipients listed in section 6.1 of the product information. It should not be used in cases of most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial and untreated bacterial infection of the eye, fungal diseases of ocular structures, and undiagnosed "red eye" that may indicate a viral infection.
7. Special Warnings and Precautions for Use
When using FML Liquifilm Ophthalmic, it is important to consider the following warnings and precautions:
- Eye drops containing corticosteroids should not be used for longer than a week, except under the careful surveillance of an eye specialist combined with regular measurement of intraocular pressure.
- Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP), which can lead to glaucoma, optic nerve damage, visual acuity defects, fields of vision defects, posterior subcapsular cataract formation, and delayed wound healing.
- Prolonged use may also suppress the host immune response, increasing the risk of secondary ocular infections.
- Steroids should be used with caution in the presence of glaucoma, and intraocular pressure should be checked frequently.
- Acute untreated eye infections may be masked or exacerbated by the presence of steroid medication.
- The use of FML Liquifilm Ophthalmic with other ocular medications should be administered 5 minutes prior to its installation.
- Visual disturbances may occur with systemic and topical corticosteroid use. If a patient experiences symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist for evaluation.
- Care should be taken to avoid touching the applicator tip to the eye or any other surface to prevent eye injury or contamination.
- FML Liquifilm Ophthalmic contains benzalkonium chloride, which may cause eye irritation and discoloration of soft contact lenses. Contact with soft contact lenses should be avoided, and lenses should be removed before using FML Liquifilm Ophthalmic and reinserted after at least 15 minutes.
8. Interaction with Other Medicinal Products and Other Forms of Interaction
No interaction studies have been performed with FML Liquifilm Ophthalmic. However, 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 outweighs the increased risk of systemic corticosteroid side effects. In such cases, patients should be monitored for systemic corticosteroid side effects.
9. Fertility, Pregnancy, and Lactation
The use of FML Liquifilm Ophthalmic during pregnancy is not recommended due to limited data on its use in pregnant women. Animal studies have shown reproductive toxicity. It is unknown whether fluorometholone/metabolites are excreted in human milk; therefore, FML Liquifilm Ophthalmic should not be used during breastfeeding.
10. Undesirable Effects
The following undesirable effects have been reported with the use of FML Liquifilm Ophthalmic:
- Very common (≥1/10): Intraocular pressure increased.
- Common (≥1/100 to <1/10): Eye irritation, conjunctival/ocular hyperemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid edema, eyelid ptosis, blurred vision, eye discharge, eye pruritus, increased lacrimation, eye edema/eye swelling, mydriasis, cataract (including subcapsular), ulcerative keratitis, ocular infection (including bacterial, fungal, and viral infections), visual field defect, punctate keratitis.
- Uncommon (≥1/1000 to <1/100): Dysgeusia (abnormal taste sensation).
- Not known (frequency cannot be estimated from the available data): Hypersensitivity reactions.
It is important to note that systemic effects are extremely uncommon with topical steroids, but rare occurrences of systemic hypercorticoidism have been reported.
11. Pharmacological Properties
FML Liquifilm Ophthalmic belongs to the pharmacotherapeutic group of corticosteroids, plain. It is a synthetic corticosteroid (glucocorticoid) and a derivative of desoxyprednisolone. Fluorometholone binds to cytoplasmic receptors and controls the synthesis of infection mediators, thereby reducing inflammatory reactions such as swelling, fibrin deposition, capillary dilation, and phagocyte migration. It also inhibits capillary proliferation, collagen deposition, and scarring. Compared to other corticosteroids, fluorometholone has a lower tendency to increase intraocular pressure.
12. Pharmaceutical Particulars
FML Liquifilm Ophthalmic is presented in a bottle and comes with an applicator tip made of low-density polyethylene (LDPE). The screw cap is made of polystyrene (MIPS). The available pack sizes are 5 ml and 10 ml of suspension. The shelf life of unopened bottles is 36 months, and the product should be discarded 28 days after first opening. It should be stored below 25°C and should not be frozen.
FML Liquifilm Ophthalmic is a valuable medication for the treatment of corticosteroid-responsive inflammation in the eyes. With its active ingredient, fluorometholone, it effectively reduces inflammation and provides relief from associated symptoms. However, it is important to follow the posology, contraindications, and special warnings and precautions to ensure safe and effective use. Whether you are a healthcare professional or a patient, this comprehensive guide aims to provide you with the necessary information about FML Liquifilm Ophthalmic. Always consult a healthcare professional for personalized advice and guidance regarding your specific condition and treatment options.
*Please note that this article is for informational purposes only and should not replace professional medical advice.