Maxidex 0.1%W/V Eye Drops Suspension
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MAXIDEX 0.1% w/v, eye drops, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexamethasone 0.1% w/v
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Eye drops, suspension
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye such as: anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, herpes zoster keratitis, superficial punctate keratitis and non-specific superficial keratitis.
Also indicated for the treatment of corneal injury from chemical, radiation or thermal burns or following penetration by foreign bodies. Indicated for postoperative use to reduce inflammatory reactions and suppress graft reaction.
4.2 Posology and method of administration
Adults, adolescents, and children (2 years of age and above)
The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the response to treatment.
Severe inflammations require one to two drops instilled into the eye every thirty to sixty minutes until a satisfactory response occurs.
Subconjunctival or systemic steroid therapy should be considered if there is no response. When a favourable response has been observed reduce the dosage towards one drop every four hours.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
Paediatric patients
The safety and efficacy of this product has not been established in children below 2 years of age.
4.3 Contraindications
• Vaccinia, varicella, or other viral diseases of cornea and conjunctiva (except herpes zoster keratitis)
• Herpes simplex keratitis
• Fungal diseases of ocular structures
• Mycobacterial ocular infections
• Acute, untreated bacterial infections
• Hypersensitivity to dexamethasone or to any of the excipients listed in section 6.1.
4.4 Special Warnings and Special Precautions for Use
• For ocular use only.
• Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity, visual field defects and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure and the lens should be checked routinely and frequently, particularly in patients with a history or presence of glaucoma. This is especially important in paediatric patients as the risk of corticosteroid-induced ocular hypertension may be greater in children and may occur earlier than in adults. The risk of corticosteroid-induced raised intraocular pressure and/or cataract formation is increased in predisposed patients (e.g. diabetes).
• Topical corticosteroids should not be used for longer than one week except under ophthalmic supervision, with regular checks of intraocular pressure.
• Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral and fungal infections and mask the clinical signs of infections. In such cases antibiotic therapy is mandatory. Fungal infection should be suspected in patients with persistent corneal ulceration and corticosteroids therapy should be discontinued if fungal infection occurs.
• Topical ophthalmic corticosteroids may slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. (See section 4.5).
• In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.
• Contact lens wear is not recommended during treatment of an ocular inflammation.
• Additionally, this product contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of MAXIDEX and wait at least 15 minutes before reinsertion.
• There is no evidence of safety in use in children under two years of age.
4.5 Interaction with Other Medicaments and Other Forms of Inter-action No interaction studies have been performed.
Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.
4.6 Pregnancy and Lactation
Pregnancy
There are no or limited amount of data from the use of MAXIDEX in pregnant woman. Studies in animals have shown reproductive toxicity (see section 5.3). Even though, the maximum daily dose (2x 30pl drops x 4 times per day = about 0.240 mg/day dexamethasone) following topical application is much lower than a standard systemic anti-inflammatory dose of about 0.5 to 10mg daily.
MAXIDEX is not recommended during pregnancy unless the clinical condition of the woman requires treatment with MAXIDEX.
Lactation
Systemically administered corticosteroids appear in human milk in quantities that could affect the child being breastfed. However, when instilled topically, systemic exposure is low. It is unknown whether MAXIDEX is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MAXIDEX therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
4.7 Effects on Ability to Drive and Use Machines
MAXIDEX has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.
4.8 Undesirable Effects
Summary of the safety profile
In clinical trials, the most common adverse reaction was ocular discomfort.
Tabulated list of adverse reactions
The following adverse reactions are classified according to the following convention: very common (> 1/10), common (> 1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and post-marketing experience with Maxidex.
|
System Organ Classification |
MedDRA Preferred Term (v. 12.0) |
|
Immune system disorders |
Not known: hypersensitivity |
|
Nervous system disorders |
Uncommon: dysgeusia Not known: dizziness, headache |
|
Eye disorders |
Common: ocular discomfort |
|
System Organ Classification |
MedDRA Preferred Term (v. 12.0) |
|
Uncommon: keratitis, conjunctivitis, keratoconjunctivitis sicca, corneal staining, photophobia, vision blurred, eye pruritus, foreign body sensation in eyes, lacrimation increased, abnormal sensation in eyes, eyelid margin crusting, eye irritation, ocular hyperaemia Not known: intraocular pressure increased, visual acuity reduced, corneal erosion, eyelid ptosis, eye pain, mydriasis |
Description of selected adverse reactions
Prolonged topical ophthalmic corticosteroids may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects, and to posterior subcapsular cataract formation (see section 4.4).
Due to the corticosteroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long treatments (see section 4.4).
Corticosteroids may reduce resistance to and aid in the establishment of infections (see section 4.4).
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
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 the national reporting system:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of the bottle (up to 10 mls) is unlikely to lead to any serious adverse effects. An ocular overdose of Maxidex can be flushed from the eye(s) with lukewarm water.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Ophthalmologicals: Anti-inflammatory Agents ATC Code S01B A01
Dexamethasone has been demonstrated by animal and human studies based on oral application to possess approximately six to seven times the potency of prednisolone and at least 30 times the potency of cortisone. The potency of the compound is accomplished by the addition of a methyl radical and a fluorine atom to the prednisolone radical.
5.2 Pharmacokinetic properties
Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. In plasma dexamethasone protein binding is less than for most other corticosteroids. Corticosteroids diffuse into tissue fluids and cerebrospinal fluid but transplacental diffusion in significant amounts has not been demonstrated. Corticosteroids are metabilised in the liver the kidney and excrete in the urine. Metabolism is similar to other corticosteroids. Intraocular penetration occurs in significant amounts and contributes to the effectiveness of dexamethasone in anterior segment inflammatory disease.
5.3 Preclinical Safety Data
Repeat dose topical ocular safety studies with dexamethasone in rabbits have shown systemic corticosteroid effects. Such effects are considered to be unlikely when MAXIDEX is used as recommended.
Dexamethasone was clastogenic in the in vitro human lymphocyte assay and in vivo in the mouse micronucleus assay at doses in excess of those obtained following topical application. Conventional carcinogenicity studies with MAXIDEX have not been performed.
Dexamethasone has been found to be teratogenic in animal models. Dexamethasone induced abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.
There are no other preclinical data of relevance to the prescriber which are additional to that included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium phosphate Polysorbate 80 Disodium edetate Sodium chloride Benzalkonium chloride Hypromellose Citric acid Purified water
6.2 Incompatibilities
None known
6.3 Shelf life
20 months (unopened), 1 month (after first opening).
6.4 Special precautions for storage
Do not store above 25°C.
Do not refrigerate or freeze Keep container tightly closed.
Discard 1 month after first opening. Store in the original package.
6.5 Nature and contents of container
Drop-Tainer - 5ml and 10ml Natural Low Density Polyethylene Bottles and Plugs.
Polystyrene or Polypropylene cap.
6.6 Special precautions for disposal
Do not touch dropper tip to any surface as this may contaminate the contents.
If the drop of medication is not retained in the eye upon dosing for any reason then instill another drop.
7 MARKETING AUTHORISATION HOLDER
Alcon Laboratories (UK) Ltd.
Frimley Business Park,
Frimley, Camberley,
Surrey, GU16 7SR United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 0649/5914R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/09/1990 / 17/09/2003 22/02/2015