Flurbiprofen Eye Drops IP 0.03 % w/v
COMPOSITION
Each ml contains:
Flurbiprofen Sodium IP 3 mg
Hypromellose BP 0.25 % w/v
Phenylmercuric Nitrate BP 0.002 % w/v
(as preservative)
Water for Injections BP q.s.
A clear, colorless to slightly yellow colored solution.
PHARMACODYNAMIC
Pharmacotherapeutic group: Anti-inflammatory agents, non-steroids.
ATC code: S01BC04
Flurbiprofen sodium is a non-steroidal anti-inflammatory agent which inhibits prostaglandin synthesis by inhibition of the cyclo-oxygenase enzyme.
Ophthalmic surgery causes prostaglandin release, with the effect that prostaglandin- mediated miosis may occur.
Treatment with Flurbiprofen sodium prior to surgery has been shown to inhibit intra-operative miosis and it is believed that this is brought about by inhibition of ocular prostaglandin release.
The sympathetic nervous system is not affected by this mechanism and acetylcholine- induced miosis has not been found to be inhibited in clinical trials.
Prostaglandins have also been shown to be mediators of certain kinds of intraocular inflammatory processes. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humour barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.
PHARMACOKINETICS
Flurbiprofen concentrations of 213 ng/ml in aqueous humor have been reported following half hourly treatment for two hours preceding surgery.
THERAPEUTIC INDICATION
The inhibition of intraoperative miosis. Flurbiprofen does not have intrinsic mydriatic properties and does not replace mydriatic agents.
The management of post-operative and post-laser trabeculoplasty inflammation in the anterior segment of the eye in patients in whom steroid therapy is not recommended.
DOSAGE AND ADMINISTRATION
Adult dosage:
For the inhibition of intraoperative miosis, 1 drop is instilled every half hour starting 2 hours before surgery. The final drop should be given not less than 30 minutes before surgery.
To control post-operative and post-laser trabeculoplasty inflammation the dosing regimen above should be followed. Beginning twenty-four hours after surgery, one drop is administered four times daily for at least one week after laser trabeculoplasty or for two to three weeks after other surgery.
Pediatric population:
The safety and efficacy of Flurbiprofen in children has not been established.
Elderly population:
There is no specific advice for the elderly.
Method of administration:
Flurbiprofen is administered topically by instillation into the conjunctival sac.
In accordance with standard practice, other topical medication should not be co-administered with Flurbiprofen. When administering other topical medications, a minimum interval of 5 minutes between instillations is recommended.
INSTRUCTION FOR USE
Apply FLURBIN Eye Drops in the following way:
- Wash your hands. Tilt your head back and look at the ceiling.
- Gently pull the lower eyelid down until there is a small pocket.
- Turn the bottle upside down and gently press the bottle to release drops into eyes that needs treatment.
- Let go of the lower lid, and close your eye for 30 seconds.
- To avoid contamination, do not let the tip of dropper touch your eye or anything else.
- Replace and tighten the cap straight after use.
OVERDOSE
A topical overdose of this eye drop may be rinsed out from the eye(s) with lukewarm tap water. Due to the characteristics of this preparation, no toxic effects are to be expected.
CONTRAINDICATION
- Hypersensitivity to the active substance or to any of the excipients.
- Flurbiprofen is contra-indicated in epithelial herpes simplex keratitis (dendritic keratitis).
- The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Flurbiprofen is contra-indicated in individuals who have previously exhibited sensitivities to these drugs.
- With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thrombocyte aggregation. The use of Flurbiprofen is contraindicated in patients with known hemostatic defects or who are receiving other medications which may prolong bleeding time. Flurbiprofen is contraindicated for intraocular use during surgical procedures.
- As with all Non-Steroidal Anti-inflammatory drugs, Flurbiprofen is contraindicated in the third trimester of pregnancy.
WARNING AND PRECAUTIONS
- It is not for injection.
- Do not use the eye drop with contact lenses.
- Wound healing may be delayed with the use of Flurbiprofen.
- There have been reports that Flurbiprofen may cause an increased bleeding tendency of ocular tissues in conjunction with surgery.
- Safety and effectiveness in infants below the age of one year have not been established.
- Patients with a history of herpes simplex keratitis should be monitored closely.
PREGNANCY AND LACTATION
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, Flurbiprofen Sodium should not be given unless clearly necessary.
If Flurbiprofen Sodium is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
- inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, Flurbiprofen Sodium is contraindicated during the third trimester of pregnancy.
Breast-feeding:
In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.
It is unknown whether Flurbiprofen/metabolites are excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Flurbiprofen therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
DRUG INTERACTION
Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in some surgical patients treated with Flurbiprofen.
ADVERSE EFFECTS
Eye disorders:
Very common: Eye irritation, eye pain, Hyphema
Additionally, the following adverse reactions have been identified during post marketing experience.
Not known: eye haemorrhage, mydriasis (prolonged mydriasis), ocular hyperaemia.
PRESENTATION
FLURBIN Eye Drops are supplied in 5 ml sterilized opaque plastic container with nozzle and cap
STORAGE AND OTHER INFORMATION
Store at temperature below 30 °C. Keep this medicine out of the sight and reach of children. Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate the solution. Use the solution within one month after opening the container.
