COMPOSITION
Each ml contains:
Sodium Cromoglicate BP 2.0 % w/v
Benzalkonium Chloride BP 0.02 % w/v (as preservative)
Water for Injections BP q.s.
A clear, colorless to almost colorless solution.
PHARMACODYNAMIC
Pharmacotherapeutic group: Ophthalmologicals; Other antiallergics
ATC code: S01GX01
The solution exerts its effect locally in the eye.
In vitro and in vivo animal studies have shown that sodium cromoglicate inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Sodium cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators from the mast cell.
Sodium cromoglicate has demonstrated the activity in vitro to inhibit the degranulation of non-sensitized rat mast cells by phospholipase A and subsequent release of chemical mediators. Sodium cromoglicate did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.
Sodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.
PHARMACOKINETICS
Sodium cromoglicate is poorly absorbed. When multiple doses of sodium cromoglicate ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of sodium cromoglicate is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the sodium cromoglicate does penetrate into the aqueous humour and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.
In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of sodium cromoglicate is absorbed following administration to the eye.
THERAPEUTIC INDICATION
For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal keratoconjunctivitis.
DOSAGE AND ADMINISTRATION
Ocular use
Adults and Children:
One or two drops to be administered into each eye four times daily or as indicated by the doctor.
Elderly
There is no evidence to suggest that dosage alteration is required for elderly patients.
INSTRUCTION FOR USE
Apply CROME 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
Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.
CONTRAINDICATION
Hypersensitivity to the active substance or to any of the excipients.
WARNING AND PRECAUTIONS
- Discard any remaining contents four weeks after opening the bottle.
- This medicine contains Benzalkonium Chloride
- As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period.
- From the limited data available, there is no difference in the adverse event profile in children compared to adults.
- Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children.
- Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. 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
PREGNANCY, LACTATION, FERTILITY AND EFFECTS ON ABILITY TO DRIVE
Fertility:
It is not known whether sodium cromoglicate has any effect on fertility.
Pregnancy:
As with all medication, caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. It should be used in pregnancy only where there is a clear need.
Lactation:
It is not known whether sodium cromoglicate is excreted in human breast milk but, on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest the use of sodium cromoglicate has any undesirable effects on the baby.
Effects on ability to drive or use machine:
Sodium cromoglicate has a minor influence on the ability to drive and use machines.
As with all eye drops, instillation of these eye drops may cause a transient blurring of vision. Patients are advised not to drive or operate machinery if affected, until their vision returns to normal.
DRUG INTERACTION
No interaction studies have been performed.
ADVERSE EFFECTS
Eye disorders
Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported rarely.
PRESENTATION
CROME Eye Drops are supplied in 5 ml sterilized opaque white bottle 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.