-
Therapeutic Category
- OTHER OPHTHALMOLOGICAL DRUGS
- OPHTHALMOLOGICAL DRUGS
- Pharmaceutical Form : Eye Gel
- Composition : Each 1 gram of ophthalmic gel contains: 2 mg carbomer (polyacrylic acid)
- Active Substance : carbomer
PHARMACODYNAMIC PROPERTIES:
The retention time of carbomer Liquid Gel was approximately 16 minutes compared with approximately 2 minutes for the conventional artificial tears eye drops depending on polyvinyl alcohol.
PHARMACOKINETIC PROPERTIES:
There are no controlled animal or human pharmacokinetic studies available. However, absorption or accumulation in eye tissues can presumably be excluded due to the high molecular weight of polyacrylic acid.
INDICATIONS:
Substitute of tear fluid for management of dry eye conditions including keratoconjunctivitis, and for unstable tear film.
CONTRAINDICATIONS:
Patients with known hypersensitivity to carbomer (polyacrylic acid) or to any of the excipients.
WARNINGS AND PRECAUTIONS:
For ocular use only.
If patients experience eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists, they are to discontinue use and consult their doctor.
carbomer Liquid Gel contains cetrimide which may cause eye irritation and is known to discolor soft contact lenses. Avoid contact with soft contact lenses.
Patients must be instructed to remove contact lenses prior to application of this product. After instillation there should be an interval of at least 15 minutes before reinsertion.
The tip of the container should not come into contact with any surface including the eye, as this may cause injury to the eye and contaminate the gel.
PREGNANCY:
No effects during pregnancy are anticipated
NURSING MOTHERS:
It is unknown whether carbomer or any of the components are excreted in human milk.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
carbomer Liquid Gel has no or negligible influence on the ability to drive and use machines.
carbomer Liquid Gel may temporarily influence the visual acuity. Patients with blurred vision driving a vehicle or operating machines should be alerted to the possibility of impaired reactions.
The patient must wait until the vision clears before driving or using machinery.
UNDESIRABLE EFFECTS:
Very common: vision blurred
Common: ocular discomfort, eyelid margin crusting, eye irritation
DOSAGE AND ADMINISTRATION:
The tip of the container should not come into contact with any surface including the eye, as this may cause injury to the eye and contaminate the gel.
Adults: 1 drop 3 – 4 times daily or as required, depending upon the severity of the disease
Elderly: No dosage amendment is necessary in the elderly
Children and adolescents aged to 18 years: No enough data about for children and adolescents.
OVERDOSE:
Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product.
STORAGE CONDITIONS: Do not store above 25°C
Do not use the drops for longer than 28-days after first opening the tube
PACKAGING: 5-10 g